Pages 1970 to 2058 include ARC 1666B to ARC 1712B

Notice, Inactive status; use of titles; continuing
education, 5.2(2), 5.6, 5.8, 10.3(4), 10.6(1),
12.1, 19.2(4), 19.3(4) ARC 1666B 1970

Schedule for rule making 1960

Publication procedures 1961

Administrative rules on CD–ROM 1961

Agency identification numbers 1968

Notice, Reciprocal registration in lieu of specific
requirement of intern development program,
2.2(2) ARC 1692B 1972

CITATION OF ADMINISTRATIVE RULES 1967

Notice 1972

Notice, Substitute authorization, 14.143
ARC 1667B 1973

Notice, Interim rulings on petitions for waivers
or variances, 1.4 ARC 1696B 1974

Notice, Requirements for a licensee requesting
additional examination, 4.3 ARC 1697B 1974

Notice—Interim matrix confinement feeding
operations 1974

Notice, Fugitive emissions of air pollutants
not listed in Clean Air Act, 22.100
ARC 1710B 1975

Notice, Compensation for damages to natural
resources, 133.2, 133.6 ARC 1711B 1975

Filed, Permits required for new or existing
stationary sources, 22.1 ARC 1705B 2053

Filed, Title V—insignificant activities,
22.100, 22.103 ARC 1707B 2053

Filed, Drinking water and wastewater revolving
loan funds, amendments to chs 44, 92, 93
ARC 1709B 2054

Filed, Water quality; effluent and pretreatment,
61.2, 61.3(3), 62.8(2) ARC 1706B 2054

Filed, Definition of adjacent—determining when
two or more open feedlots must obtain an
operating permit, 65.1 ARC 1704B 2056

Filed, Recycling operations; citizens convenience
centers and transfer stations, 104.21 to 104.24,
ch 106 ARC 1712B 2056

Notice, Trust to be considered a political
committee based on financial filing
threshold, 4.47(3) ARC 1701B 1978

Notice, Political business cards—removal of
words “paid for by,” 4.74(2) ARC 1700B 1978

Notice, Board notification of candidates for
statewide office—filing of personal financial
statement, 11.1(2) ARC 1699B 1979

Notice, Procedure for determining persons
required to file with the board—distribution of
forms, 11.2 ARC 1702B 1979

Notice, Medicaid certification and inpatient
reimbursement criteria for hospital special
units, 79.1(5) ARC 1687B 1980

Notice, Replacement of life insurance and
annuities, rescind ch 16, division I
ARC 1698B 1981

Notice, Restitution for pollution causing injury
to wild animals, ch 113 ARC 1708B 1982

Notice, Eligibility of claim—payment of
one–time reinstatement fee, 11.2(1)“c”
ARC 1695B 1984

Notice, Purpose and organization, ch 1
ARC 1683B 1984

Notice, Pharmacist licenses, rescind chs 2, 5;
adopt ch 2 ARC 1676B 1986

Notice, Pharmacy technicians, ch 3
ARC 1684B 1990

Notice, Pharmacist–intern registration and
minimum standards for evaluating practical
experience, 4.1 to 4.3, 4.5 to 4.9, 4.11
ARC 1685B 1992

Notice, General pharmacy practice, ch 6
ARC 1675B 1995

Notice, Hospital pharmacy practice, ch 7
ARC 1672B 1999

Notice, Universal practice standards, ch 8
ARC 1673B 2002

Notice, Controlled substances, rescind chs 10,
18; adopt ch 10 ARC 1674B 2010

Notice, Drugs in emergency medical service
programs, 11.1, 11.2(1), 11.3 to 11.7
ARC 1686B 2020

Notice, Code of professional responsibility
for board investigators, rescind ch 13
ARC 1681B 2022

Notice, Correctional facility pharmacy practice,
ch 15 ARC 1682B 2022

Notice, Nuclear pharmacy practice, ch 16
ARC 1670B 2025

Notice, Wholesale drug licenses, ch 17
ARC 1671B 2027

Notice, Nonresident pharmacy practice, ch 19
ARC 1679B 2031

Notice, Electronic data in pharmacy practice,
ch 21 ARC 1680B 2032

Notice, Unit dose, alternative packaging, and
emergency boxes, ch 22 ARC 1677B 2034

Notice, Long–term care pharmacy practice,
ch 23 ARC 1678B 2039

Notice, Physical therapy examiners, ch 200;
201.5(2) ARC 1689B 2043

Notice, Occupational therapy examiners,
ch 205 ARC 1690B 2044

Notice, Psychologists, 240.1 to 240.15
ARC 1693B 2046

Notice, Social workers, ch 279; 280.1 to 280.11;
281.3(2) ARC 1688B 2047

Filed, Social workers—report of mandatory
training on identifying and reporting child
abuse or dependent adult abuse, 280.1, 280.8
ARC 1691B 2057

Summarized list 1962

Public notice 2049

Notice, Annual audit reports; functions performed
by a veterinary assistant on facility grounds;
linked machines, amendments to chs 1, 2, 4,
5, 7, 9 to 11 ARC 1669B 2049

Filed, Definition of “steward”; initiation by
steward of suspension of occupational license;
gambling games of chance with prizes awarded
through promotional activities, 4.2, 4.6, 7.5(2),
11.5(4) ARC 1668B 2057

Filed, Personnel administration, amendments to
ch 3 ARC 1694B 2058

Notice Terminated, Ratemaking principles
proceeding, ch 41 ARC 1703B 2051

PUBLISHED UNDER AUTHORITY OF IOWA CODE SECTIONS 2B.5 AND 17A.6

__________________________________

The Iowa Administrative Bulletin is published biweekly in pamphlet form pursuant to Iowa Code chapters 2B and 17A and contains Notices of Intended Action on rules, Filed and Filed Emergency rules by state agencies.

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441 IAC 79 (Chapter)

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date), (page number), (ARC number).

IAB Vol. XII, No. 23 (5/16/90) p. 2050, ARC 872A

Due to reorganization of state government by 1986 Iowa Acts, chapter 1245, it was necessary to revise the agency identification numbering system, i.e., the bracketed number following the agency name.

“Umbrella” agencies and elected officials are set out below at the left–hand margin in CAPITAL letters.

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The following list will be updated as changes occur:

AGRICULTURE AND LAND STEWARDSHIP DEPARTMENT[21]

Agricultural Development Authority[25]

Soil Conservation Division[27]

ATTORNEY GENERAL[61]

AUDITOR OF STATE[81]

CITIZENS’ AIDE[141]

CIVIL RIGHTS COMMISSION[161]

COMMERCE DEPARTMENT[181]

Alcoholic Beverages Division[185]

Banking Division[187]

Credit Union Division[189]

Insurance Division[191]

Professional Licensing and Regulation Division[193]

Accountancy Examining Board[193A]

Architectural Examining Board[193B]

Engineering and Land Surveying Examining Board[193C]

Landscape Architectural Examining Board[193D]

Real Estate Commission[193E]

Real Estate Appraiser Examining Board[193F]

Savings and Loan Division[197]

Utilities Division[199]

CORRECTIONS DEPARTMENT[201]

Parole Board[205]

CULTURAL AFFAIRS DEPARTMENT[221]

Arts Division[222]

Historical Division[223]

ECONOMIC DEVELOPMENT, IOWA DEPARTMENT OF[261]

City Development Board[263]

Iowa Finance Authority[265]

EDUCATION DEPARTMENT[281]

Educational Examiners Board[282]

College Student Aid Commission[283]

Higher Education Loan Authority[284]

Iowa Advance Funding Authority[285]

Libraries and Information Services Division[286]

Public Broadcasting Division[288]

School Budget Review Committee[289]

ELDER AFFAIRS DEPARTMENT[321]

EXECUTIVE COUNCIL[361]

GENERAL SERVICES DEPARTMENT[401]

HUMAN RIGHTS DEPARTMENT[421]

Community Action Agencies Division[427]

Criminal and Juvenile Justice Planning Division[428]

Deaf Services Division[429]

Persons With Disabilities Division[431]

Latino Affairs Division[433]

Status of African–Americans, Division on the[434]

Status of Women Division[435]

HUMAN SERVICES DEPARTMENT[441]

INFORMATION TECHNOLOGY DEPARTMENT[471]

INSPECTIONS AND APPEALS DEPARTMENT[481]

Employment Appeal Board[486]

Foster Care Review Board[489]

Racing and Gaming Commission[491]

State Public Defender[493]

LAW ENFORCEMENT ACADEMY[501]

MANAGEMENT DEPARTMENT[541]

Appeal Board, State[543]

City Finance Committee[545]

County Finance Committee[547]

NATURAL RESOURCES DEPARTMENT[561]

Energy and Geological Resources Division[565]

Environmental Protection Commission[567]

Natural Resource Commission[571]

Preserves, State Advisory Board for[575]

PERSONNEL DEPARTMENT[581]

PUBLIC DEFENSE DEPARTMENT[601]

Emergency Management Division[605]

Military Division[611]

PUBLIC EMPLOYMENT RELATIONS BOARD[621]

PUBLIC HEALTH DEPARTMENT[641]

Substance Abuse Commission[643]

Professional Licensure Division[645]

Dental Examiners Board[650]

Medical Examiners Board[653]

Nursing Board[655]

Pharmacy Examiners Board[657]

PUBLIC SAFETY DEPARTMENT[661]

REGENTS BOARD[681]

Archaeologist[685]

REVENUE AND FINANCE DEPARTMENT[701]

Lottery Division[705]

SECRETARY OF STATE[721]

TRANSPORTATION DEPARTMENT[761]

Railway Finance Authority[765]

TREASURER OF STATE[781]

WORKFORCE DEVELOPMENT DEPARTMENT[871]

Labor Services Division[875]

Workers’ Compensation Division[876]

Workforce Development Board and
Workforce Development Center Administration Division[877]

Pursuant to the authority of Iowa Code section 542C.3, the Accountancy Examining Board hereby gives Notice of Intended Action to amend Chapter 5, “Renewal of Certificates and Licenses,” Chapter 10, “Continuing Education,” Chapter 12, “Fees,” and Chapter 19, “Transition Rules,” Iowa Administrative Code.

The Board recently rescinded Chapters 1 to 19 and adopted new Chapters 1 to 19 to implement the Iowa Accountancy Act of 2001, 2001 Iowa Acts, chapter 55. During the public comment period, concerns were raised by the Iowa Society of Certified Public Accountants and several of its members relating to the Board’s decision not to adopt a rule exempting from continuing education certain persons holding certificates as certified public accountants. The Board appointed a special Task Force to study this issue, including public and professional members of the Board, representatives of the Iowa Society of Certified Public Accountants, the Iowa Society of Accounting Practitioners, the Accountants Association of Iowa, and the American Business and Industry Association, and individual members of the profession.

The Task Force met on May 15, 2002, and recommended that the Board: (1) create a process for certificate and license holders to register in inactive status; (2) clarify that persons on inactive status may not practice public accounting or use restricted titles, such as “CPA” and “LPA” (with or without additional designations such as “inactive”); (3) authorize the use of the titles “CPA, retired” and “LPA, retired” undercertain conditions for persons registered in inactive statuswho are retired from gainful employment or disabled; and(4) modify the continuing education requirements following reinstatement to active status to phase in the hours required at future renewal dates.

The following amendments, as approved by the Board, memorialize the Task Force recommendations. The amendments create a process under which a person holding a lapsed or inactive certificate or license may register in inactive status; define the eligibility requirements for inactive status; describe practices which are permitted or prohibited while on inactive status; provide for the reinstatement of an inactive certificate or license to active status upon certain conditions (including fulfillment of continuing education); authorize the use of certain titles for retired or disabled practitioners; and establish a fee for renewal of inactive certificates and licenses. Additionally, to avoid confusion, all references to “effective” status in the rules are changed to “active” status. This compromise solution is consistent with the goals the Board wished to preserve, while accommodating the practitioner’s desire to have the opportunity to register in inactive status as an alternative to allowing a certificate or license to lapse.

These amendments are subject to waiver or variance pursuant to 193—Chapter 5.

Consideration will be given to all written suggestions or comments on the proposed amendments received on orbefore July 2, 2002. Comments should be addressed to Glenda Loving, Professional Licensing and Regulation Division, 1918 S.E. Hulsizer, Ankeny, Iowa 50021, or faxed to (515)281–7411. E–mail may be sent to glenda.loving@ comm7.state.ia.us.

Requests for oral presentation regarding these amendments must be submitted in writing to the address above and be received by July 2, 2002.

These amendments are intended to implement 2001 Iowa Acts, chapter 55.

The following amendments are proposed.

ITEM 1. Amend subrule 5.2(2) as follows:

5.2(2) An applicant who wishes to restore a certificate or license to effective active status must meet the basic requirement of 120 hours of continuing education earned in the preceding three–year period prior to the date of application to restore effective active status. The hours claimed to restore effective active status cannot again be used at the next renewal. At the first biennial renewal date of July 1 that is less than 12 months from the date of filing the application to restore the certificate or license to active status, the certificate or license holder shall not be required to report continuing education. At the biennial renewal date of July 1 which is more than 12 months, but less than 24 months, from the date of filing the application to restore the certificate or licenseto active status, the certificate or license holder shall report 40 hours of previously unreported continuing education earned in the one–year period ending December 31 prior to the July 1 renewal date. At the biennial renewal date of July 1 which is more than 24 months, but less than 36 months, from the date of filing the application to restore the certificate or license to active status, the certificate or license holder shall report 80 hours of continuing education earned in the two–year period ending December 31 prior to the July 1 renewal date.

ITEM 2. Amend rule 193A—5.6(272C,79GA,ch55), last sentence, as follows:

A lapsed certificate or license may be reinstated to effective active status at any time pursuant to 193A—subrule 5.2(2).

ITEM 3. Adopt new rule 193A—5.8(272C,79GA,ch55) as follows:

5.8(1) General purpose. This rule establishes a procedure under which a person issued a certificate as a certified public accountant or a license as a licensed public accountant may apply to the board to register in inactive status. Registration under this rule is available to a certificate or license holder residing within or outside the state of Iowa who is not engaged in Iowa in any practice for which a certificate or license is required. A person eligible to register as inactive may, as an alternative to such registration, allow the person’s certificate or license to lapse. The board will continue to maintain a data base on persons registered as inactive, including information which is not routinely maintained after a certificate or license has lapsed through failure to renew. A person who registers as inactive will accordingly receive renewal applications, board newsletters and other mass communications from the board.

5.8(2) Eligibility. A person holding a lapsed or active certificate or license which has not been revoked or suspended may apply on forms provided by the board to register as inactive if the person is not engaged in the state of Iowa in any practices for which a certificate or license is required, including:

a. Supervising or performing any attest services, such as audits, reviews or agreed–upon procedures (which may only be performed by a CPA within a CPA firm which holds a permit to practice);

b. Supervising or performing compilation services or otherwise issuing compilation reports (which may only be performed by a CPA or LPA); and

c. Performing any accounting, tax, consulting, or financial or managerial advisory services for any client, business, employer, government body, or other entity while holding oneself out as a CPA or LPA, or otherwise using titles restricted in 2001 Iowa Acts, chapter 55, section 13.

5.8(3) Affirmation. The application form shall contain a statement in which the applicant affirms that the applicant will not engage in any of the practices listed in subrule 5.8(2) in Iowa without first complying with all rules governing reinstatement to active status. A person in inactive status may reinstate to active status at any time pursuant to subrule 5.8(7).

5.8(4) Renewal. A person registered as inactive may renew the person’s certificate or license on the biennial schedule described in 193A—5.1(79GA,ch55). Such person is exempt from the continuing education requirements and will be charged a reduced renewal fee as provided in 193A— 12.1(79GA,ch55). An inactive certificate or license shall lapse if not timely renewed.

5.8(5) Permitted practices. A person may, while registered as inactive, perform for a client, business, employer, government body, or other entity those accounting, tax, consulting, or financial or managerial advisory services which may lawfully be performed by a person to whom a certificate or license has never been issued as long as the person does not in connection with such services use the title “CPA” or “LPA,” or any other title restricted for use only by CPAs or LPAs in 2001 Iowa Acts, chapter 55, section 13 (with or without additional designations such as “inactive”). Restricted titles may only be used by active CPAs or LPAs who are subject to continuing education requirements to ensure that the use of such titles is consistently associated with the maintenance of competency through continuing education.

5.8(6) Prohibited practices. A person who, while registered as inactive, engages in any of the practices described in subrule 5.8(2) or violates any provision of rule 193A— 14.2(79GA,ch55) is subject to disciplinary action. A person in inactive status is not authorized to verify the experience of an applicant for a CPA certificate under 2001 Iowa Acts, chapter 55, section 5(12) or an applicant for an LPA license under 2001 Iowa Acts, chapter 55, section 8(8).

5.8(7) Reinstatement. A person registered as inactive shall, prior to engaging in any of the practices listed in subrule 5.8(2) in Iowa, satisfy the conditions for reinstatement described in 193A—5.2(79GA,ch55). Such person shall be given credit for renewal fees previously paid if the person applies for reinstatement at other than the person’s regular renewal date. A person who has engaged in the practice of public accounting in another jurisdiction while registered as inactive in Iowa will be deemed to have satisfied the continuing education required for reinstatement if the person demonstrates that the person has satisfied substantially equivalent continuing education in the other jurisdiction.

5.8(8) Retired status. A person registered as an inactive holder of a certificate as a certified public accountant or license as a licensed public accountant who does not reasonably expect to return to the workforce in any capacity for which a certificate or license is required due to bona fide retirement or disability may use the title “CPA, retired” or “LPA, retired,” respectively, in the context of non–income–producing personal activities.

ITEM 4. Amend subrule 10.3(4) as follows:

10.3(4) An applicant who wishes to restore a certificate or license to effective active status must meet the basic requirement of 120 hours of continuing education hours earned in the preceding three–year period prior to the date of application to restore effective active status. The hours claimed to restore effective active status cannot again be used at the next renewal. At the first biennial renewal date of July 1 that is less than 12 months from the date of filing the application to restore the certificate or license to active status, the certificate or license holder shall not be required to report continuing education. At the biennial renewal date of July 1 which is more than 12 months, but less than 24 months, from the date of filing the application to restore the certificate or licenseto active status, the certificate or license holder shall report 40 hours of previously unreported continuing education earned in the one–year period ending December 31 prior to the July 1 renewal date. At the biennial renewal date of July 1 which is more than 24 months, but less than 36 months, from the date of filing the application to restore the certificate or license to active status, the certificate or license holder shall report 80 hours of continuing education earned in the two–year period ending December 31 prior to the July 1 renewal date.

ITEM 5. Amend subrule 10.6(1) as follows:

10.6(1) The overriding consideration in determining whether a specific program qualifies as acceptable continuing education is that it be a formal program of learning which contributes directly to the professional competence of an individual registered in this state. It will be left to each individual licensee certificate or license holder to determine the course of study to be pursued. Thus, the auditor may study accounting and auditing, the tax practitioner may study taxes, and the management advisory services practitioner may study subjects related to such practice. Job–related continuing education shall qualify as acceptable provided that the hours claimed contribute directly to the professional competence of the certificate or license holder.

ITEM 6. Amend rule 193A—12.1(79GA,ch55) as follows:

193A—12.1(79GA,ch55) Required fees. The following is a schedule of the fees for examinations, certificates, licenses, permits and renewals adopted by the board:

Initial CPA examination application:

Paid directly to CPA examination services $285

Reexamination:

Paid directly to CPA examination services

Four subjects $255

Three subjects N/A

Two subjects $170

One subject $125

Nonrefundable proctoring fee for
out–of–state candidates $100

Initial LPA examination application $120

Reexamination:

Two subjects $80

One subject $60

Original issuance of CPA certificate or LPA license
by examination (fee includes wall certificate) $100

Original issuance of CPA certificate by reciprocity
or substantial equivalency $100

CPA wall certificate issued by reciprocity
or substantial equivalency $50

Replacement of lost or destroyed CPA certificate
or LPA license $50

Original issuance of attest qualification $100

Biennial renewal of CPA certificate
or LPA license—active status $100

Penalty for failure to comply with
continuing education requirements $50 to $250

Reinstatement of lapsed CPA
certificate or LPA license $100 + renewal fee

Original issuance of a firm permit
to practice $50

Annual renewal of firm permit
to practice $50

Reinstatement of lapsed firm permit
to practice $100 + renewal fee

ITEM 7. Amend subrules 19.2(4) and 19.3(4) as follows:

19.2(4) Reinstating lapsed certificates. A CPA certificate which has lapsed may be restored to effective active status at any time prior to July 1, 2002, upon the board’s receipt of a proper application accompanied by a reinstatement fee of $100 and a renewal fee of $25 for persons whose last names begin with A to K or $50 for persons whose last names begin with L to Z. A person who fails to reinstate a lapsed CPA certificate to active status prior to July 1, 2002, may reinstate to active status on or after July 1, 2002, but in addition to payment of applicable renewal fees and a $100 reinstatement fee, the applicant must satisfy continuing education requirements as described in subrule 19.4(3).

19.3(4) Reinstating lapsed licenses. An AP license which has lapsed may be restored to effective active status at any time prior to July 1, 2002, upon the board’s receipt of a proper application accompanied by a reinstatement fee of $100, prorated renewal fee, and evidence of completion of satisfactory continuing education. A person who fails to reinstate a lapsed AP license to active status prior to July 1, 2002, must reapply for an LPA license, pay applicable application and reinstatement fees, and satisfy continuing education requirements, but the person will be deemed to be qualified for an LPA license.

Pursuant to the authority of Iowa Code section 544A.29, the Architectural Examining Board hereby gives Notice of Intended Action to amend Chapter 2, “Registration,” Iowa Administrative Code.

This proposed amendment to Chapter 2 clarifies the proc–ess by which the Board may consider experience for reciprocal registration in lieu of meeting a specific requirement of the Intern Development Program (IDP).

Consideration will be given to all written suggestions or comments on the proposed amendment on or before July 2, 2002. Comments should be addressed to Glenda Loving, Architectural Examining Board, 1918 S.E. Hulsizer, Ankeny, Iowa 50021, or faxed to (515)281–7411. E–mail may be sent to glenda.loving@comm7.state.ia.us.

This amendment is intended to implement Iowa Code chapter 544A.

The following amendment is proposed.

Amend subrule 2.2(2) as follows:

2.2(2) Registration requirements. The board, by approval of three of its members who are registered architects, may waive examination requirements for architects registered during the current year in another state or country where the qualifications prescribed at the time of registration were equal to those prescribed in Iowa. For the purpose of determining substantially equivalent qualifications, applicants who were originally registered in another state after July 1, 1984, shall have an NAAB–accredited professional degree and applicants registered after June 1, 1991, shall have met the training requirements for Intern Development Program (IDP). Applicants shall be deemed to have met the IDP requirement regardless of the date of completion of the required experience, provided the experience was completed prior to filing an application for Iowa registration. Such applicants shall not be required to show evidence of retroactive completion of IDP provided that the applicant can substantiate at least two years of undisciplined registration in all states of registration prior to the date of application for reciprocity in this state.

Pursuant to Iowa Administrative Code 361—subrule 12.2(1), the Executive Council gives Notice that the Civil Reparations Trust Fund balance as of May 17, 2002, is approximately $245,150.00. Money in the Civil Reparations Trust Fund is available for use for indigent civil litigation programs or insurance assistance programs. Application forms are available in the office of the State Treasurer by contacting GeorgAnna Madsen, Executive Secretary, State Capitol Room 114, Des Moines, Iowa 50319; telephone (515)281–5368. Applications must be filed on the thirtieth day after the date of publication of this Notice in the Iowa Administrative Bulletin, or on the thirtieth day after the date affixed to the Notice sent by first–class mail, whicheveris later. Any person/company that would like to receive future notices should make request in writing to the above–mentioned contact. Rules regarding the Civil Reparations Trust Fund can be found at 361 IAC Chapter 12.

Pursuant to the authority of Iowa Code section 272.2, the Board of Educational Examiners hereby gives Notice of Intended Action to amend Chapter 14, “Issuance of Practitioner’s Licenses and Endorsements,” Iowa Administrative Code.

The proposed new rule creates a substitute authorization, which permits an individual to substitute in a middle school, junior high school, or high school for no more than five consecutive days in one job assignment.

There will be public hearings on the proposed rule on Wednesday, July 10, 2002, from 10 until 11:30 a.m. at the following sites:

Grimes State Office Building, ICN Room, 2nd Floor

400 East 14th Street

Des Moines

AEA 4, ICN Room

1382 4th Avenue NE

Sioux Center

Cedar Falls High School, ICN Room, 1st Floor

1015 Division Street

Cedar Falls

North High School, ICN Room

626 W. 53rd Street

Davenport

Mason City High School, Room 153

1700 Fourth SE

Mason City

Persons may present their views at the public hearing either orally or in writing. At the hearing, persons will be asked to give their names and addresses for the record and to confine their remarks to the subject of the proposed rule. Persons who wish to make oral presentations at the public hearing may contact the Executive Director, Board of Educational Examiners, Grimes State Office Building, East 14th and Grand Avenue, Des Moines, Iowa 50319–0147, or at (515)281–5849, prior to the date of the public hearing.

Any interested person may make written comments or suggestions on the proposed rule through 4:30 p.m. Friday, July 12, 2002. Written comments and suggestions should be addressed to Dr. Anne E. Kruse, Executive Director, Board of Educational Examiners, at the above address or E–mailed to anne.kruse@ed.state.ia.us. Fax communication may be sent to (515)281–7669.

A waiver provision is not included, as the Board has adopted a uniform waiver rule.

This rule is intended to implement Iowa Code chapter 272.

The following amendment is proposed.

Adopt the following new rule:

282—14.143(272) Requirements for a substitute authorization. A substitute authorization allows an individual to substitute in a middle school, junior high school, or high school for no more than five consecutive days in one job assignment. An individual who holds a paraeducator certificate and completes the substitute authorization program is authorized to substitute only in the special education classroom in which the individual paraeducator is employed.

14.143(1) A substitute authorization may be issued to an individual who:

a. Has successfully completed all requirements of a board of educational examiners’ approved substitute authorization program consisting of the following components and totaling a minimum of 15 clock hours:

(1) Classroom management. This component includes an understanding of individual and group motivation and behavior to create a learning environment that encourages positive social interaction, active engagement in learning, and self–motivation.

(2) Strategies for learning. This component includes understanding and using a variety of learning strategies to encourage students’ development of critical thinking, problem solving, and performance skills.

(3) Diversity. This component includes understanding how students differ in their approaches to learning and creating learning opportunities that are equitable and are adaptable to diverse learners.

(4) Ethics. This component includes fostering relationships with parents, school colleagues, and organizations in the larger community to support students’ learning and development and to be aware of the board’s rules of professional practice and competent performance.

b. Has achieved at least one of the following:

(1) Holds a baccalaureate degree from a regionally accredited institution.

(2) Completed an approved paraeducator certification program and holds a paraeducator certificate.

c. Has attained a minimum age of 21 years.

d. Has successfully completed an Iowa division of criminal investigation background check. The background check fee will be assessed to the applicant.

e. Has successfully completed a national criminal history background check. The background check fee will be assessed to the applicant.

14.143(2) The fee for the substitute authorization is $25 for one year.

14.143(3) The substitute authorization must be renewed annually. Renewal requirements for the substitute authorization consist of a minimum of one renewal unit equivalent to 15 clock hours and completion of an approved child and dependent adult abuse training program approved by the state abuse education review panel. A waiver of the approved child and dependent adult abuse training requirement may apply under the following conditions with appropriate documentation of any of the following:

a. A person is engaged in active duty in the military service of this state or of the United States.

b. The application of the rule would impose an undue hardship on the person for whom the waiver is requested.

c. A person is practicing a licensed profession outside this state.

d. A person is otherwise subject to circumstances that would preclude the person from completing the approved child and dependent adult abuse training in this state.

Pursuant to the authority of Iowa Code section 542B.6, the Engineering and Land Surveying Examining Board gives Notice of Intended Action to amend Chapter 1, “Administration,” Iowa Administrative Code.

This amendment provides a process for ruling on petitions for waivers or variances when it would not be timely to wait until the next regularly scheduled Board meeting for a ruling from the Board.

Any interested person may make written or oral suggestions or comments on this proposed amendment on or before July 2, 2002. Comments should be directed to Gleean Coates, Executive Officer, Engineering and Land Surveying Examining Board, 1918 SE Hulsizer Road, Ankeny, Iowa 50021, or by telephone (515)281–7360.

This amendment is intended to implement Iowa Code section 17A.9A and chapter 542B.

The following amendment is proposed.

Amend rule 193C—1.4(542B) as follows:

1.4(1) The board’s rules regarding waivers and variances can be found in the uniform rules for the division of professional licensing and regulation at 193 IAC 5.

Pursuant to the authority of Iowa Code section 542B.6, the Engineering and Land Surveying Examining Board gives Notice of Intended Action to amend Chapter 4, “Engineering Licensure,” Iowa Administrative Code.

This amendment provides that a licensee holding an active certificate of licensure may apply for examinations in additional branches of engineering without submitting a formal application.

Any interested person may make written or oral suggestions or comments on this proposed amendment on or before July 2, 2002. Comments should be directed to Gleean Coates, Executive Officer, Engineering and Land Surveying Examining Board, 1918 SE Hulsizer Road, Ankeny, Iowa 50021, or by telephone (515)281–7360.

This amendment is intended to implement Iowa Code sections 542B.13, 542B.14, 542B.15 and 542B.17.

The following amendment is proposed.

Amend 193C—Chapter 4 by adopting the following new rule:

193C—4.3(542B) Requirements for a licensee requesting additional examination. A person holding an active certificate of licensure to engage in the practice of engineering issued by the state of Iowa may, upon written request and payment of the application and examination fees, take additional examinations in other branches of engineering without submitting a formal application to the board as described for initial or comity licensure.

Pursuant to the Acts of the Seventy–Ninth General Assembly, 2002 Regular Session, Senate File 2293, section 63, the Department of Natural Resources gives Notice that it will commence use of the interim matrix on June 18, 2002. After providing this Notice, the Department is authorized to use the interim matrix in evaluating applications for permits to construct confinement feeding operation structures. The June 18, 2002, effective date is subject to approval of the Environmental Protection Commission, which will be asked to approve Adopted and Filed Emergency and Notice of Intended Action documents regarding this and associated subjects; it is projected that these documents will be published in the July 10, 2002, Iowa Administrative Bulletin.

Pursuant to the authority of Iowa Code section 455B.133, the Environmental Protection Commission hereby gives Notice of Intended Action to amend Chapter 22, “Controlling Pollution,” Iowa Administrative Code.

The purpose of this proposed amendment is to delete the requirement that owners/operators of sources must count certain fugitive emissions of air pollutants not listed in the Clean Air Act as toxic air pollutants when determining whether their facility is a major source subject to the Title V permit program. Fugitive emissions are considered to be emissions that cannot reasonably pass through a stack, chimney, vent or other functionally equivalent opening.

This amendment will apply only to industrial facilities or “source categories” covered by federal New Source Performance Standards or National Emissions Standards for Hazardous Air Pollutants regulations promulgated after August 7, 1980. Sources in these categories will no longer be required to count nontoxic fugitive emissions when determining major source status under the operating permit program. Also, the U.S. Environmental Protection Agency (EPA) has proposed to delete the phrase “but only with respect to those air pollutants that have been regulated for that category” in order to make the regulatory definitions of 40 CFR Part 70 consistent with the corresponding provisions of the New Source Review program. Sources that become subject to Title V because of the deletion of this phrase will have 12 months after EPA’s approval of Iowa’s revised Title V program to apply.

A source will still be required to count all fugitive emissions of compounds that the EPA considers to be toxic air pollutants when determining whether the source is a major source and thus subject to the Title V permit program. Under the Clean Air Act, 188 chemicals are listed as toxic air pollutants because they are known to cause or suspected of causing cancer or other serious health problems.

This rule making is based upon a request from EPA Region VII on December 5, 2001, for the Department to incorporate the amendment shown below.

Any person may make written suggestions or comments on the proposed amendment on or before July 26, 2002. Written comments should be directed to Corey McCoid, Department of Natural Resources, Air Quality Bureau, 7900 Hickman Road, Suite 1, Urbandale, Iowa 50322, fax (515) 242–5094, or by electronic mail to corey.mccoid@dnr.state. ia.us.

A public hearing will be held on July 11, 2002, at 10:30 a.m. in Conference Rooms 3 and 4 at the Department’s Air Quality Bureau office located at 7900 Hickman Road, Urbandale, Iowa, at which time comments may be submitted orally or in writing. All comments must be received no later than July 26, 2002.

Any person who intends to attend a public hearing and has special requirements, such as those related to hearing or mobility, should contact Corey McCoid at (515)281–6061 to advise of any specific needs.

This amendment is intended to implement Iowa Code section 455B.133.

The following amendment is proposed.

Amend rule 567—22.100(455B), definition of “stationary source categories,” numbered paragraph “27,” as follows:

27. All Any other stationary source categories category, which as of August 7, 1980, is regulated by a standard promulgated under Section 111 or 112 of the Act, but only with respect to those air pollutants which have been regulated for that category.

Pursuant to the authority of Iowa Code sections 455A.6(6) and 455B.105(3), the Environmental Protection Commission hereby gives Notice of Intended Action to amend Chapter 133, “Rules for Determining Cleanup Actions and Responsible Parties,” Iowa Administrative Code.

These proposed amendments adopt a new rule relating to procedures and criteria for determining, valuing, and recovering compensation for damages to the natural resources caused by releases of hazardous substances. Concurrently with this rule making, the Natural Resource Commission is proposing, under independent authority, a related adoption of new 571— Chapter 113 on a related subject, restitution for pollution causing injury to wild animals. See ARC 1708B published herein.

The Department has made numerous demands in the past for restitution and received compensation in cases involving the destruction of fish by water pollution events. To date, such demands have involved only loss of fish, and have been pursuant to authority and duties assigned by law to the Natural Resource Commission. Recent events have demonstrated a need to expand the Department’s recovery of compensation for damage to the natural resources beyond fish.

Iowa Code section 455B.392, which relates to the authority and duties of the Environmental Protection Commission, provides that a person having control over a hazardous substance is strictly liable to the state for the reasonable damages to the state for the injury to, destruction of, or loss of natural resources resulting from a hazardous condition caused by that person including the costs of assessing the injury, destruction, or loss. Federal law provides similar authority for states to recover compensation for “natural resources damages,” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), 42 U.S.C.§9601 et seq., and the Clean Water Act (CWA), 33 U.S.C.§§1251–1376. Federal implementing regulations are at 43 CFR 11. These laws may be used by the Department in cases involving damages to natural resources resulting from releases of hazardous substances, without specific rules to implement the laws. However, the Department believes it would be desirable to adopt rules and to incorporate the methodologies and principles utilized in the CERCLA natural resources damages program to supplement its authority and provide guidance to the public.

The methods utilized by the Department in the past for determining and evaluating the losses have been in accordance with Special Publication 24, “Investigation and Valuation of Fish Kills,” published by the American Fisheries Society (AFS). To date, compensations received have ranged from a few dollars to over $50,000. Over the years the Department has received comments from the public regarding its valuation of fish and the use to which compensation received is put. The Department has surveyed other states to determine how these situations are handled. In addition, recent pollution events resulting in substantial losses of aquatic and other wildlife demonstrate a need for expansion of the Department’s past practices and policies, and to adopt rules on this subject. Issues raised include:

• Iowa Code section 481A.130 provides liquidated damages of $15 per fish for persons convicted of illegal taking of fish. In most cases this is much higher than the values derived from using the AFS publication. For example, the smaller, bait fish that are the most common species killed are valued at eight cents per fish. Larger, game fish are valued higher by AFS, but are usually under $15. The public has commonly asked why the Department does not charge more. This proposed rule will provide that, for listed species, the fish will be valued as provided by AFS or at $15 per fish, whichever is higher.

• Some states provide for recovery of the costs to the Department of responding to and evaluating the fish kill, and they provide for recovery of other types of public losses, such as lost recreation value. Iowa Code section 455B.392(1)(c) allows for the recovery of the costs of assessing natural resource damages. The proposed rule will provide for recovery of such costs.

• Public comments in the past questioned why the monetary recovery was not used to restock fish at the location of the kill or for restoration or enhancement projects in that location. The Department has implemented a policy in the past few years whereby money received for fish restitution is normally used for construction of natural resource enhancement projects on streams in the county where the kill occurred. Preference is given to projects on the stream impacted or the same watershed. The proposed rule will implement this general policy. In the case of natural resource damages caused by the release of hazardous substances, Iowa Code section 455B.392(5) provides that moneys recovered under this section shall be deposited in the hazardous waste remedial fund created in Iowa Code section 455B.423. The latter section specifies how money in that fund shall be spent, mostly for cleanup costs and site rehabilitation. Iowa Code section 455B.381(2) defines cleanup cost to include, among other things, costs incurred by the state or by any other person participating with the approval of the Director in the mitigation of damages from a hazardous condition. The language and legislative history of these Iowa Code provisions indicate that they were adopted to implement and complement CERCLA authority. The language proposed in new rule 567—133.6(455B) is drawn from the federal regulations that implement the natural resource damages provisions of CERCLA. Therefore, the Commission concludes that it would be consistent with Iowa law to direct moneys recovered for natural resource damages to replace, restore or rehabilitate the lost or damaged resources, for education programs relating to natural resource protection or enhancement, or for resource enhancement projects or resource acquisition of equal or greater value. If practical, such alternatives should provide similar services to the public and should be in the vicinity of the loss.

Written comments on the proposed amendments may be submitted on or before July 2, 2002, by sending such comments to Michael Murphy at the Department of Natural Resources, Wallace State Office Building, Des Moines, Iowa 50319–0034; fax (515)281–8895; or comments may be submitted electronically to mike.murphy@dnr.state.ia.us.

A public hearing will be held over the Iowa Communications Network, on July 2, 2002, at 7 p.m. at the following locations. Comments may be submitted orally or in writing. At the hearing, persons wanting to speak will be asked to give their names and addresses for the record and to confine their comments to the subject of the amendments.

Any persons who intend to attend the public hearing and have special needs such as those relating to hearing or mobility impairments should contact the Department of Natural Resources and advise of specific needs.

These amendments are intended to implement Iowa Code section 455B.392(1)(c).

The following amendments are proposed.

ITEM 1. Amend rule 567—133.2(455B,455E) by adopting the following new definitions in alphabetical order:

“AFS” means the Special Publication 24, “Investigation and Valuation of Fish Kills,” published by the American Fisheries Society.

“Air or air resources” means those naturally occurring constituents of the atmosphere, including those gases essential for human, plant, and animal life.

“Biological resources” means fish, wildlife and other bi–ota belonging to, managed by, held in trust by, appertaining to, or otherwise controlled by the state of Iowa, the United States, or local government. Fish and wildlife include freshwater aquatic and terrestrial species; game, nongame, and commercial species; and threatened and endangered species. Other biota encompass shellfish, terrestrial and aquatic plants, and other living organisms not otherwise listed in this definition.

“Damages” means the costs of restoration, rehabilitation, and replacement of resources or acquisition of equivalent resources, as determined in accordance with this chapter; the reasonable and necessary costs of the assessment, to include the cost of performing the assessment and administrative costs and expenses necessary for, and incidental to, the assessment; lost services to the public; and, in the event the damages claim is not resolved within six months after the incident leading to the damages, interest at the current rate published in the Iowa Administrative Bulletin by the department of revenue and finance pursuant to Iowa Code section 421.7. The interest amount shall be computed from the date the amount of the claim is confirmed by a final ruling of the commission in a contested case decision.

“Drinking water supply” means any raw or finished water source that is or may be used by a public water system, as defined in Iowa Code section 455B.171, or as drinking water by one or more individuals.

“Geologic resources” means those elements of Earth’s crust such as soils, sediments, rocks, and minerals, including petroleum and natural gas, that are not included in the definitions of groundwater and surface water resources.

“Groundwater resources” means water in a saturated zone or stratum beneath the surface of land or water and the rocks or sediments through which groundwater moves. It includes groundwater resources that meet the definition of drinking water supplies.

“Hazardous substance” means a hazardous substance as defined in Iowa Code section 455B.381.

“Natural resources” or “resources” means land, fish, wildlife, biota, air, water, groundwater, drinking water supplies, and other such resources belonging to, managed by, held in trust by, appertaining to, or otherwise controlled by the United States, the state of Iowa, or local government. These natural resources have been categorized into the following five groups: surface water resources, groundwater resources, air resources, geologic resources, and biological resources.

“Surface water resources” means the waters of the state, including the sediments suspended in water or lying on the bank, bed, or shoreline. This term does not include groundwater or water or sediments in ponds, lakes, or reservoirs designed for waste treatment under applicable laws regulating waste treatment.

ITEM 2. Amend 567—Chapter 133 by adopting the following new rule:

133.6(1) Applicability. This rule applies to persons who, by release of a hazardous substance to the environment, cause injury to, destruction of, or loss of natural resources held in trust by the state for the public. In most cases this would involve the destruction of aquatic life or other wildlife under the ownership of the state, as provided in Iowa Code section 481A.2. This rule relates to the compensation to the state and public for the natural resource damages and is in addition to any other legal recourse for the event or action that caused the destruction or damage.

133.6(2) Liability to the state. Persons who cause injury to, destruction of, or loss of natural resources of the state are liable to the state as provided by Iowa Code section 455B.392(1)(c). This rule establishes the methodologies and criteria for evaluating the extent and value of the damage and establishes the methods of compensation. If the person and the department cannot agree to the proper resolution of a particular case, the issues of liability, damage and compensation will be established through contested case proceedings, as provided by 567—Chapter 7.

133.6(3) Assessment. When natural resources are destroyed or damaged by an identifiable source, the degree and value of the losses shall be assessed by collecting, compiling, and analyzing relevant information, statistics, or data through prescribed methodologies to determine damages, as set forth in this rule.

a. General. Except as specified otherwise in this rule, the definitions, methodologies, and criteria in 43 CFR 11 may be used to assess natural resource damages.

b. Fish loss. Assessment of damages for fish kills shall be in accordance with the following:

(1) Wherever possible, investigators will follow the methods prescribed by AFS to determine numbers of fish killed, by species and size.

(2) During periods of ice cover or where local conditions prevent using these methods, investigators will utilize the best information available to determine numbers of fish killed, by species and size. Information may include existing data on population levels in the affected water body or nearby water bodies with similar characteristics, including any historical fish kill data.

(3) The monetary valuation of fish shall be the replacement values as published in AFS for all fish lost except those fish that are members of the families Ictaluridae (catfish/bullheads), Esocidae (northern pike/muskellunge), Salmon–idae (trout), Percichthyidae (white bass/yellow bass/wipers), Centrarchidae (black bass/crappie/sunfish/rock bass/warmouth), and Percidae (yellow perch/walleye/sauger). The value of these fish shall be $15 each, unless AFS establishes a higher value. Notwithstanding the above, the value of each fish classified by the department as an endangered or threatened species shall be $1,000.

(4) The value of lost services to the public shall be the number of fishing trips lost over the period of the resource loss, as determined through local creel survey information or through interpolation from the most recent statewide creel survey. Each trip shall be valued at $30.

(5) The cost of the investigation shall include salaries plus overhead for the time of staff, including support staff, involved in investigating the fish kill and performing the assessment; meals and lodging for staff while they are in the field conducting the assessment; mileage, valued at the current rate established by the state pursuant to Iowa Code section 18.117; costs borne by the department associated with containment or cleanup operations; and any other costs directly associated with the investigation and assessment.

133.6(4) Compensation. The department will extend to the responsible person the opportunity to reach voluntary agreement as to the amount of damages and the compensation method. If the person disputes liability or the damage amount, the department will make a demand for payment and the person may appeal and demand contested case procedures under 567—Chapter 7. The method of compensation shall be solely in the discretion of the department.

a. Direct monetary payment. Compensation will normally be by direct monetary payment to the department. The money received will be used to replace, restore or rehabilitate the lost or damaged resources. Resource enhancement projects, support of educational programs relating to resource protection or enhancement, or resource acquisition of equal or greater value also may be funded. If practical, such alternatives should provide similar services to the public and should be in the vicinity of the loss.

b. Indirect monetary payment. In appropriate cases, an equal or greater amount of compensation may be made by monetary payment to another government agency or private nonprofit group in the natural resource field for the same purposes as provided in paragraph “a.”

c. Direct funding of projects. With the approval and oversight of the department, the person may be allowed to contract directly for the same purposes as provided in paragraph “a.”

This rule is intended to implement Iowa Code section 455B.392.

Pursuant to the authority of Iowa Code section 68B.32A, the Iowa Ethics and Campaign Disclosure Board hereby gives Notice of Intended Action to amend Chapter 4, “Campaign Disclosure Procedures,” Iowa Administrative Code.

Iowa Code sections 56.6(6) and 56.2(18) require an organization that makes contributions to candidates, political parties, or political committees in excess of a specified financial threshold to register as a “political committee” (PAC). The Board believes that a “trust” is an “organization” and should be treated the same as any other organization under these sections. The Board announced this interpretation in IECDB Advisory Opinion 2001–11. The proposed amendment requires a trust that exceeds the financial filing threshold set out in statute to register as a “political committee” and file disclosure reports.

The amendment does not provide for waiver, as the amendment reflects the Board’s interpretation of a statutory definition.

Any interested person may make written comment on the proposed amendment on or before July 2, 2002. Comments should be directed to Charlie Smithson, Iowa Ethics and Campaign Disclosure Board, 514 E. Locust, Suite 104, Des Moines, Iowa 50309. Persons who wish to comment orally should contact Charlie Smithson at (515)281–3489.

This amendment is intended to implement Iowa Code chapter 56.

The following amendment is proposed.

Amend rule 351—4.47(56) by adopting new subrule 4.47(3) as follows:

4.47(3) A trust engaging in activity that would qualify it as a political committee by exceeding the financial reporting threshold in Iowa Code section 56.2(18) shall organize a committee and shall file disclosure reports in accordance with Iowa Code chapter 56.

Pursuant to the authority of Iowa Code section 68B.32A, the Iowa Ethics and Campaign Disclosure Board hereby gives Notice of Intended Action to amend Chapter 4, “Campaign Disclosure Procedures,” Iowa Administrative Code.

The Board’s current rules require a “paid for by” attribution statement to be placed on political business cards identifying the name of the person paying for the cost of the cards. The Board believes that a political business card is a small item upon which the inclusion of the attribution statement is impracticable. The proposed amendment removes the requirement for a “paid for by” attribution statement to be placed on political business cards.

The amendment does not provide for waiver as the obligation on the regulated community is being removed.

Any interested person may make written comment on the proposed amendment on or before July 2, 2002. Comments should be directed to Charlie Smithson, Iowa Ethics and Campaign Disclosure Board, 514 E. Locust, Suite 104, Des Moines, Iowa 50309. Persons who wish to comment orally should contact Charlie Smithson at (515)281–3489.

This amendment is intended to implement Iowa Code chapter 56.

The following amendment is proposed.

Amend subrule 4.74(2) as follows:

4.74(2) Items subject to requirement. In addition to those items specified by the statute, Iowa Code section 56.14(1)“b,” the requirement for an attribution statement is interpreted to apply to scratch pads, political business cards, and postcards because inclusion of the statement is not impracticable when other text is being printed, and the cost is not significantly increased by printing it.

Pursuant to the authority of Iowa Code section 68B.32A, the Iowa Ethics and Campaign Disclosure Board hereby gives Notice of Intended Action to amend Chapter 11, “Personal Financial Disclosure,” Iowa Administrative Code.

Iowa Code section 68B.35(5) requires the Board to adopta rule to include the procedure for notifying candidates for statewide office of the duty to file a personal financial disclosure statement with the Board. The proposed amendment sets out the Board’s procedure for notifying statewide candidates of the requirement to file a personal financial disclosure statement with the Board.

The amendment does not provide for waiver, as the amendment is required by statute.

Any interested person may make written comment on the proposed amendment on or before July 2, 2002. Comments should be directed to Charlie Smithson, Iowa Ethics and Campaign Disclosure Board, 514 E. Locust, Suite 104, Des Moines, Iowa 50309. Persons who wish to comment orally should contact Charlie Smithson at (515)281–3489.

This amendment is intended to implement Iowa Code chapter 68B.

The following amendment is proposed.

Amend subrule 11.1(2) as follows:

11.1(2) Persons who are candidates for statewide office shall file reports Form PFD with the board no later than 30 days after the date on which a person is required to file nomination papers for state office under Iowa Code section 43.11. Once nomination papers or an affidavit of candidacy is filed, the board shall notify the person of the requirement to file Form PFD. The notification shall be sent by first–class mail and shall include a blank form or information on how to obtain a blank form for filing.

Pursuant to the authority of Iowa Code section 68B.32A, the Iowa Ethics and Campaign Disclosure Board hereby gives Notice of Intended Action to amend Chapter 11, “Personal Financial Disclosure,” Iowa Administrative Code.

Iowa Code section 68B.35 requires certain executive branch officials and employees to file a personal financial disclosure statement. The current rule lists by agency each position title for which a form must be filed. Due to agency reorganizations, the rule is inaccurate. The proposed amendment rescinds the rule and sets out a procedure whereby on an annual basis the Board notifies each agency of the name and position title of the individuals who filed the form for the previous year. The Board then works with the agencies to determine the names and positions of those persons who will be required to file the form for the upcoming filing period. The proposed amendment reflects the current Board procedure.

The amendment does not provide for waiver, as a procedure is required by statute.

Any interested person may make written comment on the proposed amendment on or before July 2, 2002. Comments should be directed to Charlie Smithson, Iowa Ethics and Campaign Disclosure Board, 514 E. Locust, Suite 104, Des Moines, Iowa 50309. Persons who wish to comment orally should contact Charlie Smithson at (515)281–3489.

This amendment is intended to implement Iowa Code chapter 68B.

The following amendment is proposed.

Rescind rule 351—11.2(68B) and adopt the following new rule in lieu thereof:

351—11.2(68B) Procedure for determining persons required to file with the board—distribution of forms. To determine the persons in the executive branch who are required to file Form PFD, the board shall contact each agency on an annual basis and provide notification of the requirements in Iowa Code section 68B.35. This notification shall include the name and position title of each person in the agency who filed Form PFD the previous year. Each agency, in consultation with the board, shall then determine which persons are required to file Form PFD for the next filing period and shall provide the board with the appropriate names and position titles. The board shall provide each agency with blank forms for distribution to the designated persons and make blank forms available via the board’s Web site at www.state.ia.us/ethics. The board shall have the final authority to determine whether a position requires that a Form PFD be filed.

Pursuant to the authority of Iowa Code section 249A.4, the Department of Human Services proposes to amend Chapter 79, “Other Policies Relating to Providers of Medical and Remedial Care,” Iowa Administrative Code.

These amendments clarify and reorganize the Medicaid certification and inpatient reimbursement criteria for hospital “special units.” Certification as a substance abuse unit, a neonatal intensive care unit, or a psychiatric unit enables that part of a hospital to qualify for reimbursement based on special diagnosis–related group weights for those programs developed for Iowa Medicaid. Certification as a physical rehabilitation hospital or unit qualifies a facility for payment on a per–diem basis, instead of on the basis of a diagnosis–related group.

Under existing rules, in–state rehabilitation hospitals are reimbursed on a per–diem basis, while out–of–state rehabilitation hospitals are reimbursed based on diagnosis–related groups. These amendments make the basis of reimbursement uniform for all rehabilitation hospitals and units, in compliance with federal regulations and Iowa’s state Medicaid plan.

These amendments also clarify that out–of–state hospitals may certify substance abuse units. Payment for services in out–of–state facilities is authorized when medically necessary treatment is not available at an appropriate in–state facility.

These amendments do not provide for waivers in specified situations because all hospitals should be subject to the same requirements. Individual facilities may request a waiver of these standards under the Department’s general rule on exceptions at rule 441—1.8(217).

Any interested person may make written comments on the proposed amendments on or before July 3, 2002. Comments should be directed to the Office of Policy Analysis, Department of Human Services, at the Hoover State Office Building, 1305 East Walnut Street, Des Moines, Iowa 50319– 0114. Comments may be sent by fax to (515)281–4980 or by E–mail to policyanalysis@dhs.state.ia.us.

These amendments are intended to implement Iowa Code section 249A.4.

The following amendments are proposed.

ITEM 1. Amend subrule 79.1(5), paragraph “a,” by rescinding the definitions of “Medicaid–certified unit” and “transfer.”

ITEM 2. Amend subrule 79.1(5), paragraph “b,” subparagraph (1), as follows:

(1) Medicaid–certified substance Substance abuse units certified pursuant to 79.1(5)“r.” Three sets of DRG weights are developed for DRGs concerning rehabilitation of substance abuse patients. The first set of weights is developed from charges associated with treating adults in Medicaid–certified substance abuse units. The second set of weights reflects charges associated with treating adolescents in mixed–age Medicaid–certified substance abuse units. The third set of weights reflects charges associated with treating adolescents in designated adolescent–only Medicaid–certified substance abuse units.

Hospitals with these units are reimbursed using the weight that reflects the age of each patient. Out–of–state hospitals may not receive reimbursement for the rehabilitation portion of substance abuse treatment.

ITEM 3. Amend subrule 79.1(5), paragraph “b,” subparagraph (2), catchwords, as follows:

(2) Neonatal intensive care units certified pursuant to 79.1(5)“r.”

ITEM 4. Amend subrule 79.1(5), paragraph “b,” subparagraph (3), as follows:

(3) Medicaid–certified psychiatric Psychiatric units. Four sets of DRG weights are developed for DRGs concerning psychiatric treatment. The first set of weights reflects charges associated with the treatment of adult psychiatric patients in Medicaid–certified psychiatric units certified pursuant to 79.1(5)“r.” The second set of weights reflects charges associated with the treatment of adolescent patients in mixed–age Medicaid–certified psychiatric units certified pursuant to 79.1(5)“r.” The third set of weights reflects charges associated with the treatment of adolescent patients in designated adolescent–only Medicaid–certified psychiatric units certified pursuant to 79.1(5)“r.” The fourth set of weights reflects charges associated with the treatment of psychiatric patients in hospitals without Medicaid–certified psychiatric units. Hospitals are reimbursed using the weight that reflects the patient’s age and the setting for psychiatric treatment.

ITEM 5. Amend subrule 79.1(5), paragraph “g,” subparagraphs (2) and (3), as follows:

(2) Medicaid–certified substance Substance abuse and psychiatric units. When a patient is discharged to or from an acute care hospital and is admitted to or from a Medicaid–certified substance abuse or psychiatric unit certified pursuant to 79.1(5)“r,” both the discharging and admitting hospitals will receive 100 percent of the DRG payment.

(3) Medicaid–certified physical Physical rehabilitation hospitals or units. When a patient requiring physical reha–bilitation is discharged from an acute care hospital and admitted to a Medicaid–certified rehabilitation hospital or unit certified pursuant to 79.1(5)“r,” and the admission is medically appropriate, then payment for time spent in the unit is through a per diem. The discharging hospital will receive 100 percent of the DRG payment. When a patient is discharged from a certified physical rehabilitation hospital or unit and admitted to an acute care hospital, the acute care hospital will receive 100 percent of the DRG payment.

ITEM 6. Amend subrule 79.1(5), paragraph “h,” as follows:

h. Covered DRGs. Medicaid DRGs cover services provided in acute care general hospitals, with the exception of services provided in Medicaid–certified physical rehabilitation hospitals and units certified pursuant to 79.1(5)“r,” which are paid per diem, as specified in 79.1(5)“i.”

ITEM 7. Amend subrule 79.1(5), paragraph “i,” introductory paragraph, as follows:

i. Payment for Medicaid–certified physical rehabilitation hospitals and units. Payment for services provided by a Medicaid–certified physical rehabilitation payment hospital or unit certified pursuant to 79.1(5)“r” is prospective, based on a per diem rate calculated for each hospital by establishing a base year per diem rate to which an annual index is applied.

ITEM 8. Rescind subrule 79.1(5), paragraph “r,” and adopt the following new paragraph in lieu thereof:

r. Certification for reimbursement as a special unit or physical rehabilitation hospital. Certification for Medicaid reimbursement as a substance abuse unit under 79.1(5)“b”(1), a neonatal intensive care unit under 79.1(5)“b”(2), a psychiatric unit under 79.1(5)“b”(3), or a physical rehabilitation hospital or unit under 79.1(5)“i” shall be awarded as provided in this paragraph.

(1) Certification procedure. All hospital special units and physical rehabilitation hospitals must be certified by the Medicaid fiscal agent to qualify for Medicaid reimbursement as a special unit or physical rehabilitation hospital. Hospitals shall submit requests for certification to ACS Consultec, Attention: Provider Enrollment, P.O. 14422, Des Moines, Iowa 50306–3422, with documentation that the certification requirements are met. The Medicaid fiscal agent will notify the facility of any additional documentation needed after review of the submitted documentation.

Upon certification, reimbursement as a special unit or physical rehabilitation hospital shall be retroactive to the first day of the month during which the Medicaid fiscal agent received the request for certification. No additional retroactive payment adjustment shall be made when a hospital fails to make a timely request for certification.

(2) Certification criteria for substance abuse units. An in–state substance abuse unit may be certified for Medicaid reimbursement under 79.1(5)“b”(1) if the unit’s program is licensed by the Iowa department of public health as a substance abuse treatment program in accordance with Iowa Code chapter 125 and 643—Chapter 3. In addition to documentation of the license, an in–state hospital must submit documentation of the specific substance abuse programs available at the facility with a description of their staffing, treatment standards, and population served.

An out–of–state substance abuse unit may be certified for Medicaid reimbursement under 79.1(5)“b”(1) if it is excluded from the Medicare prospective payment system as a psychiatric unit pursuant to 42 Code of Federal Regulations, Sections 412.25 and 412.27, as amended to September 1, 1994. An out–of–state hospital requesting reimbursement as a substance abuse unit must initially submit a copy of its current Medicare prospective payment system exemption notice, unless the facility had certification for reimbursement as a substance abuse unit before July 1, 1993. All out–of–state hospitals certified for reimbursement for substance abuse units must submit copies of new Medicare prospective payment system exemption notices as they are issued, at least annually.

(3) Certification criteria for neonatal intensive care units. A neonatal intensive care unit may be certified for Medicaid reimbursement under 79.1(5)“b”(2) if it is certified as a level II or level III neonatal unit and the hospital where it is located is accredited by the Joint Commission on Accreditation of Healthcare Organizations or the American Osteopathic Association. The Medicaid fiscal agent shall verify the unit’s certification as a level II or level III neonatal unit in accordance with recommendations set forth by the American Academy of Pediatrics for newborn care. Neonatal units in Iowa shall be certified by the Iowa department of public health pursuant to 641—Chapter 150. Out–of–state units shall submit proof of level II or level III certification.

(4) Certification criteria for psychiatric units. A psychiatric unit may be certified for Medicaid reimbursement under 79.1(5)“b”(1) if it is excluded from the Medicare prospective payment system as a psychiatric unit pursuant to 42 Code of Federal Regulations, Sections 412.25 and 412.27, as amended to September 1, 1994.

(5) Certification criteria for physical rehabilitation hospitals and units. A physical rehabilitation hospital or unit may be certified for Medicaid reimbursement under 79.1(5)“i” if it receives or qualifies to receive Medicare reimbursement as a rehabilitative hospital or unit pursuant to 42 Code of Federal Regulations, Sections 412.600 through 412.632 (Subpart P), as amended to January 1, 2002, and the hospital is accredited by the Joint Commission on Accreditation of Healthcare Organizations or the American Osteopathic Association.

Pursuant to the authority of Iowa Code section 507B.12, the Insurance Division gives Notice of Intended Action to amend Chapter 16, “Replacement of Life Insurance and Annuities,” Iowa Administrative Code.

The proposed amendment rescinds Division I. Rules 191—16.21(507B) to 191—16.30(507B) in current Division II, which became effective July 1, 2000, are now intended to conform the administrative rules to Iowa Code chapter 507B and to regulate the replacement of life insurance and annuities.

Any person may make written comments on the proposed amendment by 4:30 p.m. on July 2, 2002. These comments should be directed to John Leonhart, Attorney, Insurance Division, 330 Maple Street, Des Moines, Iowa 50319. Comments may also be transmitted by fax to (515)281–3059 or by E–mail to john.leonhart@iid.state.ia.us.

This amendment is intended to implement Iowa Code chapter 507B.

The following amendment is proposed.

Rescind 191—Chapter 16, Division I.

Pursuant to the authority of Iowa Code section 455A.5(6)“a” and 2002 Iowa Acts, Senate File 2293, section 58, the Natural Resource Commission hereby gives Notice of Intended Action to adopt new Chapter 113, “Restitution for Pollution Causing Injury to Wild Animals,” Iowa Administrative Code.

This amendment proposes to adopt a new chapter relating to procedures and criteria for determining, valuing, and recovering compensation for injuries to wild animals, such as a fish kill caused by releases of pollutants. Concurrently with this rule making, the Environmental Protection Commission is proposing, under independent authority, adoption of amendments to 567—Chapter 133 on a related subject, compensation for natural resource damages caused by a release of hazardous substances. See ARC 1711B published herein.

Iowa Code section 481A.2 provides that the title and ownership of all fish, mussels, clams, and frogs in any public water of the state and of all wild game, animals, and birds, and all other wildlife, with limited exceptions, are declared to be in the state. Iowa Code section 456A.23 imposes a duty on the Department to protect, propagate, increase, and preserve fish and wildlife of the state and enforce by proper actions and proceedings the laws, rules and regulations relating to them. 2002 Iowa Acts, Senate File 2293, section 58, establishes a new Iowa Code section regarding restitution for pollution causing injury to wild animals. This new section provides that a person who is liable for polluting a water of this state in violation of state law shall also be liable to pay restitution to the Department for injury caused to a wild animal by the pollution. The amount of the restitution shall also include the Department’s administrative costs for investigating the incident. The Commission shall adopt rules providing for procedures for investigations and the administrative assessment of restitution amounts. The rules shall establish an opportunity to appeal a departmental action including by a contested case proceeding under Iowa Code chapter 17A. A final administrative decision assessing an amount of restitution may be enforced by the Attorney General at the request of the Director.

2002 Iowa Acts, Senate File 2293, section 58, requires that rules adopted by the Commission shall provide for methods used to determine the extent of an injury and the monetary values for the loss of injured wild animals based on species. The rules shall provide for methods used to count dead fish and to calculate restitution values. The rules may incorporate methods and values published by the American Fisheries Society. To every extent practicable, the values shall be based on the estimates of lost recreational angler opportunities where applicable. As an alternative method of valuation, the rules may provide that, for fish species that are protected by catch limits, possession limits, size limits, or closed seasons applicable to anglers, liquidated damages apply. The amount of the liquidated damages shall not exceed $15 per fish. For fish species that are classified by the Commission as endangered or threatened, the rules may establish liquidated damages not to exceed $1,000 per fish. The rules shall provide guidelines for estimating the extent of loss of a species that is affected by a pollution incident but which would not be practical to count in sample areas. The rules may establish liquidated damage amounts for species whose replacement cost is difficult to determine.

Finally, this new Iowa Code section provides that moneys collected by the Department in restitution shall be deposited into the state fish and game protection fund and shall be used exclusively to support restoration or improvement of fisheries, including but not limited to aquatic habitat improvement projects as provided in rules adopted by the Commission. However, moneys collected from restitution paid for investigative costs shall be used as determined by the Director.

The rules proposed provide:

• The methods utilized by the Department for determining and evaluating fish losses will generally be in accordance with Special Publication 24, “Investigation and Valuation of Fish Kills,” published by the American Fisheries Society (AFS). For listed species, the fish will be valued as provided by AFS or at $15 per fish, whichever is higher, and endangered or threatened species will be valued at $1,000 per fish. For wild animal species other than fish, the professional judgment of technical staff and available literature and guidance they normally rely on may be used to assess the injury.

• The value of fishing trips lost to the public over the period of the resource loss may be recovered.

• The costs of investigation may be recovered.

• Moneys received will be used to replace, restore or rehabilitate the lost or damaged resources. Resource enhancement projects, support of educational programs relating to resource protection or enhancement, or resource acquisition of equal or greater value also may be funded. If practical, such alternatives should provide similar services to the public and should be in the vicinity of the loss.

Any interested person may make written comments or suggestions regarding the proposed amendment on or before July 2, 2002. Comments should be directed to MarionConover, Department of Natural Resources, 502 East 9th Street, Des Moines, Iowa 50319; fax (515)281–6794; E–mail marion.conover@dnr.state.ia.us.

A public hearing will be held over the Iowa Communications Network on July 2, 2002, at 7 p.m. at the following locations. Comments may be submitted orally or in writing. At the hearing, persons wanting to speak will be asked to give their names and addresses for the record and to confine their comments to the subject of the amendment.

These rules are intended to implement Iowa Code sections 456A.23 and 481A.2 and 2002 Iowa Acts, Senate File 2293, section 58.

The following new chapter is proposed.

CHAPTER 113
RESTITUTION FOR POLLUTION CAUSING
INJURY TO WILD ANIMALS

571—113.1(481A) Applicability. These rules apply to persons who cause by water pollution the destruction of or injury to wild animals held in trust by the state for the public. In most cases this would involve the destruction of aquatic life or other wildlife under the ownership of the state, as provided in Iowa Code section 481A.2. These rules relate to the compensation to the state and public for the natural resource damages and are in addition to any other legal recourse for the event or action that caused the destruction or damage. The administration of this chapter shall not result in a duplication of damages collected by the department under Iowa Code section 455B.392, subsection 1, paragraph “c.”

“AFS” means Special Publication 24, “Investigation and Valuation of Fish Kills,” published by the American Fisheries Society.

“Damages” means the costs of restoration, rehabilitation, and replacement of resources or acquisition of equivalent resources, as determined in accordance with this chapter; the reasonable and necessary costs of the assessment, to include the cost of performing the assessment and administrative costs and expenses necessary for, and incidental to, the assessment; lost services to the public; and, in the event the damages claim is not resolved within six months after the incident leading to the damages, interest at the current rate published in the Iowa Administrative Bulletin by the department of revenue and finance pursuant to Iowa Code section 421.7. The interest amount shall be computed from the date the amount of the claim is confirmed by a final ruling of the commission in a contested case decision.

“Surface water resources” means the waters of the state, including the sediments suspended in water or lying on the bank, bed, or shoreline. This term does not include groundwater or water or sediments in ponds, lakes, or reservoirs designed for waste treatment under applicable laws regulating waste treatment.

“Wild animals” means fish, wildlife and other biota belonging to, managed by, held in trust by, appertaining to, or otherwise controlled by the state of Iowa, the United States, or local government. Fish and wildlife include freshwater aquatic and terrestrial species; game, nongame, and commercial species; and threatened and endangered species. Other biota encompass shellfish and other living organisms not otherwise listed in this definition.

571—113.3(481A) Liability to the state. Persons who cause by water pollution the destruction of or injury to wild animals of the state shall be liable to the state as provided by 2002 Iowa Acts, Senate File 2293, section 58. These rules establish the methodologies and criteria for evaluating the extent and value of the destruction or injury and establish the methods of compensation. If the person and the department cannot agree to the proper resolution of a particular case, the issues of liability, damage and compensation will be established through contested case proceedings, as provided by 571—Chapter 7.

571—113.4(481A) Assessment. When wild animals are destroyed or injured by an identifiable source of water pollution, the degree and value of the losses shall be assessed by collecting, compiling, and analyzing relevant information, statistics, or data through prescribed methodologies to determine damages, as set forth in this rule.

113.4(1) General. For species other than fish, the professional judgment of fish and wildlife staff and available literature and guidance normally relied on in the fish and wildlife professions may be used to assess the injuries.

113.4(2) Fish loss. Assessment of damages for fish kills shall be in accordance with the following:

a. Wherever possible, investigators will follow the methods to determine numbers of fish killed by species and size that are prescribed by AFS.

b. During periods of ice cover or where local conditions prevent using the methods in “a” above, investigators will utilize the best information available to determine numbers of fish killed by species and size. Information may include existing data on population levels in the affected water body or a nearby water body with similar characteristics, including any historical fish kill data.

c. The monetary valuation of fish shall be the replacement values as published in AFS for all fish lost except those fish that are members of the families Ictaluridae (catfish/bullheads), Esocidae (northern pike/muskellunge), Salmon–idae (trout), Percichthyidae (white bass/yellow bass/wipers), Centrarchidae (black bass/crappie/sunfish/rock bass/warmouth), and Percidae (yellow perch/walleye/sauger). The value of these fish shall be $15 each, unless AFS establishes a higher value. Notwithstanding the above, the value of each fish classified by the department as an endangered or threatened species shall be $1,000.

d. The value of lost services to the public shall be the number of fishing trips lost over the period of the resource loss, as determined through local creel survey information or through interpolation from the most recent statewide creel survey. Each trip shall be valued at $30.

e. The cost of the investigation shall include:

(1) Salaries plus overhead of staff, including support staff, involved in investigating the fish kill and performing the assessment.

(2) Any meals and lodging of staff while they are in the field conducting the assessment.

(3) Mileage valued at the current rate established pursuant to Iowa Code section 18.117.

(4) Costs borne by the department associated with containment or cleanup operations.

(5) Any other costs directly associated with the investigation and assessment.

571—113.5(481A) Compensation. The department will extend to the responsible person the opportunity to reach voluntary agreement as to the amount of damages and the compensation method. The method of compensation shall be solely in the discretion of the department. If the person disputes liability or the damage amount, these issues will be resolved through contested case proceedings.

113.5(1) Direct monetary payment. Compensation shall normally be by direct monetary payment to the department. To the extent reasonable and practical, the money received will be used to replace, restore or rehabilitate the lost or injured animals. Resource enhancement projects, support of educational programs relating to resource protection or enhancement, or resource acquisition of equal or greater value also may be funded. If practical, such alternatives should provide similar services to the public and should be in the vicinity of the loss.

113.5(2) Indirect monetary payment. In appropriate cases, an equal or greater amount of compensation may be made by monetary payment to another government agency or private nonprofit group in the natural resource field for the same purposes as provided in subrule 113.5(1).

113.5(3) Direct funding of projects. With the approval and oversight of the department, the person may be allowed to contract directly for the same purposes as provided in subrule 113.5(1).

These rules are intended to implement Iowa Code sections 456A.23 and 481A.2, and 2002 Iowa Acts, Senate File 2293, section 58.

Pursuant to the authority of Iowa Code section 455G.4(3)“a,” the Iowa Comprehensive Petroleum Underground Storage Tank Fund Board hereby gives Notice of Intended Action to amend Chapter 11, “Claims,” Iowa Administrative Code.

The proposed amendment is intended to implement changes to allow claimants who would have an otherwise eligible claim, but for the failure to maintain financial responsibility from the inception of the program, to become eligible with a one–time reinstatement fee. The larger fee charged is reflective of the failure to meet the initial requirement to obtain insurance on any tanks operating in the state after October 26, 1990.

Public comments concerning the proposed amendment will be accepted until 4 p.m. on July 2, 2002. Interested persons may submit written or oral comments by contacting the Office of the Deputy Commissioner of Insurance, Division of Insurance, 330 Maple Street, Des Moines, Iowa 50319; telephone (515)281–5705.

This amendment does not mandate additional combined expenditures exceeding $100,000 by all affected political subdivisions or agencies and entities which contract with political subdivisions to provide services.

This amendment is intended to implement Iowa Code sections 455G.9 and 455G.21.

The following amendment is proposed.

Amend subrule 11.2(1) by adopting the following new paragraph “c”:

c. A claim for benefits under any portion of 591—Chapter 11 that has been deemed ineligible due to a failure to maintain financial responsibility on a tank or tanks may be eligible, notwithstanding the failure to maintain financial responsibility, under the following conditions:

(1) The release for which the claim is made occurred prior to October 26, 1990; and

(2) The claimant is in compliance with all other requirements of this chapter; and

(3) The claimant pays a reinstatement fee equal to two times the reinstatement fee provided for in 591—paragraph 11.2(1)“b.” The amount of $500 per tank shall be used to calculate the charge for reinstatement for the period from October 26, 1990, to July 1, 1991; and

(4) The application for reinstatement complies with 591—subparagraph 11.2(1)“b”(4).

Pursuant to the authority of Iowa Code section 147.76, the Board of Pharmacy Examiners hereby gives Notice of Intended Action to rescind Chapter 1, “Purpose and Organization,” Iowa Administrative Code, and to adopt a new Chapter 1 with the same title.

Pursuant to Executive Order Number 8, comments, complaints, and recommendations were solicited from members of the Board and staff, from licensees and registrants, and from members of the public. Existing rules and proposed new rules were reviewed based on need, clarity, cost, fairness, intent and statutory authority. The following amendment was approved at the April 23, 2002, regular meeting of the Board of Pharmacy Examiners.

The proposed amendment rescinds current rules and adopts new rules regarding the organization of the Board and the Board’s mission, authority, and responsibilities. The rules provide that meetings of the Board are open to the public except as otherwise provided by law and identify the means by which members of the public may direct communications to or establish contact with the Board. The rules also provide for a fee for the return, for any reason, of a check submitted in payment of a Board fee.

Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657— Chapter 34.

Any interested person may present written comments, data, views, and arguments on the proposed amendmentnot later than 4:30 p.m. on July 17, 2002. Such written materials should be sent to Terry Witkowski, AdministrativeAssistant, Board of Pharmacy Examiners, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309–4688, or by E–mail to terry.witkowski@ibpe.state.ia.us.

This amendment is intended to implement Iowa Code sections 17A.3, 21.3 through 21.5, 124.301, 147.14, 147.76, 147.96, 155A.2, 155A.6, 155A.11, 155A.13, 155A.13A, 155A.14, 155A.17, 272C.3, and 272C.4.

The following amendment is proposed.

Rescind 657—Chapter 1 and adopt the following new chapter in lieu thereof:

CHAPTER 1
PURPOSE AND ORGANIZATION

657—1.1(17A) Board mission. The board of pharmacy examiners promotes, preserves, and protects the public health, safety, and welfare by fostering the provision of pharmaceutical care to all Iowans through the effective regulation of the practice of pharmacy, the operation of pharmacies, the appropriate utilization of pharmacy technicians, the distribution of prescription drugs and devices, and the education and training of pharmacists.

657—1.2(17A,147,272C) Description and organization of board. The board is comprised of five pharmacist members and two representatives of the general public, all appointed by the governor. An administrative staff headed by a board–appointed executive secretary/director assists board members.

The board’s authority for regulating the practice of pharmacy and the legal distribution and dispensing of prescription drugs and devices and of precursor substances in the state of Iowa is found in Iowa Code chapters 124, 124A, 124B, 126, 147, 155A, 205, and 272C.

657—1.3(17A,272C) Responsibilities. The responsibilities of the board include but are not limited to:

1. Licensing of qualified applicants for the practice of pharmacy, by examination, renewal, and reciprocity under the provisions of Iowa Code chapters 147 and 155A.

2. Administering a continuing education program to ensure continued competency of individuals licensed by the board to practice pharmacy. Authority for this function comes from Iowa Code chapter 272C.

3. Regulating the legal distribution of prescription drugs through the licensing of pharmacies and wholesalers under the authority of Iowa Code chapter 155A.

4. Regulating the legal distribution of controlled substances through the registration of authorized persons and entities engaged in the manufacture and distribution of controlled substances throughout the state under the authority of Iowa Code chapter 124.

5. Registering pharmacist–interns and administering an internship program to prepare individuals for the practice of pharmacy pursuant to the authority of Iowa Code chapter 155A.

6. Registering pharmacy technicians assisting in the technical functions of the practice of pharmacy pursuant to the authority of Iowa Code chapter 155A.

7. Performing compliance investigations and audits of all persons or entities registered pursuant to Iowa Code chapter 124 and compliance inspections and investigations of any persons or entities licensed or registered pursuant to Iowa Code chapter 155A. These investigations and audits are conducted to ensure accountability for all controlled substances and to ensure compliance with laws regulating the practice of pharmacy and the distribution of prescription drugs and devices in Iowa.

8. Regulating the legal distribution of precursor substances through the issuance of permits to vendors and recipients of precursor substances throughout the state under the authority of Iowa Code chapter 124B.

9. Instituting disciplinary actions, hearing contested cases, issuing decisions and orders, and enforcing the terms of disciplinary orders filed against licensees, registrants, or permit holders for grounds provided in Iowa Code sections 124.303, 124.304, 124B.12, 147.55, 155A.6, 155A.12, 155A.13A, 155A.15, and 155A.17, as appropriate.

657—1.4(17A,272C) Submission of complaints andrequests. Members of the general public may obtain information or submit requests or complaints relative to the practice of pharmacy, continuing education for pharmacists, the legal distribution and dispensing of prescription drugs, or any other matters relating to the function and authority of the board. Correspondence should be submitted to the Executive Secretary/Director, Board of Pharmacy Examiners, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309–4688. Communication may also be submitted via the board’s Web site at www.state.ia.us/ibpe.

657—1.5(17A,21) Meetings. All meetings of the board shall be open and public, and all members of the public shall be permitted to attend any meeting unless Iowa Code section 21.5 or another provision of law authorizes a closed session. Closed session shall only be by affirmative public vote of either two–thirds of the members of the board or all of the members present at the meeting.

1.5(1) Where held. Meetings of the board shall be held in Des Moines, Iowa, except as designated otherwise by the chairperson.

1.5(2) Meeting schedule and public notice. The board shall set the dates of its meetings at the first meeting following May 1 of each fiscal year. Notices of meetings shall be routinely posted in the space set aside for that purpose in the governor’s office, in the office of the board, and on the board’s Web site at www.state.ia.us/ibpe. Members ofthe general public may obtain the dates, times, and locationsof board meetings by submitting a request to the Executive Secretary/Director, Board of Pharmacy Examiners, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309–4688, or by accessing the board’s Web site.

1.5(3) Special meetings. Special meetings of the board may be called by the chairperson or upon written request of four of its members.

a. The reason for calling a special meeting shall be recorded in the minutes.

b. Special meetings shall be open to the public except as otherwise provided by statute.

1.5(4) Minutes of meetings. The executive secretary shall keep a record of all minutes of the board, and these minutes, except as otherwise provided by statute, shall be open to the public for inspection.

1.5(5) Quorum. A majority of the members of the board shall constitute a quorum.

Rules 657—1.1(17A) through 657—1.5(17A,21) are intended to implement Iowa Code sections 17A.3, 21.3 through 21.5, 124.301, 147.14, 147.76, 155A.2, 272C.3, and 272C.4.

657—1.6(124,147,155A) Fee for returned check. A fee of $20 may be charged for a check returned for any reason. If a license, registration, or permit has been issued by the board office based on a check for the payment of fees and the check is later returned by the bank, the board shall request payment by certified check, cashier’s check, or money order. If the fees, including the fee for a returned check, are not paid within 15 calendar days of notification of the returned check, the license, registration, or permit is no longer in effect and the status reverts to what it would have been had the license, registration, or permit not been issued. Late payment penalties will be assessed, as provided in board rules, for subsequent requests to renew or reissue the license, registration, or permit.

This rule is intended to implement Iowa Code sections 124.301, 147.96, 155A.6, 155A.11, 155A.13, 155A.13A, 155A.14, and 155A.17.

Pursuant to the authority of Iowa Code sections 147.76, 155A.11, and 272C.2, the Board of Pharmacy Examiners hereby gives Notice of Intended Action to rescind Chapter 2, “Licensure,” and adopt new Chapter 2, “Pharmacist Licenses,” and to rescind Chapter 5, “Licensure by Reciprocity,” Iowa Administrative Code.

Pursuant to Executive Order Number 8, comments, complaints, and recommendations were solicited from members of the Board and staff, from licensees and registrants, and from members of the public. Existing rules and proposed new rules were reviewed based on need, clarity, cost, fairness, intent and statutory authority. The following amendments were approved at the April 23, 2002, regular meeting of the Board of Pharmacy Examiners.

The proposed amendments rescind current rules and adopt new rules regarding licensure to practice pharmacy in Iowa. Many of the provisions included in these new rules were previously included in other chapters of Board rules. Those provisions, including requirements for licensure by reciprocity from Chapter 5, have been relocated as new rules in Chapter 2 to simplify identification of all requirements regarding pharmacist licensure. The rules address initial licensure by examination, score transfer, and license transfer and provide for licensure of graduates from foreign colleges of pharmacy. The rules also provide for renewal of pharmacist licenses and define continuing education requirements for pharmacist license renewal.

Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657— Chapter 34.

Any interested person may present written comments, data, views, and arguments on the proposed amendments not later than 4:30 p.m. on July 17, 2002. Such written materials should be sent to Terry Witkowski, Administrative Assistant, Board of Pharmacy Examiners, 400 S.W. Eighth Street,Suite E, Des Moines, Iowa 50309–4688, or by E–mail toterry.witkowski@ibpe.state.ia.us.

These amendments are intended to implement Iowa Code sections 147.10, 147.36, 147.94, 147.96, 155A.8, 155A.9, 155A.11, 155A.39, and 272C.2.

The following amendments are proposed.

ITEM 1. Rescind 657—Chapter 2 and adopt the following new chapter in lieu thereof:

CHAPTER 2
PHARMACIST LICENSES

657—2.1(147,155A) Licensure by examination. The board of pharmacy examiners, in conjunction with the National Association of Boards of Pharmacy (NABP), shall provide for the administration of pharmacist licensure examinations.

2.1(1) Components. Applicants shall take and pass the following components: the North American Pharmacist Licensure Examination (NAPLEX); the Multistate Pharmacy Jurisprudence Examination (MPJE), Iowa Edition. A total scaled score of no less than 75 is required to pass each examination.

2.1(2) Timeliness. To be eligible for a license by examination, the candidate shall pass all components in Iowa within a period of one year beginning with the date the candidate passed an initial component. A candidate may request waiver or variance from this deadline pursuant to the procedures and requirements of 657—Chapter 34.

657—2.2(155A) Application for examination—requirements. Application for examination shall be on forms provided by the board, and all requested information shall be provided on or with such application. An applicant shall complete the NABP Computerized Examination Registration Form to apply for registration to take the NAPLEX. An applicant shall complete an additional registration form to apply for registration to take the MPJE, Iowa Edition.

2.2(1) Required information. The application for examination shall require that the applicant provide the following: name; address; telephone number; mother’s maiden name; date of birth; social security number; name and location of college of pharmacy and date of graduation; one current photograph of a quality at least similar to a passport photograph; and internship experience. Each applicant shall also declare the following: history of prior pharmacist licensure examinations and record of offenses including but not limited to charges, convictions, and fines which relate to the profession or that may affect the licensee’s ability to practice pharmacy.

2.2(2) Sworn statement. The application for examination shall be made as a sworn statement before a notary public, and the notary public shall witness the signature of the applicant.

657—2.3(147,155A) Examination fee. The fee for examination shall consist of the biennial license fee, a processing fee, administration fees, and examination registration fees.

2.3(1) Fees to the board. The biennial license fee shall be the fee established by rule 2.11(147,155A), including surcharge. The processing fee shall be $40. No refunds of the processing fee shall be made for cancellation or withdrawal of applications. The license fee and processing fee shall be payable to the Iowa Board of Pharmacy Examiners and may be remitted in the form of personal check, money order, or certified check. No refund of fees shall be made for failure to complete all licensure requirements within the period specified in subrule 2.1(2).

2.3(2) Fees to NABP. The examination registration and administration fees shall be amounts determined by NABP, shall be payable to the National Association of Boards of Pharmacy, and shall be in the form of a certified check or money order. Refunds of fees paid to NABP shall be at the discretion of NABP.

2.3(3) Submission of forms and fees. The biennial license fee including surcharge, the processing fee, the administration fees, and the examination registration fees shall accompany the applications and registration forms and shall be submitted to the Board of Pharmacy Examiners, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309–4688, or as otherwise directed by the board.

657—2.4(155A) Internship requirements. Each applicant shall furnish to the board evidence certifying completion of satisfactory internship experience. Internship experience shall comply with the requirements in 657—Chapter 4.

657—2.5(155A) College graduate certification. Each applicant shall furnish a certificate from a recognized college of pharmacy stating that the applicant has successfully graduated from a school or college of pharmacy with either a bachelor of science degree in pharmacy or a doctor of pharmacy (Pharm.D.) degree. Certification shall be completed by an individual authorized by the college on a form provided by the board. A recognized college of pharmacy is an institution that meets the minimum standards of the American Council on Pharmaceutical Education and appears on its list of accredited colleges of pharmacy as published by the council as of July 1 of each year.

657—2.6(147) Reexamination applications and fees. A candidate who fails to pass the NAPLEX once shall be allowed to schedule a time to retake the examination no less than 91 days following administration of the failed examination. A candidate who fails to pass the MPJE, Iowa Edition, once shall be allowed to schedule a time to retake the examination no less than 30 days following administration of the failed examination. A candidate who fails to pass either examination following a second or subsequent examination may petition the board for permission to take the examination again. Determination of a candidate’s eligibility to take an examination more than two times shall be at the discretion of the board.

Each applicant for reexamination shall file an application on forms provided by the board. Processing fees of $30 each will be charged to take NAPLEX or MPJE, Iowa Edition, and shall be paid to the board as provided in subrule 2.3(1). In addition, candidates will be required to complete the appropriate examination registration application as provided in rule 2.2(155A) and to pay to NABP the registration and administration fees for each examination as provided in subrule 2.3(2). All applications, registration forms, and fees shall be submitted to the board as provided in subrule 2.3(3).

657—2.7(147) Examination results. Examination scores and original licensee certificates shall be provided to each new licensee as soon after the examinations as possible.

657—2.8(155A) Transfer of examination scores. The board of pharmacy examiners participates in the NAPLEX score transfer program offered by NABP. This program allows candidates for pharmacist licensure to take the standardized NAPLEX in one state and have the score from that examination transferred to other participant states in which the candidate is seeking licensure. MPJE scores cannot be transferred.

2.8(1) Score transfer application. The NAPLEX Score Transfer Form must be completed and submitted with the proper fee to NABP prior to, or postmarked no later than, the date on which the candidate takes the NAPLEX. The fee to NABP for score transfer is determined by NABP. Payment shall be made in the form of a money order or certified check payable to the National Association of Boards of Pharmacy. NABP makes no refunds of score transfer fees.

2.8(2) Requirements and deadline. Score transfer candidates shall meet the requirements established in rules 2.1(147,155A) through 2.5(155A) within 12 months of the date of transfer. No refund of fees paid to the board will be made for failure to complete all licensure requirements within this one–year period.

2.8(3) Fees. In addition to the score transfer fee identified in subrule 2.8(1), fees for licensure pursuant to the NABP score transfer program shall consist of the fees identified in rule 2.3(147,155A) excluding the NAPLEX examination registration and administration fees.

657—2.9(147,155A) Licensure by license transfer/reciprocity. An applicant for license transfer/reciprocity must be a pharmacist licensed by examination in a state or territory of the United States with which Iowa has a reciprocal agreement and the license by examination must be in good standing at the time of the application. All candidates shall take and pass the MPJE, Iowa Edition, as provided in subrule 2.1(1). Any candidate who fails to pass the examination shall be eligible for reexamination as provided in rule 2.6(147).

2.9(1) Eligibility. Each applicant for license transfer to this state who obtains the applicant’s license after January 1, 1980, must have passed the NABP Licensure Examination (NABPLEX), the NAPLEX, or an equivalent examination as determined by NABP.

a. Preliminary application. Each applicant for license transfer/reciprocity to Iowa shall complete and submit to NABP, with the appropriate fee as indicated on the application, the NABP Preliminary Application for Transfer of Pharmaceutic Licensure. Refunds of fees paid to NABP shall be at the discretion of NABP.

b. Foreign pharmacy graduates. If the applicant is a graduate of a school or college of pharmacy located outside the United States that has not been recognized and approved by the board, proof of qualifications shall include certification from the FPGEC pursuant to subrule 2.10(1).

2.9(2) Application requirements. Application to the board shall consist of the final application for license transfer prepared by NABP pursuant to the NABP license transfer program and the application for registration for the MPJE, Iowa Edition. A foreign pharmacy graduate shall submit certification from the FPGEC as provided in subrule 2.10(1). Applications, together with other required information and fees, shall be submitted to the board as provided in subrule 2.3(3).

2.9(3) MPJE required. An applicant shall also be required to submit the registration application for MPJE, Iowa Edition, as provided in rule 2.2(155A) and the registration and administration fees pursuant to subrule 2.3(2).

2.9(4) Fees. The fee for license transfer shall consist of the biennial license fee established by rule 2.11(147,155A) including surcharge and a processing fee of $50. No refunds of the processing fee shall be made for cancellation or withdrawal of an application. The license fee and processing fee shall be payable to the Iowa Board of Pharmacy Examiners and may be remitted in the form of personal check, money order, or certified check.

2.9(5) Timeliness. A final application for license transfer is valid for 12 months following the date of issuance by NABP. A candidate for license transfer shall complete, within that one–year period, all licensure requirements established by this rule. No refund of fees will be made for failure to complete all licensure requirements within this one–year period.

2.10(1) Education equivalency. Any applicant who is a graduate of a school or college of pharmacy located outside the United States that has not been recognized and approved by the board shall be deemed to have satisfied the requirements of Iowa Code section 155A.8, subsection 1, by certification by the Foreign Pharmacy Graduate Equivalency Commission (FPGEC). Each applicant shall have successfully passed the Foreign Pharmacy Graduate Equivalency Examination (FPGEE) given by the FPGEC established by the NAPB. The FPGEE is hereby recognized and approved by the board. Each applicant shall also demonstrate proficiency in written English by passing the Test of English as a Foreign Language (TOEFL) and proficiency in spoken Eng–lish by passing the Test of Spoken English (TSE). The TOEFL and TSE are hereby recognized and approved by the board. Certification by the FPGEC shall be evidence of the applicant’s successfully passing the FPGEE, TSE, and TOEFL, and certification is a prerequisite to taking the licensure examinations required in subrule 2.1(1).

2.10(2) Internship. A foreign pharmacy graduate applicant shall also be required to obtain internship experience in one or more board–licensed community or hospital pharmacies as provided in rule 657—4.7(155A). Internship requirements shall, in all other aspects, meet the requirements established in 657—Chapter 4.

657—2.11(147,155A) License expiration and renewal. A license to practice pharmacy shall expire on the second thirtieth day of June following the date of issuance of the license, except a new pharmacist license issued between April 1 and June 29, which license shall expire on the third thirtieth day of June following the date of issuance. The license renewal certificate shall be issued upon completion of the renewal application and timely payment of a $100 fee plus applicable surcharge pursuant to 657—30.8(155A).

2.11(1) Late payment penalty. Failure to renew the license before July 1 following expiration shall require a renewal fee of $200 plus applicable surcharge pursuant to 657—30.8(155A). Failure to renew the license before August 1 following expiration shall require a renewal fee of $300 plus applicable surcharge pursuant to 657— 30.8(155A). Failure to renew the license before September 1 following expiration shall require a renewal fee of $400 plus applicable surcharge pursuant to 657—30.8(155A). Failure to renew the license before October 1 following expiration may require an appearance before the board and shall require a renewal fee of $500 plus applicable surcharge pursuant to 657—30.8(155A). In no event shall the fee for late renewal of the license exceed $500 plus applicable surcharge pursuant to 657—30.8(155A). The provisions of Iowa Code section 147.11 shall apply to a license that is not renewed within five months of the expiration date.

2.11(2) Delinquent license. If a license is not renewed before its expiration date, the license is delinquent and the licensee may not practice pharmacy in the state of Iowa until the licensee reactivates the delinquent license. A pharmacist who continues to practice pharmacy in Iowa without a current license may be subject to disciplinary sanctions pursuant to the provisions of 657—subrule 36.1(4).

2.12(1) Continuing education program attendance. Continuing education programs that carry the seal of an American Council on Pharmaceutical Education (ACPE) approved provider will automatically qualify for continuing education credit. Program attendance is mandated in order to receive credit unless it is a correspondence course that ACPE approved. Requests for approval of non–ACPE provider programs shall be submitted to the board office no later than the date the program commences by the pharmacist requesting individual credit for completing the program. The request shall be made on forms provided by the board office. A pharmacist who is continuing formal education in health–related graduate programs may be exempted from meeting the continuing education requirements during the period of such enrollment. An applicant for this exemption shall petition the board, as soon as possible following enrollment in the qualifying graduate program, on forms provided by the board office.

2.12(2) Continuing education unit required. The nationally accepted measurement of continuing education is referred to as CEU (continuing education unit), and the board of pharmacy examiners employs that measurement. Ten contact hours of approved continuing education are equivalent to one CEU. The board of pharmacy examiners will require 3.0 CEUs each renewal period.

2.12(3) Continuing education program attendance certificate.

a. An approved provider will be required to make available to an individual pharmacist a certificate that indicates successful completion and participation in a continuing education program. The certificate will carry the following information:

(1) Pharmacist’s full name.

(2) Pharmacist’s license number.

(3) Number of contact hours for program attended.

(4) Date and place of continuing education program.

(5) Name of program provider.

(6) An indicator of the type or category of continuing education program completed.

b. A pharmacist must retain certificates in the pharmacist’s personal files for four years.

2.12(4) Continuing education program topics. Each pharmacist is required to obtain a minimum of 50 percent of the pharmacist’s required 3.0 continuing education units (CEUs) in ACPE–approved courses dealing with drug therapy. Programs qualifying for the drug therapy course requirement will include the ACPE topic designator “01” in the last two digits of the program number.

2.12(5) New license holders licensed by examination. After the initial license is issued by examination, the new license holder is exempt from meeting continuing education requirements for the first license renewal. Regardless of when the license is first issued, the new license holder will be required to obtain, prior to the second renewal, 30 contact hours (3.0 CEUs) of continuing education pursuant to subrules 2.12(1) through 2.12(4).

2.12(6) New license holders licensed by license transfer/reciprocity. After the initial license is issued by license transfer, the new license holder will be required to obtain, prior to the first license renewal, 30 contact hours (3.0 CEUs) of continuing education credits pursuant to subrules 2.12(1) through 2.12(4).

2.12(7) Reporting continuing education credits.

a. A pharmacist shall submit on or with the renewal application form documentation that the continuing education requirements have been met. Documentation shall be in a format that includes the following:

(1) The total number of credits accumulated for the renewal period;

(2) The individual programs attended;

(3) The dates of participation;

(4) The credits awarded for each course;

(5) The name of the provider of each course; and

(6) Identification of the programs completed to comply with the drug therapy course requirements in subrule 2.12(4).

b. The board may require a pharmacist to submit the program attendance certificates that document completion of the programs included with or on the renewal application.

c. Failure to receive the renewal application shall not relieve the pharmacist of the responsibility of meeting continuing education requirements.

2.12(8) Relicensure examination. Nothing in these rules precludes the board from requiring an applicant for renewal to submit to a relicensure examination.

2.12(9) Physical disability or illness. The board may, in individual cases involving physical disability or illness, grant waivers of the minimum continuing education requirements or extensions of time within which to fulfill the same or make the required reports. No waiver or extension of time shall be granted unless written application is made and signed by the licensee and the licensee’s physician. The board may grant waivers of the minimum continuing education requirements for physical disability or illness for any period of time not to exceed one renewal period. In the event that the physical disability or illness upon which a waiver has been granted continues beyond the period of the waiver, the licensee must reapply for an extension of the waiver. The board may, as a condition of any waiver granted, require the licensee to make up all or any portion of the waived continuing education requirements by any method prescribed by the board.

2.13(1) Active license. Active license status applies to a pharmacist who has submitted the renewal application and fee and has met Iowa requirements for continuing education or to a pharmacist who is a resident of another state, licensed to practice pharmacy in that state, and has met the continuing education requirements of that state. An Iowa licensee actively practicing in a state that does not require continuing education for license renewal shall be required to meet Iowa continuing education requirements. A pharmacist meeting the continuing education requirements of another state must provide documentation on the renewal application of the pharmacist’s license status in that state.

2.13(2) Inactive license. Failure of a pharmacist to comply with the continuing education requirements during the renewal period will result in the issuance of a renewal card marked “inactive” upon submission of the renewal application and fee. Reactivation of an inactive pharmacist license shall be accomplished by the appropriate method described below. Internship, in each instance where internship is mentioned below, shall be in a pharmacy approved by the board. The pharmacist will be issued an intern registration certificate.

a. An inactive pharmacist who wishes to become active and who has been actively practicing pharmacy during the last five years in any state or states which required continuing education during that five–year period shall submit proof of continued licensure in good standing in the state or states of such practice.

b. An inactive pharmacist who wishes to become active and who has been actively practicing pharmacy during the last five years in a state which does not require continuing education shall submit proof of continued licensure in good standing in the state or states of such practice. The pharmacist shall also complete one of the following options:

(1) Take and successfully pass the MPJE, Iowa Edition, as provided in subrule 2.1(1);

(2) Complete 160 hours of internship for each year the pharmacist was on inactive status (not to exceed 1,000 hours); or

(3) Obtain one and one–half times the number of continuing education credits required under 2.12(2) for each renewal period the pharmacist was inactive.

c. An inactive pharmacist who wishes to become active and who has not been actively practicing pharmacy during the past five years, and whose license has been inactive for not more than five years, shall complete one of the following options:

(1) Successfully pass all components of the licensure examination as required in rule 2.1(147,155A);

(2) Complete 160 hours of internship for each year the pharmacist was on inactive status; or

(3) Obtain one and one–half times the number of continuing education credits required under 2.12(2) for each renewal period the pharmacist was inactive.

d. An inactive pharmacist who wishes to become active and who has not been actively practicing pharmacy for more than five years shall petition the board for reactivation of the license to practice pharmacy under one or more of the following options:

(1) Successfully pass all components of the licensure examination as required in rule 2.1(147,155A);

(2) Complete 160 hours internship for each year the pharmacist was on inactive status (not to exceed 1,000 hours); or

(3) Obtain one and one–half times the number of continuing education credits required under 2.12(2) for each renewal period the pharmacist was inactive.

657—2.14(155A) Fees for additional license certificates. Additional original license certificates for licensed pharmacists may be obtained from the board of pharmacy examiners for a prepaid fee of $10 each. Only original license certificates issued by the board of pharmacy examiners for licensed pharmacists are valid.

These rules are intended to implement Iowa Code sections 147.10, 147.36, 147.94, 147.96, 155A.8, 155A.9, 155A.11, 155A.39, and 272C.2.

ITEM 2. Rescind and reserve 657—Chapter 5.

Pursuant to the authority of Iowa Code sections 147.76 and 155A.6, the Board of Pharmacy Examiners hereby gives Notice of Intended Action to rescind Chapter 3, “License Fees, Renewal Dates, Fees for Duplicate Licenses and Certification of Examination Scores,” and adopt new Chapter 3, “Pharmacy Technicians,” Iowa Administrative Code.

Pursuant to Executive Order Number 8, comments, complaints, and recommendations were solicited from members of the Board and staff, from licensees and registrants, and from members of the public. Existing rules and proposed new rules were reviewed based on need, clarity, cost, fairness, intent and statutory authority. The following amendment was approved at the April 23, 2002, regular meeting of the Board of Pharmacy Examiners.

The proposed amendment rescinds current Chapter 3 regarding renewal and fees for various licenses issued by the Board. The provisions of those rules have been incorporated into other revised or new chapters dealing with the individual license types. Rules regarding pharmacy technicians included in new Chapter 3 are being relocated from Chapter 22 (see ARC 1677B herein). The provisions of the new rules establish requirements and procedures for the registration of pharmacy technicians; identify who is required to register and define timely registration; and establish fees for registration and late registration. The rules also provide for the training and utilization of pharmacy technicians; identify duties which may and may not be delegated to pharmacy technicians; and identify reasons for denial of a registration and the penalties that may be imposed in the discipline of a pharmacy technician.

Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657— Chapter 34.

Any interested person may present written comments, data, views, and arguments on the proposed amendment not later than 4:30 p.m. on July 17, 2002. Such written materials should be sent to Terry Witkowski, Administrative Assistant, Board of Pharmacy Examiners, 400 S.W. Eighth Street,Suite E, Des Moines, Iowa 50309–4688, or by E–mail to terry.witkowski@ibpe.state.ia.us.

These rules are intended to implement Iowa Code sections 147.72, 155A.6, 155A.23, 155A.33, and 155A.39.

The following amendment is proposed.

Rescind 657—Chapter 3 and adopt the following new chapter in lieu thereof:

CHAPTER 3
PHARMACY TECHNICIANS

“Board” means the Iowa board of pharmacy examiners.

“Pharmacy technician” means a person who is enrolled in a technician training program or who is employed in Iowa by a licensed pharmacy under the responsibility of an Iowa–licensed pharmacist to assist in the technical functions of the practice of pharmacy, as provided in rules 3.22(155A) through 3.24(155A).

“Supervising pharmacist” means an Iowa–licensed pharmacist who is on duty in an Iowa–licensed pharmacy and who is responsible for the actions of a pharmacy technician or other supportive personnel.

“Supportive personnel” means a person, other than a licensed pharmacist, a registered pharmacist–intern, or a registered pharmacy technician, who may perform nontechnical duties assigned by the pharmacist under the pharmacist’s supervision, including but not limited to delivery, billing, cashier, and clerical functions.

657—3.2(155A) Purpose of registration. A registration program for pharmacy technicians is established for the purposes of identification, tracking, and disciplinary action. The registration shall not include any determination of the competency of the registered individual.

657—3.3(155A) Registration required. Any person employed in Iowa as a pharmacy technician, unless identified in rule 3.4(155A), shall obtain and maintain during such employment a current registration as a pharmacy technician pursuant to these rules. An individual accepting employment as a pharmacy technician in Iowa who fails to register as a pharmacy technician as provided by this rule may be subject to disciplinary sanctions as provided in rule 3.30(155A).

3.3(1) Original application required. Any person not currently registered with the board as a pharmacy technician shall complete an application for registration within 90 days of accepting employment in an Iowa pharmacy as a pharmacy technician. Such application shall be received in the board office before the expiration of this 90–day period.

3.3(2) College–based training program. A person who is enrolled in a college–based technician training program is required to obtain a pharmacy technician registration prior to beginning on–site practical experience.

3.3(3) Registration number. Each pharmacy technician registered with the board will be assigned a unique registration number.

657—3.4(155A) Registration not required. A pharmacist–intern or a licensed health care provider whose registration or license is in good standing and who assists in the technical functions of the practice of pharmacy is not required to register as a pharmacy technician.

657—3.5(155A) Certification of pharmacy technicians. The certification and recertification of pharmacy technicians shall be voluntary and not mandatory. Pharmacy technician certification does not supplant the need for licensed pharmacist control over the performance of delegated functions nor does certification exempt the pharmacy technician from registration pursuant to these rules.

657—3.6 and 3.7 Reserved.

3.8(1) Required information. The application form for a pharmacy technician registration shall require the following:

a. Information sufficient to identify the applicant including, but not limited to, name, address, date of birth, gender, and social security number;

b. Educational background;

c. Work experience;

d. Current place or places of employment;

e. Any other information deemed necessary by the board.

3.8(2) Declaration of current impairment or limitations. The applicant shall declare any current use of drugs, alcohol, or other chemical substances that in any way impairs or limits the applicant’s ability to perform the duties of a pharmacy technician with reasonable skill and safety.

3.8(3) History of felony or misdemeanor crimes. The applicant shall declare any history of being charged, convicted, found guilty of, or entering a plea of guilty or no contest to a felony or misdemeanor crime (other than minor traffic violations with fines under $100).

3.8(4) Sworn signature. The applicant shall sign the application under penalty of perjury and shall submit it to the board.

657—3.9(155A) Registration renewal. A pharmacy technician registration shall expire on the second last day of the birth month following initial registration. Registration shall not require continuing education for renewal.

3.10(1) Initial fee. The fee for obtaining an initial registration shall be $30 plus applicable surcharge pursuant to 657—30.8(155A).

3.10(2) Renewal fee. The renewal fee for obtaining a biennial registration shall be $30 plus applicable surcharge pursuant to 657—30.8(155A).

3.10(3) Timeliness. Fees shall be paid at the time the new application or the renewal application is submitted for filing.

3.10(4) Form of payment. Fee payment shall be in the form of a personal check, certified or cashier’s check, or money order payable to Iowa Board of Pharmacy Examiners.

3.11(1) Fee. A person required to register or renew the person’s registration under the provisions of Iowa Code section 155A.6 who files a late application shall pay an additional $30 late payment fee.

3.11(2) Timeliness of initial application. An application for initial registration shall be assessed a late payment fee if not received within the applicable period specified in rule 3.3(155A).

3.11(3) Timeliness of renewal application. An application for registration renewal shall be assessed a late payment fee if not received by the expiration date of that registration. If a registration is not renewed before its expiration date, the registration is delinquent and the registrant may not continue employment as a pharmacy technician until the registration is reactivated. An individual who continues employment as a pharmacy technician without a current registration may be subject to disciplinary sanctions as provided in rule 3.30(155A).

657—3.12(155A) Registration certificates. The technician shall maintain the original certificate of registration as a pharmacy technician issued by the board. Each pharmacy utilizing pharmacy technicians shall be responsible for verifying that all technicians working in the pharmacy are registered and that technician registrations remain current and active.

657—3.13(155A) Notifications to the board. A pharmacy technician shall report to the board within ten days a change of the technician’s name, address, or pharmacy employment status.

657—3.14 to 3.16 Reserved.

657—3.17(155A) Training and utilization of pharmacy technicians. All Iowa–licensed pharmacies utilizing pharmacy technicians shall develop, implement, and periodically review written policies and procedures for the training and utilization of pharmacy technicians appropriate to the practice of pharmacy. Pharmacy policies shall specify the frequency of review. Technician training shall be documented and maintained by the pharmacy for the duration of employment. Policies and procedures and documentation of technician training shall be available for inspection by the board or an agent of the board.

3.18(1) Identification badge. A pharmacy technician shall wear a visible identification badge while on duty that clearly identifies the person as a pharmacy technician and includes at least the technician’s first name.

3.18(2) Misrepresentation prohibited. A pharmacy technician shall not represent himself or herself in any manner as a pharmacist.

657—3.19 Reserved.

657—3.20(155A) Responsibility of supervising pharmacist. The ultimate responsibility for the actions of a pharmacy technician shall remain with the supervising pharmacist.

657—3.21(155A) Delegation of technical functions. A pharmacist may delegate technical dispensing functions to a pharmacy technician, but only if the pharmacist is on site when delegated functions are performed, except as provided in 657—subrule 6.7(2). The pharmacist shall provide and document the final verification for the accuracy, validity, completeness, and appropriateness of the patient’s prescription or medication order prior to the delivery of the medication to the patient or the patient’s representative.

657—3.22(155A) Technical functions. At the discretion of the supervising pharmacist, technical functions which may be delegated to a pharmacy technician include, but are not limited to, the following:

1. Performing packaging, manipulative, or repetitive tasks relating to the processing of a prescription or medication order in a licensed pharmacy.

2. Accepting prescription refill authorizations communicated to a pharmacy by a prescriber or by the prescriber’s office.

3. Contacting prescribers to obtain prescription refill authorizations.

4. Collecting pertinent patient information.

5. Inspecting drug supplies provided and controlled by an Iowa–licensed pharmacy, including but not limited to drug supplies maintained in an ambulance or other emergency medical service vehicle, a long–term care facility, a hospital nursing unit, or a hospice facility.

657—3.23(155A) Tasks a pharmacy technician shall not perform. A pharmacy technician shall not:

1. Provide the final verification for the accuracy, validity, completeness, or appropriateness of a filled prescription or medication order;

2. Conduct prospective drug use review or evaluate a patient’s medication record for purposes identified in rule 657—8.21(155A);

3. Provide patient counseling, consultation, or patient–specific drug information;

4. Make decisions that require a pharmacist’s professional judgment such as interpreting or applying information.

657—3.24(155A) New prescription drug orders or medication orders. At the discretion of the supervising pharmacist, a pharmacy technician may be allowed to accept new prescription drug orders or medication orders communicated to the pharmacy by a prescriber or by the prescriber’s agent if the pharmacy technician has received appropriate training pursuant to the pharmacy’s policies and procedures. The supervising pharmacist shall remain responsible for ensuring the accuracy, validity, and completeness of the information received by the pharmacy technician.

657—3.25 to 3.27 Reserved.

657—3.28(147,155A) Unethical conduct or practice. Violation by a pharmacy technician of any of the provisions of this rule shall constitute unethical conduct or practice and may be grounds for disciplinary action as provided in rule 3.30(155A).

3.28(1) Misrepresentative deeds. A pharmacy technician shall not make any statement tending to deceive, misrepresent, or mislead anyone, or be a party to or an accessory to any fraudulent or deceitful practice or transaction in pharmacy or in the operation or conduct of a pharmacy.

3.28(2) Confidentiality. In the absence of express written consent from the patient or written order or direction of a court, except where the best interests of the patient require, a pharmacy technician shall not divulge or reveal to any person other than the patient or the patient’s authorized representative, the prescriber or other licensed practitioner then caring for the patient, a licensed pharmacist, or a person duly authorized by law to receive such information, any of the following:

a. The contents of any prescription drug order or medication order or the therapeutic effect thereof or the nature of professional pharmaceutical services rendered to a patient;

b. The nature, extent, or degree of illness suffered by any patient; or

c. Any medical information furnished by the prescriber.

3.28(3) Discrimination. It is unethical to unlawfully discriminate between patients or groups of patients for reasons of religion, race, creed, color, gender, gender identity, sexual orientation, marital status, age, national origin, physical or mental disability, or disease state when providing pharmaceutical services.

3.28(4) Unethical conduct or behavior. A pharmacy technician shall not exhibit unethical behavior in connection with the technician’s pharmacy employment. Unethical behavior shall include, but is not limited to, the following acts: verbal or physical abuse, coercion, intimidation, harassment, sexual advances, threats, degradation of character, indecent or obscene conduct, and theft.

657—3.29(155A) Denial of registration. The board may deny an application for registration as a pharmacy technician for any violation of the laws of this state, another state, or the United States relating to prescription drugs, controlled substances, or nonprescription drugs or for any violation of Iowa Code chapter 124, 124A, 124B, 126, 147, 155A, or 205 or any rule of the board.

3.30(1) Violations. The board may impose discipline for any violation of the laws of this state, another state, or the United States relating to prescription drugs, controlled substances, or nonprescription drugs, or for any violation of Iowa Code chapter 124, 124A, 124B, 126, 147, 155A, or 205 or any rule of the board.

3.30(2) Sanctions. The board may impose the following disciplinary sanctions:

a. Revocation of a pharmacy technician registration.

b. Suspension of a pharmacy technician registration until further order of the board or for a specified period.

c. Nonrenewal of a pharmacy technician registration.

d. Prohibit permanently, until further order of the board, or for a specified period, the engaging in specified procedures, methods or acts.

e. Probation.

f. Order a physical or mental examination.

g. Impose civil penalties not to exceed $25,000.

h. Issue citation and warning.

i. Such other sanctions allowed by law as may be appropriate.

These rules are intended to implement Iowa Code sections 147.72, 155A.6, 155A.23, 155A.33, and 155A.39.

Pursuant to the authority of Iowa Code sections 147.76 and 155A.6, the Board of Pharmacy Examiners hereby gives Notice of Intended Action to amend Chapter 4, “Pharmacist–Intern Registration and Minimum Standards for Evaluating Practical Experience,” Iowa Administrative Code.

Pursuant to Executive Order Number 8, comments, complaints, and recommendations were solicited from members of the Board and staff, from licensees and registrants, and from members of the public. Existing rules and proposed new rules were reviewed based on need, clarity, cost, fairness, intent and statutory authority. The following amendments were approved at the April 23, 2002, regular meeting of the Board of Pharmacy Examiners.

The proposed amendments define “board,” “internship booklet,” and “nontraditional internship booklet” and modify other definitions for clarity. The amendments provide for the registration as a pharmacist–intern of an individual participating in a residency or fellowship program in Iowa, whether or not the individual is licensed to practice pharmacy in another state, to ensure that the individual is authorized to perform functions necessary for successful completion of the program. The amendments clarify requirements for internship eligibility and training requirements for foreign pharmacy graduates, define the term of an internship registration and provide for automatic termination of a registration under identified circumstances, and increase the one–time registration fee from $10 to $30, plus surcharge. Other amendments add catchphrases at the beginning of subrules, amend references to rules and subrules, and modify language for clarity.

Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657— Chapter 34.

Any interested person may present written comments, data, views, and arguments on the proposed amendments not later than 4:30 p.m. on July 17, 2002. Such written materials should be sent to Terry Witkowski, Administrative Assistant, Board of Pharmacy Examiners, 400 S.W. Eighth Street,Suite E, Des Moines, Iowa 50309–4688, or by E–mail to terry.witkowski@ibpe.state.ia.us.

These amendments are intended to implement Iowa Code section 155A.6.

The following amendments are proposed.

ITEM 1. Amend 657—Chapter 4, title, as follows:

CHAPTER 4
PHARMACIST–INTERN REGISTRATION AND
MINIMUM STANDARDS FOR EVALUATING
PRACTICAL EXPERIENCE PHARMACIST–INTERNS

ITEM 2. Amend rule 657—4.1(155A) as follows:

“Pharmacist–intern” or “intern” means a person enrolled in a college of pharmacy or actively pursuing a pharmacy degree, or as otherwise provided by the board, who is registered with the Iowa board of pharmacy examiners. The purpose of this registration is to obtain for the purpose of obtaining instruction in the practice of pharmacy from a preceptor pursuant to the requirements of Iowa Code section 155A.6. “Pharmacist–intern” includes a graduate of an approved college of pharmacy, or a foreign graduate who has established educational equivalency pursuant to the requirements of rule 4.7(155A), who is registered with the board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist in Iowa. “Pharmacist–intern” may include an individual participating in a residency or fellowship program in Iowa, whether or not the individual is licensed as a pharmacist in another state. Registration is required of all students enrolled in Iowa colleges of pharmacy after they have successfully completed one semester in a college of pharmacy.

“Pharmacist preceptor” or “preceptor” means a pharmacist licensed to practice pharmacy whose license is current and in good standing. Preceptors shall meet the conditions and requirements of rule 4.9(155A). No pharmacist shall serve as a preceptor while the pharmacist’s license to practice pharmacy is the subject of disciplinary sanction by a pharmacist licensing authority.

ITEM 3. Amend subrule 4.2(1) as follows:

4.2(1) Goal. The goal of internship is for the pharmacist–intern, over a period of time, to attain and build upon the knowledge, skills, responsibilities, and ability to safely, efficiently, and effectively practice pharmacy under the laws and rules of the state of Iowa.

ITEM 4. Amend subrule 4.2(2), introductory paragraph, as follows:

4.2(2) Objectives. The objectives of internship are as follows:

ITEM 5. Amend rule 657—4.3(155A) as follows:

657—4.3(155A) 1500–hour requirements. Internship cre–dit may be obtained only after internship registration with the board and successful completion of one semester in a college of pharmacy. Internship shall consist of a minimum of 1500 hours, 1000 hours of which may be a college–based clinical program approved or accepted by the board. Programs shall be structured to provide experience in community, institutional, and clinical pharmacy practices. The remaining 500 hours shall be acquired under the supervision of the preceptor one or more preceptors in a licensed pharmacy or other board–approved location, at a rate of no more than 48 hours per week. At least 250 hours shall be earned in a traditional licensed general or hospital pharmacy where the goal and objectives of internship in rule 657—4.2(155A) 4.2(155A) apply. Internship credit toward the stipulated 500 hours will not be allowed if it is acquired concurrent with academic training. “Concurrent time” means internship experience acquired while the person is a full–time student carrying, in a given school term, at least 75 percent of the average number of credit hours per term needed to graduate and receive an entry level degree in pharmacy. Credit toward the 500 hours will be granted for experience gained during recognized holiday periods, such as spring break and Christmas break. The competencies in subrule 4.2(2) shall not apply to college–based clinical programs.

ITEM 6. Amend rule 657—4.5(155A) as follows:

657—4.5(155A) Requirements for internships obtained under other state Out–of–state internship programs. Graduates from Candidates enrolled in out–of–state colleges of pharmacy will who complete the internship requirements of that state shall be deemed to have met Iowa satisfied Iowa’s internship requirements. upon presentation of documents attesting to Candidates shall submit documentation from the out–of–state internship program certifying completion of their state internship that state’s requirements. Graduates of Candidates enrolled in colleges of pharmacy located in states which have with no formal internship requirements must meet the requirements established for Iowa college of pharmacy graduates training program shall submit documentation from that state’s board of pharmacy or college of pharmacy certifying that the candidate has completed all prelicensure training requirements.

ITEM 7. Amend rule 657—4.6(155A) as follows:

4.6(1) Registration requirements and term of registration. Every person shall register with the board before beginning the person’s internship experience, whether or not for the purpose of fulfilling the requirements of rule 4.3(155A). Registration is required of all students enrolled in Iowa colleges of pharmacy after they have successfully completed one semester in the college of pharmacy. Colleges of pharmacy located in Iowa shall, at least annually, certify to the board the names of students who have successfully completed one semester in the college of pharmacy or who have withdrawn from the college of pharmacy.

4.6(2) Term of registration. Registration shall remain in effect as long as the board is satisfied that the intern is pursuing a degree in pharmacy in good faith and with reasonable diligence. A pharmacist–intern may request the intern’s registration be extended beyond the automatic termination of such the registration pursuant to the procedures and requirements of 657—Chapter 34. Registration Except as provided by the definition of pharmacist–intern in rule 4.1(155A), registration shall automatically terminate upon the earliest of any of the following:

a. Licensure to practice pharmacy in any state;

b. Lapse, exceeding one year, in the pursuit of a degree in pharmacy; or

c. One year following graduation from the college of pharmacy.

4.6(2) 4.6(3) Identification, reports, and notifications. Credit for internship time will not be granted unless registration and other required records and affidavits are completed.

a. The pharmacist–intern shall be so designated in all relationships with the public and health professionals. The While on duty in the pharmacy, the intern shall wear visible to the public a name badge or name tag with including the intern’s name and designation, pharmacist–intern or pharmacy student, clearly and visibly imprinted thereon while on duty in the pharmacy.

b. Registered interns shall notify the board office within ten days of a change of name, employment or residence address.

c. Notarized affidavits of experience in non–college–sponsored programs shall be filed with the board office within 90 days after the successful completion of the appropriate internship booklet. These affidavits shall include certification of competencies and shall certify only the number of hours and dates of training which are nonconcurrent with college of pharmacy enrollment as provided in rule 4.3(155A). An individual registered as a pharmacist–intern while participating in an Iowa residency or fellowship program shall not be required to file affidavits of experience or to submit certification of competencies.

4.6(3) 4.6(4) No credit prior to registration. Credit will not be given for internship experience obtained prior to the individual’s registration as a pharmacist–intern. Credit for Iowa college–based clinical programs (1000 hours) will not be granted unless registration is completed issued before the student begins the program.

4.6(4) 4.6(5) Nontraditional internship. Credit shall not be given for internship experience obtained at a nontraditional site or program unless the board, prior to the intern’s beginning the period of internship, approves the program. Internship training at any site which is not licensed as a general or hospital pharmacy is considered a nontraditional internship. Written application for approval of a nontraditional internship program shall include site– or program–specific competencies, consistent with the goal and objectives of internship in 657—4.2(155A) rule 4.2(155A), to be attained during that internship. Application shall be on forms provided by the board. A preceptor supervising a nontraditional internship program shall be a pharmacist, and the requirements of 657—4.9(155A) rule 4.9(155A) shall apply to all preceptors.

ITEM 8. Amend rule 657—4.7(155A) as follows:

657—4.7(155A) Foreign pharmacy graduates. Foreign pharmacy graduates who are candidates for licensure in Iowa will be required to obtain a minimum of 1500 hours of internship in a licensed pharmacy or other board–approved location. These candidates must shall register with the board as per as provided in rule 4.6(155A). Internship credit will not be granted until the candidate has been issued an intern registration card. Applications for registration must shall be accompanied by documentation certification from the Foreign Pharmacy Graduate Examination Commission (FPGEC) that the foreign pharmacy graduate has passed the Foreign Pharmacy Graduate Equivalency Examination (FPGEE), the Test of Spoken English (TSE), and the Test of English as a Foreign Language (TOEFL). The board may waive any or grant credit to a foreign pharmacy graduate, based on the candidate’s experience in the practice of pharmacy, for all or any portion of the required 1500 hours if they of internship training. The candidate shall provide detailed information regarding the candidate’s experience in the practice of pharmacy. The board shall determine, on a case–by–case basis, whether and to what extent that the candidate’s experience as a practicing pharmacist in the foreign country meets the goals and objectives established in rule 4.2(155A).

ITEM 9. Amend rule 657—4.8(155A) as follows:

657—4.8(155A) Fees. The fee for registration as apharmacist–intern is $10 $30, plus applicable surcharge pursuant to 657—30.8(155A), which fee shall be payable with the application.

ITEM 10. Amend rule 657—4.9(155A) as follows:

4.9(1) Licensed pharmacist. A preceptor shall be a licensed pharmacist in good standing pursuant to the definition of pharmacist preceptor in 657—4.1(155A) rule 4.1(155A).

4.9(2) Competencies and affidavits. A preceptor shall be responsible for initialing and dating those competencies the intern attained under the supervision of the preceptor and for completing the affidavit certifying the number of hours and the dates of each internship training period under the supervision of the preceptor.

4.9(3) Number of interns. A preceptor may supervise no more than two pharmacist–interns concurrently.

4.9(4) Responsibility. A preceptor shall be responsible for all functions performed by a pharmacist–intern.

ITEM 11. Amend rule 657—4.11(155A) as follows:

4.11(1) Grounds for discipline. The board may impose discipline for any violation of the laws of this state, another state, or the United States relating to prescription drugs, controlled substances, or nonprescription drugs, or for any violation of Iowa Code chapter 124, 124A, 124B, 126, 147, 155A, or 205, or any rule of the board.

4.11(2) Sanctions. The board may impose the following disciplinary sanctions:

a. Revocation of a pharmacist–intern registration.

b. Suspension of a pharmacist–intern registration until further order of the board or for a specified period.

c. Prohibit permanently, until further order of the board, or for a specified period, the engaging in specified procedures, methods, or acts.

d. Such other sanctions allowed by law as may be appropriate.

ITEM 12. Amend 657—Chapter 4, implementation sentence, as follows:

These rules are intended to implement Iowa Code section 155A.6.

Pursuant to the authority of Iowa Code sections 124.301, 147.76, and 155A.13, the Board of Pharmacy Examiners hereby gives Notice of Intended Action to rescind Chapter 6, “General Pharmacy Licenses,” and adopt new Chapter 6, “General Pharmacy Practice,” Iowa Administrative Code.

Pursuant to Executive Order Number 8, comments, complaints, and recommendations were solicited from members of the Board and staff, from licensees and registrants, and from members of the public. Existing rules and proposed new rules were reviewed based on need, clarity, cost, fairness, intent and statutory authority. The following amendment was approved at the April 23, 2002, regular meeting of the Board of Pharmacy Examiners.

The amendment establishes a new Chapter 6 which sets out requirements and procedures for general pharmacy practice including required pharmacy references; responsibilities of the pharmacist in charge; prescription information, label, and transfer requirements; required components of thepatient record system and patient counseling and instruction; pharmacy department security; and general pharmacyrecord–keeping requirements. The rules also provide an exemption from duplicative equipment and reference requirements for a pharmacy colocated with an existing pharmacy with immediate access to certain required equipment and references.

Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657— Chapter 34.

Any interested person may present written comments, data, views, and arguments on the proposed amendment not later than 4:30 p.m. on July 17, 2002. Such written materials should be sent to Terry Witkowski, Administrative Assistant, Board of Pharmacy Examiners, 400 S.W. Eighth Street,Suite E, Des Moines, Iowa 50309–4688, or by E–mail toterry.witkowski@ibpe.state.ia.us.

This amendment is intended to implement Iowa Code sections 124.301, 124.303, 124.306, 126.10, 126.11, 155A.6, 155A.13, 155A.27, 155A.28, 155A.31, and 155A.33 through 155A.36.

The following amendment is proposed.

Rescind 657—Chapter 6 and adopt the following new Chapter 6 in lieu thereof:

CHAPTER 6
GENERAL PHARMACY PRACTICE

657—6.1(155A) Purpose and scope. A general pharmacy is a location where a pharmacist provides pharmaceutical services or dispenses pharmaceutical products to patients in accordance with pharmacy laws. This chapter does not apply to a hospital pharmacy as defined in 657—Chapter 7. The requirements of these rules for general pharmacy practice are in addition to the requirements of 657—Chapter 8 and other rules of the board relating to services provided by the pharmacy.

657—6.2(155A) Pharmacist in charge. One professionally competent, legally qualified pharmacist in charge in each pharmacy shall be responsible for, at a minimum, the following:

1. Ensuring that the pharmacy utilizes an ongoing, systematic program for achieving performance improvement and ensuring the quality of pharmaceutical services;

2. Ensuring that the pharmacy employs an adequate number of qualified personnel commensurate with the size and scope of services provided by the pharmacy;

3. Ensuring the availability of any equipment and references necessary for the particular practice of pharmacy;

4. Ensuring that a pharmacist performs prospective drug use review as specified in rule 657—8.21(155A);

5. Ensuring that a pharmacist provides patient counseling as specified in rule 6.14(155A);

6. Dispensing drugs to patients, including the packaging, preparation, compounding, and labeling functions performed by pharmacy personnel;

7. Delivering drugs to the patient or the patient’s agent;

8. Ensuring that patient medication records are maintained as specified in rule 6.13(155A);

9. Training pharmacy technicians and supportive personnel;

10. Procuring and storing prescription drugs and devices and other products dispensed from the pharmacy;

11. Disposing of and distributing drugs from the pharmacy;

12. Maintaining records of all transactions of the pharmacy necessary to maintain accurate control over and accountability for all drugs as required by applicable state and federal laws, rules, and regulations;

13. Establishing and maintaining effective controls against the theft or diversion of prescription drugs and rec–ords for such drugs;

14. Establishing and implementing policies and procedures for all operations of the pharmacy;

15. Ensuring the legal operation of the pharmacy, including meeting all inspection and other requirements of state and federal laws, rules, or regulations governing the practice of pharmacy.

657—6.3(155A) Reference library. References may be printed or computer–accessed. A reference library shall be maintained which includes, as a minimum, one current reference from each of the following categories, including access to current periodic updates.

1. Iowa pharmacy laws, rules, and regulations.

2. A patient information reference, such as:

• USP Dispensing Information, Volume II (Advice for the Patient);

• Professional’s Guide to Patient Drug Facts by Facts and Comparisons; or

• Leaflets which provide patient information in compliance with rule 6.14(155A).

3. A reference on drug interactions, such as:

• First DataBank’s Evaluations of Drug Interactions;

• Hansten & Horn’s Drug Interactions Analysis & Management; or

• Drug Interaction Facts by Facts and Comparisons.

4. A general information reference, such as:

• Facts and Comparisons;

• USP Dispensing Information, Volume I (Drug Information for the Health Care Professional); or

• AHFS Drug Information.

5. A drug equivalency reference, such as:

• Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book);

• ABC–Approved Bioequivalency Codes; or

• USP Dispensing Information, Volume III (Approved Drug Products and Legal Requirements).

6. A reference on natural or herbal medicines, such as:

• Natural Medicines — Comprehensive Database; or

• The Review of Natural Products.

7. The readily accessible telephone number of a poison control center that serves the area.

8. Additional references as may be necessary for the pharmacist to adequately meet the needs of the patients served.

657—6.4(155A) Exemption from duplicate requirements. A pharmacy established in the same location as another licensed pharmacy and with direct and immediate access to required references, refrigerator, or sink with hot and cold running water may utilize the references, refrigerator, or sink of the other pharmacy to satisfy the requirements of rule 6.3(155A) or 657—8.5(155A), paragraphs “1” and “2.”

657—6.5 and 6.6 Reserved.

657—6.7(124,155A) Security. While on duty, each pharmacist shall be responsible for the security of the prescription department, including provisions for effective control against theft of, diversion of, or unauthorized access to prescription drugs, records for such drugs, and patient records as provided in 657—Chapter 21.

6.7(1) Department locked. The prescription department shall be locked by key or combination so as to prevent access when a pharmacist is not on site except as provided in subrule 6.7(2).

6.7(2) Temporary absence of pharmacist. In the temporary absence of the pharmacist, only the pharmacist in charge may designate persons who may be present in the prescription department to perform technical and nontechnical functions designated by the pharmacist in charge. Activities identified in subrule 6.7(3) may not be performed during such temporary absence of the pharmacist. A temporary absence is an absence of short duration not to exceed two hours. In the absence of the pharmacist, the pharmacy shall notify the public that the pharmacist is temporarily absent and that no prescriptions will be dispensed until the pharmacist returns.

6.7(3) Activities prohibited in absence of pharmacist. Activities which shall not be designated and shall not be performed during the temporary absence of the pharmacist include:

a. Dispensing or distributing any prescription drugs or devices to patients or others.

b. Providing the final verification for the accuracy, validity, completeness, or appropriateness of a filled prescription or medication order.

c. Conducting prospective drug use review or evaluating a patient’s medication record for purposes identified in rule 657—8.21(155A).

d. Providing patient counseling, consultation, or drug information.

e. Making decisions that require a pharmacist’s professional judgment such as interpreting or applying information.

f. Transferring prescriptions to or from other pharmacies.

657—6.8(124,155A) Prescription processing documentation. All prescriptions shall be dated and assigned a unique identification number that shall be recorded on the original prescription. The original prescription, whether transmitted orally, electronically, or in writing shall be retained by the pharmacy filling the prescription. Refill documentation shall include date of refill and the initials or other unique identification of the pharmacist. The name, strength, and either the manufacturer’s or distributor’s name or the National Drug Code (NDC) of the actual drug product dispensed shall be maintained and be readily retrievable.

657—6.9(124,155A) Transfer of prescription. Transfer of prescription drug order information. For the purpose of refill dispensing, the transfer of original prescription drug order information is permissible between pharmacies, subject to the following requirements:

6.9(1) Schedule III, IV, or V prescriptions. The transfer of original prescription drug order information for controlled substances listed in Schedule III, IV, or V is permissible between pharmacies on a one–time basis except as provided in subrule 6.9(9).

6.9(2) Noncontrolled substances prescriptions. The transfer of original prescription drug order information for noncontrolled prescription drugs between pharmacies is permissible as long as the number of transfers does not exceed the number of originally authorized refills.

6.9(3) Communication. The transfer is communicateddirectly between pharmacists or as authorized in subrule 6.9(9).

6.9(4) Prescriptions maintained. Both the original and the transferred prescription drug orders are maintained for a period of two years from the date of last refill.

6.9(5) Record of transfer out. The pharmacist transferring the prescription drug order information shall:

a. Invalidate the prescription drug order;

b. Record on or with the invalidated prescription drug order the following information:

(1) The name, address, and, for a controlled substance, the DEA registration number of the pharmacy to which such prescription is transferred;

(2) The name of the pharmacist receiving the prescription drug order information;

(3) The name of the pharmacist transferring the prescription drug order information; and

(4) The date of the transfer.

6.9(6) Original prescription status. The original prescription drug order shall be invalidated in the data processing system for purposes of filling or refilling, but shall be maintained in the data processing system for refill history purposes.

6.9(7) Data processing system record. The data processing system shall have a mechanism to prohibit the transfer or refilling of controlled substance prescription drug orders which have been previously transferred.

6.9(8) Record of transfer received. The pharmacist receiving the transferred prescription drug order information shall:

a. Indicate that the prescription drug order has been transferred;

b. Record on or with the transferred prescription drug order the following information:

(1) Original date of issuance and date of dispensing, if different from date of issuance;

(2) Original prescription number;

(3) Number of valid refills remaining, the date of last refill, and, for a controlled substance, the dates and locations of all previous refills;

(4) Name, address, and, for a controlled substance, the DEA registration number of the pharmacy from which such prescription drug order information is transferred;

(5) Name of the pharmacist transferring the prescription drug order information; and

(6) If transferring a controlled substance prescription from a pharmacy utilizing a shared electronic database system as described in subrule 6.9(9) to a pharmacy outside that shared system, the pharmacy name, location, DEA registration number, and prescription number from which the prescription was originally filled.

6.9(9) Electronic transfer between pharmacies. Pharmacies electronically accessing the same prescription drug order records via a real–time, on–line database may electronically transfer prescription information, including controlled substance prescription information, up to the maximum refills permitted by law and the prescriber’s authorization, if the following requirements are met.

a. The data processing system shall have a mechanism to send a message to the transferring pharmacy containing the following information:

(1) The fact that the prescription drug order was transferred;

(2) The unique identification number of the prescription drug order transferred;

(3) The name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information; and

(4) The date and time of transfer.

b. A pharmacist in the transferring pharmacy shall review the message and document the review by signing and dating a hard copy of the message or logbook containing the information required on the message as soon as practical, but in no event more than 72 hours from the time of such transfer.

c. For transfers of controlled substance prescriptions, all information requirements included in subrules 6.9(1) and 6.9(3) through 6.9(8) shall be satisfied in the electronic system. Transfers of controlled substance prescriptions shall also identify the pharmacy name, address, DEA registration number, and prescription number from which the prescription was originally filled.

6.10(1) Required information. The label affixed to or on the dispensing container of any prescription drug or device dispensed by a pharmacy pursuant to a prescription drug order shall bear the following:

a. Serial number (a unique identification number of the prescription);

b. The name, telephone number, and address of the pharmacy;

c. The name of the patient or, if such drug is prescribed for an animal, the species of the animal and the name of its owner;

d. The name of the prescribing practitioner;

e. The date the prescription is dispensed;

f. The directions or instructions for use, including precautions to be observed;

g. Unless otherwise directed by the prescriber, the label shall bear the name, strength, and quantity of the drug dispensed. If a pharmacist selects an equivalent drug product for a brand name drug product prescribed by a practitioner, the prescription container label shall identify the generic drug and may identify the brand name drug for which the selection is made. The dual identification allowed under this paragraph shall take the form of the following statement on the drug container label: “(generic name) Generic for (brand name product)”.

h. The initials of the dispensing pharmacist.

6.10(2) Exceptions. The requirements of subrule 6.10(1) do not apply to unit dose dispensing systems, 657— 22.1(155A); sterile products, 657—8.30(126,155A); and patient med paks, 657—22.5(126,155A).

657—6.11 and 6.12 Reserved.

6.13(1) Information required. A patient record system shall be maintained by all pharmacies for patients for whom prescription drug orders are dispensed. The patient record system shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispensed drugs at the time a prescription drug order is presented for dispensing. The pharmacist shall be responsible for obtaining, recording, and maintaining the following information:

a. Full name of the patient for whom the drug is intended;

b. Address and telephone number of the patient;

c. Patient’s age or date of birth;

d. Patient’s gender;

e. Known allergies;

f. Significant patient information including a list of all prescription drug orders dispensed by the pharmacy during the two years immediately preceding the most recent entry showing the name of the drug or device, prescription number, name and strength of the drug, the quantity and date received, and the name of the prescriber; and

g. Pharmacist comments relevant to the individual’s drug therapy, including:

(1) Drug reactions,

(2) Idiosyncrasies,

(3) Chronic conditions or disease states of the patient,

(4) The identity of any other drugs, over–the–counter drugs, herbals, other alternative medications, or devices currently being used by the patient that may relate to prospective drug review.

6.13(2) Record retained. A patient record shall be maintained for a period of not less than two years from the date of the last entry in the patient record. This record may be a hard copy or a computerized form.

6.13(3) Confidential. Information in the patient record shall be deemed to be confidential and may be released only as provided in rule 657—8.16(124,155A).

6.14(1) Counseling required. Upon receipt of a new prescription drug order and following a prospective drug use review pursuant to 657—8.21(155A), a pharmacist shall counsel each patient or patient’s caregiver. The counseling shall be on matters which, in the pharmacist’s professional judgment, will enhance or optimize drug therapy. Appropriate elements of patient counseling may include:

a. The name and description of the drug;

b. The dosage form, dose, route of administration, and duration of drug therapy;

c. Intended use of the drug, if known, and expected action;

d. Special directions and precautions for preparation, administration, and use by the patient;

e. Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

f. Techniques for self–monitoring drug therapy;

g. Proper storage;

h. Prescription refill information;

i. Action to be taken in the event of a missed dose;

j. Pharmacist comments relevant to the individual’s drug therapy including any other information peculiar to the specific patient or drug.

6.14(2) Instruction. A pharmacist may instruct patients and demonstrate procedures for self–monitoring of medical conditions and for self–administration of drugs.

6.14(3) Counseling area. A pharmacy shall contain an area which is suitable for confidential patient counseling. Such area shall:

a. Be easily accessible to both patient and pharmacists and not allow patient access to prescription drugs;

b. Be designed to maintain the confidentiality and privacy of the pharmacist/patient communication.

6.14(4) Oral counseling not practicable. If in the pharmacist’s professional judgment oral counseling is not practicable, the pharmacist may use alternative forms of patient information. “Not practicable” refers to patient variables including, but not limited to, the absence of the patient or patient’s caregiver, the patient’s or caregiver’s hearing impairment, or a language barrier. “Not practicable” does not include pharmacy variables such as inadequate staffing, technology failure, or high prescription volume. Alternative forms of patient information may include written information leaflets, pictogram labels, video programs, or information generated by electronic data processing equipment. When used in place of oral counseling, alternative forms of patient information shall advise the patient or caregiver that the pharmacist may be contacted for consultation in person at the pharmacy by toll–free telephone or collect telephone call. A combination of oral counseling and alternative forms of counseling is encouraged.

6.14(5) Exception. Patient counseling, as described above, shall not be required for inpatients of an institution where other licensed health care professionals are authorized to administer the drugs.

6.14(6) Refusal of consultation. A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such consultation. A patient or caregiver’s refusal of consultation shall be documented by the pharmacist. The absence of any record of a refusal of the pharmacist’s attempt to counsel shall be presumed to signify that the offer was accepted and that counseling was provided.

657—6.15(124,126) Return of drugs and other items. For the protection of the public health and safety, prescription drugs and devices, controlled substances, and items of personal contact nature may be returned to the pharmacy for reuse or resale only as herein provided:

6.15(1) Integrity maintained. Prescription drugs and devices may be returned, exchanged, or resold only if, in the professional judgment of the pharmacist, the integrity of the prescription drug has not in any way been compromised.

6.15(2) Controlled substances. Under no circumstances shall pharmacy personnel accept from a patient or a patient’s agent any controlled substances for return, exchange, or resale except to the same patient.

6.15(3) Noncontrolled substance returns. Prescription drugs, excluding controlled substances, may be returned and reused as authorized in 657—subrule 8.25(6).

6.15(4) Personal contact items. Pharmacy personnel shall not accept for reuse or resale any items of personal contact nature that have been removed from the original package or container after sale.

657—6.16(124,155A) Records. Every inventory or other record required to be kept under Iowa Code chapters 124 and 155A or rules of the board shall be kept by the pharmacy and be available for inspection and copying by the board or its representative for at least two years from the date of the inventory or record except as specifically identified by law or rule. Controlled substance records shall be maintained in a readily retrievable manner in accordance with federal requirements and 657—Chapter 10.

6.16(1) Combined records. If controlled substances, prescription drugs, or nonprescription drug items are listed on the same record, the controlled substances shall be asterisked, red–lined, or in some other manner readily identifiable from all other items appearing on the records;

6.16(2) Prescriptions maintained. The original prescription drug order shall be maintained for a period of two years following the date of last activity on the prescription;

6.16(3) Number imprinted. The original hard–copy prescription shall be imprinted with the prescription or control number assigned to the prescription drug order;

6.16(4) Alternative data retention system. Records, except when specifically required to be maintained in original or hard–copy form, may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:

a. The records maintained in the alternative system contain all of the information required on the manual record; and

b. The data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.

These rules are intended to implement Iowa Code sections 124.301, 124.303, 124.306, 126.10, 126.11, 155A.6, 155A.13, 155A.27, 155A.28, 155A.31, and 155A.33 through 155A.36.

Pursuant to the authority of Iowa Code sections 124.301, 147.76, and 155A.13, the Board of Pharmacy Examiners hereby gives Notice of Intended Action to rescind Chapter 7, “Hospital Pharmacy Licenses,” and adopt new Chapter 7, “Hospital Pharmacy Practice,” Iowa Administrative Code.

Pursuant to Executive Order Number 8, comments, complaints, and recommendations were solicited from members of the Board and staff, from licensees and registrants, and from members of the public. Existing rules and proposed new rules were reviewed based on need, clarity, cost, fairness, intent and statutory authority. This amendment was approved at the April 23, 2002, regular meeting of the Board of Pharmacy Examiners.

The proposed amendment establishes requirements and procedures for hospital pharmacy practice including required pharmacy references; responsibilities of the pharmacist in charge; drug information, control, and distribution requirements; maintenance of a patient profile system and identification of adverse drug reactions; pharmacy department security; and hospital pharmacy record–keeping requirements.

Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657— Chapter 34.

Any interested person may present written comments, data, views, and arguments on the proposed amendment not later than 4:30 p.m. on July 17, 2002. Such written materials should be sent to Terry Witkowski, Administrative Assistant, Board of Pharmacy Examiners, 400 S.W. Eighth Street,Suite E, Des Moines, Iowa 50309–4688, or by E–mail toterry.witkowski@ibpe.state.ia.us.

This amendment is intended to implement Iowa Code sections 124.301, 124.303, 124.306, 126.10, 126.11, 155A.6, 155A.13, 155A.27, 155A.28, 155A.31, and 155A.33 through 155A.36.

The following amendment is proposed.

Rescind 657—Chapter 7 and adopt the following new chapter in lieu thereof:

CHAPTER 7
HOSPITAL PHARMACY PRACTICE

657—7.1(155A) Purpose and scope. Hospital pharmacy means and includes a pharmacy licensed by the board and located within any hospital, health system, institution, or establishment which maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may or may not be admitted for overnight stay at the facility. A hospital is a facility licensed pursuant to Iowa Code chapter 135B. This chapter does not apply to a pharmacy located within such a facility for the purpose of providing outpatient prescriptions. A pharmacy providing outpatient prescriptions is and shall be licensed as a general pharmacy subject to the requirements of 657—Chapter 6. The requirements of these rules for hospital pharmacy practice are in addition to the requirements of 657—Chapter 8 and other rules of the board relating to services provided by the pharmacy.

657—7.2(155A) Pharmacist in charge. One professionally competent, legally qualified pharmacist in charge in each pharmacy shall be responsible for, at a minimum, the following:

1. Ensuring that the pharmacy utilizes an ongoing, systematic program for achieving performance improvement and ensuring the quality of pharmaceutical services;

• Where 24–hour operation of the pharmacy is not feasible, a pharmacist shall be available on an “on call” basis. Drug dispensing by nonpharmacists shall be minimized and eliminated wherever possible.

• The requirements contained in these rules apply to all hospitals, regardless of size or type. A part–time pharmacist in charge has the same obligations and responsibilities as a full–time pharmacist in charge.

2. Ensuring that the pharmacy employs an adequate number of qualified personnel commensurate with the size and scope of services provided by the pharmacy;

3. Ensuring the availability of any equipment and references necessary for the particular practice of pharmacy;

4. Ensuring that a pharmacist performs therapeutic drug monitoring and drug use evaluation;

5. Ensuring that a pharmacist provides drug information to other health professionals and to patients;

6. Dispensing drugs to patients, including the packaging, preparation, compounding, and labeling functions performed by pharmacy personnel;

7. Delivering drugs to the patient or the patient’s agent;

8. Ensuring that patient medication records are maintained as specified in rule 7.10(124,155A);

9. Training pharmacy technicians and supportive personnel;

10. Procuring and storing prescription drugs and devices and other products dispensed from the pharmacy;

11. Disposing of and distributing drugs from the pharmacy;

12. Maintaining records of all transactions of the pharmacy necessary to maintain accurate control over and accountability for all drugs as required by applicable state and federal laws, rules, and regulations;

13. Establishing and maintaining effective controls against the theft or diversion of prescription drugs, controlled substances, and records for such drugs;

14. Preparing a written operations manual governing pharmacy functions; periodically reviewing and revising those policies and procedures to reflect changes in processes, organization, and other pharmacy functions; and ensuring that all pharmacy personnel are familiar with the contents of the manual;

15. Ensuring the legal operation of the pharmacy, including meeting all inspection and other requirements of state and federal laws, rules, and regulations governing the practice of pharmacy.

657—7.3(155A) Reference library. References may be printed or computer–accessed. A reference library shall be maintained which includes, as a minimum, one current reference from each of the following categories, including access to current periodic updates.

1. Iowa pharmacy laws, rules, and regulations.

2. A patient information reference such as:

• USP Dispensing Information, Volume II (Advice for the Patient);

• Professional’s Guide to Patient Drug Facts by Facts and Comparisons; or

• Leaflets which provide patient information in compliance with rule 657—6.14(155A).

3. A reference on drug interactions such as:

• First DataBank’s Evaluations of Drug Interactions;

• Hansten & Horn’s Drug Interactions, Analysis & Management; or

• Drug Interaction Facts by Facts and Comparisons.

4. A general information reference such as:

• Facts and Comparisons;

• USP Dispensing Information, Volume I (Drug Information for the Health Care Professional); or

• AHFS Drug Information.

5. A drug equivalency reference such as:

• Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book);

• ABC – Approved Bioequivalency Codes; or

• USP Dispensing Information, Volume III (Approved Drug Products and Legal Requirements).

6. An injectable–drug compatibility reference such as:

• Betty Gahart’s Intravenous Medications; or

• Trissel’s Handbook on Injectable Drugs.

7. A drug identification reference such as:

• Mosby’s GenRx;

• Identidex by Micromedix;

• Ident–a–Drug; or

• Other drug identification reference to enable identification of drugs brought into the facility by patients.

8. The readily accessible telephone number of a poison control center that serves the area.

9. Additional references as may be necessary for the pharmacist to adequately meet the needs of the patients served. For example, the treatment of pediatric patients and oncology patients would require additional references unique to these specialties.

657—7.4 and 7.5 Reserved.

657—7.6(124,155A) Security. The pharmacy shall be located in an area or areas that facilitate the provision of services to patients and shall be integrated with the facility’s communication and transportation systems. The following conditions must be met to ensure appropriate control over drugs and chemicals in the pharmacy:

7.6(1) Pharmacist responsibility. Each pharmacist, while on duty, shall be responsible for the security of the pharmacy area, including provisions for effective control against theft of, diversion of, or unauthorized access to drugs or devices, controlled substances, records for such drugs, and patientrecords as provided in 657—Chapter 21. Policies and procedures shall identify the minimum amount of time that a pharmacist is available at the hospital pharmacy.

7.6(2) Access when pharmacist absent. Policies and procedures shall be established which identify who will have access to the pharmacy when the pharmacist is absent from the facility and the procedures to be followed for obtaining drugs and chemicals during that absence. When the pharmacist is absent from the facility, the pharmacy is closed.

7.6(3) Locked areas. All pharmacy areas where drugs or devices are maintained or stored and where a pharmacist is not continually present shall be locked.

7.6(4) Verification by pharmacist. When the pharmacy is open, patient–specific drugs or devices shall not be distributed prior to the pharmacist’s final verification and approval.

7.6(5) Drugs or devices in patient care areas. Drugs or devices maintained or stored in patient care areas shall be locked unless the patient care unit is staffed by health care personnel and the medication area is visible to staff at all times.

657—7.7 Reserved.

657—7.8(124,126,155A) Drug distribution and control. Policies and procedures governing drug distribution and control shall be developed by the pharmacist in charge with input from other involved hospital staff such as physicians and nurses, from committees such as the pharmacy and therapeutics committee or its equivalent, and from any related patient care committee. It is essential that the pharmacist in charge or designee routinely be available to or on all patient care areas to establish rapport with the personnel and to become familiar with and contribute to medical and nursing procedures relating to drugs.

7.8(1) Drug preparation. The pharmacist shall institute the control procedures needed to ensure that patients receive the correct drugs at the proper times. Adequate quality assurance procedures shall be developed.

a. All drugs dispensed by the pharmacist for administration to patients shall be in single unit packages if practicable. The need for nurses to manipulate drugs prior to their administration shall be minimized.

b. Pharmacy personnel shall, except as specified in policies and procedures, prepare all sterile products, including chemotherapy injections, continuous and intermittent intravenous preparations, and irrigation solutions, in conformance with 657—8.30(126,155A).

c. Pharmacy personnel shall compound or prepare drug formulations, strengths, dosage forms, and packages useful in the care of patients.

7.8(2) Drug formulary. The pharmacist in charge shall maintain a current formulary of drug products approved for use in the institution and shall be responsible for specifications for those drug products and for selecting their source of supply.

7.8(3) Medication orders. There shall be no manual or electronic transcribing of medication orders by nursing or clerical staffs except for their own records. Hospitalwide and pharmacy stand–alone computer systems shall be secure against unauthorized entry. The use of abbreviations and chemical symbols on medication orders shall be discouraged but, if used, shall be limited to abbreviations and chemical symbols approved by the appropriate patient care committee. All systems shall provide for review and verification by the pharmacist of the prescriber’s original order before the drug is dispensed except for emergency use.

7.8(4) Stop order. A written policy or other system concerning stop orders shall be established to ensure that medication orders are not inappropriately continued.

7.8(5) Emergency drug supplies and floor stock. Supplies of drugs for use in medical emergencies shall be immediately available at each nursing unit or service area as specified in policies and procedures. Authorized stocks shall be periodically reviewed in a multidisciplinary manner. All drug storage areas within the hospital shall be routinely inspected to ensure that no outdated or unusable items are present and that all stock items are properly labeled and stored.

7.8(6) Disaster services. The pharmacy shall be prepared to provide drugs and pharmaceutical services in the event of a disaster affecting the availability of drugs or internal access to drugs or access to the pharmacy.

7.8(7) Drugs brought into the institution. Policies and procedures shall be established governing the use of drugs brought into the institution. Procedures shall address identification of the drug and methods for ensuring the integrity of the product prior to permitting its use by the patient.

7.8(8) Samples. The use of drug samples within the institution shall be eliminated to the extent possible. Sample use is prohibited for hospital inpatient use. If the use of drug samples is permitted for hospital outpatients, that use of samples shall be controlled and the samples shall be distributed through the pharmacy or through a process developed in cooperation with the pharmacy and the institution’s appropriate patient care committee, subject to oversight by the pharmacy.

7.8(9) Investigational drugs. If investigational drugs are used in the institution:

a. A pharmacist shall be a member of the institutional review board.

b. The pharmacy shall be responsible, in cooperation with the principal investigator, for providing information about investigational drugs used in the institution and for the distribution and control of those drugs.

7.8(10) Hazardous drugs and chemicals. The pharmacist, in cooperation with other hospital staff, shall establish policies and procedures for handling drugs and chemicals that are known occupational hazards. The procedures shall maintain the integrity of the drug or chemical and protect hospital personnel.

7.8(11) Leave meds. Labeling of prescription drugs for a patient on leave from the facility for a period in excess of 24 hours shall comply with 657—subrule 6.10(1). The dispensing pharmacy shall be responsible for packaging and labeling leave meds in compliance with this subrule.

7.8(12) Discharge meds. Drugs authorized for a patient being discharged from the facility shall be labeled in compliance with 657—subrule 6.10(1) before the patient removes those drugs from the facility premises. The dispensing pharmacy shall be responsible for packaging and labeling discharge meds in compliance with this subrule.

7.8(13) Own–use outpatient prescriptions. If the hospital pharmacy dispenses own–use outpatient prescriptions, the pharmacy shall comply with all requirements for patient rec–ord systems and patient counseling as provided in rules 657—6.13(155A) and 657—6.14(155A), respectively. Prescriptions shall be labeled in compliance with 657—subrule 6.10(1), and the pharmacy shall comply with other applicable provisions of 657—Chapter 6 regarding outpatient prescription dispensing.

657—7.9(124,155A) Drug information. The pharmacy is responsible for providing the institution’s staff and patients with accurate, comprehensive information about drugs and their use and shall serve as its center for drug information.

7.9(1) Staff education. The pharmacist shall keep the institution’s staff well informed about the drugs used in the institution and their various dosage forms and packagings.

7.9(2) Patient education. The pharmacist shall help ensure that all patients are given adequate information about the drugs that they receive. This is particularly important for ambulatory, home care, and discharged patients. These patient education activities shall be coordinated with the nursing and medical staffs and patient education department, if any.

657—7.10(124,155A) Ensuring rational drug therapy. An important aspect of pharmaceutical services is that of maximizing rational drug use. The pharmacist, in concert with the medical staff, shall develop policies and procedures for ensuring the quality of drug therapy.

7.10(1) Patient profile. Sufficient patient information shall be collected, maintained, and reviewed by the pharmacist to ensure meaningful and effective participation in patient care. This requires that a drug profile be maintained for each patient receiving care at the hospital. A pharmacist–conducted drug history from patients may be useful in this regard.

a. Appropriate clinical information about patients shall be available and accessible to the pharmacist for use in daily practice.

b. The pharmacist shall review each patient’s current drug regimen and directly communicate any suggested changes to the prescriber.

7.10(2) Adverse drug events. The pharmacist, in cooperation with the appropriate patient care committee, shall develop a mechanism for the reporting and review, by the committee or other appropriate medical group, of adverse drug events. The pharmacist shall be informed of all reported adverse drug events occurring in the facility.

657—7.11 Reserved.

657—7.12(124,126,155A) Drugs dispensed to patients as a result of an emergency room visit. In those facilities with 24–hour pharmacy services, only a pharmacist or prescribing practitioner may dispense any drugs to an outpatient, including emergency department patients. In those facilities without 24–hour pharmacy services, or those facilities without outpatient pharmacy services or when the facility’s outpatient pharmacy is closed, the following procedures shall be observed in dispensing drugs:

7.12(1) Patients examined in emergency room. Drugs may be dispensed only to patients who have been examined in the emergency room.

7.12(2) Accountability. Drugs may be dispensed only in accordance with the system of control and accountability for drugs administered or dispensed from the emergency room.

a. The system shall be developed and supervised by the pharmacist in charge and the facility’s emergency department committee, or a similar group or person responsible for policy in that department.

b. The system shall identify drugs of the nature and type to meet the immediate needs of emergency room patients.

c. Controlled substances maintained in the emergency room are kept for use by, or at the direction of, prescribers in the emergency room. In order to receive a controlled substance, a patient must be examined in the emergency room by a prescriber who shall determine the need for the drug. It is not permissible under state and federal requirements for a prescriber to see a patient outside the emergency room setting, or talk to the patient on the telephone, and then proceed to call the emergency room and order the administration of a stocked controlled substance upon the patient’s arrival at the emergency room.

d. The pharmacist in charge is responsible for maintaining accurate records of dispensing of drugs from the emergency room.

7.12(3) Prepackaging. Drugs dispensed in greater than a 24–hour supply may be dispensed only in prepackaged quantities not to exceed a 72–hour supply or the minimum prepackaged quantity in suitable containers. Prepackaged drugs shall be prepared pursuant to the requirements of 657— 22.3(126). Drugs dispensed pursuant to this subrule shall be appropriately labeled as required in subrule 7.12(4), including necessary auxiliary labels.

7.12(4) Labeling. At the time of delivery of the drug, the practitioner shall appropriately complete the label, such that the dispensing container bears a label with at least the following information:

a. Name and address of the hospital;

b. Date dispensed;

c. Name of prescriber;

d. Name of patient;

e. Directions for use;

f. Name and strength of drug.

7.12(5) Delivery of drug to patient. The practitioner, or a licensed nurse under the supervision of the practitioner, shall give the appropriately labeled, prepackaged drug to the patient or patient’s caregiver and shall explain the correct use of the drug.

657—7.13(124,155A) Records. Every inventory or other record required to be kept under this chapter or other board rules or under Iowa Code chapters 124 and 155A shall be kept by the pharmacy and be available for inspection and copying by the board or its representative for at least two years from the date of such inventory or record unless a longer retention period is specified for the particular inventory or record.

7.13(1) Medication order information. Each original medication order contained in inpatient records shall bear the following information:

a. Patient name and identification number;

b. Drug name, strength, and dosage form;

c. Directions for use;

d. Date ordered;

e. Practitioner’s signature or that of the practitioner’s authorized agent.

7.13(2) Medication order maintained. The original medication order shall be maintained with the medication administration record in the medical records of the patient following discharge.

7.13(3) Documentation of drug administration. Each dose of medication administered shall be properly recorded in the patient’s medical record.

These rules are intended to implement Iowa Code sections 124.301, 124.303, 124.306, 126.10, 126.11, 155A.6, 155A.13, 155A.27, 155A.28, 155A.31, and 155A.33 through 155A.36.

Pursuant to the authority of Iowa Code sections 124.301, 147.76, 155A.13, and 155A.14, the Board of Pharmacy Examiners hereby gives Notice of Intended Action to rescind Chapter 8, “Minimum Standards for the Practice of Pharmacy,” and adopt a new Chapter 8, “Universal Practice Standards,” Iowa Administrative Code.

Pursuant to Executive Order Number 8, comments, complaints, and recommendations were solicited from members of the Board and staff, from licensees and registrants, and from members of the public. Existing rules and proposed new rules were reviewed based on need, clarity, cost, fairness, intent and statutory authority. The following amendment was approved at the April 23, 2002, regular meeting of the Board of Pharmacy Examiners.

The amendment rescinds current rules regarding pharmacy practice standards. The substance of many of the current rules is maintained in new rules within this and other chapters of Board rules, but the rules have been amended for clarity and reorganized into more logical subject groupings. The new rules establish minimum standards applicable to all pharmacies and to all pharmacists engaged in the practice of pharmacy in Iowa. These include requirements and fees for pharmacy licensure and renewal, equipment and environmental requirements for the storage of drugs in all pharmacy practice settings, record–keeping requirements, and provisions for the training and utilization of pharmacy technicians. The rules define unethical conduct in the practice of pharmacy, identify criteria necessary for the control and release of confidential information, and provide for alternative means of delivering prescription medications to patients. Requirements for prospective drug use review and for the preparation of sterile products are established. Requirements for administration of certain immunizations by pharmacists are maintained without change from the current rule.

Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657— Chapter 34.

Any interested person may present written comments, data, views, and arguments on the proposed amendment not later than 4:30 p.m. on July 17, 2002. Such written materials should be sent to Terry Witkowski, Administrative Assistant, Board of Pharmacy Examiners, 400 S.W. Eighth Street,Suite E, Des Moines, Iowa 50309–4688, or by E–mail toterry.witkowski@ibpe.state.ia.us.

This amendment is intended to implement Iowa Code sections 124.101, 124.301, 124.306, 124.308, 126.10, 126.11, 126.16, 135C.33, 147.7, 147.55, 147.72, 147.74, 147.76, 155A.2 through 155A.4, 155A.6, 155A.10, 155A.12 through 155A.15, 155A.19, 155A.20, 155A.27 through 155A.29, 155A.32, and 155A.33.

The following amendment is proposed.

Rescind 657—Chapter 8 and adopt the following new Chapter 8 in lieu thereof:

CHAPTER 8
UNIVERSAL PRACTICE STANDARDS

657—8.1(155A) Purpose and scope. The requirements of these rules apply to all Iowa–licensed pharmacists and to all pharmacies providing the services addressed in this chapter to patients in Iowa and are in addition to rules of the board relating to specific types of pharmacy licenses issued by the board.

657—8.2(155A) Pharmaceutical care. Pharmaceutical care is a comprehensive, patient–centered, outcomes–oriented pharmacy practice in which the pharmacist accepts responsibility for assisting the prescriber and the patient in optimizing the patient’s drug therapy plan and works to promote health, to prevent disease, and to optimize drug therapy. Pharmaceutical care does not include the prescribing of drugs without the consent of the prescribing practitioner.

8.2(1) Drug therapy problems. In providing pharmaceutical care, the pharmacist shall strive to identify, resolve, and prevent drug therapy problems.

8.2(2) Drug therapy plan. In providing pharmaceuti–cal care, the pharmacist shall access and evaluate patient–specific information, identify drug therapy problems, and utilize that information in a documented plan of therapy that assists the patient or the patient’s caregiver in achieving optimal drug therapy. In concert with the patient, the patient’s prescribing practitioner, and the patient’s other health care providers, the pharmacist shall assess, monitor, and suggest modifications of the plan as appropriate.

8.2(3) Eligibility. Any Iowa–licensed pharmacist may practice pharmaceutical care.

8.3(1) Pharmacy operations. The pharmacy and the pharmacist in charge share responsibility for ensuring that all operations of the pharmacy are in compliance with federal and state laws, rules, and regulations relating to pharmacy operations and the practice of pharmacy.

8.3(2) Practice functions. The pharmacist is responsible for all functions performed in the practice of pharmacy. The pharmacist maintains responsibility for any and all delegated functions including functions delegated to pharmacist–interns, pharmacy technicians, and other supportive personnel.

8.3(3) Pharmacist–documented verification. The pharmacist shall provide and document the final verification for the accuracy, validity, completeness, and appropriateness of the patient’s prescription or medication order prior to the delivery of the medication to the patient or the patient’s representative.

8.4(1) Display of pharmacist license. During any period the pharmacist is working in a pharmacy, each pharmacist shall display, in a position visible to the public, an original license to practice pharmacy. A current license renewal certificate, which may be a photocopy of an original renewal certificate, shall be displayed with the original license.

8.4(2) Identification codes. A permanent log of the initials or codes identifying by name each dispensing pharmacist, pharmacist–intern, and pharmacy technician shall be maintained for a minimum of two years and shall be available for inspection and copying by the board or its representative. The initials or identification code shall be unique to the individual to ensure that each pharmacist, pharmacist–intern, and pharmacy technician can be identified.

8.4(3) Temporary or intermittent pharmacy staff. The pharmacy shall maintain a log of all pharmacists,pharmacist–interns, and pharmacy technicians who have worked at that pharmacy and who are not regularly staffed at that pharmacy. Such log shall include the dates and shifts worked by each pharmacist, pharmacist–intern, and pharmacy technician and shall be available for inspection and copying by the board or its representative for a minimum of two years following the date of the entry.

657—8.5(155A) Environment and equipment requirements. There shall be adequate space, equipment, and supplies for the professional and administrative functions of the pharmacy. Space and equipment in an amount and type to provide secure, environmentally controlled storage of drugs shall be available.

1. Refrigeration. The pharmacy shall maintain one or more refrigeration units. The temperature of the refrigerator shall be maintained within a range compatible with the proper storage of drugs requiring refrigeration and a thermometer shall be maintained in the refrigerator to verify the temperature.

2. Sink. The pharmacy shall have a sink with hot and cold running water located within the pharmacy department and available to all pharmacy personnel; the sink shall be maintained in a sanitary condition.

3. Orderly and clean. The pharmacy shall be arranged in an orderly fashion and kept clean. All required equipment shall be in good operating condition and maintained in a sanitary manner.

4. Light and ventilation. The pharmacy shall be properly lighted and ventilated.

5. Temperature and humidity. The temperature and humidity of the pharmacy shall be maintained within a range compatible with the proper storage of drugs.

6. Other equipment. The pharmacist in charge shall ensure the availability of any other equipment necessary for the particular practice of pharmacy and to meet the needs of the patients served by the pharmacy.

657—8.6(155A) Health of personnel. Only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of the drug dispensing, preparation, compounding, or storage areas. Any person shown, either by medical examination or pharmacist determination, to have an apparent illness or open lesions that may adversely affect the quality or safety of a drug product or another individual shall be excluded from direct contact with components, bulk drug substances, drug product containers, closures, in–process materials, drug products, and patients until the condition is corrected or determined by competent medical personnel not to jeopardize the quality or safety of drug products or patients. All personnel who normally assist the pharmacist shall be instructed to report to the pharmacist any health conditions that may have an adverse effect on drug products or may pose a health or safety risk to others.

8.7(1) Source. Procurement of prescription drugs and devices shall be from a drug wholesaler licensed by the board to distribute to Iowa pharmacies or, on a limited basis, from another licensed pharmacy or licensed practitioner located in the United States.

8.7(2) Sufficient stock. A pharmacy shall maintain sufficient stock of drugs and devices to fulfill the foreseeable needs of the patients served by the pharmacy.

8.7(3) Manner of storage. Drugs and devices shall be stored in a manner to protect their identity and integrity.

8.7(4) Storage temperatures. All drugs and devices shall be stored at the proper temperature, as defined by the following terms:

a. “Controlled room temperature” means temperature maintained thermostatically between 15 degrees and 30 degrees Celsius (59 degrees and 86 degrees Fahrenheit);

b. “Cool” means temperature between 8 degrees and 15 degrees Celsius (46 degrees and 59 degrees Fahrenheit). Drugs and devices may be stored in a refrigerator unless otherwise specified on the labeling;

c. “Refrigerate” means temperature maintained thermostatically between 2 degrees and 8 degrees Celsius (36 degrees and 46 degrees Fahrenheit); and

d. “Freeze” means temperature maintained thermostatically between -20 degrees and -10 degrees Celsius (-4 degrees and 14 degrees Fahrenheit).

8.7(5) Product recall. There shall be a system for removing from use, including unit dose, any drugs and devices subjected to a product recall.

657—8.8(124,155A) Out–of–date drugs or devices. Any drug or device bearing an expiration date shall not be dispensed for use beyond the expiration date of the drug or device. Outdated drugs or devices shall be removed from dispensing stock and shall be quarantined until such drugs or devices are properly disposed of.

657—8.9(124,155A) Records. Every inventory or other record required to be maintained by a pharmacy pursuant to board rules or Iowa Code chapters 124 and 155A shall be maintained and be available for inspection and copying by the board or its representative for at least two years from the date of such inventory or record unless a longer retention period is specified for the particular record or inventory. The following records shall be maintained for at least two years.

8.9(1) Drug supplier invoices. All pharmacies shall maintain supplier invoices of prescription drugs and controlled substances upon which the actual date of receipt of the controlled substances by the pharmacist or other responsible individual is clearly recorded.

8.9(2) Drug supplier credits. All pharmacies shall maintain supplier credit memos for controlled substances and prescription drugs.

657—8.10 Reserved.

657—8.11(147,155A) Unethical conduct or practice. The provisions of this rule apply to licensed pharmacies, licensed pharmacists and registered pharmacist–interns.

8.11(1) Misrepresentative deeds. A pharmacist shall not make any statement intended to deceive, misrepresent or mislead anyone, or be a party to or an accessory to any fraudulent or deceitful practice or transaction in pharmacy or in the operation or conduct of a pharmacy.

8.11(2) Undue influence.

a. A pharmacist shall not accept professional employment or share or receive compensation in any form arising out of, or incidental to, the pharmacist’s professional activities from a prescriber of prescription drugs or any other person or corporation in which one or more such prescribers have a proprietary or beneficial interest sufficient to permit them to directly or indirectly exercise supervision or control over the pharmacist in the pharmacist’s professional responsibilities and duties or over the pharmacy wherein the pharmacist practices.

b. The prohibition in paragraph “a” shall not applyuntil April 23, 2006, to a pharmacist who is working at aprescriber–owned pharmacy location licensed as of April 23, 1981.

c. A prescriber may employ a pharmacist to provide nondispensing, drug information, or other cognitive services.

8.11(3) Lease agreements. A pharmacist shall not lease space for a pharmacy under any of the following conditions:

a. From a prescriber of prescription drugs or a group, corporation, association, or organization of such prescribers on a percentage of income basis;

b. From a group, corporation, association, or organization in which prescribers have majority control or have directly or indirectly a majority beneficial or proprietary interest on a percentage of income basis; or

c. If the rent is not reasonable according to commonly accepted standards of the community in which the pharmacy will be located.

8.11(4) Nonconformance with law. A pharmacist shall not knowingly serve in a pharmacy which is not operated in conformance with law, or which engages in any practice which if engaged in by a pharmacist would be unethical conduct.

8.11(5) Freedom of choice/solicitation/kickbacks/fee–splitting and imprinted prescription blanks or forms. Apharmacist or pharmacy shall not enter into any agreement which negates a patient’s freedom of choice of pharmacy services. A pharmacist shall not participate in agreements or arrangements with any person, corporation, partnership, association, firm, or others involving premiums, “kickbacks,” fee–splitting, or special charges in exchange for recommending, promoting, accepting, or promising to accept the professional pharmaceutical services of any pharmacist or pharmacy as compensation or inducement for placement of business or solicitation of patronage with any pharmacist or pharmacy. “Kickbacks” include, but are not limited to, medication carts, facsimile machines, any other equipment, or preprinted forms or supplies for the exclusive use of the registrant. A pharmacist shall not provide, cause to be provided, or offer to provide to any person authorized to prescribe, prescription blanks or forms bearing the pharmacist’s or pharmacy’s name, address, or other means of identification.

8.11(6) Discrimination. It is unethical to unlawfully discriminate between patients or groups of patients for reasons of religion, race, creed, color, gender, gender identity, sexual orientation, marital status, age, national origin, physical or mental disability, or disease state when providing pharmaceutical services.

8.11(7) Claims of professional superiority. A pharmacist shall not make a claim, assertion, or inference of professional superiority in the practice of pharmacy which cannot be substantiated, nor claim an unusual, unsubstantiated capacity to supply a drug or professional service to the community.

8.11(8) Unprofessional conduct or behavior. A pharmacist shall not exhibit unprofessional behavior in connection with the practice of pharmacy or refuse to provide reasonable information or answer reasonable questions for the benefit of the patient. Unprofessional behavior shall include, but not be limited to, the following acts: verbal abuse, coercion, intimidation, harassment, sexual advances, threats, degradation of character, indecent or obscene conduct, and theft.

657—8.12(126,147) Advertising. Prescription drug price and nonprice information may be provided to the public by a pharmacy so long as the information is not false or misleading and is not in violation of any federal or state laws applicable to the advertisement of such articles generally and if all of the following conditions are met:

1. All charges for services to the consumer must be stated.

2. The effective dates for the prices listed shall be stated.

3. No reference shall be made to controlled substances listed in Schedules II through V of the latest revision of the Iowa uniform controlled substances Act and the rules of the Iowa board of pharmacy examiners.

657—8.13(135C,155A) Personnel histories. Pursuant to the requirements of Iowa Code section 135C.33, the provisions of this rule shall apply to any pharmacy employing any person to provide patient care services in a patient’s home. For the purposes of this rule, “employed by the pharmacy” shall include any individual who is paid to provide treatment or services to any patient in the patient’s home, whether the individual is paid by the pharmacy or by any other entity such as a corporation, a temporary staffing agency, or an independent contractor. Specifically excluded from the requirements of this rule are individuals such as delivery persons or couriers who do not enter the patient’s home for the purpose of instructing the patient or the patient’s caregiver in the use or maintenance of the equipment, device, or drug being delivered, or who do not enter the patient’s home for the purpose of setting up or servicing the equipment, device, or drug used to treat the patient in the patient’s home.

8.13(1) Applicant acknowledgement. The pharmacy shall ask the following question of each person seeking employment in a position that will provide in–home services: “Do you have a record of founded child or dependent adult abuse or have you ever been convicted of a crime, in this state or any other state?” The applicant shall also be informed that a criminal history and dependent adult abuserecord check will be conducted. The applicant shall indicate, by signed acknowledgment, that the applicant has been informed that such record checks will be conducted.

8.13(2) Criminal history check. Prior to the employment of any person to provide in–home services as described by this rule, the pharmacy shall submit to the department of public safety a form specified by the department of public safety and receive the results of a criminal history check.

8.13(3) Abuse history checks. Prior to the employment of any person to provide in–home services as described by this rule, the pharmacy shall submit to the department of human services a form specified by the department of human services and receive the results of a dependent adult abuse rec– ord check. The pharmacy may submit to the department of human services a form specified by the department of human services to request a child abuse history check.

a. A person who has a criminal record, founded dependent adult abuse report, or founded child abuse report shall not be employed by a pharmacy to provide in–home services unless the department of human services has evaluated the crime or founded abuse report, has concluded that the crime or founded abuse does not merit prohibition from such employment, and has notified the pharmacy that the person may be employed to provide in–home services.

b. The pharmacy shall keep copies of all record checks and evaluations for a minimum of two years following receipt of the record or for a minimum of two years after the individual is no longer employed by the pharmacy, whichever is greater.

657—8.14(155A) Training and utilization of pharmacy technicians. All Iowa–licensed pharmacies utilizing pharmacy technicians shall develop, implement, and periodically review written policies and procedures for the training and utilization of pharmacy technicians appropriate to the practice of pharmacy at that licensed location. Pharmacy policies shall specify the frequency of review. Technician training shall be documented and maintained by the pharmacy for the duration of employment. Policies and procedures and documentation of technician training shall be available for inspection by the board or an agent of the board.

657—8.15(155A) Delivery of prescription drugs and devices. Prescription drug orders, prescription devices, and completed prescription drug containers may be delivered, in compliance with all laws, rules, and regulations relating to the practice of pharmacy, to patients at any place of business licensed as a pharmacy.

8.15(1) Alternative methods. A licensed pharmacy may, by means of its employee or by use of a common carrier, pick up or deliver prescriptions to the patient or the patient’s caregiver as follows:

a. At the office or home of the prescriber;

b. At the residence of the patient or caregiver;

c. At the hospital or medical care facility in which a patient is confined; or

d. At the patient’s or caregiver’s place of employment only pursuant to the following requirements:

(1) The pharmacy shall obtain and maintain the written consent of the patient or patient’s caregiver for receipt or delivery at the place of employment;

(2) The prescription shall be delivered directly to or received directly from the patient, the caregiver, or an authorized agent identified in the written consent; and

(3) The pharmacy shall ensure the security of confidential information as defined in subrule 8.16(1).

8.15(2) Policies and procedures required. Every pharmacy shipping or otherwise delivering prescription drugs or devices to Iowa patients shall develop and implement policies and procedures to ensure accountability, safe delivery, and compliance with temperature requirements as defined by subrule 8.7(4).

8.16(1) Definition. “Confidential information” means information accessed or maintained by the pharmacy in the patient’s records which contains personally identifiable information that could be used to identify the patient. This includes but is not limited to patient name, address, telephone number, and social security number; prescriber name and address; and prescription and drug or device information such as therapeutic effect, diagnosis, allergies, disease state, pharmaceutical services rendered, medical information, and drug interactions, regardless of whether such information is communicated to or from the patient, is in the form of paper, is preserved on microfilm, or is stored on electronic media.

8.16(2) Release of confidential information. Confidential information in the patient record may be released only as follows:

a. Pursuant to the express written consent or release of the patient or the order or direction of a court.

b. To the patient or the patient’s authorized representative.

c. To the prescriber or other licensed practitioner then caring for the patient.

d. To another licensed pharmacist when the best interests of the patient require such release.

e. To the board or its representative or to such other persons or governmental agencies duly authorized by law to receive such information.

A pharmacist shall utilize the resources available to determine, in the professional judgment of the pharmacist, that any persons requesting confidential patient information pursuant to this rule are entitled to receive that information.

8.16(3) Exceptions. Nothing in this rule shall prohibit pharmacists from releasing confidential patient information as follows:

a. Transferring a prescription to another pharmacy upon the request of the patient or the patient’s authorized representative.

b. Providing a copy of a nonrefillable prescription to the person for whom the prescription was issued which is clearly marked as a copy and not to be filled.

c. Providing drug therapy information to physicians or other authorized prescribers for their patients.

8.16(4) System security and safeguards. To maintain the integrity and confidentiality of patient records and prescription drug orders, any system or computer utilized shall have adequate security including system safeguards designed to prevent and detect unauthorized access, modification, or manipulation of patient records and prescription drug orders.

8.16(5) Record disposal. Disposal of any materials containing or including patient–specific or confidential information shall be conducted in a manner to preserve patient confidentiality.

657—8.17 and 8.18 Reserved.

657—8.19(124,126,155A) Manner of issuance of a prescription drug or medication order. A prescription drug order or medication order may be transmitted from a prescriber to a pharmacy in written form, orally including telephone voice communication, or by electronic transmission in accordance with applicable federal and state laws and rules. Any prescription drug order or medication order provided to a patient in written or printed form shall include the original, hand–written signature of the prescriber.

8.19(1) Verification. The pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of any prescription drug order or medication order consistent with federal and state laws and rules. In exercising professional judgment, the prescribing practitioner and the pharmacist shall take adequate measures to guard against the diversion of prescription drugs and controlled substances through prescription forgeries.

8.19(2) Transmitting agent. The prescribing practitioner may authorize an agent to transmit to the pharmacy a prescription drug order or medication order orally or by electronic transmission provided that the identity of the transmitting agent is included in the order.

8.19(3) Receiving agent. Regardless of the means of transmission to a pharmacy, only a pharmacist, a pharmacist–intern, or a pharmacy technician shall be authorized to receive a prescription drug or medication order from a practitioner or the practitioner’s agent.

8.19(4) Legitimate purpose. The pharmacist shall ensure that the prescription drug or medication order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner acting in the usual course of the practitioner’s professional practice.

657—8.20(155A) Valid prescriber/patient relationship. Prescription drug orders and medication orders shall be valid as long as a prescriber/patient relationship exists. Once the prescriber/patient relationship is broken and the prescriber is no longer available to treat the patient or oversee the patient’s use of a prescription drug, the order loses its validity and the pharmacist, on becoming aware of the situation, shall cancel the order and any remaining refills. The pharmacist shall, however, exercise prudent judgment based upon individual circumstances to ensure that the patient is able to obtain a sufficient amount of the prescribed drug to continue treatment until the patient can reasonably obtain the service of another prescriber and a new order can be issued.

657—8.21(155A) Prospective drug use review. For purposes of promoting therapeutic appropriateness and ensuring rational drug therapy, a pharmacist shall review the patientrecord, information obtained from the patient, and each prescription drug or medication order to identify:

1. Overutilization or underutilization;

2. Therapeutic duplication;

3. Drug–disease contraindications;

4. Drug–drug interactions;

5. Incorrect drug dosage or duration of drug treatment;

6. Drug–allergy interactions;

7. Clinical abuse/misuse;

8. Drug–prescriber contraindications.

Upon recognizing any of the above, the pharmacist shall take appropriate steps to avoid or resolve the problem and shall, if necessary, include consultation with the prescriber. The review and assessment of patient records shall not be delegated to staff assistants but may be delegated to registered pharmacist–interns under the direct supervision of the pharmacist.

657—8.22 to 8.29 Reserved.

8.30(1) Definitions. For the purpose of this rule, the following definitions shall apply:

“Aseptic preparation” means the use of procedures that are designed to preclude contamination by microorganisms during processing.

“Batch preparation” means the compounding or repackaging of non–patient–specific multiple units in anticipation of patient needs.

“Class 100 condition” means an environment in which air particle count does not exceed a total of 100 particles of 0.5 microns and larger per cubic foot.

“Compounding” means the constitution, reconstitution, combination, dilution, or another process causing a change in the form, composition, or strength of any ingredient or any other attribute of a product.

“Critical area” means the area where sterilized products or containers are exposed to the environment during aseptic preparation.

“Hazardous drug” means a pharmaceutical that is antineoplastic, carcinogenic, mutagenic, or teratogenic.

“Home care patient” means a patient in the home environment or a patient in a nursing or residential facility or institution who receives products from a pharmacy located outside the facility or institution.

“Manipulating” means the process of opening and closing the sterile field of a product for adjustment or attachment.

“Repackaging” means the subdivision or transfer of a product from a container or device into a different container or device.

“Sterile product” means a drug or nutritional substance that is free from living microorganisms and is compounded, manipulated, or repackaged by pharmacy personnel, using aseptic technique and other quality assurance procedures.

8.30(2) Personnel and training.

a. Pharmacist.

(1) Each pharmacy shall have a pharmacist responsible for supervising the preparation of sterile products compounded, repackaged, or manipulated within the pharmacy.

(2) The pharmacist shall have the responsibility for the compounding, repackaging, or manipulating of all sterile products, including education and training of all personnel concerning proper aseptic technique, incompatibility, and provision of proper incompatibility information.

(3) When any part of these processes is not under direct pharmacy supervision, the pharmacist shall have the responsibility for providing written guidelines and for approving the procedures to ensure that all pharmaceutical requirements are met.

b. Nonpharmacists.

(1) Only technical functions may be performed by nonpharmacists and only under the supervision of a pharmacist.

(2) A pharmacist shall ensure the accuracy of the sterile product prepared by a nonpharmacist prior to administration or dispensing to the patient.

c. Training. All personnel involved in compounding, repackaging, or manipulating sterile products, including pharmacists, pharmacist–interns, pharmacy technicians, and nurses, shall receive documented on–the–job training and related education commensurate with the tasks they are to perform prior to the regular performance of those tasks. Personnel shall understand and follow written policies and procedures for preparing and handling sterile products.

8.30(3) Reference requirements. References may be printed or computer–accessed. In addition to requirements set forth in rule 657—6.3(155A), 657—7.3(155A), 657— 15.4(155A), or 657—16.5(155A), as appropriate, all pharmacies involved in the preparation of sterile products shall maintain a minimum of one current reference, including access to current periodic updates, from each of the following categories:

a. A general information reference such as American Hospital Formulary Service, Drug Information or comparable type reference.

b. An injectable drug compatibility reference such as Trissel’s Handbook of Injectable Drugs or comparable type reference.

8.30(4) Policies and procedures. A pharmacy providing sterile products shall prepare and maintain current policies and procedures and shall ensure their ready availability to all personnel involved with sterile product preparation. Policies and procedures shall be available for inspection by the board or agents of the board and shall include, but not be limited to, the following:

a. Compounding, dispensing, and delivery of sterile products.

b. Quality assurance programs for the purpose of monitoring personnel qualifications, training, and performance.

c. Product integrity.

d. Equipment and facilities.

e. Guidelines regarding patient education.

8.30(5) Labeling requirements for patient–specific sterile products. At the time of delivery of the sterile product, the dispensing container shall bear a label with at least the following information:

a. Name and quantity of all contents.

b. Patient’s name.

c. For home care patient prescriptions, unique serial number or prescription number.

d. Preparer’s initials.

e. Stability (expiration) date and time (if pertinent) as set forth in the pharmacy’s policy and procedure manual.

f. The prescribed flow rate in ml/hr, if applicable.

g. Auxiliary labels as needed.

8.30(6) Labeling requirements for batch–prepared sterile products for later dispensing. Each container of a batch product prepared in anticipation of later dispensing shall bear a label with at least the following information:

a. Name and quantity of all contents.

b. Internal code to identify the date and time of preparation and the preparer’s and pharmacist’s initials.

c. Stability (expiration) date and time (if pertinent) as set forth in the pharmacy’s policy and procedure manual.

d. Auxiliary labels as needed.

8.30(7) Space, equipment, and access. There shall be appropriate space and equipment suitable for the preparation of sterile products and other drug compounding and packaging operations. An appropriate sterile preparation hood or room, certified annually, shall be accessible to and utilized by personnel for the preparation of IV solutions and other sterile products.

a. The preparation area shall be structurally isolated from general work and storage areas.

b. The preparation area shall be utilized only for the preparation of sterile products or drugs requiring aseptic preparation.

c. The laminar airflow hood, room, or other devices used in the preparation of sterile products shall be capable of maintaining a critical area meeting Class 100 conditions during normal activity.

d. Disposal containers for hazardous drugs and wastes, including materials from patients’ homes if applicable, shall be available.

e. Pumping devices shall be available as needed.

f. Supplies and attire adequate to maintain an environment suitable for the aseptic preparation of sterile products shall be available and shall be appropriately utilized.

g. A sink with hot and cold running water, with bactericidal soap available for the purpose of hand scrubs, shall be maintained convenient to the area for preparing sterile products.

8.30(8) Drugs added to parenteral, enteral, or irrigation solutions. Whenever drugs are added to parenteral, enteral, or irrigation solutions, whether within or outside the direct and personal supervision of a licensed pharmacist, the admixture shall be labeled with a distinctive supplementary label indicating the following information:

a. The patient’s name;

b. The drug name, dosage, and strength per unit/volume of the drug added;

c. The date and time of addition or dilution;

d. The expiration date, administration time, and infusion rate when applicable; and

e. The identity of the person adding the drug.

If the drug is intended for addition, dilution, or reconstitution in a facility by a licensed nurse outside the direct and personal supervision of a pharmacist, specific directions for dilution, reconstitution, or addition shall accompany the drug.

8.30(9) Additional requirements for the sterile preparation of hazardous drugs.

a. All hazardous drugs shall be compounded in a vertical flow biological safety cabinet. Other product preparation may not be done concurrently in this cabinet.

b. Protective apparel, including disposable gloves and gowns with tight cuffs, shall be worn by personnel compounding hazardous drugs.

c. Safety containment techniques for compounding hazardous drugs shall be used in conjunction with the aseptic techniques required for preparing sterile products.

d. Disposal of hazardous waste shall comply with applicable federal and state laws and regulations.

e. Written procedures for handling both major and minor spills of hazardous drugs shall be developed and maintained with the policies and procedures required in 8.30(4).

f. Prepared doses of hazardous drugs shall be dispensed and labeled inside and outside with precautions and shall be distributed in a manner to minimize the risk of accidental rupture or spilling of the primary container.

8.30(10) Additional records required. The pharmacy shall maintain records of lot numbers of the nonsterile components used in compounding sterile products.

8.30(11) Environmental controls for sterile products. The pharmacy shall ensure the environmental control of all sterile products in a manner that maintains sanitation, required storage temperatures, and exposure to light at the following times:

a. While the products are held in the pharmacy.

b. At the time of delivery to a patient.

c. During storage of products in the patient’s home, if applicable.

8.30(12) Quality assurance. To monitor personnel performance, equipment, and facilities, a pharmacy shall have a documented, ongoing quality assurance control program that includes the following as a minimum:

a. Certification of all clean rooms and laminar flow hoods by an independent contractor for operational efficiency at least annually with records of certification to be maintained for two years.

b. Written procedures requiring sampling if microbial contamination is suspected.

c. End–product testing, including tests for particulate matter and testing for pyrogens, which is documented prior to the release of the product from quarantine if batch preparation of sterile products is performed using nonsterile chemicals.

d. Written justification of the chosen expiration dates for compounded products.

e. Documentation of quality assurance audits at planned intervals based upon the needs of individual patients, including infection control and sterile technique audits.

f. Documentation that infusion devices provided by the pharmacy for the administration of sterile products have received biomedical maintenance to provide for proper care, cleaning, and operation of the equipment.

8.30(13) Responsibilities for patient care. The pharmacy and pharmacist have the following responsibilities:

a. The pharmacist shall be knowledgeable of the roles of the physician, patient, pharmacy, and home health care provider, if applicable, related to delivery of care and the monitoring of the patients.

b. The pharmacy shall have a pharmacist accessible at all times to respond to questions and needs of another health professional or a patient.

c. The pharmacist shall use the clinical and laboratory data of each patient to monitor initial and ongoing drug therapy. If the pharmacist does not have access to the data, the name of the health care provider assuming responsibility for monitoring drug therapy shall be documented in the patient’s profile.

d. The pharmacist shall report to the prescribing physician any knowledge of unexpected or untoward response to drug therapy.

8.30(14) Patient training. If sterile products are provided to the patient in the home, the pharmacist shall verify the patient’s or caregiver’s training and competence in managing therapy. A pharmacist shall be involved, directly or indirectly, in training patients about drug compounding, labeling, storage, stability, or incompatibility. The pharmacist shall verify that the patient’s or caregiver’s competence is reassessed at intervals appropriate to the condition of the patient and type of drug therapy provided.

657—8.31 Reserved.

657—8.32(124,155A) Individuals qualified to administer. The board designates the following as qualified individuals to whom a practitioner may delegate the administration of prescription drugs. Any person specifically authorized under pertinent sections of the Iowa Code to administer prescription drugs shall construe nothing in this rule to limit that authority.

1. Persons who have successfully completed a medication administration course.

2. Licensed pharmacists.

657—8.33(147,155A) Supervision of pharmacists who administer adult immunizations. A physician may prescribe via written protocol adult immunizations for influenza and pneumococcal vaccines for administration by an authorized pharmacist if the physician meets these requirements for supervising the pharmacist.

8.33(1) Definitions.

a. “Authorized pharmacist” means an Iowa–licensed pharmacist who has documented that the pharmacist has successfully completed an educational program meeting the training standards on vaccine administration as provided by an American Council on Pharmaceutical Education (ACPE)–approved provider of continuing pharmaceutical education that:

(1) Requires documentation by the pharmacist of current certification in the American Heart Association or the Red Cross Basic Cardiac Life Support Protocol for health care providers;

(2) Is an evidence–based course that includes study material and hands–on training and techniques for administering vaccines, requires testing with a passing score, complies with current Centers for Disease Control and Prevention guidelines, and provides instruction and experiential training in the following content areas:

1. Standards for immunization practices;

2. Basic immunology and vaccine protection;

3. Vaccine–preventable diseases;

4. Recommended immunization schedules;

5. Vaccine storage and management;

6. Informed consent;

7. Physiology and techniques for vaccine administration;

8. Pre– and post–vaccine assessment and counseling;

9. Immunization record management; and

10. Management of adverse events, including identification, appropriate response, documentation, and reporting.

b. “Vaccine” means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

c. “Written protocol” means a physician’s order for one or more patients that contains, at a minimum, the following:

(1) A statement identifying the individual physician authorized to prescribe drugs and responsible for the delegation of administration of adult immunizations for influenza and pneumococcus;

(2) A statement identifying the individual authorized pharmacists;

(3) A statement that forbids an authorized pharmacist from delegating the administration of adult immunizations to anyone other than another authorized pharmacist or a registered nurse;

(4) A statement identifying the vaccines that may be administered by an authorized pharmacist, the dosages, and the route of administration;

(5) A statement identifying the activities an authorized pharmacist shall follow in the course of administering adult immunizations, including:

1. Procedures for determining if a patient is eligible to receive the vaccine;

2. Procedures for determining the appropriate scheduling and frequency of drug administration in accordance with applicable guidelines;

3. Procedures for record keeping and long–term record storage including batch or identification numbers;

4. Procedures to follow in case of life–threatening reactions; and

5. Procedures for the pharmacist and patient to follow in case of reactions following administration.

(6) A statement that describes how the authorized pharmacist shall report the administration of adult immunizations, within 30 days, to the physician issuing the written protocols and to the patient’s primary care physician if one has been designated by the patient. In case of serious complications, the authorized pharmacist shall notify the physicians within 24 hours and submit a VAERS report to the bureau of immunizations, Iowa department of public health. (VAERS is the Vaccine Advisory Event Reporting System.) A serious complication is one that requires further medical or therapeutic intervention to effectively protect the patient from further risk, morbidity, or mortality.

8.33(2) Supervision. A physician who prescribes adult immunizations to an authorized pharmacist for administration shall adequately supervise that pharmacist. Physician supervision shall be considered adequate if the delegating physician:

a. Ensures that the authorized pharmacist is prepared as described in subrule 8.33(1), paragraph “a”;

b. Provides a written protocol that is updated at least annually;

c. Is available through direct telecommunication for consultation, assistance, and direction, or provides physician backup to provide these services when the physician supervisor is not available;

d. Is an Iowa–licensed physician who has a working relationship with an authorized pharmacist within the physician’s local provider service area.

8.33(3) Administration of other adult immunizations by pharmacists. A physician may prescribe, for an individual patient by prescription or medication order, other adult immunizations to be administered by an authorized pharmacist.

This rule is intended to implement Iowa Code sections 147.76, 155A.3, 155A.4, and 272C.3.

657—8.34 Reserved.

657—8.35(155A) Pharmacy license. A pharmacy license issued by the board is required for all sites where prescription drugs are offered for sale or dispensed under the supervision of a pharmacist. A pharmacy license issued by the board is also required for all sites where drug information or other cognitive pharmacy services, including but not limited to drug use review and patient counseling, are provided by a pharmacist. The board may issue any of the following types of pharmacy licenses: a general pharmacy license, a hospital pharmacy license, a special or limited use pharmacy license, or a nonresident pharmacy license. Nonresident pharmacy license applicants shall comply with board rules regarding nonresident pharmacy practice except when specific exemptions have been granted. Applicants for general or hospital pharmacy practice shall comply with board rules regarding general or hospital pharmacy practice except when specific exemptions have been granted. Any pharmacy located within Iowa that dispenses controlled substances must also register pursuant to 657—Chapter 10.

8.35(1) Exemptions. Applicants who are granted exemptions shall be issued a “general pharmacy license with exemption,” a “hospital pharmacy license with exemption,” a “nonresident pharmacy license with exemption,” or a “limited use pharmacy license with exemption” and shall comply with the provisions set forth by that exemption. A written petition for exemption from certain licensure requirements shall be submitted pursuant to the procedures and requirements of 657—Chapter 34 and will be determined on a case–by–case basis.

8.35(2) Limited use pharmacy license. Limited use pharmacy license may be issued for nuclear pharmacy practice, correctional facility pharmacy practice, and veterinary pharmacy practice. Applications for limited use pharmacy license for these and other limited use practice settings shall be determined on a case–by–case basis.

8.35(3) Application form. Application for licensure and license renewal shall be on forms provided by the board. The application for a pharmacy license shall require an indication of the pharmacy ownership classification. If the owner is a sole proprietorship (100 percent ownership), the name and address of the owner shall be indicated. If the owner is a partnership or limited partnership, the names and addresses of all partners shall be listed or attached. If the owner is a corporation, the names and addresses of the officers and directors of the corporation shall be listed or attached. Any other pharmacy ownership classification shall be further identified and explained on the application. The application form shall require the name, signature, and license number of the pharmacist in charge. The names and license numbers of all pharmacists engaged in practice in the pharmacy, the names and registration numbers of all pharmacy technicians working in the pharmacy, and the average number of hours worked by each pharmacist and each pharmacy technician shall be listed or attached. Additional information may be required of specific types of pharmacy license applicants. The application shall be signed by the pharmacy owner or the owner’s, partnership’s, or corporation’s authorized representative.

8.35(4) License expiration and renewal. General pharmacy licenses, hospital pharmacy licenses, special or limited use pharmacy licenses, and nonresident pharmacy licenses shall be renewed before January 1 of each year. The fee for a new or renewal license shall be $100.

a. Late payment penalty. Failure to renew the pharmacy license before January 1 following expiration shall require a renewal fee of $200. Failure to renew the license before February 1 following expiration shall require a renewal fee of $300. Failure to renew the license before March 1 following expiration shall require a renewal fee of $400. Failure to renew the license before April 1 following expiration shall require a renewal fee of $500 and may require an appearance before the board. In no event shall the fee for late renewal of a pharmacy license exceed $500.

b. Delinquent license. If a license is not renewed before its expiration date, the license is delinquent and the licensee may not operate or provide pharmacy services to patients in the state of Iowa until the licensee renews the delinquent license. A pharmacy that continues to operate in Iowa without a current license may be subject to disciplinary sanctions pursuant to the provisions of 657—subrule 36.1(4).

8.35(5) Inspection of new pharmacy location. If the new pharmacy location within Iowa was not a licensed pharmacy immediately prior to the proposed opening of the new pharmacy, the pharmacy location shall require an on–site inspection by a pharmacy board inspector prior to the issuance of the pharmacy license. The purpose of the inspection is to determine compliance with requirements pertaining to space, library, equipment, security, temperature control, and drug storage safeguards. Inspection may be scheduled anytime following submission of necessary license and registration applications and prior to opening for business as a pharmacy. Prescription drugs, including controlled substances, may not be delivered to a new pharmacy location prior to satisfactory completion of the opening inspection.

8.35(6) Pharmacy license changes. When a pharmacy changes its name, location, ownership, or pharmacist in charge, a new pharmacy license application with a $100 license fee shall be submitted to the board office. Upon receipt of the fee and properly completed application, the board will issue a new pharmacy license certificate. The old license certificate shall be returned to the board office within 10 days of the change of name, location, ownership, or pharmacist in charge.

a. A change of pharmacy location in Iowa shall require an on–site inspection of the new location as provided in subrule 8.35(5) if the new location was not a licensed pharmacy immediately prior to the relocation.

b. A change of ownership of a currently licensed Iowa pharmacy, or a change of pharmacy location to another existing Iowa pharmacy location, shall not require on–site inspection pursuant to subrule 8.35(5). A new pharmacy license is required as provided above. In those cases in which the pharmacy is owned by a corporation, the sale or transfer of all stock of the corporation does not constitute a change of ownership provided the corporation that owns the pharmacy continues to exist following the stock sale or transfer.

c. A change of pharmacist in charge shall require completion and submission of the application and fee for new pharmacy license within 90 days following the vacancy.

8.35(7) Pharmacy closing. At least two weeks prior to the closing of a pharmacy, a written notice shall be sent to the board and to the Drug Enforcement Administration (DEA) notifying those agencies of the intent to discontinue business or sell the pharmacy including the anticipated date of sale or closing.

a. Prior notification shall include the name, address, DEA registration number, Iowa pharmacy license number, and Iowa controlled substances Act (CSA) registration number of the closing pharmacy and of the pharmacy to which prescription drugs will be transferred. Notification shall also include the name, address, DEA registration number, Iowa pharmacy license number, and CSA registration number of the location at which prescription files, patient profiles, and controlled substance receipt and disbursement records will be maintained.

b. A complete inventory of all prescription drugs being transferred shall be taken as of the close of business. The inventory shall serve as the ending inventory for the closing pharmacy as well as a record of additional or starting inventory for the pharmacy to whom the drugs are transferred. A copy of the inventory shall be included in the records of each licensee.

(1) DEA Form 222 is required for transfer of Schedule II controlled substances.

(2) The inventory of controlled substances shall becompleted pursuant to the requirements in 657— 10.35(124,155A).

(3) The inventory of all noncontrolled prescription drugs may be estimated.

(4) The inventory shall include the name, strength, dosage form, and quantity of all prescription drugs transferred.

(5) Controlled substances requiring destruction or other disposal shall be transferred in the same manner as all other drugs. The new owner is responsible for the disposal of these substances as provided in rule 657—10.18(124).

c. The license certificate and CSA certificate of the closing or selling pharmacy shall be returned to the board office within 10 days of closing or sale. The DEA registration certificate and all unused DEA Forms 222 shall be returned to the DEA.

d. A location that no longer houses a licensed pharmacy shall not display any sign, placard, or other notification, visible to the public, which identifies the location as a pharmacy. A sign or other public notification that cannot feasibly be removed shall be covered so as to conceal the identification as a pharmacy.

These rules are intended to implement Iowa Code sections 124.101, 124.301, 124.306, 124.308, 126.10, 126.11, 126.16, 135C.33, 147.7, 147.55, 147.72, 147.74, 147.76, 155A.2 through 155A.4, 155A.6, 155A.10, 155A.12 through 155A.15, 155A.19, 155A.20, 155A.27 through 155A.29, 155A.32, and 155A.33.

Pursuant to the authority of Iowa Code sections 124.301, 126.2, and 147.76, the Board of Pharmacy Examiners hereby gives Notice of Intended Action to rescind Chapter 10, “Controlled Substances (Drugs),” and adopt new Chapter 10, “Controlled Substances,” and to rescind Chapter 18, “Anabolic Steroids,” Iowa Administrative Code.

Pursuant to Executive Order Number 8, comments, complaints, and recommendations were solicited from members of the Board and staff, from licensees and registrants, and from members of the public. Existing rules and proposed new rules were reviewed based on need, clarity, cost, fairness, intent and statutory authority. The following amendments were approved at the April 23, 2002, regular meeting of the Board of Pharmacy Examiners.

The proposed amendments rescind current rules regarding controlled substances. Existing rules are confusing and disorganized. Procedures currently addressed by office policy have been incorporated into the new rules. The amendments also rescind rules identifying anabolic steroids. These substances are now classified as controlled substances and therefore need not be separately defined in Chapter 18.

The new rules identify individuals and business entities requiring registration under the Iowa Uniform Controlled Substances Act and include requirements for registration, fees for registration and renewal, and term of registration. The rules include prescription, record keeping, reporting, disposal, inventory, and security requirements for controlled substances in the possession of various types of registrants. Procedures for denial, modification, suspension, and revocation of a registration, including grounds for those administrative actions, are identified. The rules also provide for the revision of controlled substances schedules, for the temporary designation of a drug as a controlled substance, identify excluded substances, and define anabolic steroid.

Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657— Chapter 34.

Any interested person may present written comments, data, views, and arguments on the proposed amendments not later than 4:30 p.m. on July 17, 2002. Such written materials should be sent to Terry Witkowski, Administrative Assistant, Board of Pharmacy Examiners, 400 S.W. Eighth Street,Suite E, Des Moines, Iowa 50309–4688, or by E–mail toterry.witkowski@ibpe.state.ia.us.

These amendments are intended to implement Iowa Code sections 124.201, 124.301 to 124.308, 124.402, 124.403, 124.501, 126.2, 126.11, 147.88, 147.95, 147.99, 155A.13, 155A.17, 155A.26, 155A.37, and 205.3.

The following amendments are proposed.

ITEM 1. Rescind 657—Chapter 10 and adopt the following new chapter in lieu thereof:

CHAPTER 10
CONTROLLED SUBSTANCES

657—10.1(124) Who shall register. Any person or busi–ness located in Iowa who manufactures, distributes, dispenses, prescribes, imports or exports, conducts research or instructional activities, or conducts chemical analysis with controlled substances in the state of Iowa, or who proposes to engage in such activities with controlled substances in the state, shall obtain and maintain a registration issued by the board unless exempt from registration pursuant to rule 10.6(124). A person or business required to be registered shall not engage in any activity for which registration is required until the application for registration is granted and the board has issued a certificate of registration to such person or business.

Manufacturers, distributors, importers and exporters, individual practitioners (M.D., D.O., D.D.S., D.V.M., D.P.M., O.D., P.A., resident physician, advanced registered nurse practitioner), pharmacies, hospitals and animal shelters, care facilities, researchers and dog trainers, analytical laboratories, and teaching institutions shall register on forms provided by the board office. To be eligible to register, individual practitioners must hold a current, active license in good standing, issued by the appropriate Iowa professional licensing board, to practice their profession in Iowa.

657—10.2(124) Application forms. Application forms may be obtained from the Board of Pharmacy Examiners, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309–4688. Forms are also available on the board’s Web site, www.state.ia.us/ibpe. Registration renewal forms will be mailed to each registrant approximately 60 days before the expiration date of the registration. A registrant who has not received a renewal form 45 days before the expiration date of the registration is responsible for contacting the board to request an application.

10.2(1) Signature requirements. Each application, attachment, or other document filed as part of an application shall be signed by the applicant as follows:

a. If the applicant is an individual practitioner, the practitioner shall sign the application and supporting documents.

b. If the applicant is a business, the application and supporting documents shall be signed by the person ultimately responsible for the security and maintenance of controlled substances at the registered location.

10.2(2) Submission of multiple applications. Any person or business required to obtain more than one registration may submit all applications in one package. Each application shall be complete and shall not refer to any accompanying application or any attachment to an accompanying application for required information.

657—10.3(124) Registration and renewal. For each registration or timely renewal of a registration to manufacture, distribute, dispense, prescribe, import or export, conduct research or instructional activities, or conduct chemical analysis with controlled substances listed in Schedules I through V of Iowa Code chapter 124, registrants shall pay a biennial fee of $50.

10.3(1) Time and method of payment. Registration and renewal fees shall be paid at the time the application for registration or renewal is submitted. Payment should be made in the form of a personal, certified, or cashier’s check or a money order made payable to the Iowa Board of Pharmacy Examiners. Payments made in the form of foreign currency or third–party endorsed checks will not be accepted.

10.3(2) Late renewal. Any registered person or business may apply, on forms provided by the board office, for registration renewal not more than 60 days prior to the expiration of the registration. Failure to renew a registration prior to the first day of the month following expiration shall require a renewal fee of $100. Payment shall be made as specified in subrule 10.3(1).

657—10.4(124) Exemptions—registration fee. The registration fee is waived for federal, state, and local law enforcement agencies and for the following federal and state institutions: hospitals, health care or teaching institutions, and analytical laboratories authorized to possess, manufacture, distribute, and dispense controlled substances in the course of official duties.

10.4(1) Law enforcement officials. In order to enable law enforcement agency laboratories to obtain and transfer controlled substances for use as standards in chemical analysis, such laboratories shall maintain a registration to conduct chemical analysis. Such laboratories shall be exempt from payment of a fee for registration.

10.4(2) Registration and duties not exempt. Exemption from payment of a registration or registration renewal fee as provided in this rule does not relieve the agency or institution of registration nor of any other requirements or duties prescribed by law.

657—10.5(124) Separate registration for independentactivities; coincident activities. The following activities are deemed to be independent of each other and shall require separate registration. Any person or business engaged in more than one of these activities shall be required to separately register for each independent activity, provided, however, that registration in an independent activity shall authorize the registrant to engage in activities identified coincident with that independent activity.

10.5(1) Manufacturing controlled substances. A person or business registered to manufacture controlled substances in Schedules I through V may distribute any substances for which registration to manufacture was issued. A person or business registered to manufacture controlled substances in Schedules II through V may conduct chemical analysis and preclinical research, including quality control analysis, with any substances listed in those schedules for which the person or business is registered to manufacture.

10.5(2) Distributing controlled substances. This independent activity includes the delivery, other than by administering or dispensing, of controlled substances listed in Schedules I through V. No coincident activities are authorized.

10.5(3) Dispensing or instructing with controlled substances. This independent activity includes, but is not limited to, prescribing by individual practitioners, dispensing by pharmacies and hospitals, and conducting instructional activities with controlled substances listed in Schedules II through V. A person or business registered for this independent activity may conduct research and instructional activities with those substances for which the person or business is registered to the extent authorized under state law.

10.5(4) Conducting research with controlled substances listed in Schedule I. A researcher may manufacture or import the substances for which registration was issued provided that such manufacture or import is permitted under the federal Drug Enforcement Administration (DEA) registration. A researcher may distribute the substances for which registration was issued to persons or businesses registered or authorized to conduct research with that class of substances or registered or authorized to conduct chemical analysis with controlled substances.

10.5(5) Conducting research with controlled substances listed in Schedules II through V. A researcher may conduct chemical analysis with controlled substances in those schedules for which registration was issued, may manufacture such substances if and to the extent such manufacture is permitted under the federal DEA registration, and may import such substances for research purposes. A researcher may distribute controlled substances in those schedules for which registration was issued to persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances, and to persons exempted from registration pursuant to Iowa Code subsection 124.302(3), and may conduct instructional activities with controlled substances.

10.5(6) Conducting chemical analysis with controlled substances. A person or business registered to conduct chemical analysis with controlled substances listed in Schedules I through V may manufacture and import controlled substances for analytical or instructional activities; may distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempt from registration pursuant to Iowa Code subsection 124.302(3); may export such substances to persons in other countries performing chemical analysis or enforcing laws relating to controlled substances or drugs in those countries; and may conduct instructional activities with controlled substances.

10.5(7) Importing or exporting controlled substances. A person or business registered to import controlled substances listed in Schedules I through V may distribute any substances for which such registration was issued.

657—10.6(124) Separate registrations for separate locations; exemption from registration. A separate registration is required for each principal place of business or professional practice location where controlled substances are manufactured, distributed, imported, exported, or dispensed unless the person or business is exempt from registration pursuant to Iowa Code subsection 124.302(3) or this rule.

10.6(1) Warehouse. A warehouse where controlled substances are stored by or on behalf of a registered person or business shall be exempt from registration except as follows:

a. Registration of the warehouse shall be required if such controlled substances are distributed directly from that warehouse to registered locations other than the registered location from which the substances were delivered to the warehouse.

b. Registration of the warehouse shall be required if such controlled substances are distributed directly from that warehouse to persons exempt from registration pursuant to Iowa Code subsection 124.302(3).

10.6(2) Sales office. An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised shall be exempt from registration. Such office shall not contain controlled substances, except substances used for display purposes or for lawful distribution as samples, and shall not serve as a distribution point for filling sales orders.

10.6(3) Prescriber’s office. An office used by a prescriber who is registered at another location and where controlled substances are prescribed but where no supplies of controlled substances are maintained shall be exempt from reg–istration. However, a prescriber who practices at more than one office location where controlled substances are administered or otherwise dispensed as a regular part of the prescriber’s practice shall register at each location wherein the prescriber maintains supplies of controlled substances.

10.6(4) Prescriber in hospital. A prescriber who is registered at another location and who treats patients and may order the administration of controlled substances in a hospital other than the prescriber’s registered practice location shall not be required to obtain a separate registration for the hospital.

10.6(5) Affiliated interns, residents, or foreign physi–cians. An individual practitioner who is an intern, resident, or foreign physician may dispense and prescribe controlled substances under the registration of the hospital or other institution which is registered and by whom the registrant is employed provided that:

a. The hospital or other institution by which the individual practitioner is employed has determined that the practitioner is permitted to dispense or prescribe drugs by the appropriate licensing board;

b. Such individual practitioner is acting only in the scope of employment in the hospital or institution;

c. The hospital or other institution authorizes the intern, resident, or foreign physician to dispense or prescribe under the hospital registration and designates a specific internal code number, letters, or combination thereof which shall be appended to the institution’s DEA registration number, preceded by a hyphen (e.g., AP1234567–10 or AP1234567–12); and

d. The hospital or institution maintains a current list of internal code numbers identifying the corresponding individual practitioner, available for the purpose of verifying the authority of the prescribing individual practitioner.

657—10.7 to 10.9 Reserved.

657—10.10(124,147,155A) Inspection. The board may inspect, or cause to be inspected, the establishment of an applicant or registrant. The board shall review the application for registration and other information regarding an applicant or registrant in order to determine whether the applicant or registrant has met the applicable standards of Iowa Code chapter 124 and these rules.

657—10.11(124) Modification or termination of registration. A registered individual or business may apply to modify a current registration as provided by this rule.

10.11(1) Change of substances authorized. Any registrant may apply to modify the substances authorized by the registration by submitting a written request to the board. The request shall include the registrant’s name, address, telephone number, registration number, and the substances or schedules to be added to or removed from the registration and shall be signed by the same person who signed the most recent application for registration or registration renewal. No fee shall be required for the modification.

10.11(2) Change of address of registered location.

a. Individual practitioner, researcher, analytical laboratory, or teaching institution. An entity registered under these classifications may apply to change the address of the registered location by submitting a written request to the board. The request shall include the registrant’s name, current address, new address, telephone number, effective date of the address change, and registration number, and shall be signed by the registered individual practitioner or the same person who signed the most recent application for registration or registration renewal. No fee shall be required for the modification.

b. Pharmacy, hospital, care facility, manufacturer, distributor, importer, or exporter. An entity registered under these classifications shall apply to change the address of the registered location by submitting a completed application for registration. Applications may be obtained and shall be submitted as provided in rule 657—10.2(124). A fee of $50 shall accompany each completed application.

10.11(3) Change of registrant’s name.

a. Individual practitioner, researcher, analytical laboratory, or teaching institution. An entity registered under these classifications may apply to change the registrant’s name by submitting a written request to the board. The request shall include the registrant’s current name, the new name, address, telephone number, effective date of the name change, and registration number, and shall be signed by the registered individual practitioner or the same person who signed the most recent application for registration or registration renewal. No fee shall be required for the modification. Change of name, as used in this paragraph, refers to a change of the legal name of the registrant and does not authorize the transfer of a registration issued to an individual practitioner or researcher to another individual practitioner or researcher.

b. Pharmacy, hospital, care facility, manufacturer, distributor, importer, or exporter. An entity registered under these classifications shall apply to change the registrant name by submitting a completed application for registration. Applications may be obtained and shall be submitted as provided in rule 657—10.2(124). A fee of $50 shall accompany each completed application.

10.11(4) Change of ownership of registered business entity. A change of immediate ownership of a pharmacy, hospital, care facility, manufacturer, distributor, analytical laboratory, teaching institution, importer, or exporter shall require the completion of an application for registration. Applications may be obtained and shall be submitted as provided in rule 657—10.2(124). A fee of $50 shall accompany each completed application.

10.11(5) Change of responsible individual. Any registrant, except an individual practitioner, a researcher, a hospital, or a pharmacy, may apply to change the responsible individual authorized by the registration by submitting a written request to the board. The request shall include the registrant’s name, address, telephone number, the name and title of the current responsible individual and of the new responsible individual, the effective date of the change, and the registration number, and shall be signed by the new responsible individual. No fee shall be required for the modification.

a. Individual practitioners and researchers. Responsibility under a registration issued to an individual practitioner or researcher shall remain with the named individual practitioner or researcher. The responsible individual under such registration may not be changed.

b. Pharmacies and hospitals. The responsible pharmacist may execute a power of attorney for DEA order forms to change responsibility under the registration issued to the pharmacy or hospital. The power of attorney shall include the name, address, DEA registration number, and Iowa uniform controlled substances Act (CSA) registration number of the registrant. The power of attorney shall identify the current and new responsible individuals and shall authorize the new responsible individual to execute applications and official DEA order forms to requisition Schedule II controlled substances. The power of attorney shall be signed by both individuals, shall be witnessed by two adults, and shall be maintained by the registrant and available for inspection or copying by representatives of the board or other state or federal authorities.

10.11(6) Termination of registration. A registration issued to an individual shall terminate upon the death of the individual. A registration issued to an individual or business shall terminate when the registered individual or business ceases legal existence, discontinues business, or discontinues professional practice.

10.12(1) Grounds for suspension or revocation. The board may suspend or revoke any registration upon a finding that the registrant:

a. Has furnished false or fraudulent material information in any application filed under this chapter;

b. Has had the registrant’s federal registration to manufacture, distribute, or dispense controlled substances suspended or revoked;

c. Has been convicted of a public offense under any state or federal law relating to any controlled substance. For the purpose of this section only, a conviction shall include a plea of guilty, a forfeiture of bail or collateral deposited to secure a defendant’s appearance in court which forfeiture has not been vacated, or a finding of guilt in a criminal action even though entry of the judgment or sentence has been withheld and the individual has been placed on probation;

d. Has committed such acts as would render the registrant’s registration under Iowa Code section 124.303 inconsistent with the public interest as determined by that section;

e. Has been subject to discipline by the registrant’s respective professional licensing board and the discipline revokes, suspends, or modifies the registrant’s authority regarding controlled substances (including, but not limited to, limiting or prohibiting the registrant from prescribing or handling controlled substances). A certified copy of the rec–ord of licensee discipline or a copy of the licensee’s surrender of the professional license shall be conclusive evidence.

10.12(2) Limited suspension or revocation. If the board finds grounds to suspend or revoke a registration, the board may limit revocation or suspension of the registration to the particular controlled substance with respect to which the grounds for revocation or suspension exist. If the revocation or suspension is limited to a particular controlled substance or substances, the registrant shall be given a new certificate of registration for all substances not affected by revocation or suspension; no fee shall be required for the new certificate of registration. The registrant shall deliver the old certificate of registration to the board.

10.12(3) Denial of registration or registration renewal. If upon examination of an application for registration or registration renewal, including any other information the board has or receives regarding the applicant, the board determines that the issuance of the registration would be inconsistent with the public interest, the board shall serve upon the applicant an order to show cause why the registration should not be denied.

10.12(4) Considerations in denial of registration. In determining the public interest, the board shall consider all of the following factors:

a. Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific, or industrial channels.

b. Compliance with applicable state and local law.

c. Any convictions of the applicant under any federal and state laws relating to any controlled substance.

d. Past experience in the manufacture or distribution of controlled substances, and the existence in the applicant’s establishment of effective controls against diversion.

e. Furnishing by the applicant of false or fraudulent material in any application filed under this chapter.

f. Suspension or revocation of the applicant’s federal registration to manufacture, distribute, or dispense controlled substances as authorized by federal law.

g. Any other factors relevant to and consistent with the public health and safety.

10.12(5) Order to show cause. Before denying, modifying, suspending, or revoking a registration, the board shall serve upon the applicant or registrant an order to show cause why the registration should not be denied, modified, revoked, or suspended. The order to show cause shall contain a statement of the basis therefor and shall call upon the applicant or registrant to appear before an administrative law judge or the board at a time and place not less than 30 days after the date of service of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted. If the order to show cause involves the possible denial of registration renewal, the order shall be served not later than 30 days before the expiration of the registration. Proceedings to refuse renewal of registration shall not abate the existing registration, which shall remain in effect pending the outcome of the administrative hearing unless the board issues an order of immediate suspension pursuant to subrule 10.12(9).

10.12(6) Hearing requested. If an applicant or registrant who has received an order to show cause desires a hearing on the matter, the applicant or registrant shall file a request for a hearing within 30 days after the date of service of the order to show cause. If a hearing is requested, the board shall hold a hearing pursuant to 657—Chapter 35 at the time and place stated in the order and without regard to any criminal pros–ecution or other proceeding. Unless otherwise ordered by the board, an administrative law judge employed by the department of inspections and appeals shall be assigned to preside over the case and to render a proposed decision for the board’s consideration.

10.12(7) Waiver of hearing. If an applicant or registrant entitled to a hearing on an order to show cause fails to file a request for hearing, or if the applicant or registrant requests a hearing but fails to appear at the hearing, the applicant or registrant shall be deemed to have waived the opportunity for a hearing unless the applicant or registrant shows good cause for such failure.

10.12(8) Final board order when hearing waived. If an applicant or registrant entitled to a hearing waives or is deemed to have waived the opportunity for a hearing, the executive secretary/director of the board may cancel the hearing and issue, on behalf of the board, the board’s final order on the order to show cause.

10.12(9) Order of immediate suspension. The board may suspend any registration simultaneously with the service upon the registrant of an order to show cause why such registration should not be revoked or suspended if it finds there is an imminent danger to the public health or safety that warrants such action. If the board suspends a registration simultaneously with the service of the order to show cause upon the registrant, it shall serve an order of immediate suspension containing a statement of its findings regarding the danger to public health or safety upon the registrant with the order to show cause. The suspension shall continue in effect until the conclusion of the proceedings, including judicial review thereof, under the provisions of the Iowa administrative procedures Act, unless sooner withdrawn by the board or dissolved by the order of the district court or an appellate court.

10.12(10) Disposition of controlled substances. If the board suspends or revokes a registration, the registrant shall promptly return the certificate of registration to the board. Also, upon service of the order of the board suspending or revoking the registration, the registrant shall deliver all affected controlled substances in the registrant’s possession to the board or authorized agent of the board. Upon receiving the affected controlled substances from the registrant, the board or its authorized agent shall place all such substances under seal and retain the sealed controlled substances pending final resolution of any appeals or until a court of competent jurisdiction directs otherwise. No disposition may be made of the substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a court, upon application, orders the sale of perishable substances and the deposit of proceeds of the sale with the court. Upon a revocation order becoming final, all such controlled substances may be forfeited to the state.

10.12(11) Notifications. The board shall promptly notify the Drug Enforcement Agency of the United States Department of Justice and the Iowa department of public safety of all orders suspending or revoking registration and all forfeitures of controlled substances.

657—10.13 and 10.14 Reserved.

657—10.15(124,155A) Security requirements. All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a person has provided effective controls against diversion, the board shall use the security requirements set forth in these rules as standards for the physical security controls and operating procedures necessary to prevent diversion.

10.15(1) Physical security. Physical security controls shall be commensurate with the schedules and quantity of controlled substances in the possession of the registrant in normal business operation. A registrant shall periodically review and adjust security measures based on rescheduling of substances or changes in the quantity of substances in the possession of the registrant.

a. Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.

b. Controlled substances listed in Schedules II through V may be stored in a securely locked, substantially constructed cabinet. However, pharmacies and hospitals may disperse these substances throughout the stock of noncontrolled substances in a manner so as to obstruct the theft or diversion of the controlled substances.

10.15(2) Factors in evaluating physical security systems. In evaluating the overall security system of a registrant or applicant necessary to maintain effective controls against theft or diversion of controlled substances, the board may consider any of the following factors it deems relevant to the need for strict compliance with the requirements of this rule:

a. The type of activity conducted;

b. The type, form, and quantity of controlled substances handled;

c. The location of the premises and the relationship such location bears to security needs;

d. The type of building construction comprising the facility and the general characteristics of the building or buildings;

e. The type of vault, safe, and secure enclosures available;

f. The type of closures on vaults, safes, and secure enclosures;

g. The adequacy of key control systems or combination lock control systems;

h. The adequacy of electronic detection and alarm systems, if any;

i. The adequacy of supervision over employees having access to controlled substances, to storage areas, or to manufacturing areas;

j. The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;

k. The procedures for handling business guests, visitors, maintenance personnel, and nonemployee service personnel;

l. The availability of local police protection or of the registrant’s or applicant’s security personnel; and

m. The adequacy of the registrant’s or applicant’s system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances.

10.15(3) Manufacturing and compounding storage areas. Raw materials, bulk materials awaiting further processing, and finished products which are controlled substances listed in any schedule shall be stored pursuant to federal laws and regulations.

657—10.16(124) Report of theft or loss of controlled substances. A registrant shall report in writing, on forms provided by the board, any theft or significant loss of any controlled substance upon discovery of the theft or loss. The report shall be submitted to the board office within two weeks of the discovery of the theft or loss. Thefts shall be reported whether or not the controlled substances are subsequently recovered or the responsible parties are identified and action taken against them. A copy of the report shall be maintained in the files of the registrant.

657—10.17(124) Accountability of stock supply. An individual who administers a controlled substance from a non–patient–specific, stock supply in an institutional setting shall personally document on a separate readily retrievable record system each dose administered, wasted, or returned to the pharmacy. Such documentation shall not be delegated to another individual. Wastage documentation shall include the signature of a witnessing licensed health care practitioner.

Distribution records for non–patient–specific, floor–stocked controlled substances shall bear the following information:

• Patient’s name;

• Prescriber who ordered drug;

• Name of drug, dosage form, and strength;

• Time and date of administration to patient and quantity administered;

• Signature or unique electronic signature of individual administering controlled substance;

• Returns to the pharmacy;

• Waste, which is required to be witnessed and cosigned by another licensed health care practitioner.

657—10.18(124) Disposal. Any persons legally authorized to possess controlled substances in the course of their professional practice or the conduct of their business shall dispose of such drugs pursuant to the procedures and requirements of this rule. Disposal records shall be maintained in the files of the registrant.

10.18(1) Registrant stock supply. Pharmacy personnel, registrants, and registrant staff shall remove from current inventory and dispose of controlled substances by one of the following procedures.

a. The responsible individual shall utilize the services of a DEA–registered and Iowa–licensed disposal firm.

b. The board may authorize and instruct the registrant to dispose of the controlled substances in one of the following manners:

(1) By delivery to an agent of the board or to the board office;

(2) By destruction of the drugs in the presence of a board officer, agent, inspector, or other authorized individual; or

(3) By such other means as the board may determine to ensure that drugs do not become available to unauthorized persons.

10.18(2) Previously dispensed controlled substances. Controlled substances dispensed to or for a patient and subsequently requiring destruction due to discontinuance of the drug, death of the patient, or other reasons necessitating destruction may be destroyed or otherwise disposed of by a pharmacist in witness of one other responsible adult pursuant to this subrule. All licenses and registrations issued to the pharmacy, the pharmacist, and any individual witnessing the destruction or other disposition shall not be subject to sanctions relating to controlled substances at the time of the destruction or disposition. The individuals involved in the destruction or other disposition shall not have been subject to any criminal, civil, or administrative action relating to violations of controlled substances laws, rules, or regulations within the past five years. The pharmacist in charge shall be responsible for designating pharmacists authorized to participate in the destruction or other disposition pursuant to this subrule. The authorized pharmacist shall prepare and maintain in the pharmacy a readily retrievable record of the destruction or other disposition, which shall be clearly marked to indicate the destruction or other disposition of noninventory or patient drugs. The record shall include, at a minimum, the following:

a. Source of the controlled substance (patient identifier or administering practitioner, if applicable, and date of return);

b. The name, strength, and dosage form of the substance;

c. The quantity returned and destroyed or otherwise disposed;

d. The date the substance is destroyed or otherwise disposed;

e. The signatures or other unique identification of the pharmacist and the witness.

657—10.19 and 10.20 Reserved.

657—10.21(124,126,155A) Prescription requirements. All prescriptions for controlled substances shall be dated as of, and manually signed on, the day issued. Controlled substances prescriptions shall be valid for six months following date of issue.

10.21(1) Form of prescription. All prescriptions shall bear the full name and address of the patient; the drug name, strength, dosage form, quantity prescribed, and directions for use; and the name, address, and DEA registration number of the prescriber. All prescriptions issued by individual prescribers shall include the legibly preprinted, typed, or hand–printed name of the prescriber as well as the prescriber’s signature. When an oral order is not permitted, prescriptions shall be written with ink, indelible pencil, or typed print and shall be manually signed by the prescriber. A secretary or agent may prepare a prescription for the signature of the prescriber but the prescribing practitioner is responsible for the accuracy, completeness, and validity of the prescription. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by this rule.

10.21(2) Verification by pharmacist. The pharmacist shall verify the authenticity of the prescription with the individual prescriber in each case when a prescription for a Schedule II controlled substance is presented for filling and neither the prescribing individual practitioner issuing the prescription nor the patient or patient’s agent is known to the pharmacist. The pharmacist is required to record the manner by which the prescription was verified and include the pharmacist’s name or initials.

10.21(3) Intern, resident, foreign physician. An intern, resident, or foreign physician exempted from registration pursuant to subrule 10.6(5) shall include on all prescriptions issued the hospital’s registration number and the special internal code number assigned by the hospital in lieu of the prescriber’s registration number required by this rule. Each prescription shall include the stamped or printed name of the intern, resident, or foreign physician as well as the prescriber’s signature.

10.21(4) Valid prescriber/patient relationship. Once the prescriber/patient relationship is broken and the prescriber is no longer available to treat the patient or to oversee the patient’s use of the controlled substance, a prescription shall lose its validity. A prescriber/patient relationship shall be broken when the prescriber dies, retires, or moves out of the local service area or when the prescriber’s authority to prescribe is suspended, revoked, or otherwise modified to exclude authority for the schedule in which the prescribed substance is listed. The pharmacist, upon becoming aware of the situation, shall cancel the prescription and any remaining refills. However, the pharmacist shall exercise prudent judgment based upon individual circumstances to ensure that the patient is able to obtain a sufficient amount of the drug to continue treatment until the patient can reasonably obtain the service of another prescriber and a new prescription can be issued.

10.21(5) Schedule II prescriptions. With appropriate verification, a pharmacist may add information provided by the patient or patient’s agent, such as the patient’s address, to a Schedule II controlled substance prescription. A pharmacist shall never change the patient’s name, the controlled substance prescribed except for generic substitution, or the name or signature of the prescriber. After consultation with the prescribing practitioner and documentation of such consultation, a pharmacist may change or add the following information on a Schedule II controlled substance prescription:

a. The drug strength;

b. The dosage form;

c. The drug quantity;

d. The directions for use; and

e. The date the prescription was issued.

10.22(1) Emergency situation defined. For the purposes of authorizing an oral or electronically transmitted prescription for a Schedule II controlled substance listed in Iowa Code section 124.206, the term “emergency situation” means those situations in which the prescribing practitioner determines that all of the following apply:

a. Immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user.

b. No appropriate alternative treatment is available, including administration of a drug that is not a Schedule II controlled substance.

c. It is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance prior to the dispensing.

10.22(2) Requirements of emergency prescription. In the case of an emergency situation as defined herein, a pharmacist may dispense a controlled substance listed in Schedule II pursuant to an electronic transmission or upon receiving oral authorization of a prescribing individual practitioner provided that:

a. The quantity prescribed and dispensed is limited to the smallest available quantity to meet the needs of the patient during the emergency period. Dispensing beyond the emergency period requires a written prescription manually signed by the prescribing individual practitioner.

b. If the pharmacist does not know the prescribing individual practitioner, the pharmacist shall make a reasonable effort to determine that the authorization came from an authorized prescriber. The pharmacist shall record the manner by which the authorization was verified and include the pharmacist’s name or initials.

c. The pharmacist shall prepare a temporary written rec–ord of the emergency prescription. The temporary writtenrecord shall consist of a hard copy of the electronic transmission or a written record of the oral transmission authorizing the emergency dispensing.

d. Within seven days after authorizing an emergency prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of 657—10.21(124, 126,155A), the prescription shall have written on its face “Authorization for Emergency Dispensing” and the date of the emergency order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the seven–day period. The written prescription shall be attached to and maintained with the temporary written record prepared pursuant to paragraph “c.”

e. The pharmacist shall notify the board if the prescribing individual fails to deliver a written prescription. Failure of the pharmacist to so notify the board, or failure of the prescribing individual to deliver the required written prescription as herein required, shall void the authority conferred by this subrule.

657—10.23(124) Schedule II prescriptions—partial filling. The partial filling of a prescription for a controlled substance listed in Schedule II is permitted as provided in this rule.

10.23(1) Insufficient supply on hand. If the pharmacist is unable to supply the full quantity called for in a prescription and makes a notation of the quantity supplied on the prescription record, a partial fill of the prescription is permitted. The remaining portion of the prescription must be filled within 72 hours of the first partial filling. If the remaining portion is not or cannot be filled within the 72–hour period, the pharmacist shall so notify the prescriber. No further quantity may be supplied beyond 72 hours without a new prescription.

10.23(2) Long–term care or terminally ill patient. A prescription for a Schedule II controlled substance written for a patient in a long–term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units as provided by this subrule.

a. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist shall contact the practitioner prior to partially filling the prescription. Both the pharmacist and the practitioner have a corresponding responsibility to ensure that the controlled substance is for a terminally ill patient.

b. The pharmacist shall record on the prescription whether the patient is “terminally ill” or an “LTCF patient.” For each partial filling, the dispensing pharmacist shall record on the back of the prescription, or on another appropriate uniformly maintained and readily retrievable record, the date of the partial filling, the quantity dispensed, the remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist.

c. The total quantity of Schedule II controlled substances dispensed in all partial fillings shall not exceed the total quantity prescribed. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of the drug.

d. Information pertaining to current Schedule II prescriptions for patients in a LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system pursuant to rule 657— 21.4(124,155A).

657—10.24(124) Schedule II medication order. Schedule II controlled substances may be administered or dispensed to institutionalized patients pursuant to a medication order as provided in 657—subrule 7.13(1) or rule 657—23.18(124, 155A), as applicable.

657—10.25 and 10.26 Reserved.

10.27(1) Schedule II prescription. A prescription for a Schedule II controlled substance may be transmitted viafacsimile to the pharmacy only as provided in rules 657— 21.12(124,155A) to 657—21.16(124,155A).

10.27(2) Schedule III, IV, or V prescription. A prescription for a Schedule III, IV, or V controlled substance may be transmitted via facsimile to the pharmacy as provided in rule 657—21.9(124,155A).

657—10.28(124,155A) Schedule III, IV, or V refills. No prescription for a controlled substance listed in Schedule III, IV, or V shall be filled or refilled more than six months after the date on which it was issued nor be refilled more than five times.

10.28(1) Record. Each filling and refilling of a prescription shall be entered on the prescription or on another uniformly maintained and readily retrievable record.

a. The following information shall be retrievable by the prescription number: the name and dosage form of the controlled substance, the date filled or refilled, the quantity dispensed, the initials of the dispensing pharmacist for each refill, and the total number of refills authorized for that prescription.

b. If the pharmacist merely initials and dates the back of the prescription, it shall be deemed that the full face amount of the prescription has been dispensed.

10.28(2) Oral refill authorization. The prescribing practitioner may authorize additional refills of Schedule III, IV, or V controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met:

a. The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issuance of the original prescription.

b. The pharmacist who obtains the oral authorization records on the reverse of the original prescription the date, the quantity of each refill, and the number of additional refills authorized and initials the prescription showing who received authorization from the prescriber who issued the original prescription.

c. The quantity of each additional refill is equal to or less than the quantity authorized for the initial filling of the original prescription.

d. The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five–refill, six–month limitation.

10.28(3) Automated data processing record system. An automated data processing record system may be used for the storage and retrieval of Schedule III, IV, and V controlled substance prescription fill and refill information subject to the conditions and requirements of rules 657—21.4(124, 155A) and 657—21.5(124,155A).

657—10.29(124,155A) Schedule III, IV, or V partial fills. The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible provided that each partial fill is recorded in the same manner as a refill. The total quantity dispensed in all partial fills shall not exceed the total quantity prescribed. No dispensing shall occur later than six months after the date on which the prescription was issued.

657—10.30(124,155A) Schedule III, IV, and V medication order. A Schedule III, IV, or V controlled substance may be administered or dispensed to institutionalized patients pursuant to a medication order as provided in 657—subrule 7.13(1) or rule 657—23.9(124,155A), as applicable.

657—10.31(124,155A) Dispensing Schedule V controlled substances without a prescription. A controlled substance listed in Schedule V, which substance is not a prescription drug as determined under the federal Food, Drug and Cosmetic Act, may be dispensed or administered without a prescription by a pharmacist to a purchaser at retail pursuant to the conditions of this rule.

10.31(1) Who may dispense. Dispensing shall be by a licensed Iowa pharmacist or by a registered pharmacist–intern under the direct supervision of a pharmacist preceptor.

a. Except as provided in this subrule, dispensing shall not be by a pharmacy technician or other nonpharmacist employee even if under the direct supervision of a pharmacist.

b. This subrule does not prohibit, after the pharmacist has fulfilled the professional and legal responsibilities set forth in this rule, the completion of the actual cash or credit transaction or the delivery of the substance by a nonpharma–cist.

10.31(2) Frequency and quantity. Dispensing at retail to the same purchaser in any 48–hour period shall be limited to no more than one of the following quantities of a Schedule V substance:

a. 240 cc (8 ounces) of any controlled substance containing opium;

b. 120 cc (4 ounces) of any other controlled substance;

c. 48 dosage units of any controlled substance containing opium;

d. 24 dosage units of any other controlled substance.

10.31(3) Age of purchaser. The purchaser shall be at least 18 years of age.

10.31(4) Identification. The pharmacist shall require every purchaser under this rule not known by the pharmacist to furnish suitable identification, including proof of age when appropriate.

10.31(5) Record. A bound record book for dispensing of Schedule V controlled substances pursuant to this rule shall be maintained by the pharmacist. The book shall contain the name and address of each purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser.

10.31(6) Prescription not required under other laws. No other federal or state law or regulation requires a prescription prior to distributing or dispensing a Schedule V substance.

657—10.32 and 10.33 Reserved.

657—10.34(124,155A) Records. Every inventory or other record required to be kept under this chapter or under Iowa Code chapter 124 shall be kept by the registrant and be available for inspection and copying by the board or its representative for at least two years from the date of such inventory or record except as otherwise required in these rules. Controlled substances records shall be maintained in a readily retrievable manner that establishes the receipt and distribution of all controlled substances.

10.34(1) Schedule I and II records. Inventories and rec–ords of controlled substances listed in Schedules I and II shall be maintained separately from all other records of the registrant.

10.34(2) Schedule III, IV, and V records. Inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all otherrecords of the registrant or in such form that the required information is readily retrievable from the ordinary business records of the registrant.

10.34(3) Date of record. The date on which a controlled substance is actually received, imported, distributed, exported, or otherwise transferred shall be used as the date of receipt or distribution.

10.34(4) Receipt and disbursement records. Each record of receipt or disbursement of controlled substances, unless otherwise provided in these rules or pursuant to federal law, shall include the following:

a. The name of the substance;

b. The strength and dosage form of the substance;

c. The number of units or commercial containers acquired from other registrants, including the date of receipt and the name, address, and DEA registration number of the registrant from whom the substances were acquired;

d. The number of units or commercial containers distributed to other registrants, including the date of distribution and the name, address, and DEA registration number of the registrant to whom the substances were distributed; and

e. The number of units or commercial containers disposed of in any other manner, including the date and manner of disposal and the name, address, and DEA registration number of the registrant to whom the substances were distributed for disposal, if appropriate.

10.34(5) Dispensing records. Each record of dispensing of controlled substances to a patient or research subject shall include the following information:

a. The name and address of the person to whom dispensed;

b. The date of dispensing;

c. The name of the substance;

d. The quantity of the substance dispensed; and

e. The name or initials of the individual who dispensed or administered the substance.

10.34(6) Ordering or distributing Schedule I or II substances. Except as otherwise provided under federal law, a DEA Form 222 is required for each distribution of a Schedule I or II controlled substance. An order form may be executed only on behalf of the registrant named on the order form and only if the registrant’s DEA and Iowa registrations for the substances being purchased have not expired or been revoked or suspended by the issuing agency.

a. Order forms shall be obtained, executed, and filled pursuant to DEA requirements. Each form shall be complete, legible, and properly prepared, executed, or endorsed and shall contain no alteration, erasure, or change of any description.

b. The purchaser shall submit Copy 1 and Copy 2 of the order form to the supplier.

c. The purchaser shall maintain Copy 3 of the order form in the files of the registrant. Upon receipt of the substances from the supplier, the purchaser shall record on Copy 3 of the order form the quantity of each substance received, and the date of receipt, and shall initial each record of receipt.

d. The supplier shall record on Copy 1 and Copy 2 of the order form the quantity of each substance distributed to the purchaser and the date on which the shipment is made. The supplier shall maintain Copy 1 of the order form in the files of the supplier and shall forward Copy 2 of the order form to the DEA district office.

e. Order forms shall be maintained separately from all other records of the registrant.

f. Each unaccepted, defective, or otherwise “void” order form and any attached statement or other documents relating to any order form shall be maintained in the files of the registrant.

g. If the registration of any purchaser of Schedule I or II controlled substances is terminated for any reason, or if the registrant changes name or address as shown on the registration, the registrant shall return all unused order forms to the DEA district office.

657—10.35(124,155A) Inventory requirements. Responsibility for taking any inventory rests with the registrant or, in the case of a registered business, shall rest with the owner of the business. A registrant or owner of a registered business may delegate the actual taking of any inventory.

10.35(1) Record and procedure. Each inventory record shall comply with the requirements of this subrule and shall be maintained for a minimum of four years from the date of the inventory.

a. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken.

b. Each inventory shall be maintained in written, typewritten, or printed form at the registered location.

c. Controlled substances shall be deemed to be on hand if they are in the possession of or under the control of the registrant. These shall include prescriptions prepared for dispensing to a patient but not yet delivered to the patient and substances stored in a warehouse on behalf of the registrant.

d. A separate inventory shall be made for each registered location and for each independent activity registered except as otherwise provided under federal law.

e. The inventory shall be taken either as of opening of business or as of the close of business on the inventory date and the time shall be indicated on the inventory record.

f. The inventory record, unless otherwise provided under federal law, shall include the following information:

(1) The name of the substance;

(2) The strength and dosage form of the substance;

(3) The quantity of the substance; and

(4) The number of commercial containers of each strength and dosage form of the substance.

g. If the substance is listed in Schedule I or II, the quantity shall be an exact count or measure of the substance.

h. If the substance is listed in Schedule III, IV, or V, the quantity may be an estimated count or measure of the substance unless the container holds more than 1,000 tablets or capsules. If the commercial container holds more than 1,000 tablets or capsules, an exact count of the contents shall be made.

10.35(2) Initial inventory. A new registrant shall take an inventory of all stocks of controlled substances on hand on the date the new registrant first engages in the manufacture, distribution, or dispensing of controlled substances. If the registrant commences business or the registered activity with no controlled substances on hand, the initial inventory shall record that fact.

10.35(3) Biennial inventory. After the initial inventory is taken, a registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date that is within two years of the previous biennial inventory date.

10.35(4) Change of ownership. Both the current owner and the prospective owner shall be responsible for taking an inventory of all controlled substances whenever there is a change of ownership of any pharmacy or drug wholesaler licensed pursuant to Iowa Code section 155A.13 or 155A.17, respectively.

10.35(5) Change of pharmacist in charge (PIC). An inventory of all controlled substances shall be completed whenever there is a change of PIC. The inventory shall be taken at the close of business of the last day of the terminating PIC’s employment and before opening for business the first day of the new PIC’s employment. A single inventory shall be sufficient if there is no lapse between employment of the terminating PIC and the new PIC.

10.35(6) Change of registered location. A registrant shall take an inventory of all controlled substances whenever there is a change of registered location. The inventory shall be taken at the close of business of the last day at the location being vacated. This inventory shall serve as the ending inventory for the location being vacated as well as a record of starting inventory for the new location.

10.35(7) Discontinuing registered activity. A registrant shall take an inventory of controlled substances at the close of business of the last day the registrant is engaged in registered activities. If the registrant is selling or transferring the remaining controlled substances to another registrant, this inventory shall serve as the ending inventory for the registrant discontinuing business as well as a record of additional or starting inventory for the registrant to whom the substances are transferred.

10.35(8) Newly controlled substances. On the effective date of the addition of a previously noncontrolled substance to any schedule of controlled substances, any registrant who possesses the newly controlled substance shall take an inventory of all stocks of the substance on hand. The inventoryrecord shall be maintained with the most recent controlled substances inventory. Thereafter, the newly controlled substance shall be included in each inventory made by the registrant.

657—10.36(124) Samples and other complimentary packages—records. Complimentary packages and samples of controlled substances may be distributed to practitioners pursuant to federal and state law only if the person distributing the items leaves with the practitioner a specific written list of the items delivered.

10.36(1) Distribution record. The record form for the distribution of complimentary packages of controlled substances shall contain the following information:

a. The name, address, Iowa wholesale drug license number, and DEA registration number of the supplier;

b. The name, address, Iowa controlled substance registration number, and DEA registration number of the practitioner;

c. The name, strength, and quantity of the specific controlled substances delivered; and

d. The date of delivery.

10.36(2) Reports to the board. Any person who distributes controlled substances pursuant to this rule shall report all such distributions to the board. Reports shall:

a. Include the information identified in subrule 10.36(1). Reports may consist of copies of those distribution records or may be computer–generated listings identifying those distributions.

b. Be submitted as soon as practicable after distribution to the practitioner but no less often than once each calendar quarter.

10.36(3) Practitioner records. A practitioner who regularly administers or dispenses controlled substances shall keep records of the receipt and disbursement of such drugs, including complimentary packages and samples. Records shall be filed in a readily retrievable manner in accordance with federal requirements and shall be made available for inspection and copying by agents of the board or other authorized individuals for at least two years from the date of the record.

10.37(1) Application for exception. Any person seeking to have any compound, mixture, or preparation containing any depressant or stimulant substance listed in any of the schedules in Iowa Code chapter 124 excepted from the application of all or any part of that chapter may apply to the board of pharmacy examiners for such exception.

a. An application for an exception under this rule shall provide evidence that an exception has been granted under the federal Controlled Substances Act.

b. The board shall permit any interested person to file written comments on or objections to the proposal for exception and shall designate the time during which such filings may be made. After consideration of the application and any comments on or objections to the proposal for exception, the board shall issue its findings on the application.

10.37(2) Designation of new controlled substance. The board may designate any new substance as a controlled substance to be included in any of the schedules in Iowa Code chapter 124 no sooner than 30 days following publication in the Federal Register of a final order so designating the substance under federal law. Designation of a new controlled substance under this subrule shall be temporary as provided in Iowa Code section 124.201, subsection 4.

10.37(3) Objection to designation of a new controlled substance. The board may object to the designation of any new substance as a controlled substance within 30 days following publication in the Federal Register of a final order so designating the substance under federal law. The board shall file objection to the designation of a substance as controlled, shall afford all interested parties an opportunity to be heard, and shall issue the board’s decision on the new designation as provided in Iowa Code section 124.201, subsection 4.

657—10.38(124) Temporary designation of controlled substances. Reserved.

657—10.39(124,126) Excluded substances. The Iowa board of pharmacy examiners hereby excludes from all schedules the current list of “Excluded Nonnarcotic Products” identified in Title 21, CFR, Part 1308, Section 22. Copies of the list of excluded products may be obtained by written request to the board office at 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309–4688.

657—10.40(124,126) Anabolic steroid defined. Anabolic steroid, as defined in Iowa Code section 126.2, paragraph 2, includes any substance identified as such in Iowa Code section 124.208, paragraph 6, or in Iowa Code section 126.2, paragraph 2.

These rules are intended to implement Iowa Code sections 124.201, 124.301 to 124.308, 124.402, 124.403, 124.501, 126.2, 126.11, 147.88, 147.95, 147.99, 155A.13, 155A.17, 155A.26, 155A.37, and 205.3.

ITEM 2. Rescind and reserve 657—Chapter 18.

Pursuant to the authority of Iowa Code sections 124.301, 147.76, and 155A.13, the Board of Pharmacy Examiners hereby gives Notice of Intended Action to amend Chapter 11, “Drugs in Emergency Medical Service Programs,” Iowa Administrative Code.

Pursuant to Executive Order Number 8, comments, complaints, and recommendations were solicited from members of the Board and staff, from licensees and registrants, and from members of the public. Existing rules and proposed new rules were reviewed based on need, clarity, cost, fairness, intent and statutory authority. The following amendments were approved at the April 23, 2002, regular meeting of the Board of Pharmacy Examiners.

The proposed amendments add, modify, and delete definitions to maintain uniformity with definitions adopted by the Department of Public Health. Provisions regarding payment for nonproduct services, destruction of unused portions of controlled substances, and individual responsibilities are clarified. Other amendments add catch phrases to subrules and modify language to clarify the intent of the rules.

Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657— Chapter 34.

Any interested person may present written comments, data, views, and arguments on the proposed amendments not later than 4:30 p.m. on July 17, 2002. Such written materials should be sent to Terry Witkowski, Administrative Assistant, Board of Pharmacy Examiners, 400 S.W. Eighth Street,Suite E, Des Moines, Iowa 50309–4688, or by E–mail toterry.witkowski@ibpe.state.ia.us.

These amendments are intended to implement Iowa Code chapter 147A and Iowa Code sections 124.301 and 155A.13.

The following amendments are proposed.

ITEM 1. Amend rule 657—11.1(124,147A,155A) as follows:

657—11.1(124,147A,155A) Definitions. For the purpose of this chapter, the following definitions shall apply:

“Ambulance service” means any privately or publicly owned service program which that utilizes ambulances in order to provide patient transportation and emergency medical care at the scene of an emergency or while en route to a hospital or during transfer from one medical care facility to another or to a private home. An ambulance service may use first response or nontransport rescue vehicles to supplement ambulance vehicles services.

“Board” means the Iowa board of pharmacy examiners.

“Department” means the Iowa department of public health.

“Drug” means a substance as defined in Iowa Code section 155A.3(13) or a device as defined in Iowa Code section 155A.3(10).

“Emergency medical technician” means any emergency medical technician or EMT as defined in 641— 132.1(147A).

“EMS” means emergency medical services.

“Medical director” means any physician licensed under Iowa Code chapter 148, 150, or 150A who shall be responsible for overall medical direction of the service program and who has completed a medical director workshop, sponsored by the department, within one year of assuming duties.

“Physician” means any individual licensed under Iowa Code chapter 148, 150, or 150A.

“Physician assistant” means any individual licensed under Iowa Code chapter 148C.

“Physician designee” means any registered nurse licensed under Iowa Code chapter 152, or any physician assistant licensed under Iowa Code chapter 148C and approved by the board of physician assistant examiners, who holds a current course completion card in advanced cardiac life support (ACLS). The physician designee may act acts as an intermediary for a supervising physician in accordance with written policies and protocols in directing the actions of advanced emergency medical care personnel in accordance with written policies and protocols providing emergency medical services.

“Responsible individual” means, in a medical director–based service, the medical director for the service; in apharmacy–based service, the pharmacist in charge of the base pharmacy.

“Service” or “service program” means any 24–hour emergency medical care ambulance service, rescue, or first response or nontransport service that has received authorization by the department.

“Supervising physician” means any physician licensed under Iowa Code chapter 148, 150, or 150A. The supervising physician is responsible for medical direction of emergency medical care personnel when such personnel are providing emergency medical care.

ITEM 2. Amend subrule 11.2(1), paragraph “a,” as follows:

a. A formal written agreement shall be made between the base pharmacy and the service establishing that the EMS is operating as an extension of the base pharmacy with respect to the drugs. It shall not be unethical pharmacy practice for the service contract to provide for payment to the pharmacy of reasonable fees or charges for nonproduct pharmacy services.

ITEM 3. Amend subrule 11.3(3) as follows:

11.3(3) Controlled substance disposal or destruction. The disposal or destruction of the unused portion of a controlled substance shall be documented in writing and signed by two the paramedic or paramedic specialist responsible for administration of the controlled substance and witnessed by one of the emergency service program personnel or a licensed health care professional. Outdated or unwanted controlled substances shall be returned to the service base for proper disposal or destruction.

ITEM 4. Amend subrule 11.3(4) as follows:

11.3(4) Administration of drugs and intravenous infusion products. An emergency medical technician appropriately certified EMS provider shall not administer a drug or intravenous infusion product without the verbal or written order of a physician, physician assistant, or physician designee, or by written protocol. The service program’s responsible individual shall be responsible for ensuring proper documentation of orders given and drugs administered.

ITEM 5. Amend subrule 11.3(5) as follows:

11.3(5) Drug control policies and procedures. The service program’s responsible individual shall be responsible for developing and implementing a ensure that written drug and intravenous infusion product safeguard security and control policy policies and procedures are developed and implemented for the service. The policy policies and procedures shall include address, but not be limited to, procedures regarding the following:

a. Controlled substances;

b. Medication orders;

d c. Adverse drug and intravenous infusion product reaction reports;

e d. Drug and intravenous infusion product administration;

f e. Drug and intravenous infusion product defect reports and product recalls;

h f. Outdated or unused drugs and intravenous infusion products and their timely disposal;

k g. Drug and intravenous infusion product inventory control and security;

l h. Records Record keeping;

m i. Drug and intravenous infusion product procurement, storage, and ownership;

n j. Inspections and frequency of inspections;

o k. Drug exchange programs.

ITEM 6. Amend rule 657—11.4(124,147A,155A) as follows:

657—11.4(124,147A,155A) Procurement and storage. The responsible individual for the service shall be responsible for the procurement and storage of drugs and intravenous infusion products for the service program.

11.4(1) Temperature. All drugs and intravenous infusion products shall be stored at the proper temperatures as defined by the USP/NF.

11.4(2) Expiration. Any drug or intravenous infusion product bearing an expiration date may not be administered after the expiration date.

11.4(3) Outdates. Outdated drugs and intravenous infusion products shall be quarantined together until such time as the items can be lawfully disposed of lawfully.

ITEM 7. Amend rule 657—11.5(124,147A,155A) as follows:

657—11.5(124,147A,155A) Records. Every The responsible individual shall ensure that every inventory or other rec–ord required to be kept under Iowa Code chapter 124 or 155A and board rules shall be kept by the responsible individual for is maintained by the service program and be available for inspection and copying by the board or its representative for at least two years from the date of such inventory or record. Controlled substances inventories shall be maintained for at least four years from the date of the inventory.

ITEM 8. Amend rule 657—11.6(124,147A,155A) as follows:

11.6(1) Inspection by program’s responsible individual. The responsible individual for the service program shall ensure proper inspection on a periodic basis of the drugs and intravenous infusion products used by the service on a periodic basis. Proof of periodic inspection shall be in writing and made available upon request of the board or department.

11.6(2) Inspection by regulatory agencies. Drugs and intravenous infusion products used by the service program, as well as records maintained by the responsible individual or service program, shall be subject to inspection and audit by the board. They Controlled substances and controlled substances records shall also be subject to inspection and audit by the federal Drug Enforcement Administration.

ITEM 9. Amend rule 657—11.7(124,147A,155A) as follows:

657—11.7(124,147A,155A) Security and control. The responsible individual for the service program shall be responsible for developing and implementing ensure that the program’s policies and procedures for the security and control of the service program’s drug and intravenous infusion products, including provisions provide for adequate safeguards against theft or diversion of dangerous drugs prescription drugs or devices, controlled substances, and records for such drugs and devices. The following conditions must be met to ensure appropriate control over drugs and intravenous infusion products.

11.7(1) Access authorized. Policies and procedures shall identify who will have access to the drugs and intravenous infusion products.

11.7(2) Limited access. Drugs and intravenous infusion products shall be secured at all times in a manner that limits access to authorized personnel only.

ITEM 10. Amend 657—Chapter 11, implementation sentence, as follows:

These rules are intended to implement Iowa Code chapter 147A and Iowa Code sections 124.301 and 155A.13.

Pursuant to the authority of Iowa Code section 147.76, the Board of Pharmacy Examiners hereby gives Notice of Intended Action to rescind Chapter 13, “Code of Professional Responsibility for Board Investigators,” Iowa Administrative Code.

Pursuant to Executive Order Number 8, comments, complaints, and recommendations were solicited from members of the Board and staff, from licensees and registrants, and from members of the public. Existing rules were reviewed based on need, clarity, cost, fairness, intent and statutory authority. The following amendment was approved at the April 23, 2002, regular meeting of the Board of Pharmacy Examiners.

The proposed amendment rescinds current rules establishing a code of professional responsibility for Board investigators. Iowa Code section 155A.37 directs the Board to “adopt” such a code of responsibility but does not direct, nor does it authorize, the Board to establish the code by rule. The Board has adopted, in lieu of these rules and by administrative policy, a code of professional responsibility for Board investigators.

Any interested person may present written comments, data, views, and arguments on the proposed amendmentnot later than 4:30 p.m. on July 17, 2002. Such written materials should be sent to Terry Witkowski, AdministrativeAssistant, Board of Pharmacy Examiners, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309–4688, or by E–mail to terry.witkowski@ibpe.state.ia.us.

This amendment is intended to implement Iowa Code section 155A.37.

The following amendment is proposed.

Rescind and reserve 657—Chapter 13.

Pursuant to the authority of Iowa Code sections 124.301, 147.76, and 155A.13, the Board of Pharmacy Examiners hereby gives Notice of Intended Action to rescind Chapter 15, “Correctional Facility Pharmacy Licenses,” and to adopt new Chapter 15, “Correctional Facility Pharmacy Practice,” Iowa Administrative Code.

Pursuant to Executive Order Number 8, comments, complaints, and recommendations were solicited from members of the Board and staff, from licensees and registrants, and from members of the public. Existing rules and proposed new rules were reviewed based on need, clarity, cost, fairness, intent and statutory authority. The following amendment was approved at the April 23, 2002, regular meeting of the Board of Pharmacy Examiners.

The proposed amendment rescinds existing rules regarding correctional facility pharmacies and adopts new rules for this specialty practice. The substance of the new rules does not differ substantially from existing rules. Duplicative requirements have been removed, and the rules have been amended for clarity and reorganized. The new rules clarify the responsibilities of the pharmacist in charge, establish security and distribution requirements for all drugs maintained by the pharmacy, and define requirements for the establishment of policies and procedures regarding drug distribution and control within the facility.

Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657— Chapter 34.

Any interested person may present written comments, data, views, and arguments on the proposed amendment not later than 4:30 p.m. on July 17, 2002. Such written materials should be sent to Terry Witkowski, Administrative Assistant, Board of Pharmacy Examiners, 400 S.W. Eighth Street,Suite E, Des Moines, Iowa 50309–4688, or by E–mail toterry.witkowski@ibpe.state.ia.us.

This amendment is intended to implement Iowa Code sections 124.301, 124.303, 124.306, 124.308, 126.10, 126.11, 155A.13, 155A.27, 155A.28, 155A.31, 155A.32, and 155A.34 through 155A.36.

The following amendment is proposed.

Rescind 657—Chapter 15 and adopt the following new chapter in lieu thereof:

CHAPTER 15
CORRECTIONAL FACILITY PHARMACY PRACTICE

657—15.1(155A) Purpose and scope. It is the intent of these rules to authorize the department of corrections to distribute prescription drugs to inmates in correctional institutions by and through a network of pharmacies located in facilities operated pursuant to Iowa Code chapter 246. The pharmacies shall be licensed by the board with limited–use pharmacy licenses designated as correctional facility pharmacy licenses and shall be located in facilities operated pursuant to Iowa Code chapter 246. Pharmacists shall be responsible for any delegated act performed by supportive personnel under their supervision. The requirements of these rules for correctional facility pharmacy practice are in addition to the requirements of 657—Chapter 8 and other rules of the board relating to the services provided by the pharmacies.

657—15.2(126,155A) Definitions. For purposes of this chapter, the following definitions shall apply:

“Board” means the Iowa board of pharmacy examiners.

“Department” means the Iowa department of corrections.

“Medication prescription order” means an order for a drug or device for a person in custody status in a correctional institution, originated by a practitioner authorized to prescribe, and which meets the information requirements for a prescription order but is recorded, distributed, and administered as though it were a medication order.

“Provisional stock” means a limited inventory of drugs stored outside the confines of the correctional facility pharmacy and accessible to designated health services staff for the purpose of initiating emergency or first–dose medication prescription orders issued during periods when the pharmacist is unavailable.

657—15.3(155A) Pharmacist in charge. One professionally competent, legally qualified pharmacist in charge in each pharmacy shall be responsible for, at a minimum, the following:

1. Ensuring that the pharmacy utilizes an ongoing, systematic program for achieving performance improvement and ensuring the quality of pharmaceutical services;

2. Ensuring that the pharmacy employs an adequate number of qualified personnel commensurate with the size and scope of services provided by the pharmacy;

3. Ensuring that a quarterly inspection of all pharmaceuticals located at the correctional facility including emergency and provisional stocks located outside the confines of the pharmacy is completed and documented;

4. Ensuring the availability of any equipment and references necessary for the particular practice of pharmacy;

5. Preparing a written operations manual governing pharmacy functions; periodically reviewing and revising those policies and procedures to reflect changes in processes, organization, and other pharmacy functions; ensuring that policies and procedures are consistent with board rules and the policies and rules of the department relating to pharmaceutical services; and ensuring that all pharmacy personnel are familiar with the contents of the manual;

6. Ensuring that a pharmacist performs prospective drug use reviews as specified in rule 657—8.21(155A);

7. Ensuring that a pharmacist provides drug information to other health professionals, to other caregivers, and to patients as required or requested;

8. Dispensing drugs to patients, including the packaging, preparation, compounding, and labeling functions performed by pharmacy personnel;

9. Delivering drugs to the patient or the patient’s agent;

10. Ensuring that patient medication records are maintained as specified in rule 15.8(124,126,155A);

11. Training pharmacy technicians and supportive personnel;

12. Establishing policies for the procurement and storage of prescription drugs and devices and other products dispensed from the pharmacy;

13. Disposing of and distributing drugs from the pharmacy;

14. Maintaining records of all transactions of the pharmacy necessary to maintain accurate control over and accountability for all drugs as required by applicable state and federal laws, rules, and regulations;

15. Establishing and maintaining effective controls against the theft or diversion of prescription drugs and rec–ords for such drugs;

16. Ensuring the legal operation of the pharmacy, including meeting all inspection and other requirements of state and federal laws, rules, and regulations governing the practice of pharmacy.

657—15.4(155A) Reference library. References may be printed or computer–accessed. Each correctional facility pharmacy shall have on site, as a minimum, one current reference from each of the following categories, including access to current periodic updates.

1. Iowa pharmacy laws, rules, and regulations.

2. A patient information reference such as:

• USP Dispensing Information, Volume II (Advice for the Patient);

• Professional’s Guide to Patient Drug Facts by Facts and Comparisons; or

• Leaflets which provide patient information in compliance with rule 657—6.14(155A).

3. A reference on drug interactions such as:

• First DataBank’s Evaluations of Drug Interactions;

• Hansten & Horn’s Drug Interactions Analysis & Management; or

• Drug Interaction Facts by Facts and Comparisons.

4. A general information reference such as:

• Facts and Comparisons;