Print
House File 2377 - EnrolledAn Actrelating to the regulation of certain substances,
including the regulation of the practice of pharmacy,
providing penalties, and including effective date
provisions.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
DIVISION I
REGULATION OF THE PRESCRIPTION MONITORING PROGRAM
Section 1. Section 124.550, subsection 2, Code 2018, is
amended to read as follows:
2. “Prescribing practitioner” means a practitioner who
has prescribed or is contemplating the authorization of
a prescription for the patient about whom information is
requested. “Prescribing practitioner” does not include a
licensed veterinarian.
Sec. 2. Section 124.550, Code 2018, is amended by adding the
following new subsection:
NEW SUBSECTION. 4. “Program” means the information program
for drug prescribing and dispensing.
Sec. 3. Section 124.551, subsection 2, Code 2018, is amended
to read as follows:
2. a. The program shall collect from pharmacies dispensing
information for controlled substances identified pursuant to
section 124.554, subsection 1, paragraph “g”, and from first
responders as defined in section 147A.1, subsection 7, with
the exception of emergency medical care providers as defined
in section 147A.1, subsection 4, administration information
for opioid antagonists. The department of public health
shall provide information for the administration of opioid
antagonists to the board as prescribed by rule for emergency
medical care providers as defined in section 147A.1, subsection
4. The board shall adopt rules requiring the following
information to be provided regarding the administration of
opioid antagonists:
(1) Patient identification.
(2) Identification of the person administering opioid
antagonists.
(3) The date of administration.
(4) The quantity of opioid antagonists administered.
b. The information collected shall be used by prescribing
practitioners and pharmacists on a need-to-know basis for
-1-purposes of improving patient health care by facilitating early
identification of patients who may be at risk for addiction,
or who may be using, abusing, or diverting drugs for unlawful
or otherwise unauthorized purposes at risk to themselves and
others, or who may be appropriately using controlled substances
lawfully prescribed for them but unknown to the practitioner.
Sec. 4. NEW SECTION. 124.551A Prescribing practitioner
program registration.
A prescribing practitioner shall register for the program at
the same time the prescribing practitioner applies to the board
to register or renews registration to prescribe controlled
substances as required by the board. Once the prescribing
practitioner registers for the program, the prescribing
practitioner or the prescribing practitioner’s designated agent
shall utilize the program database prior to issuing an opioid
prescription as prescribed by rules adopted by the prescribing
practitioner’s licensing board to assist the prescribing
practitioner in determining appropriate treatment options
and to improve the quality of patient care. A prescribing
practitioner shall not be required to utilize the program
database to assist in the treatment of a patient receiving
inpatient hospice care or long-term residential facility
patient care.
Sec. 5. Section 124.552, Code 2018, is amended to read as
follows:
124.552 Information reporting.
1. Each Unless otherwise prohibited by federal or state law,
each licensed pharmacy that dispenses controlled substances
identified pursuant to section 124.554, subsection 1, paragraph
“g”, to patients in the state, and each licensed pharmacy
located in the state that dispenses such controlled substances
identified pursuant to section 124.554, subsection 1,
paragraph “g”, to patients inside or outside the state, unless
specifically excepted in this section or by rule, and each
prescribing practitioner furnishing, dispensing, or supplying
-2-controlled substances to the prescribing practitioner’s
patient, shall submit the following prescription information
to the program:
a. Pharmacy identification.
b. Patient identification.
c. Prescribing practitioner identification.
d. The date the prescription was issued by the prescribing
practitioner.
e. The date the prescription was dispensed.
f. An indication of whether the prescription dispensed is
new or a refill.
g. Identification of the drug dispensed.
h. Quantity of the drug dispensed.
i. The number of days’ supply of the drug dispensed.
j. Serial or prescription number assigned by the pharmacy.
k. Type of payment for the prescription.
l. Other information identified by the board and advisory
council by rule.
2. Information shall be submitted electronically in a
secure format specified by the board unless the board has
granted a waiver and approved an alternate secure format.
3. Information shall be timely transmitted as designated
by the board and advisory council by rule within one business
day of the dispensing of the controlled substance, unless the
board grants an extension. The board may grant an extension if
either of the following occurs:
a. The pharmacy or prescribing practitioner suffers
a mechanical or electronic failure, or cannot meet the
deadline established by the board for other reasons beyond the
pharmacy’s or practitioner’s control.
b. The board is unable to receive electronic submissions.
4. This section shall not apply to a prescribing
practitioner furnishing, dispensing, supplying, or
administering drugs to the prescribing practitioner’s patient,
or to dispensing by a licensed pharmacy for the purposes of
-3-inpatient hospital care, inpatient hospice care, or long-term
residential facility patient care.
Sec. 6. Section 124.553, subsection 4, Code 2018, is amended
by striking the subsection.
Sec. 7. Section 124.554, subsection 1, paragraphs b, c, d,
and g, Code 2018, are amended to read as follows:
b. An electronic format for the submission of information
from pharmacies and prescribing practitioners.
c. A waiver to submit information in another format for
a pharmacy or prescribing practitioner unable to submit
information electronically.
d. An application by a pharmacy or prescribing practitioner
for an extension of time for transmitting information to the
program.
g. Including all schedule II controlled substances, and
those substances in schedules III and IV that the advisory
council and board determine can be addictive or fatal if not
taken under the proper care and direction of a prescribing
practitioner, and opioid antagonists.
Sec. 8. Section 124.557, Code 2018, is amended to read as
follows:
124.557 Drug information program fund.
The drug information program fund is established to be used
by the board to fund or assist in funding the program. The
board may make deposits into the fund from any source, public
or private, including grants or contributions of money or other
items of value, which it determines necessary to carry out the
purposes of this subchapter. The board may add a surcharge
of not more than twenty-five percent to the applicable fee
for a registration issued pursuant to section 124.302 and the
surcharge shall be deposited into the fund. Moneys received
by the board to establish and maintain the program must
be used for the expenses of administering this subchapter.
Notwithstanding section 8.33, amounts contained in the fund
that remain unencumbered or unobligated at the close of the
-4-fiscal year shall not revert but shall remain available for
expenditure for the purposes designated in future years.
Sec. 9. Section 124.558, subsection 1, Code 2018, is amended
to read as follows:
1. Failure to comply with requirements. A pharmacist,
pharmacy, prescribing practitioner, or agent of a pharmacist
or prescribing practitioner who knowingly fails to comply
with the confidentiality requirements of this subchapter
or who delegates program information access to another
individual except as provided in section 124.553, is subject to
disciplinary action by the appropriate professional licensing
board. A pharmacist, or pharmacy, or prescribing practitioner
that knowingly fails to comply with other requirements of this
subchapter is subject to disciplinary action by the board.
Each licensing board may adopt rules in accordance with chapter
17A to implement the provisions of this section.
DIVISION II
ELECTRONIC PRESCRIPTIONS
Sec. 10. Section 124.308, Code 2018, is amended by striking
the section and inserting in lieu thereof the following:
124.308 Prescriptions.
1. Except when dispensed directly by a practitioner to an
ultimate user, a prescription drug as defined in section 155A.3
that is a controlled substance shall not be dispensed without
a prescription, unless such prescription is authorized by a
practitioner and complies with this section, section 155A.27,
applicable federal law and regulation, and rules of the board.
2. a. Beginning January 1, 2020, every prescription issued
for a controlled substance shall be transmitted electronically
as an electronic prescription pursuant to the requirements in
subsection 2, paragraph “b”, unless exempt under subsection 2,
paragraph “c”.
b. Except for prescriptions identified in paragraph “c”,
a prescription that is transmitted pursuant to paragraph “a”
shall be transmitted to a pharmacy by a practitioner or the
-5-practitioner’s authorized agent in compliance with federal
law and regulation for electronic prescriptions of controlled
substances. The practitioner’s electronic prescription system
and the receiving pharmacy’s dispensing system shall comply
with federal law and regulation for electronic prescriptions of
controlled substances.
c. Paragraph “b” shall not apply to any of the following:
(1) A prescription for a patient residing in a nursing home,
long-term care facility, correctional facility, or jail.
(2) A prescription authorized by a licensed veterinarian.
(3) A prescription dispensed by a department of veterans
affairs pharmacy.
(4) A prescription requiring information that makes
electronic submission impractical, such as complicated or
lengthy directions for use or attachments.
(5) A prescription for a compounded preparation containing
two or more components.
(6) A prescription issued in response to a public health
emergency in a situation where a non-patient specific
prescription would be permitted.
(7) A prescription issued pursuant to an established and
valid collaborative practice agreement, standing order, or drug
research protocol.
(8) A prescription issued during a temporary technical
or electronic failure at the practitioner’s or pharmacy’s
location, provided that a prescription issued pursuant to
this subparagraph shall indicate on the prescription that the
practitioner or pharmacy is experiencing a temporary technical
or electronic failure.
(9) A prescription issued in an emergency situation
pursuant to federal law and regulation rules of the board.
d. A practitioner, as defined in section 124.101, subsection
27, paragraph “a”, who violates paragraph “a” is subject
to an administrative penalty of two hundred fifty dollars
per violation, up to a maximum of five thousand dollars per
-6-calendar year. The assessment of an administrative penalty
pursuant to this paragraph by the appropriate licensing board
of the practitioner alleged to have violated paragraph “a”
shall not be considered a disciplinary action or reported
as discipline. A practitioner may appeal the assessment of
an administrative penalty pursuant to this paragraph, which
shall initiate a contested case proceeding under chapter
17A. A penalty collected pursuant to this paragraph shall be
deposited into the drug information program fund established
pursuant to section 124.557. The board shall be notified
of any administrative penalties assessed by the appropriate
professional licensing board and deposited into the drug
information program fund under this paragraph.
e. A pharmacist who receives a written, oral, or facsimile
prescription shall not be required to verify that the
prescription is subject to an exception under paragraph “c”
and may dispense a prescription drug pursuant to an otherwise
valid written, oral, or facsimile prescription. However, a
pharmacist shall exercise professional judgment in identifying
and reporting suspected violations of this section to the
board or the appropriate professional licensing board of the
practitioner.
3. A prescription issued prior to January 1, 2020, or a
prescription that is exempt from the electronic prescription
requirement in subsection 2, paragraph “c”, may be transmitted
by a practitioner or the practitioner’s authorized agent to a
pharmacy in any of the following ways:
a. Electronically, if transmitted in accordance with
the requirements for electronic prescriptions pursuant to
subsection 2.
b. By facsimile for a schedule III, IV, or V controlled
substance, or for a schedule II controlled substance only
pursuant to federal law and regulation and rules of the board.
c. Orally for a schedule III, IV, or V controlled substance,
or for a schedule II controlled substance only in an emergency
-7-situation pursuant to federal regulation and rules of the
board.
d. By providing an original signed prescription to a patient
or a patient’s authorized representative.
4. If permitted by federal law and in accordance with
federal requirements, an electronic or facsimile prescription
shall serve as the original signed prescription and the
practitioner shall not provide a patient, a patient’s
authorized representative, or the dispensing pharmacy with a
signed, written prescription. An original signed prescription
shall be retained for a minimum of two years from the date of
the latest dispensing or refill of the prescription.
5. A prescription for a schedule II controlled substance
shall not be filled more than six months after the date
of issuance. A prescription for a schedule II controlled
substance shall not be refilled.
6. A prescription for a schedule III, IV, or V controlled
substance shall not be filled or refilled more than six months
after the date on which the prescription was issued or be
refilled more than five times.
7. A controlled substance shall not be distributed or
dispensed other than for a medical purpose.
8. A practitioner, medical group, or pharmacy that is unable
to timely comply with the electronic prescribing requirements
in subsection 2, paragraph “b”, may petition the board for an
exemption from the requirements based upon economic hardship,
technical limitations that the practitioner, medical group, or
pharmacy cannot control, or other exceptional circumstances.
The board shall adopt rules establishing the form and specific
information to be included in a request for an exemption
and the specific criteria to be considered by the board in
determining whether to approve a request for an exemption. The
board may approve an exemption for a period of time determined
by the board not to exceed one year from the date of approval,
and may be renewed annually upon request subject to board
-8-approval.
Sec. 11. Section 155A.27, Code 2018, is amended by striking
the section and inserting in lieu thereof the following:
155A.27 Requirements for prescription.
1. Except when dispensed directly by a prescriber to an
ultimate user, a prescription drug shall not be dispensed
without a prescription, authorized by a prescriber, and based
on a valid patient-prescriber relationship.
2. a. Beginning January 1, 2020, every prescription issued
for a prescription drug shall be transmitted electronically as
an electronic prescription to a pharmacy by a prescriber or the
prescriber’s authorized agent unless exempt under paragraph
“b”.
b. Paragraph “a” shall not apply to any of the following:
(1) A prescription for a patient residing in a nursing home,
long-term care facility, correctional facility, or jail.
(2) A prescription authorized by a licensed veterinarian.
(3) A prescription for a device.
(4) A prescription dispensed by a department of veterans
affairs pharmacy.
(5) A prescription requiring information that makes
electronic transmission impractical, such as complicated or
lengthy directions for use or attachments.
(6) A prescription for a compounded preparation containing
two or more components.
(7) A prescription issued in response to a public health
emergency in a situation where a non-patient specific
prescription would be permitted.
(8) A prescription issued for an opioid antagonist pursuant
to section 135.190 or a prescription issued for epinephrine
pursuant to section 135.185.
(9) A prescription issued during a temporary technical
or electronic failure at the location of the prescriber or
pharmacy, provided that a prescription issued pursuant to
this subparagraph shall indicate on the prescription that the
-9-prescriber or pharmacy is experiencing a temporary technical
or electronic failure.
(10) A prescription issued pursuant to an established and
valid collaborative practice agreement, standing order, or drug
research protocol.
(11) A prescription issued in an emergency situation
pursuant to federal law and regulation and rules of the board.
c. A practitioner, as defined in section 124.101, subsection
27, paragraph “a”, who violates paragraph “a” is subject
to an administrative penalty of two hundred fifty dollars
per violation, up to a maximum of five thousand dollars per
calendar year. The assessment of an administrative penalty
pursuant to this paragraph by the appropriate licensing board
of the practitioner alleged to have violated paragraph “a”
shall not be considered a disciplinary action or reported
as discipline. A practitioner may appeal the assessment of
an administrative penalty pursuant to this paragraph, which
shall initiate a contested case proceeding under chapter
17A. A penalty collected pursuant to this paragraph shall be
deposited into the drug information program fund established
pursuant to section 124.557. The board shall be notified
of any administrative penalties assessed by the appropriate
professional licensing board and deposited into the drug
information program fund under this paragraph.
d. A pharmacist who receives a written, oral, or facsimile
prescription shall not be required to verify that the
prescription is subject to an exception under paragraph “b”
and may dispense a prescription drug pursuant to an otherwise
valid written, oral, or facsimile prescription. However, a
pharmacist shall exercise professional judgment in identifying
and reporting suspected violations of this section to the
board or the appropriate professional licensing board of the
prescriber.
3. For prescriptions issued prior to January 1, 2020,
or for prescriptions exempt from the electronic prescription
-10-requirement in subsection 2, paragraph “b”, a prescriber or the
prescriber’s authorized agent may transmit a prescription for a
prescription drug to a pharmacy by any of the following means:
a. Electronically.
b. By facsimile.
c. Orally.
d. By providing an original signed prescription to a patient
or a patient’s authorized representative.
4. A prescription shall be issued in compliance with
this subsection. Regardless of the means of transmission, a
prescriber shall provide verbal verification of a prescription
upon request of the pharmacy.
a. If written, electronic, or facsimile, each prescription
shall contain all of the following:
(1) The date of issue.
(2) The name and address of the patient for whom, or the
owner of the animal for which, the drug is dispensed.
(3) The name, strength, and quantity of the drug prescribed.
(4) The directions for use of the drug, medicine, or device
prescribed.
(5) The name, address, and written or electronic signature
of the prescriber issuing the prescription.
(6) The federal drug enforcement administration number, if
required under chapter 124.
b. If electronic, each prescription shall comply with all
of the following:
(1) The prescriber shall ensure that the electronic system
used to transmit the electronic prescription has adequate
security and safeguards designed to prevent and detect
unauthorized access, modification, or manipulation of the
prescription.
(2) Notwithstanding paragraph “a”, subparagraph (5),
for prescriptions that are not controlled substances, if
transmitted by an authorized agent, the electronic prescription
shall not require the written or electronic signature of the
-11-prescriber issuing the prescription.
c. If facsimile, in addition to the requirements of
paragraph “a”, each prescription shall contain all of the
following:
(1) The identification number of the facsimile machine
which is used to transmit the prescription.
(2) The date and time of transmission of the prescription.
(3) The name, address, telephone number, and facsimile
number of the pharmacy to which the prescription is being
transmitted.
d. If oral, the prescriber issuing the prescription
shall furnish the same information required for a written
prescription, except for the written signature and address
of the prescriber. Upon receipt of an oral prescription,
the recipient shall promptly reduce the oral prescription to
a written format by recording the information required in a
written prescription.
e. A prescription transmitted by electronic, facsimile,
or oral means by a prescriber’s agent shall also include
the name and title of the prescriber’s agent completing the
transmission.
5. An electronic, facsimile, or oral prescription
shall serve as the original signed prescription and the
prescriber shall not provide a patient, a patient’s authorized
representative, or the dispensing pharmacist with a signed
written prescription. Prescription records shall be retained
pursuant to rules of the board.
6. This section shall not prohibit a pharmacist,
in exercising the pharmacist’s professional judgment,
from dispensing, at one time, additional quantities of a
prescription drug, with the exception of a prescription drug
that is a controlled substance as defined in section 124.101,
up to the total number of dosage units authorized by the
prescriber on the original prescription and any refills of
the prescription, not to exceed a ninety-day supply of the
-12-prescription drug as specified on the prescription.
7. A prescriber, medical group, institution, or pharmacy
that is unable to timely comply with the electronic prescribing
requirements in subsection 2, paragraph “a”, may petition
the board for an exemption from the requirements based upon
economic hardship, technical limitations that the prescriber,
medical group, institution, or pharmacy cannot control, or
other exceptional circumstances. The board shall adopt rules
establishing the form and specific information to be included
in a request for an exemption and the specific criteria to be
considered by the board in determining whether to approve a
request for an exemption. The board may approve an exemption
for a period of time determined by the board, not to exceed one
year from the date of approval, and may be annually renewed
subject to board approval upon request.
Sec. 12. Section 155A.29, subsection 4, Code 2018, is
amended to read as follows:
4. An authorization to refill a prescription drug order may
shall be transmitted to a pharmacist pharmacy by a prescriber
or the prescriber’s authorized agent through word of mouth,
note, telephone, facsimile, or other means of communication
initiated by or directed by the practitioner. The transmission
shall include the information required pursuant to section
155A.27, except that prescription drug orders for controlled
substances shall be transmitted pursuant to section 124.308,
and, if not transmitted directly by the practitioner,
shall identify by also include the name and title of the
practitioner’s agent completing the transmission.
DIVISION III
PRESCRIBER ACTIVITY REPORTS
Sec. 13. Section 124.553, subsection 1, Code 2018, is
amended by adding the following new paragraph:
NEW PARAGRAPH. h. A prescribing practitioner for the
issuance of a required report pursuant to section 124.554,
subsection 3.
-13- Sec. 14. Section 124.554, subsection 1, Code 2018, is
amended by adding the following new paragraph:
NEW PARAGRAPH. j. The issuance annually of a prescribing
practitioner activity report compiled from information from the
program pursuant to subsection 3.
Sec. 15. Section 124.554, Code 2018, is amended by adding
the following new subsection:
NEW SUBSECTION. 3. a. Beginning February 1, 2019,
and annually by February 1 thereafter, the board shall
electronically, and at as low a cost as possible, issue each
prescribing practitioner who prescribed a controlled substance
reported to the program as dispensed in the preceding calendar
year in this state a prescribing practitioner activity report
which shall include but not be limited to the following:
(1) A summary of the prescribing practitioner’s history of
prescribing controlled substances.
(2) A comparison of the prescribing practitioner’s history
of prescribing controlled substances with the history of other
prescribing practitioners of the same profession or specialty.
(3) The prescribing practitioner’s history of program use.
(4) General patient risk factors.
(5) Educational updates.
(6) Other pertinent information identified by the board and
advisory council by rule.
b. Information provided to a prescribing practitioner in a
report required under this subsection is privileged and shall
be kept confidential pursuant to section 124.553, subsection 3.
Sec. 16. Section 124.556, Code 2018, is amended to read as
follows:
124.556 Education and treatment.
The program for drug prescribing and dispensing shall
include education initiatives and outreach to consumers,
prescribing practitioners, and pharmacists, and shall also
include assistance for identifying substance abuse treatment
programs and providers. The program shall also include
-14-educational updates and information on general patient risk
factors for prescribing practitioners. The board and advisory
council shall adopt rules, as provided under section 124.554,
to implement this section.
DIVISION IV
SUBSTANCE ABUSE PREVENTION
Sec. 17. Section 124.550, Code 2018, is amended by adding
the following new subsection:
NEW SUBSECTION. 3. “Proactive notification” means
a notification by the board, generated based on factors
determined by the board and issued to a specific prescribing
practitioner or pharmacist, indicating that a patient may
be practitioner shopping or pharmacy shopping or at risk of
abusing or misusing a controlled substance.
Sec. 18. Section 124.553, subsection 1, Code 2018, is
amended by adding the following new paragraph:
NEW PARAGRAPH. g. A prescribing practitioner or pharmacist
through the use of a targeted distribution of proactive
notifications.
Sec. 19. Section 124.553, subsections 2 and 3, Code 2018,
are amended to read as follows:
2. The board shall maintain a record of each person that
requests information from the program and of all proactive
notifications distributed to prescribing practitioners and
dispensing pharmacists as provided in subsection 1, paragraph
“g”. Pursuant to rules adopted by the board and advisory
council under section 124.554, the board may use the records
to document and report statistical information, and may
provide program information for statistical, public research,
public policy, or educational purposes, after removing
personal identifying information of a patient, prescribing
practitioner, dispenser, or other person who is identified in
the information.
3. Information contained in the program and any information
obtained from it, and information contained in the records
-15-of requests for information from the program and information
distributed to prescribing practitioners and dispensing
pharmacists as provided in subsection 1, paragraph “g”,
is privileged and strictly confidential information. Such
information is a confidential public record pursuant to section
22.7, and is not subject to discovery, subpoena, or other
means of legal compulsion for release except as provided in
this subchapter. Information from the program shall not be
released, shared with an agency or institution, or made public
except as provided in this subchapter.
Sec. 20. Section 124.554, subsection 1, Code 2018, is
amended by adding the following new paragraph:
NEW PARAGRAPH. k. The establishment of thresholds or other
criteria or measures to be used in identifying an at-risk
patient as provided in section 124.553, subsection 1, paragraph
“g”, and the targeted distribution of proactive notifications
suggesting review of the patient’s prescription history.
Sec. 21. NEW SECTION. 147.162 Rules and directives relating
to opioids.
1. Any board created under this chapter that licenses a
prescribing practitioner shall adopt rules under chapter 17A
establishing penalties for prescribing practitioners that
prescribe opioids in dosage amounts exceeding what would be
prescribed by a reasonably prudent prescribing practitioner
engaged in the same practice.
2. For the purposes of this section, “prescribing
practitioner” means a licensed health care professional with the
authority to prescribe prescription drugs including opioids.
Sec. 22. NEW SECTION. 272C.2C Continuing education minimum
requirements — medicine and surgery and osteopathic medicine and
surgery, nursing, dentistry, podiatry, and physician assistants.
1. The board of medicine, board of dentistry, board of
physician assistants, board of podiatry, and board of nursing
shall establish rules requiring a person licensed pursuant to
section 148.3, 148C.3, 149.3, or 152.6 or chapter 153 who has
-16-prescribed opioids to a patient during the previous licensure
cycle to receive continuing education credits regarding the
United States centers for disease control and prevention
guideline for prescribing opioids for chronic pain, including
recommendations on limitations on dosages and the length of
prescriptions, risk factors for abuse, and nonopioid and
nonpharmacologic therapy options, as a condition of license
renewal. Each licensing board shall have the authority
to determine how often a licensee must receive continuing
education credits.
2. The rules established pursuant to this section shall
include the option for a licensee to attest as part of the
license renewal process that the licensee is not subject to the
requirement to receive continuing education credits pursuant
to this section, due to the fact that the licensee did not
prescribe opioids to a patient during the previous licensure
cycle.
Sec. 23. RESCISSION OF ADMINISTRATIVE RULES.
1. 653 Iowa administrative code, rule 11.4, subrule (1),
paragraph “d”, is rescinded.
2. As soon as practicable, the Iowa administrative code
editor shall remove the language of the Iowa administrative
rule referenced in subsection 1 of this section from the Iowa
administrative code.
DIVISION V
REGISTRATION
Sec. 24. Section 124.302, subsections 1 and 4, Code 2018,
are amended to read as follows:
1. Every person who manufactures, distributes, or dispenses
any controlled substance within in this state or who proposes
to engage in the manufacture, distribution, or dispensing
of any controlled substance within this state, shall obtain
and maintain a biennial registration issued by the board in
accordance with its rules.
4. A separate registration is required for each principal
-17-place of business or professional practice where the applicant
manufactures, distributes, or dispenses, or conducts research
with controlled substances.
Sec. 25. Section 124.304, subsection 1, Code 2018, is
amended to read as follows:
1. The board may suspend, revoke, or restrict a registration
under section 124.303 to manufacture, distribute, or dispense
a controlled substance, or otherwise discipline a registrant,
upon a finding that any of the following apply to the
registrant:
a. The registrant has furnished false or fraudulent material
information in any application filed under this chapter or
any other chapter which applies to the registrant or the
registrant’s practice.
b. The registrant has had the registrant’s federal
registration to manufacture, distribute, or dispense, or
conduct research with controlled substances suspended, revoked,
or restricted.
c. The registrant 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 the entry of the
judgment or sentence has been withheld and the individual
placed on probation.
d. The registrant has committed such acts as would
render the registrant’s registration under section 124.303
inconsistent with the public interest as determined under that
section.
e. If the registrant is a licensed health care professional,
the registrant has had the registrant’s professional license
revoked or suspended or has been otherwise disciplined in a
way that restricts the registrant’s authority to handle or
-18-prescribe controlled substances.
Sec. 26. Section 124.304, subsections 2, 3, and 4, Code
2018, are amended to read as follows:
2. The board may limit revocation, or suspension, or
restriction of a registration or discipline of a registrant
to the particular controlled substance with respect to
which grounds for revocation, or suspension, restriction, or
discipline exist.
3. If the board suspends, or revokes, or restricts a
registration, or otherwise disciplines a registrant, all
controlled substances owned or possessed by the registrant
at the time of the suspension, revocation, restriction,
or discipline, or at the time of the effective date of the
revocation order, may be placed under seal. No disposition
may be made of 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 the proceeds of the sale with the
court. Upon a revocation an order becoming final, all such
controlled substances may be forfeited to the state.
4. The board shall promptly notify the bureau and
the department of all orders suspending, or revoking, or
restricting a registration and all forfeitures of controlled
substances, or otherwise disciplining a registrant.
Sec. 27. Section 124.305, Code 2018, is amended to read as
follows:
124.305 Order to show cause Contested case proceedings.
1. Before denying, Prior to suspending, restricting, or
revoking a registration, or refusing a renewal of registration,
or otherwise disciplining a registrant, the board shall serve
upon the applicant or registrant an order to show cause why
registration should not be denied, revoked, or suspended, or
why the renewal should not be refused. The order to show
cause shall contain a statement of the basis therefor and
shall call upon the applicant or registrant to appear before
-19-the board at a time and place not less than thirty days after
the date of service of the order, but in the case of a denial
or renewal of registration the show cause order shall be
served not later than thirty days before the expiration of
the registration a notice in accordance with section 17A.12,
subsection 1. The proceedings shall comply with the contested
case procedures in accordance with chapter 17A. These The
proceedings shall also be conducted without regard to any
criminal prosecution or other proceeding. Proceedings to
refuse renewal of registration shall not abate the existing
registration which shall remain in effect pending the outcome
of the administrative hearing.
2. The board, without an order to show cause, may suspend
any registration while simultaneously with the institution
of proceedings under section 124.304, or where renewal of
registration is refused, pursuing emergency adjudicative
proceedings in accordance with section 17A.18A, if it finds
that there is an imminent danger to the public health or
safety which warrants this action. The suspension shall
continue in effect until the conclusion of the proceedings,
including judicial review thereof, under the provisions of
the Iowa administrative procedure Act, chapter 17A, unless
sooner withdrawn by the board or dissolved by the order of the
district court or an appellate court.
DIVISION VI
CONTROLLED SUBSTANCES — PRECURSOR SUBSTANCES
Sec. 28. Section 124.204, subsection 9, Code 2018, is
amended by adding the following new paragraphs:
NEW PARAGRAPH. t. Methyl 2-(1-(5-fluoropentyl)-
1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical,
positional, and geometric isomers, salts, and salts of isomers.
Other names: 5F-ADB; 5F-MDMB-PINACA.
NEW PARAGRAPH. u. Methyl 2-(1-(5-fluoropentyl)-1H-
indazole-3-carboxamido)-3-methylbutanoate, its optical,
positional, and geometric isomers, salts, and salts of isomers.
-20-Other name: 5F-AMB.
NEW PARAGRAPH. v. N-(adamantan-1-yl)-1-(5-
fluoropentyl)-1H-indazole-3-carboxamide, its optical,
positional, and geometric isomers, salts, and salts of isomers.
Other names: 5F-APINACA, 5F-AKB48.
NEW PARAGRAPH. w. N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide,
its optical, positional, and geometric isomers, salts, and
salts of isomers. Other name: ADB-FUBINACA.
NEW PARAGRAPH. x. Methyl 2-(1-(cyclohexylmethyl)-1H-
indole-3-carboxamido)-3,3-dimethylbutanoate, its optical,
positional, and geometric isomers, salts, and salts of isomers.
Other names: MDMB-CHMICA, MMB-CHMINACA.
NEW PARAGRAPH. y. Methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical,
positional, and geometric isomers, salts, and salts of
isomers. Other name: MDMB-FUBINACA.
NEW PARAGRAPH. z. N-(4-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)isobutyramide, its isomers, esters,
ethers, salts, and salts of isomers, esters, and ethers. Other
names: 4-fluoroisobutyryl fentanyl, para-fluoroisobutyryl
fentanyl.
NEW PARAGRAPH. aa. N-(2-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl) propionamide. Other names: ortho-
fluorofentanyl or 2-fluorofentanyl.
NEW PARAGRAPH. ab. N-(1-phenethylpiperidin-4-yl)-N-
phenyltetrahydrofuran-2-carboxamide. Other name:
tetrahydrofuranyl fentanyl.
NEW PARAGRAPH. ac. 2-methoxy-N-(1-phenethylpiperidin-4-
yl)-N-phenylacetamide. Other name: methoxyacetyl fentanyl.
NEW PARAGRAPH. ad. N-(1-phenethylpiperidin-4-yl)-N-
phenylacrylamide. Other names: acryl fentanyl or
acryloylfentanyl.
NEW PARAGRAPH. ae. Methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3-methylbutanoate, its optical,
-21-positional, and geometric isomers, salts, and salts of isomers.
Other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA.
Sec. 29. Section 124.206, subsection 7, Code 2018, is
amended by adding the following new paragraph:
NEW PARAGRAPH. c. Dronabinol [(-)-delta-9-trans-
tetrahydrocannabinol] in an oral solution in a drug product
approved for marketing by the United States food and drug
administration.
Sec. 30. Section 124B.2, subsection 1, Code 2018, is amended
by adding the following new paragraph:
NEW PARAGRAPH. ab. Alpha-phenylacetoacetonitrile and its
salts, optical isomers, and salts of optical isomers. Other
name: APAAN.
Sec. 31. EFFECTIVE DATE. This division of this Act, being
deemed of immediate importance, takes effect upon enactment.
DIVISION VII
GOOD SAMARITAN IMMUNITY
Sec. 32. NEW SECTION. 124.418 Persons seeking medical
assistance for drug-related overdose.
1. As used in this section, unless the context otherwise
requires:
a. “Drug-related overdose” means a condition of a person for
which each of the following is true:
(1) The person is in need of medical assistance.
(2) The person displays symptoms including but not limited
to extreme physical illness, pinpoint pupils, decreased level
of consciousness including coma, or respiratory depression.
(3) The person’s condition is the result of, or a prudent
layperson would reasonably believe such condition to be the
result of, the consumption or use of a controlled substance.
b. “Overdose patient” means a person who is, or would
reasonably be perceived to be, suffering a drug-related
overdose and who has not previously received immunity under
this section.
c. “Overdose reporter” means a person who seeks medical
-22-assistance for an overdose patient and who has not previously
received immunity under this section.
d. “Protected information” means information or evidence
collected or derived as a result of any of the following:
(1) An overdose patient’s good-faith actions to seek
medical assistance while experiencing a drug-related overdose.
(2) An overdose reporter’s good-faith actions to seek
medical assistance for an overdose patient experiencing a
drug-related overdose if all of the following are true:
(a) The overdose patient is in need of medical assistance
for an immediate health or safety concern.
(b) The overdose reporter is the first person to seek
medical assistance for the overdose patient.
(c) The overdose reporter provides the overdose reporter’s
name and contact information to medical or law enforcement
personnel.
(d) The overdose reporter remains on the scene until
assistance arrives or is provided.
(e) The overdose reporter cooperates with medical and law
enforcement personnel.
(f) Medical assistance was not sought during the execution
of an arrest warrant, search warrant, or other lawful search.
2. Protected information shall not be considered to support
probable cause and shall not be admissible as evidence against
an overdose patient or overdose reporter for any of the
following offenses:
a. Delivery of a controlled substance under section 124.401,
subsection 1, if such delivery involved the sharing of the
controlled substance without profit.
b. Possession of a controlled substance under section
124.401, subsection 5.
c. Violation of section 124.407.
d. Violation of section 124.414.
3. A person’s pretrial release, probation, supervised
release, or parole shall not be revoked based on protected
-23-information.
4. Notwithstanding any other provision of law to the
contrary, a court may consider the act of providing first aid
or other medical assistance to someone who is experiencing a
drug-related overdose as a mitigating factor in a criminal
prosecution.
5. Nothing in this section shall do any of the following:
a. Preclude or prevent an investigation by law enforcement
of the drug-related overdose where medical assistance was
provided.
b. Be construed to limit or bar the use or admissibility
of any evidence or information obtained in connection with the
investigation of the drug-related overdose in the investigation
or prosecution of other crimes or violations which do not
qualify for immunity under this section and which are committed
by any person, including the overdose patient or overdose
reporter.
c. Preclude the investigation or prosecution of any person
on the basis of evidence obtained from sources other than the
specific drug-related overdose where medical assistance was
provided.
-24-______________________________
LINDA UPMEYERSpeaker of the House______________________________
CHARLES SCHNEIDERPresident of the Senate I hereby certify that this bill originated in the House and is known as House File 2377, Eighty-seventh General Assembly.______________________________
CARMINE BOALChief Clerk of the HouseApproved _______________, 2018______________________________
KIM REYNOLDSGovernorss/rh/md
including the regulation of the practice of pharmacy,
providing penalties, and including effective date
provisions.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
DIVISION I
REGULATION OF THE PRESCRIPTION MONITORING PROGRAM
Section 1. Section 124.550, subsection 2, Code 2018, is
amended to read as follows:
2. “Prescribing practitioner” means a practitioner who
has prescribed or is contemplating the authorization of
a prescription for the patient about whom information is
requested. “Prescribing practitioner” does not include a
licensed veterinarian.
Sec. 2. Section 124.550, Code 2018, is amended by adding the
following new subsection:
NEW SUBSECTION. 4. “Program” means the information program
for drug prescribing and dispensing.
Sec. 3. Section 124.551, subsection 2, Code 2018, is amended
to read as follows:
2. a. The program shall collect from pharmacies dispensing
information for controlled substances identified pursuant to
section 124.554, subsection 1, paragraph “g”, and from first
responders as defined in section 147A.1, subsection 7, with
the exception of emergency medical care providers as defined
in section 147A.1, subsection 4, administration information
for opioid antagonists. The department of public health
shall provide information for the administration of opioid
antagonists to the board as prescribed by rule for emergency
medical care providers as defined in section 147A.1, subsection
4. The board shall adopt rules requiring the following
information to be provided regarding the administration of
opioid antagonists:
(1) Patient identification.
(2) Identification of the person administering opioid
antagonists.
(3) The date of administration.
(4) The quantity of opioid antagonists administered.
b. The information collected shall be used by prescribing
practitioners and pharmacists on a need-to-know basis for
-1-purposes of improving patient health care by facilitating early
identification of patients who may be at risk for addiction,
or who may be using, abusing, or diverting drugs for unlawful
or otherwise unauthorized purposes at risk to themselves and
others, or who may be appropriately using controlled substances
lawfully prescribed for them but unknown to the practitioner.
Sec. 4. NEW SECTION. 124.551A Prescribing practitioner
program registration.
A prescribing practitioner shall register for the program at
the same time the prescribing practitioner applies to the board
to register or renews registration to prescribe controlled
substances as required by the board. Once the prescribing
practitioner registers for the program, the prescribing
practitioner or the prescribing practitioner’s designated agent
shall utilize the program database prior to issuing an opioid
prescription as prescribed by rules adopted by the prescribing
practitioner’s licensing board to assist the prescribing
practitioner in determining appropriate treatment options
and to improve the quality of patient care. A prescribing
practitioner shall not be required to utilize the program
database to assist in the treatment of a patient receiving
inpatient hospice care or long-term residential facility
patient care.
Sec. 5. Section 124.552, Code 2018, is amended to read as
follows:
124.552 Information reporting.
1. Each Unless otherwise prohibited by federal or state law,
each licensed pharmacy that dispenses controlled substances
identified pursuant to section 124.554, subsection 1, paragraph
“g”, to patients in the state, and each licensed pharmacy
located in the state that dispenses such controlled substances
identified pursuant to section 124.554, subsection 1,
paragraph “g”, to patients inside or outside the state, unless
specifically excepted in this section or by rule, and each
prescribing practitioner furnishing, dispensing, or supplying
-2-controlled substances to the prescribing practitioner’s
patient, shall submit the following prescription information
to the program:
a. Pharmacy identification.
b. Patient identification.
c. Prescribing practitioner identification.
d. The date the prescription was issued by the prescribing
practitioner.
e. The date the prescription was dispensed.
f. An indication of whether the prescription dispensed is
new or a refill.
g. Identification of the drug dispensed.
h. Quantity of the drug dispensed.
i. The number of days’ supply of the drug dispensed.
j. Serial or prescription number assigned by the pharmacy.
k. Type of payment for the prescription.
l. Other information identified by the board and advisory
council by rule.
2. Information shall be submitted electronically in a
secure format specified by the board unless the board has
granted a waiver and approved an alternate secure format.
3. Information shall be timely transmitted as designated
by the board and advisory council by rule within one business
day of the dispensing of the controlled substance, unless the
board grants an extension. The board may grant an extension if
either of the following occurs:
a. The pharmacy or prescribing practitioner suffers
a mechanical or electronic failure, or cannot meet the
deadline established by the board for other reasons beyond the
pharmacy’s or practitioner’s control.
b. The board is unable to receive electronic submissions.
4. This section shall not apply to a prescribing
practitioner furnishing, dispensing, supplying, or
administering drugs to the prescribing practitioner’s patient,
or to dispensing by a licensed pharmacy for the purposes of
-3-inpatient hospital care, inpatient hospice care, or long-term
residential facility patient care.
Sec. 6. Section 124.553, subsection 4, Code 2018, is amended
by striking the subsection.
Sec. 7. Section 124.554, subsection 1, paragraphs b, c, d,
and g, Code 2018, are amended to read as follows:
b. An electronic format for the submission of information
from pharmacies and prescribing practitioners.
c. A waiver to submit information in another format for
a pharmacy or prescribing practitioner unable to submit
information electronically.
d. An application by a pharmacy or prescribing practitioner
for an extension of time for transmitting information to the
program.
g. Including all schedule II controlled substances, and
those substances in schedules III and IV that the advisory
council and board determine can be addictive or fatal if not
taken under the proper care and direction of a prescribing
practitioner, and opioid antagonists.
Sec. 8. Section 124.557, Code 2018, is amended to read as
follows:
124.557 Drug information program fund.
The drug information program fund is established to be used
by the board to fund or assist in funding the program. The
board may make deposits into the fund from any source, public
or private, including grants or contributions of money or other
items of value, which it determines necessary to carry out the
purposes of this subchapter. The board may add a surcharge
of not more than twenty-five percent to the applicable fee
for a registration issued pursuant to section 124.302 and the
surcharge shall be deposited into the fund. Moneys received
by the board to establish and maintain the program must
be used for the expenses of administering this subchapter.
Notwithstanding section 8.33, amounts contained in the fund
that remain unencumbered or unobligated at the close of the
-4-fiscal year shall not revert but shall remain available for
expenditure for the purposes designated in future years.
Sec. 9. Section 124.558, subsection 1, Code 2018, is amended
to read as follows:
1. Failure to comply with requirements. A pharmacist,
pharmacy, prescribing practitioner, or agent of a pharmacist
or prescribing practitioner who knowingly fails to comply
with the confidentiality requirements of this subchapter
or who delegates program information access to another
individual except as provided in section 124.553, is subject to
disciplinary action by the appropriate professional licensing
board. A pharmacist, or pharmacy, or prescribing practitioner
that knowingly fails to comply with other requirements of this
subchapter is subject to disciplinary action by the board.
Each licensing board may adopt rules in accordance with chapter
17A to implement the provisions of this section.
DIVISION II
ELECTRONIC PRESCRIPTIONS
Sec. 10. Section 124.308, Code 2018, is amended by striking
the section and inserting in lieu thereof the following:
124.308 Prescriptions.
1. Except when dispensed directly by a practitioner to an
ultimate user, a prescription drug as defined in section 155A.3
that is a controlled substance shall not be dispensed without
a prescription, unless such prescription is authorized by a
practitioner and complies with this section, section 155A.27,
applicable federal law and regulation, and rules of the board.
2. a. Beginning January 1, 2020, every prescription issued
for a controlled substance shall be transmitted electronically
as an electronic prescription pursuant to the requirements in
subsection 2, paragraph “b”, unless exempt under subsection 2,
paragraph “c”.
b. Except for prescriptions identified in paragraph “c”,
a prescription that is transmitted pursuant to paragraph “a”
shall be transmitted to a pharmacy by a practitioner or the
-5-practitioner’s authorized agent in compliance with federal
law and regulation for electronic prescriptions of controlled
substances. The practitioner’s electronic prescription system
and the receiving pharmacy’s dispensing system shall comply
with federal law and regulation for electronic prescriptions of
controlled substances.
c. Paragraph “b” shall not apply to any of the following:
(1) A prescription for a patient residing in a nursing home,
long-term care facility, correctional facility, or jail.
(2) A prescription authorized by a licensed veterinarian.
(3) A prescription dispensed by a department of veterans
affairs pharmacy.
(4) A prescription requiring information that makes
electronic submission impractical, such as complicated or
lengthy directions for use or attachments.
(5) A prescription for a compounded preparation containing
two or more components.
(6) A prescription issued in response to a public health
emergency in a situation where a non-patient specific
prescription would be permitted.
(7) A prescription issued pursuant to an established and
valid collaborative practice agreement, standing order, or drug
research protocol.
(8) A prescription issued during a temporary technical
or electronic failure at the practitioner’s or pharmacy’s
location, provided that a prescription issued pursuant to
this subparagraph shall indicate on the prescription that the
practitioner or pharmacy is experiencing a temporary technical
or electronic failure.
(9) A prescription issued in an emergency situation
pursuant to federal law and regulation rules of the board.
d. A practitioner, as defined in section 124.101, subsection
27, paragraph “a”, who violates paragraph “a” is subject
to an administrative penalty of two hundred fifty dollars
per violation, up to a maximum of five thousand dollars per
-6-calendar year. The assessment of an administrative penalty
pursuant to this paragraph by the appropriate licensing board
of the practitioner alleged to have violated paragraph “a”
shall not be considered a disciplinary action or reported
as discipline. A practitioner may appeal the assessment of
an administrative penalty pursuant to this paragraph, which
shall initiate a contested case proceeding under chapter
17A. A penalty collected pursuant to this paragraph shall be
deposited into the drug information program fund established
pursuant to section 124.557. The board shall be notified
of any administrative penalties assessed by the appropriate
professional licensing board and deposited into the drug
information program fund under this paragraph.
e. A pharmacist who receives a written, oral, or facsimile
prescription shall not be required to verify that the
prescription is subject to an exception under paragraph “c”
and may dispense a prescription drug pursuant to an otherwise
valid written, oral, or facsimile prescription. However, a
pharmacist shall exercise professional judgment in identifying
and reporting suspected violations of this section to the
board or the appropriate professional licensing board of the
practitioner.
3. A prescription issued prior to January 1, 2020, or a
prescription that is exempt from the electronic prescription
requirement in subsection 2, paragraph “c”, may be transmitted
by a practitioner or the practitioner’s authorized agent to a
pharmacy in any of the following ways:
a. Electronically, if transmitted in accordance with
the requirements for electronic prescriptions pursuant to
subsection 2.
b. By facsimile for a schedule III, IV, or V controlled
substance, or for a schedule II controlled substance only
pursuant to federal law and regulation and rules of the board.
c. Orally for a schedule III, IV, or V controlled substance,
or for a schedule II controlled substance only in an emergency
-7-situation pursuant to federal regulation and rules of the
board.
d. By providing an original signed prescription to a patient
or a patient’s authorized representative.
4. If permitted by federal law and in accordance with
federal requirements, an electronic or facsimile prescription
shall serve as the original signed prescription and the
practitioner shall not provide a patient, a patient’s
authorized representative, or the dispensing pharmacy with a
signed, written prescription. An original signed prescription
shall be retained for a minimum of two years from the date of
the latest dispensing or refill of the prescription.
5. A prescription for a schedule II controlled substance
shall not be filled more than six months after the date
of issuance. A prescription for a schedule II controlled
substance shall not be refilled.
6. A prescription for a schedule III, IV, or V controlled
substance shall not be filled or refilled more than six months
after the date on which the prescription was issued or be
refilled more than five times.
7. A controlled substance shall not be distributed or
dispensed other than for a medical purpose.
8. A practitioner, medical group, or pharmacy that is unable
to timely comply with the electronic prescribing requirements
in subsection 2, paragraph “b”, may petition the board for an
exemption from the requirements based upon economic hardship,
technical limitations that the practitioner, medical group, or
pharmacy cannot control, or other exceptional circumstances.
The board shall adopt rules establishing the form and specific
information to be included in a request for an exemption
and the specific criteria to be considered by the board in
determining whether to approve a request for an exemption. The
board may approve an exemption for a period of time determined
by the board not to exceed one year from the date of approval,
and may be renewed annually upon request subject to board
-8-approval.
Sec. 11. Section 155A.27, Code 2018, is amended by striking
the section and inserting in lieu thereof the following:
155A.27 Requirements for prescription.
1. Except when dispensed directly by a prescriber to an
ultimate user, a prescription drug shall not be dispensed
without a prescription, authorized by a prescriber, and based
on a valid patient-prescriber relationship.
2. a. Beginning January 1, 2020, every prescription issued
for a prescription drug shall be transmitted electronically as
an electronic prescription to a pharmacy by a prescriber or the
prescriber’s authorized agent unless exempt under paragraph
“b”.
b. Paragraph “a” shall not apply to any of the following:
(1) A prescription for a patient residing in a nursing home,
long-term care facility, correctional facility, or jail.
(2) A prescription authorized by a licensed veterinarian.
(3) A prescription for a device.
(4) A prescription dispensed by a department of veterans
affairs pharmacy.
(5) A prescription requiring information that makes
electronic transmission impractical, such as complicated or
lengthy directions for use or attachments.
(6) A prescription for a compounded preparation containing
two or more components.
(7) A prescription issued in response to a public health
emergency in a situation where a non-patient specific
prescription would be permitted.
(8) A prescription issued for an opioid antagonist pursuant
to section 135.190 or a prescription issued for epinephrine
pursuant to section 135.185.
(9) A prescription issued during a temporary technical
or electronic failure at the location of the prescriber or
pharmacy, provided that a prescription issued pursuant to
this subparagraph shall indicate on the prescription that the
-9-prescriber or pharmacy is experiencing a temporary technical
or electronic failure.
(10) A prescription issued pursuant to an established and
valid collaborative practice agreement, standing order, or drug
research protocol.
(11) A prescription issued in an emergency situation
pursuant to federal law and regulation and rules of the board.
c. A practitioner, as defined in section 124.101, subsection
27, paragraph “a”, who violates paragraph “a” is subject
to an administrative penalty of two hundred fifty dollars
per violation, up to a maximum of five thousand dollars per
calendar year. The assessment of an administrative penalty
pursuant to this paragraph by the appropriate licensing board
of the practitioner alleged to have violated paragraph “a”
shall not be considered a disciplinary action or reported
as discipline. A practitioner may appeal the assessment of
an administrative penalty pursuant to this paragraph, which
shall initiate a contested case proceeding under chapter
17A. A penalty collected pursuant to this paragraph shall be
deposited into the drug information program fund established
pursuant to section 124.557. The board shall be notified
of any administrative penalties assessed by the appropriate
professional licensing board and deposited into the drug
information program fund under this paragraph.
d. A pharmacist who receives a written, oral, or facsimile
prescription shall not be required to verify that the
prescription is subject to an exception under paragraph “b”
and may dispense a prescription drug pursuant to an otherwise
valid written, oral, or facsimile prescription. However, a
pharmacist shall exercise professional judgment in identifying
and reporting suspected violations of this section to the
board or the appropriate professional licensing board of the
prescriber.
3. For prescriptions issued prior to January 1, 2020,
or for prescriptions exempt from the electronic prescription
-10-requirement in subsection 2, paragraph “b”, a prescriber or the
prescriber’s authorized agent may transmit a prescription for a
prescription drug to a pharmacy by any of the following means:
a. Electronically.
b. By facsimile.
c. Orally.
d. By providing an original signed prescription to a patient
or a patient’s authorized representative.
4. A prescription shall be issued in compliance with
this subsection. Regardless of the means of transmission, a
prescriber shall provide verbal verification of a prescription
upon request of the pharmacy.
a. If written, electronic, or facsimile, each prescription
shall contain all of the following:
(1) The date of issue.
(2) The name and address of the patient for whom, or the
owner of the animal for which, the drug is dispensed.
(3) The name, strength, and quantity of the drug prescribed.
(4) The directions for use of the drug, medicine, or device
prescribed.
(5) The name, address, and written or electronic signature
of the prescriber issuing the prescription.
(6) The federal drug enforcement administration number, if
required under chapter 124.
b. If electronic, each prescription shall comply with all
of the following:
(1) The prescriber shall ensure that the electronic system
used to transmit the electronic prescription has adequate
security and safeguards designed to prevent and detect
unauthorized access, modification, or manipulation of the
prescription.
(2) Notwithstanding paragraph “a”, subparagraph (5),
for prescriptions that are not controlled substances, if
transmitted by an authorized agent, the electronic prescription
shall not require the written or electronic signature of the
-11-prescriber issuing the prescription.
c. If facsimile, in addition to the requirements of
paragraph “a”, each prescription shall contain all of the
following:
(1) The identification number of the facsimile machine
which is used to transmit the prescription.
(2) The date and time of transmission of the prescription.
(3) The name, address, telephone number, and facsimile
number of the pharmacy to which the prescription is being
transmitted.
d. If oral, the prescriber issuing the prescription
shall furnish the same information required for a written
prescription, except for the written signature and address
of the prescriber. Upon receipt of an oral prescription,
the recipient shall promptly reduce the oral prescription to
a written format by recording the information required in a
written prescription.
e. A prescription transmitted by electronic, facsimile,
or oral means by a prescriber’s agent shall also include
the name and title of the prescriber’s agent completing the
transmission.
5. An electronic, facsimile, or oral prescription
shall serve as the original signed prescription and the
prescriber shall not provide a patient, a patient’s authorized
representative, or the dispensing pharmacist with a signed
written prescription. Prescription records shall be retained
pursuant to rules of the board.
6. This section shall not prohibit a pharmacist,
in exercising the pharmacist’s professional judgment,
from dispensing, at one time, additional quantities of a
prescription drug, with the exception of a prescription drug
that is a controlled substance as defined in section 124.101,
up to the total number of dosage units authorized by the
prescriber on the original prescription and any refills of
the prescription, not to exceed a ninety-day supply of the
-12-prescription drug as specified on the prescription.
7. A prescriber, medical group, institution, or pharmacy
that is unable to timely comply with the electronic prescribing
requirements in subsection 2, paragraph “a”, may petition
the board for an exemption from the requirements based upon
economic hardship, technical limitations that the prescriber,
medical group, institution, or pharmacy cannot control, or
other exceptional circumstances. The board shall adopt rules
establishing the form and specific information to be included
in a request for an exemption and the specific criteria to be
considered by the board in determining whether to approve a
request for an exemption. The board may approve an exemption
for a period of time determined by the board, not to exceed one
year from the date of approval, and may be annually renewed
subject to board approval upon request.
Sec. 12. Section 155A.29, subsection 4, Code 2018, is
amended to read as follows:
4. An authorization to refill a prescription drug order may
shall be transmitted to a pharmacist pharmacy by a prescriber
or the prescriber’s authorized agent through word of mouth,
note, telephone, facsimile, or other means of communication
initiated by or directed by the practitioner. The transmission
shall include the information required pursuant to section
155A.27, except that prescription drug orders for controlled
substances shall be transmitted pursuant to section 124.308,
and, if not transmitted directly by the practitioner,
shall identify by also include the name and title of the
practitioner’s agent completing the transmission.
DIVISION III
PRESCRIBER ACTIVITY REPORTS
Sec. 13. Section 124.553, subsection 1, Code 2018, is
amended by adding the following new paragraph:
NEW PARAGRAPH. h. A prescribing practitioner for the
issuance of a required report pursuant to section 124.554,
subsection 3.
-13- Sec. 14. Section 124.554, subsection 1, Code 2018, is
amended by adding the following new paragraph:
NEW PARAGRAPH. j. The issuance annually of a prescribing
practitioner activity report compiled from information from the
program pursuant to subsection 3.
Sec. 15. Section 124.554, Code 2018, is amended by adding
the following new subsection:
NEW SUBSECTION. 3. a. Beginning February 1, 2019,
and annually by February 1 thereafter, the board shall
electronically, and at as low a cost as possible, issue each
prescribing practitioner who prescribed a controlled substance
reported to the program as dispensed in the preceding calendar
year in this state a prescribing practitioner activity report
which shall include but not be limited to the following:
(1) A summary of the prescribing practitioner’s history of
prescribing controlled substances.
(2) A comparison of the prescribing practitioner’s history
of prescribing controlled substances with the history of other
prescribing practitioners of the same profession or specialty.
(3) The prescribing practitioner’s history of program use.
(4) General patient risk factors.
(5) Educational updates.
(6) Other pertinent information identified by the board and
advisory council by rule.
b. Information provided to a prescribing practitioner in a
report required under this subsection is privileged and shall
be kept confidential pursuant to section 124.553, subsection 3.
Sec. 16. Section 124.556, Code 2018, is amended to read as
follows:
124.556 Education and treatment.
The program for drug prescribing and dispensing shall
include education initiatives and outreach to consumers,
prescribing practitioners, and pharmacists, and shall also
include assistance for identifying substance abuse treatment
programs and providers. The program shall also include
-14-educational updates and information on general patient risk
factors for prescribing practitioners. The board and advisory
council shall adopt rules, as provided under section 124.554,
to implement this section.
DIVISION IV
SUBSTANCE ABUSE PREVENTION
Sec. 17. Section 124.550, Code 2018, is amended by adding
the following new subsection:
NEW SUBSECTION. 3. “Proactive notification” means
a notification by the board, generated based on factors
determined by the board and issued to a specific prescribing
practitioner or pharmacist, indicating that a patient may
be practitioner shopping or pharmacy shopping or at risk of
abusing or misusing a controlled substance.
Sec. 18. Section 124.553, subsection 1, Code 2018, is
amended by adding the following new paragraph:
NEW PARAGRAPH. g. A prescribing practitioner or pharmacist
through the use of a targeted distribution of proactive
notifications.
Sec. 19. Section 124.553, subsections 2 and 3, Code 2018,
are amended to read as follows:
2. The board shall maintain a record of each person that
requests information from the program and of all proactive
notifications distributed to prescribing practitioners and
dispensing pharmacists as provided in subsection 1, paragraph
“g”. Pursuant to rules adopted by the board and advisory
council under section 124.554, the board may use the records
to document and report statistical information, and may
provide program information for statistical, public research,
public policy, or educational purposes, after removing
personal identifying information of a patient, prescribing
practitioner, dispenser, or other person who is identified in
the information.
3. Information contained in the program and any information
obtained from it, and information contained in the records
-15-of requests for information from the program and information
distributed to prescribing practitioners and dispensing
pharmacists as provided in subsection 1, paragraph “g”,
is privileged and strictly confidential information. Such
information is a confidential public record pursuant to section
22.7, and is not subject to discovery, subpoena, or other
means of legal compulsion for release except as provided in
this subchapter. Information from the program shall not be
released, shared with an agency or institution, or made public
except as provided in this subchapter.
Sec. 20. Section 124.554, subsection 1, Code 2018, is
amended by adding the following new paragraph:
NEW PARAGRAPH. k. The establishment of thresholds or other
criteria or measures to be used in identifying an at-risk
patient as provided in section 124.553, subsection 1, paragraph
“g”, and the targeted distribution of proactive notifications
suggesting review of the patient’s prescription history.
Sec. 21. NEW SECTION. 147.162 Rules and directives relating
to opioids.
1. Any board created under this chapter that licenses a
prescribing practitioner shall adopt rules under chapter 17A
establishing penalties for prescribing practitioners that
prescribe opioids in dosage amounts exceeding what would be
prescribed by a reasonably prudent prescribing practitioner
engaged in the same practice.
2. For the purposes of this section, “prescribing
practitioner” means a licensed health care professional with the
authority to prescribe prescription drugs including opioids.
Sec. 22. NEW SECTION. 272C.2C Continuing education minimum
requirements — medicine and surgery and osteopathic medicine and
surgery, nursing, dentistry, podiatry, and physician assistants.
1. The board of medicine, board of dentistry, board of
physician assistants, board of podiatry, and board of nursing
shall establish rules requiring a person licensed pursuant to
section 148.3, 148C.3, 149.3, or 152.6 or chapter 153 who has
-16-prescribed opioids to a patient during the previous licensure
cycle to receive continuing education credits regarding the
United States centers for disease control and prevention
guideline for prescribing opioids for chronic pain, including
recommendations on limitations on dosages and the length of
prescriptions, risk factors for abuse, and nonopioid and
nonpharmacologic therapy options, as a condition of license
renewal. Each licensing board shall have the authority
to determine how often a licensee must receive continuing
education credits.
2. The rules established pursuant to this section shall
include the option for a licensee to attest as part of the
license renewal process that the licensee is not subject to the
requirement to receive continuing education credits pursuant
to this section, due to the fact that the licensee did not
prescribe opioids to a patient during the previous licensure
cycle.
Sec. 23. RESCISSION OF ADMINISTRATIVE RULES.
1. 653 Iowa administrative code, rule 11.4, subrule (1),
paragraph “d”, is rescinded.
2. As soon as practicable, the Iowa administrative code
editor shall remove the language of the Iowa administrative
rule referenced in subsection 1 of this section from the Iowa
administrative code.
DIVISION V
REGISTRATION
Sec. 24. Section 124.302, subsections 1 and 4, Code 2018,
are amended to read as follows:
1. Every person who manufactures, distributes, or dispenses
any controlled substance within in this state or who proposes
to engage in the manufacture, distribution, or dispensing
of any controlled substance within this state, shall obtain
and maintain a biennial registration issued by the board in
accordance with its rules.
4. A separate registration is required for each principal
-17-place of business or professional practice where the applicant
manufactures, distributes, or dispenses, or conducts research
with controlled substances.
Sec. 25. Section 124.304, subsection 1, Code 2018, is
amended to read as follows:
1. The board may suspend, revoke, or restrict a registration
under section 124.303 to manufacture, distribute, or dispense
a controlled substance, or otherwise discipline a registrant,
upon a finding that any of the following apply to the
registrant:
a. The registrant has furnished false or fraudulent material
information in any application filed under this chapter or
any other chapter which applies to the registrant or the
registrant’s practice.
b. The registrant has had the registrant’s federal
registration to manufacture, distribute, or dispense, or
conduct research with controlled substances suspended, revoked,
or restricted.
c. The registrant 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 the entry of the
judgment or sentence has been withheld and the individual
placed on probation.
d. The registrant has committed such acts as would
render the registrant’s registration under section 124.303
inconsistent with the public interest as determined under that
section.
e. If the registrant is a licensed health care professional,
the registrant has had the registrant’s professional license
revoked or suspended or has been otherwise disciplined in a
way that restricts the registrant’s authority to handle or
-18-prescribe controlled substances.
Sec. 26. Section 124.304, subsections 2, 3, and 4, Code
2018, are amended to read as follows:
2. The board may limit revocation, or suspension, or
restriction of a registration or discipline of a registrant
to the particular controlled substance with respect to
which grounds for revocation, or suspension, restriction, or
discipline exist.
3. If the board suspends, or revokes, or restricts a
registration, or otherwise disciplines a registrant, all
controlled substances owned or possessed by the registrant
at the time of the suspension, revocation, restriction,
or discipline, or at the time of the effective date of the
revocation order, may be placed under seal. No disposition
may be made of 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 the proceeds of the sale with the
court. Upon a revocation an order becoming final, all such
controlled substances may be forfeited to the state.
4. The board shall promptly notify the bureau and
the department of all orders suspending, or revoking, or
restricting a registration and all forfeitures of controlled
substances, or otherwise disciplining a registrant.
Sec. 27. Section 124.305, Code 2018, is amended to read as
follows:
124.305 Order to show cause Contested case proceedings.
1. Before denying, Prior to suspending, restricting, or
revoking a registration, or refusing a renewal of registration,
or otherwise disciplining a registrant, the board shall serve
upon the applicant or registrant an order to show cause why
registration should not be denied, revoked, or suspended, or
why the renewal should not be refused. The order to show
cause shall contain a statement of the basis therefor and
shall call upon the applicant or registrant to appear before
-19-the board at a time and place not less than thirty days after
the date of service of the order, but in the case of a denial
or renewal of registration the show cause order shall be
served not later than thirty days before the expiration of
the registration a notice in accordance with section 17A.12,
subsection 1. The proceedings shall comply with the contested
case procedures in accordance with chapter 17A. These The
proceedings shall also be conducted without regard to any
criminal prosecution or other proceeding. Proceedings to
refuse renewal of registration shall not abate the existing
registration which shall remain in effect pending the outcome
of the administrative hearing.
2. The board, without an order to show cause, may suspend
any registration while simultaneously with the institution
of proceedings under section 124.304, or where renewal of
registration is refused, pursuing emergency adjudicative
proceedings in accordance with section 17A.18A, if it finds
that there is an imminent danger to the public health or
safety which warrants this action. The suspension shall
continue in effect until the conclusion of the proceedings,
including judicial review thereof, under the provisions of
the Iowa administrative procedure Act, chapter 17A, unless
sooner withdrawn by the board or dissolved by the order of the
district court or an appellate court.
DIVISION VI
CONTROLLED SUBSTANCES — PRECURSOR SUBSTANCES
Sec. 28. Section 124.204, subsection 9, Code 2018, is
amended by adding the following new paragraphs:
NEW PARAGRAPH. t. Methyl 2-(1-(5-fluoropentyl)-
1H-indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical,
positional, and geometric isomers, salts, and salts of isomers.
Other names: 5F-ADB; 5F-MDMB-PINACA.
NEW PARAGRAPH. u. Methyl 2-(1-(5-fluoropentyl)-1H-
indazole-3-carboxamido)-3-methylbutanoate, its optical,
positional, and geometric isomers, salts, and salts of isomers.
-20-Other name: 5F-AMB.
NEW PARAGRAPH. v. N-(adamantan-1-yl)-1-(5-
fluoropentyl)-1H-indazole-3-carboxamide, its optical,
positional, and geometric isomers, salts, and salts of isomers.
Other names: 5F-APINACA, 5F-AKB48.
NEW PARAGRAPH. w. N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide,
its optical, positional, and geometric isomers, salts, and
salts of isomers. Other name: ADB-FUBINACA.
NEW PARAGRAPH. x. Methyl 2-(1-(cyclohexylmethyl)-1H-
indole-3-carboxamido)-3,3-dimethylbutanoate, its optical,
positional, and geometric isomers, salts, and salts of isomers.
Other names: MDMB-CHMICA, MMB-CHMINACA.
NEW PARAGRAPH. y. Methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3,3-dimethylbutanoate, its optical,
positional, and geometric isomers, salts, and salts of
isomers. Other name: MDMB-FUBINACA.
NEW PARAGRAPH. z. N-(4-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)isobutyramide, its isomers, esters,
ethers, salts, and salts of isomers, esters, and ethers. Other
names: 4-fluoroisobutyryl fentanyl, para-fluoroisobutyryl
fentanyl.
NEW PARAGRAPH. aa. N-(2-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl) propionamide. Other names: ortho-
fluorofentanyl or 2-fluorofentanyl.
NEW PARAGRAPH. ab. N-(1-phenethylpiperidin-4-yl)-N-
phenyltetrahydrofuran-2-carboxamide. Other name:
tetrahydrofuranyl fentanyl.
NEW PARAGRAPH. ac. 2-methoxy-N-(1-phenethylpiperidin-4-
yl)-N-phenylacetamide. Other name: methoxyacetyl fentanyl.
NEW PARAGRAPH. ad. N-(1-phenethylpiperidin-4-yl)-N-
phenylacrylamide. Other names: acryl fentanyl or
acryloylfentanyl.
NEW PARAGRAPH. ae. Methyl 2-(1-(4-fluorobenzyl)-1H-
indazole-3-carboxamido)-3-methylbutanoate, its optical,
-21-positional, and geometric isomers, salts, and salts of isomers.
Other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA.
Sec. 29. Section 124.206, subsection 7, Code 2018, is
amended by adding the following new paragraph:
NEW PARAGRAPH. c. Dronabinol [(-)-delta-9-trans-
tetrahydrocannabinol] in an oral solution in a drug product
approved for marketing by the United States food and drug
administration.
Sec. 30. Section 124B.2, subsection 1, Code 2018, is amended
by adding the following new paragraph:
NEW PARAGRAPH. ab. Alpha-phenylacetoacetonitrile and its
salts, optical isomers, and salts of optical isomers. Other
name: APAAN.
Sec. 31. EFFECTIVE DATE. This division of this Act, being
deemed of immediate importance, takes effect upon enactment.
DIVISION VII
GOOD SAMARITAN IMMUNITY
Sec. 32. NEW SECTION. 124.418 Persons seeking medical
assistance for drug-related overdose.
1. As used in this section, unless the context otherwise
requires:
a. “Drug-related overdose” means a condition of a person for
which each of the following is true:
(1) The person is in need of medical assistance.
(2) The person displays symptoms including but not limited
to extreme physical illness, pinpoint pupils, decreased level
of consciousness including coma, or respiratory depression.
(3) The person’s condition is the result of, or a prudent
layperson would reasonably believe such condition to be the
result of, the consumption or use of a controlled substance.
b. “Overdose patient” means a person who is, or would
reasonably be perceived to be, suffering a drug-related
overdose and who has not previously received immunity under
this section.
c. “Overdose reporter” means a person who seeks medical
-22-assistance for an overdose patient and who has not previously
received immunity under this section.
d. “Protected information” means information or evidence
collected or derived as a result of any of the following:
(1) An overdose patient’s good-faith actions to seek
medical assistance while experiencing a drug-related overdose.
(2) An overdose reporter’s good-faith actions to seek
medical assistance for an overdose patient experiencing a
drug-related overdose if all of the following are true:
(a) The overdose patient is in need of medical assistance
for an immediate health or safety concern.
(b) The overdose reporter is the first person to seek
medical assistance for the overdose patient.
(c) The overdose reporter provides the overdose reporter’s
name and contact information to medical or law enforcement
personnel.
(d) The overdose reporter remains on the scene until
assistance arrives or is provided.
(e) The overdose reporter cooperates with medical and law
enforcement personnel.
(f) Medical assistance was not sought during the execution
of an arrest warrant, search warrant, or other lawful search.
2. Protected information shall not be considered to support
probable cause and shall not be admissible as evidence against
an overdose patient or overdose reporter for any of the
following offenses:
a. Delivery of a controlled substance under section 124.401,
subsection 1, if such delivery involved the sharing of the
controlled substance without profit.
b. Possession of a controlled substance under section
124.401, subsection 5.
c. Violation of section 124.407.
d. Violation of section 124.414.
3. A person’s pretrial release, probation, supervised
release, or parole shall not be revoked based on protected
-23-information.
4. Notwithstanding any other provision of law to the
contrary, a court may consider the act of providing first aid
or other medical assistance to someone who is experiencing a
drug-related overdose as a mitigating factor in a criminal
prosecution.
5. Nothing in this section shall do any of the following:
a. Preclude or prevent an investigation by law enforcement
of the drug-related overdose where medical assistance was
provided.
b. Be construed to limit or bar the use or admissibility
of any evidence or information obtained in connection with the
investigation of the drug-related overdose in the investigation
or prosecution of other crimes or violations which do not
qualify for immunity under this section and which are committed
by any person, including the overdose patient or overdose
reporter.
c. Preclude the investigation or prosecution of any person
on the basis of evidence obtained from sources other than the
specific drug-related overdose where medical assistance was
provided.
-24-______________________________
LINDA UPMEYERSpeaker of the House______________________________
CHARLES SCHNEIDERPresident of the Senate I hereby certify that this bill originated in the House and is known as House File 2377, Eighty-seventh General Assembly.______________________________
CARMINE BOALChief Clerk of the HouseApproved _______________, 2018______________________________
KIM REYNOLDSGovernorss/rh/md