CHAPTER 10
CONTROLLED SUBSTANCES
[Prior to 2/10/88, see Pharmacy Examiners[620] Ch 8]
657—10.1(124) Purpose and scope. This chapter establishes the minimum standards for any activity that involves controlled substances. Any person or business that manufactures; distributes; dispenses; prescribes; conducts instructional activities, research, or chemical analysis with; or imports or exports controlled substances listed in Schedules I through V of Iowa Code chapter 124 in or into the state of Iowa, or that proposes to engage in such activities, shall obtain and maintain a registration issued by the board unless exempt from registration pursuant to rule 657—10.8(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. A registration is not transferable to any person or business.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.2(124) Definitions. For the purposes of this chapter, the following definitions shall apply:
“Authorized collection program” means a program administered by a registrant that has modified its registration with DEA to collect controlled substances for the purpose of disposal. Federal regulations for such programs can be found at www.deadiversion.usdoj.gov/drug_disposal/. Modification to the registrant’s Iowa controlled substances Act registration shall not be required.
“Board” means the Iowa board of pharmacy.
“CSA” means the Iowa uniform controlled substances Act.
“CSA registration” or “registration” means the registration issued by the board pursuant to the CSA that signifies the registrant’s authorization to engage in registered activities with controlled substances.
“DEA” means the United States Department of Justice, Drug Enforcement Administration.
“Individual practitioner” means a physician or surgeon (M.D.), osteopathic physician or surgeon (D.O.), dentist (D.D.S. or D.M.D.), doctor of veterinary medicine (D.V.M.), podiatric physician (D.P.M.), optometrist (O.D.), physician assistant (P.A.), resident physician, advanced registered nurse practitioner (A.R.N.P.), or prescribing psychologist.
“Prescription monitoring program,” “PMP,” or “program” means the program established pursuant to 657—Chapter 37 for the collection and maintenance of PMP information and for the provision of PMP information to authorized individuals.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4455C, IAB 5/22/19, effective 6/26/19]
657—10.3(124) Who shall register. The following persons or businesses shall register on forms provided by the board:
	1.	Manufacturers, distributors, importers, and exporters located in Iowa. Effective January 1, 2018, nonresident manufacturers, distributors, importers, and exporters distributing controlled substances into Iowa.
	2.	Reverse distributors located in Iowa. Effective January 1, 2018, nonresident reverse distributors engaging in the transfer of controlled substances with registrants located in Iowa.
	3.	Individual practitioners located in Iowa who are administering, dispensing, or prescribing controlled substances and individual practitioners located outside of Iowa who are dispensing or prescribing controlled substances via telehealth services to patients located in Iowa.
	4.	Pharmacies located in Iowa that are dispensing controlled substances. Effective January 1, 2018, pharmacies located outside of Iowa that are delivering controlled substances to patients located in Iowa.
	5.	Hospitals located in Iowa that are administering or dispensing controlled substances. Effective January 1, 2018, hospitals located outside of Iowa that are administering or dispensing controlled substances to patients located in Iowa.
	6.	Emergency medical service programs that are administering controlled substances to patients located in Iowa.
	7.	Care facilities that are located in Iowa.
	8.	Researchers, analytical laboratories, and teaching institutions that are located in Iowa.
	9.	Animal shelters and dog training facilities that are located in Iowa.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.4(124) Who may register. On a case-by-case basis, the board may issue a registration to a business location not listed in rule 657—10.3(124) if it would be impractical to require each individual practitioner who administers or dispenses controlled substances to separately register at the business location. Examples of business locations that may be eligible for a registration pursuant to this rule include, but are not limited to, ambulatory surgical centers as defined in Iowa Code section 147.163, dialysis centers, federally qualified health centers, and standalone clinics associated with a hospital system.
[ARC 7025C, IAB 5/31/23, effective 7/5/23]
657—10.5(124) Application. Applicants for initial registration, registration renewal pursuant to rule 657—10.6(124), or modifications pursuant to rule 657—10.9(124) shall complete the appropriate application and shall include all required information and attachments.
	10.5(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. If the applicant is a pharmacy, the responsible individual shall be the pharmacist in charge, unless the applicant petitions the board for an alternate responsible individual.
	10.5(2) Prescribing practitioner PMP registration required. A prescribing practitioner, except for a licensed veterinarian, shall register for the PMP at the same time the prescribing practitioner applies for registration.
	10.5(3) Registration fee exemptions. 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. 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 (analytical laboratory). Such laboratories shall be exempt from any registration fee. Exemption from payment of any fees as provided in this subrule does not relieve the entity of registration or of any other requirements or duties prescribed by law.
	10.5(4) Fees. Each application shall include a nonrefundable registration fee, except as provided in subrule 10.5(3), of $90 per biennium, which may be prorated to the expiration date of the applicant’s underlying professional license or other board license if applicable, and may include a nonrefundable surcharge of not more than 25 percent of the registration fee for deposit into the program fund.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4455C, IAB 5/22/19, effective 6/26/19]
657—10.6(124) Registration renewal. Each registration shall be renewed prior to its expiration. A registrant may renew its registration up to 60 days prior to the registration expiration. The nonrefundable fee for registration renewal shall be $90 per biennium and may include a nonrefundable surcharge of not more than 25 percent of the registration fee for deposit into the program fund.
	10.6(1) Delinquent registration grace period. A registration renewal application that is submitted after expiration but within 30 days following expiration shall be considered delinquent and shall require the nonrefundable payment of the application fee plus a nonrefundable late penalty fee of $90 and may require payment of a surcharge of not more than 25 percent of the applicable fees for deposit into the program fund. A registrant that submits a completed registration renewal application, nonrefundable late application fee, and nonrefundable late penalty fee within 30 days following expiration shall not be subject to disciplinary action for continuing to operate in the 30 days following expiration.
	10.6(2) Delinquent registration reactivation beyond grace period. If a registration renewal application is not postmarked or hand-delivered to the board office within 30 days following the registration’s expiration date, the registrant may not conduct operations that involve controlled substances until the registrant reactivates the registration. A registrant may apply for reactivation by submitting a registration application for reactivation. The nonrefundable fee for reactivation shall be $360 and may include a nonrefundable surcharge of not more than 25 percent of the applicable fee for deposit into the program fund. As part of the reactivation application, the registrant shall disclose the activities conducted with respect to controlled substances while the registration was expired. A registrant that continues to conduct activities with respect to controlled substances without an active registration may be subject to disciplinary sanctions.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4455C, IAB 5/22/19, effective 6/26/19]
657—10.7(124) Separate registration for independent activities; 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.
	10.7(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.
	10.7(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.
	10.7(3) Dispensing, administering, prescribing, or instructing with controlled substances. These independent activities include, but are not limited to, prescribing, administering, and dispensing 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 these independent activities may conduct research and instructional activities with those substances for which the person or business is registered to the extent authorized under state law. If an entity that engages in the distribution, administration, dispensing, or storing of controlled substances maintains multiple licenses, such as a hospital that has both inpatient and outpatient pharmacies, a separate registration shall be maintained for each license.
	10.7(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 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.
	10.7(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 exempt from registration pursuant to Iowa Code section 124.302(3), and may conduct instructional activities with controlled substances.
	10.7(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 section 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.
	10.7(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.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.8(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, dispensed, stored, or collected for the purpose of disposal unless the person or business is exempt from registration pursuant to Iowa Code section 124.302(3), this rule, or federal regulations.
	10.8(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 section 124.302(3).
	10.8(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.
	10.8(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 registration. 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.
	10.8(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 at the location of the hospital.
	10.8(5) Affiliated interns, residents, or foreign physicians. 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 practitioner 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 or practice in the hospital, institution, internship program, or residency program.
	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).
	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.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.9(124) Modification or termination of registration. A registered individual or business shall apply to modify a current registration as provided by this rule. When submission of an application and fee is required, such application and fee shall be timely submitted pursuant to rule 657—10.5(124). A registrant which has timely submitted an application for registration modification and fee may continue to service Iowa patients while the registration modification is pending final approval. A registrant which has submitted an application for registration modification after the required date of submission pursuant to this rule but within 30 days of the required date of submission shall be assessed a nonrefundable late penalty fee of $90 in addition to the application fee. A registrant which has submitted an application for registration modification 31 days or later following the required date of submission pursuant to this rule shall be assessed a nonrefundable late penalty fee of $360.
	10.9(1) Change of substances authorized. Any registrant shall 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.
	10.9(2) Change of address of registered location.
	a. 	Individual practitioner or researcher. An entity registered as an individual practitioner or researcher shall 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, service program, manufacturer, distributor, analytical laboratory, teaching institution, importer, or exporter. An entity registered as a pharmacy, hospital, care facility, service program, manufacturer, distributor, analytical laboratory, teaching institution, importer, or exporter shall apply to change the address of the registered location by submitting a completed application and fee for registration as provided in rule 657—10.5(124). The registrant shall submit a completed application and fee for change in registration simultaneously with any other required application pursuant to the board’s rules for the applicable license or registration. In the absence of a simultaneous license or registration application, the registrant shall submit a completed application and fee for change in registration no less than 30 days in advance of the change of address.
	10.9(3) Change of registrant’s name.
	a. 	Individual practitioner or researcher. An entity registered as an individual practitioner or researcher shall apply to change the registrant’s name by submitting a written request to the board. The request shall include the registrant’s current name, 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, service program, manufacturer, distributor, analytical laboratory, teaching institution, importer, or exporter. An entity registered as a pharmacy, hospital, care facility, service program, manufacturer, distributor, analytical laboratory, teaching institution, importer, or exporter shall apply to change the registrant name by submitting a completed application and fee for registration as provided in rule 657—10.5(124). The registrant shall submit a completed application and fee for change in registration simultaneously with any other required application pursuant to the board’s rules for the applicable license or registration. In the absence of a simultaneous license or registration application, the registrant shall submit a completed application and fee for change in registration no less than 30 days in advance of the change of registrant’s name.
	10.9(4) Change of ownership of registered business entity. A change of immediate ownership of a pharmacy, hospital, care facility, service program, manufacturer, distributor, analytical laboratory, teaching institution, importer, or exporter shall require the submission of a completed application and fee for registration as provided in rule 657—10.5(124). The registrant shall submit a completed application and fee for change in registration simultaneously with any other required application pursuant to the board’s rules for the applicable license or registration. In the absence of a simultaneous license or registration application, the registrant shall submit a completed application and fee for change in registration no less than 30 days in advance of the change of registrant’s ownership.
	10.9(5) Change of responsible individual. Any registrant, except an individual practitioner or researcher or a pharmacy or hospital, shall 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, and 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 or transferred.
	b. 	Pharmacy, hospital, care facility, service program, manufacturer, distributor, analytical laboratory, teaching institution, importer, or exporter. The registrant shall submit a completed application and fee for change in registration simultaneously with any other required application pursuant to the board’s rules for the applicable license or registration. In the absence of a simultaneous license or registration application, the registrant shall submit a completed application and fee for change in registration within ten days of the identification of a new responsible individual.
	10.9(6) Termination of registration. 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. A registration issued to an individual shall terminate upon the death of the individual.
	10.9(7) Cancellation of registration. An individual registrant who no longer needs a registration due to discontinuation of practice in Iowa or discontinuation of possessing, administering, dispensing, or prescribing controlled substances shall contact the board to request cancellation of the registration. An individual registrant may renew the registration upon a return to practice in Iowa or a return to possessing, administering, dispensing, or prescribing controlled substances by submitting an application and a nonrefundable fee for registration renewal of $90 per biennium and a nonrefundable surcharge of not more than 25 percent of the registration fee for deposit into the program fund.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4455C, IAB 5/22/19, effective 6/26/19; ARC 5096C, IAB 7/15/20, effective 8/19/20]
657—10.10(124) Denial of application or discipline of registration.
	10.10(1) Grounds for denial or discipline. The board may deny any application or discipline any registration upon a finding that the applicant or registrant:
	a. 	Has furnished false or fraudulent material information.
	b. 	Has had the applicant’s or registrant’s federal registration to manufacture, distribute, or dispense controlled substances suspended, revoked, or otherwise sanctioned.
	c. 	Has been convicted of a public offense under any state or federal law relating to any controlled substance. For the purpose of this rule 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 if entry of the judgment or sentence has been withheld and the applicant or registrant has been placed on probation.
	d. 	Has committed such acts as would render the applicant’s or 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 applicant’s or registrant’s respective professional licensing board and the discipline revokes or suspends the applicant’s or registrant’s professional license or otherwise disciplines the applicant’s or registrant’s professional license in a way that restricts the applicant’s or registrant’s authority to handle or prescribe controlled substances. A copy of the record of licensee discipline or a copy of the licensee’s surrender of the professional license shall be conclusive evidence.
	f. 	Has failed to obtain or maintain active registration while engaged in activities which require registration.
	10.10(2) Considerations in denial of application or discipline of registration. In determining the public interest, the board shall consider all the following factors:
	a. 	Maintenance of effective controls against diversion of controlled substances into channels other than legitimate medical, scientific, or industrial channels.
	b. 	Compliance with applicable state and local law.
	c. 	Any convictions of the applicant or registrant 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 or registrant’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 or registrant’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.
	h. 	Failure of a prescribing practitioner, except a licensed veterinarian, to register with the PMP pursuant to subrule 10.5(2).
	10.10(3) Proceedings.
	a. 	Prior to denying an application for registration, the board shall serve upon the applicant a notice of intent to deny the application. An applicant has 30 days to appeal a notice of intent to deny the application. If the notice of intent to deny the application is timely appealed, a notice of hearing shall be issued, initiating a contested case proceeding governed by 657—Chapter 35. Proceedings to refuse renewal of a registration shall not abate the existing registration, which shall remain in effect pending the outcome of the contested case proceeding. A registration may be disciplined in accordance with 657—Chapters 35 and 36.
	b. 	Prior to sanctioning a registration, the board shall serve upon the registrant a notice of hearing and statement of charges. The notice shall contain a statement of the basis therefore and shall call upon the 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 notice. The notice shall also contain a statement of the legal basis for such hearing and for the sanction of registration and a summary of the matters of fact and law asserted. 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. A registration may be disciplined in accordance with 657—Chapters 35 and 36.
	10.10(4) Disposition of controlled substances. Upon service of an order of the board suspending or revoking a 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 filing 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’s becoming final, all such controlled substances may be forfeited to the state.
[ARC 4455C, IAB 5/22/19, effective 6/26/19]
657—10.11(124,147,155A) Registration verification. The board may require a nonrefundable fee of $15 for completion of a request for written verification of any registration.
[ARC 4455C, IAB 5/22/19, effective 6/26/19]
657—10.12(124) 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.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.13(124) Security requirements. All registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant 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.
	10.13(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 or safe.
	b. 	Controlled substances listed in Schedules II through V may be stored in a securely locked, substantially constructed cabinet or safe. 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.
	c. 	Controlled substances collected via an authorized collection program for the purpose of disposal shall be stored pursuant to federal regulations, which can be found at www.deadiversion.usdoj.gov/drug_disposal/.
	10.13(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.
	m. 	The adequacy of the registrant’s or applicant’s system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances.
	10.13(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.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.14(124) Accountability of controlled substances. The registrant shall maintain ultimate accountability of controlled substances and records maintained at the registered location.
	10.14(1) Records. Pursuant to rule 657—10.36(124,155A), records shall be available for inspection and copying by the board or its authorized agents for two years from the date of the record.
	10.14(2) Policies and procedures. The registrant shall have policies and procedures that identify, at a minimum:
	a. 	Adequate storage for all controlled substances to ensure security and proper conditions with respect to temperature and humidity.
	b. 	Access to controlled substances and records of controlled substances by employees of the registrant.
	c. 	Proper disposition of controlled substances.
	d. 	To the extent possible, a separation of duties related to the purchasing, receiving, stocking, dispensing, and reconciling of controlled substance inventory.
	e. 	The reconciliation of controlled substances in Schedule II pursuant to subrule 10.18(4).
	f. 	The accountability measures for controlled substances in Schedules III through V pursuant to rule 657—10.20(124).
	g. 	A controlled substance accountability program to document review of controlled substance inventory adjustments, review patterns of controlled substance loss, and create an action plan following a report of theft or loss pursuant to subrule 10.21(5).
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 6330C, IAB 6/1/22, effective 7/6/22]
657—10.15  Reserved.
657—10.16(124) Receipt and disbursement of controlled substances. Each transfer of a controlled substance between two registrants, to include a transfer between two separately registered locations regardless of any common ownership, except as provided in subrule 10.16(2), shall require a record of the transaction. Each registrant shall maintain a copy of the record for at least two years from the date of the transfer. Records of the transfer of Schedule II controlled substances shall be created and maintained separately from records of the transfer of Schedules III through V controlled substances pursuant to rule 657—10.36(124,155A). Upon receipt of a controlled substance, the individual responsible for receiving the controlled substance shall date and sign the receipt record.
	10.16(1) Record. The record, 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 which 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 which the substances were distributed.
	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 which the substances were distributed for disposal, if appropriate.
	10.16(2) Distribution of samples and other complimentary packages. 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 provides to the practitioner a record that contains the information found in this subrule. The individual responsible for receiving the controlled substances shall sign and date the record.
	a. 	The name, address, and DEA registration number of the supplier.
	b. 	The name, address, and DEA registration number of the practitioner.
	c. 	The name, strength, dosage form, and quantity of the specific controlled substances delivered.
	d. 	The date of delivery.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.17(124) Ordering or distributing Schedule I or II controlled substances. A registrant authorized to order or distribute Schedule I or II controlled substances shall do so only pursuant to and in compliance with DEA regulations via a DEA Form 222 or via the DEA Controlled Substances Ordering System (CSOS).
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 5349C, IAB 12/30/20, effective 2/3/21]
657—10.18(124) Schedule II perpetual inventory. Each registrant located in Iowa that maintains Schedule II controlled substances shall maintain a perpetual inventory system for all Schedule II controlled substances pursuant to this rule. All records relating to the perpetual inventory shall be maintained at the registered location and shall be available for inspection and copying by the board or its representative for a period of two years from the date of the record. The perpetual inventory shall accurately reflect the on-hand inventory of Schedule II substances, and the registrant is responsible for ensuring that the perpetual inventory record is accurate and matches the actual on-hand inventory at all times.
	10.18(1) Record format. The perpetual inventory record may be maintained in a manual or an electronic record format. Any electronic record shall provide for hard-copy printout of all transactions recorded in the perpetual inventory record for any specified period of time and shall state the current inventory quantities of each drug at the time the record is printed.
	10.18(2) Information included. The perpetual inventory record shall identify all receipts for and disbursements of Schedule II controlled substances by drug or by national drug code (NDC) number. The record shall be updated to identify each receipt, disbursement, and current balance of each individual drug or NDC number. The record shall also include incident reports and reconciliation records pursuant to subrules 10.18(3) and 10.18(4).
	10.18(3) Changes to a record. If a perpetual inventory record is able to be changed, the individual making a change to the record shall complete an incident report documenting the change. The incident report shall identify the specific information that was changed including the information before and after the change, shall identify the individual making the change, and shall include the date and the reason the record was changed. If the electronic record system documents within the perpetual inventory record all of the information that must be included in an incident report, a separate report is not required.
	10.18(4) Reconciliation. The registrant shall be responsible for reconciling or ensuring the completion of a reconciliation of the perpetual inventory balance with the physical inventory of all Schedule II controlled substances at least annually. Any discrepancies discovered during reconciliation shall be investigated and reported to the pharmacist in charge or responsible individual immediately but no later than one business day following the discovery. The registrant shall determine the need for further investigation, and significant losses shall be reported to the board pursuant to rule 657—10.21(124) and to the DEA pursuant to federal DEA regulations. Periodic reconciliation records shall be maintained and available for review and copying by the board or its authorized agents for a period of two years from the date of the record. The reconciliation process shall be completed using the following procedures or a combination thereof:
	a. 	The individual responsible for a disbursement shall verify that the physical inventory matches the perpetual inventory following each transaction and documents that reconciliation in the perpetual inventory record. If controlled substances are maintained on the patient care unit, the nurse or other responsible licensed health care provider verifies that the physical inventory matches the perpetual inventory following each dispensing and documents that reconciliation in the perpetual inventory record. If any Schedule II controlled substances in the registrant’s current inventory have been disbursed and verified in this manner within the year and there are no discrepancies noted, no additional reconciliation action is required. A perpetual inventory record for a drug that has had no activity within the year shall be reconciled pursuant to paragraph 10.18(4)“b.”
	b. 	A physical count of each Schedule II controlled substance stocked by the registrant that has not been reconciled pursuant to paragraph 10.18(4)“a” shall be completed at least once each year, and that count shall be reconciled with the perpetual inventory record balance. The physical count and reconciliation may be completed over a period of time not to exceed one year in a manner that ensures that the perpetual inventory and the physical inventory of Schedule II controlled substances are annually reconciled. The individual performing the reconciliation shall record the date, the time, the individual’s initials or unique identification, and any discrepancies between the physical inventory and the perpetual inventory.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 5349C, IAB 12/30/20, effective 2/3/21; ARC 6330C, IAB 6/1/22, effective 7/6/22]
657—10.19(124) Physical count and record of inventory. Each registrant shall be responsible for taking a complete and accurate inventory of all stocks of controlled substances under the control of the registrant pursuant to this rule. The responsible individual may delegate the actual taking of any inventory.
	10.19(1) Record and procedure. Each inventory record, except the periodic count and reconciliation required pursuant to subrule 10.18(4), shall comply with the requirements of this subrule and shall be maintained for a minimum of two 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 and at the time the inventory is taken.
	b. 	Each inventory shall be maintained in a handwritten, typewritten, or electronically printed form at the registered location. An inventory of Schedule II controlled substances shall be maintained separately from an inventory of all other controlled substances.
	c. 	Controlled substances shall be deemed to be on hand if they are in the possession of or under the control of the registrant. Controlled substances on hand shall include prescriptions prepared for dispensing to a patient but not yet delivered to the patient, substances maintained in emergency medical service programs, care facility or hospice emergency supplies, outdated or adulterated substances pending destruction, and substances stored in a warehouse on behalf of the registrant. Controlled substances obtained through an authorized collection program for the purpose of disposal shall not be examined, inspected, counted, sorted, inventoried, or otherwise handled.
	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 prior to opening or following the close of business on the inventory date, and the inventory record shall identify either opening or close of business.
	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, which shall be an exact count or measure of the substance and may not be an estimated count or measure, except for liquid products packaged in nonincremented containers, which may be estimated to the nearest one-fourth container.
	(4)	Information required of authorized collection programs pursuant to federal regulations for such collection programs.
	(5)	The signature of the person or persons responsible for taking the inventory.
	(6)	The date and time (opening or closing) of the inventory.
	10.19(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, storage, 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.
	10.19(3) Annual inventory. After the initial inventory is taken, a registrant shall take a new inventory of all stocks of controlled substances on hand at least annually. The annual inventory may be taken on any date that is within 372 days after the date of the previous annual inventory.
	10.19(4) Change of ownership, pharmacist in charge, or registered location.
	a. 	When there is a change in ownership or location for a registration, an inventory shall be taken of all controlled substances in compliance with subrule 10.19(1). The inventory shall be taken following the close of business on the last day under terminating ownership or at the location being vacated. The inventory shall serve as the ending inventory for the terminating owner or location being vacated, as well as a record of the beginning inventory for the new owner or location.
	b. 	When there is a change of pharmacist in charge, including when the incoming pharmacist in charge is temporary or interim pursuant to 657—paragraph 8.35(6)“d,” an inventory shall be taken of all controlled substances in compliance with subrule 10.19(1). An inventory shall be taken following the close of business on the last day of duty of the outgoing pharmacist in charge. The inventory may serve as the beginning inventory for the incoming pharmacist in charge, unless the incoming pharmacist in charge did not immediately assume the duties of pharmacist in charge following the outgoing pharmacist in charge. Any lapse in time between the outgoing pharmacist in charge and the incoming pharmacist in charge shall cause an inventory to be taken prior to the opening of business on the first day of duty of the incoming pharmacist in charge. An inventory count shall not be required in the case of an interim pharmacist in charge if the pharmacy maintains perpetual inventory logs for all controlled substances pursuant to rule 657—10.20(124).
	10.19(5) Discontinuing registered activity. A registrant shall take an inventory of controlled substances at the close of business 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 which the substances are transferred.
	10.19(6) New or rescheduled controlled substances. On the effective date of the addition of a previously noncontrolled substance to any schedule of controlled substances or the rescheduling of a previously controlled substance to another schedule, any registrant who possesses the newly scheduled or rescheduled controlled substance shall take an inventory of all stocks of the substance on hand. That inventory record shall be maintained with the most recent controlled substances inventory record. Thereafter, the controlled substance shall be included in the appropriate schedule of each inventory made by the registrant.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 6330C, IAB 6/1/22, effective 7/6/22]
657—10.20(124) Schedule III through V accountability. A registrant shall ensure accountability of Schedule III through V controlled substances through one or more of the measures identified herein.
	1.	Perpetual inventory log, which may be maintained by electronic means, so long as the system complies with the perpetual inventory requirements in rule 657—10.18(124).
	2.	Documented audit and reconciliation of all controlled substances every six months.
	3.	Routine documented cycle counts of substances, so long as all controlled substances are counted every 90 days and identified discrepancies are investigated and documented.
	4.	Other measure preapproved by the board.
[ARC 6330C, IAB 6/1/22, effective 7/6/22]
657—10.21(124) Report of theft or loss. A registrant shall report to the board and the DEA any theft or significant loss of controlled substances when the loss is attributable to other than inadvertent error. Thefts or other losses of controlled substances shall be reported whether or not the controlled substances are subsequently recovered or the responsible parties are identified and action taken against them.
	10.21(1) Immediate notice to board. If the theft was committed by a registrant or licensee of the board, or if there is reason to believe that the theft was committed by a registrant or licensee of the board, the registrant from which the controlled substances were stolen shall notify the board immediately upon discovery of the theft and shall identify to the board the registrant or licensee suspected of the theft.
	10.21(2) Immediate notice to DEA. A registrant shall deliver notice, immediately upon discovery of a reportable theft or loss of controlled substances, to the Des Moines DEA field office via telephone, facsimile, or a brief written message explaining the circumstances of the theft or loss.
	10.21(3) Timely report submission. Within 14 calendar days of discovery of the theft or loss, a registrant shall submit directly to the DEA a Form 106 or alternate required form via the DEA website at www.deadiversion.usdoj.gov/. A copy of the report that was completed and submitted to the DEA shall be immediately submitted to the board via facsimile, email attachment, or personal or commercial delivery.
	10.21(4) Record maintained. A copy of the report shall be maintained in the registrant’s files for a minimum of two years following the date the report was completed.
	10.21(5) Action plan following loss. Within seven days following the report of theft or loss, a registrant shall develop and initiate implementation of an action plan to address the conditions which contributed to the theft or loss. The action plan shall include any directives, including, but not limited to, inventory counts, audits, and perpetual inventory counts provided by a board compliance officer.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 6330C, IAB 6/1/22, effective 7/6/22]
657—10.22(124) Disposal of registrant stock. A registrant shall dispose of controlled substances pursuant to the requirements of this rule. Disposal records shall be maintained by the registrant for at least two years from the date of the record.
	10.22(1) Registrant stock supply. Controlled substances shall be removed from current inventory and disposed of by one of the following procedures.
	a. 	The registrant shall utilize the services of a DEA-registered and Iowa-licensed reverse distributor.
	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.
	(3)	By such other means as the board may determine to ensure that drugs do not become available to unauthorized persons.
	10.22(2) Waste resulting from administration or compounding. Except as otherwise specifically provided by federal or state law or rules of the board, the unused portion of a controlled substance resulting from administration to a patient from a registrant’s stock or emergency supply or resulting from drug compounding operations may be destroyed or otherwise disposed of by the registrant, a certified paramedic, or a pharmacist in witness of one other licensed health care provider or a registered pharmacy technician 18 years of age or older pursuant to this subrule. A written record of the wastage shall be made and maintained by the registrant for a minimum of two years following the wastage. The record shall include the following:
	a. 	The controlled substance wasted.
	b. 	The date of wastage.
	c. 	The quantity or estimated quantity of the wasted controlled substance.
	d. 	The source of the controlled substance, including identification of the patient to whom the substance was administered or the drug compounding process utilizing the controlled substance.
	e. 	The reason for the waste.
	f. 	The signatures of both individuals involved in the wastage.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4455C, IAB 5/22/19, effective 6/26/19]
657—10.23(124) Disposal of previously dispensed controlled substances.
	10.23(1) Registrant disposal. Except as provided in 657—Chapter 23 for care facilities, a registrant may not dispose of previously dispensed controlled substances unless the registrant has modified its registration with DEA to administer an authorized collection program. A registrant shall not take possession of a previously dispensed controlled substance except for reuse for the same patient or except as provided in paragraph 10.23(2)“b.”
	10.23(2) Hospice disposal.
	a. 	An employee of a hospice program, acting within the scope of employment, may dispose of a controlled substance of a hospice program patient following the death of the patient or the expiration of the controlled substance pursuant to and in compliance with federal law.
	b. 	A physician of a hospice program patient may dispose of a patient’s controlled substance which is no longer required due to a change in the patient’s care plan.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4455C, IAB 5/22/19, effective 6/26/19]
657—10.24(124,126,155A) Prescription requirements. All prescriptions for controlled substances shall be dated as of, and signed on, the day issued. Controlled substances prescriptions shall be valid for six months following date of issue. A prescription for a Schedule III, IV, or V controlled substance may include authorization to refill the prescription no more than five times within the six months following date of issue. A prescription for a Schedule II controlled substance shall not be refilled. Beginning January 1, 2020, all prescriptions for controlled substances shall be transmitted electronically to a pharmacy pursuant to rule 657—21.6(124,155A), except as provided in rule 657—21.8(124,155A).
	10.24(1) Form of prescription. All prescriptions for controlled substances 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 for controlled substances issued by individual prescribers shall include the legibly preprinted, typed, or hand-printed name of the prescriber as well as the prescriber’s written or electronic signature. A prescription for a controlled substance issued prior to January 1, 2020, or a prescription for a controlled substance that is exempt from the electronic prescription mandate pursuant to rule 657—21.8(124,155A), may be transmitted via nonelectronic methods as described in this rule.
	a. 	When an oral order is not permitted, or when a prescriber is unable to prepare and transmit an electronic prescription in compliance with DEA requirements for electronic prescriptions, prescriptions shall be written with ink, indelible pencil, or typed print and shall be manually signed by the prescriber. If the prescriber utilizes an electronic prescription application that meets DEA requirements for electronic prescriptions, the prescriber may electronically prepare and transmit a prescription for a controlled substance to a pharmacy that utilizes a pharmacy prescription application that meets DEA requirements for electronic prescriptions.
	b. 	A prescriber’s agent may prepare a prescription for the review, authorization, and manual or electronic signature of the prescriber, but the prescribing practitioner is responsible for the accuracy, completeness, and validity of the prescription.
	c. 	An electronic prescription for a controlled substance shall not be transmitted to a pharmacy except by the prescriber in compliance with DEA regulations.
	d. 	A prescriber shall securely maintain the unique authentication credentials issued to the prescriber for utilization of the electronic prescription application and authentication of the prescriber’s electronic signature. Unique authentication credentials issued to any individual shall not be shared with or disclosed to any other prescriber, agent, or individual.
	e. 	A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by this rule.
	10.24(2) Verification by pharmacist.
	a. 	The pharmacist shall verify the authenticity of the prescription with the individual prescriber or the prescriber’s agent in each case when a written or oral 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 shall verify the authenticity of the prescription with the individual prescriber or the prescriber’s agent in any case when the pharmacist questions the validity of, including the legitimate medical purpose for, the prescription. The pharmacist is required to record the manner by which the prescription was verified and include the pharmacist’s name or unique identifier.
	b. 	A pharmacist who receives a written, oral, or facsimile prescription shall not be required to verify that the prescription is subject to an exception to the electronic prescription mandate provided in rule 657—21.8(124,155A) and may dispense a prescription drug pursuant to an otherwise valid written, oral, or facsimile prescription pursuant to this rule.
	10.24(3) Intern, resident, foreign physician. An intern, resident, or foreign physician exempt from registration pursuant to subrule 10.8(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 legibly printed name of the prescribing intern, resident, or foreign physician as well as the prescriber’s signature.
	10.24(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 deemed 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.
	10.24(5) Facsimile transmission of a controlled substance prescription. With the exception of an authorization for emergency dispensing as provided in rule 657—10.26(124), a prescription for a controlled substance in Schedules II, III, IV and V may be transmitted via facsimile from a prescriber to a pharmacy only as provided in rule 657—21.7(124,155A).
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4580C, IAB 7/31/19, effective 9/4/19]
657—10.25(124) Dispensing records. Each registrant shall create a record of controlled substances dispensed to a patient or research subject.
	10.25(1) Record maintained and available. The record shall be maintained for two years from the date of dispensing and be available for inspection and copying by the board or its authorized agents.
	10.25(2) Record contents. The record shall include the following information:
	a. 	The name and address of the person to whom dispensed.
	b. 	The date of dispensing.
	c. 	The name or NDC number, strength, dosage form, and quantity of the substance dispensed.
	d. 	The name of the prescriber, unless dispensed by the prescriber.
	e. 	The unique identification of each technician, pharmacist, pharmacist-intern, prescriber, or prescriber’s agent involved in dispensing.
	f. 	The serial number or unique identification number of the prescription.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.26(124) Schedule II emergency prescriptions.
	10.26(1) Emergency situation defined. For the purposes of authorizing an oral or facsimile transmission of a 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 manually signed written prescription to be presented to the pharmacy before the pharmacy dispenses the controlled substance, or the prescribing practitioner is unable to provide a DEA-compliant electronic prescription to the pharmacy before the pharmacy dispenses the controlled substance.
	10.26(2) Requirements of emergency prescription. In the case of an emergency situation as defined in subrule 10.26(1), a pharmacist may dispense a controlled substance listed in Schedule II pursuant to a facsimile 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 or a DEA-compliant electronic prescription.
	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 unique identification.
	c. 	The pharmacist shall prepare a temporary written record of the emergency prescription. The temporary written record shall consist of a hard copy of the facsimile transmission or a written record of the oral transmission authorizing the emergency dispensing. A written record is not required to consist of a handwritten record and may be a printed facsimile or a print of a computer-generated record of the prescription if the printed record includes all of the required elements for the prescription. If the emergency prescription is transmitted by the practitioner’s agent, the record shall include the first and last names and title of the individual who transmitted the prescription.
	d. 	If the emergency prescription is transmitted via facsimile transmission, the means of transmission shall not obscure or render the prescription information illegible due to security features of the paper utilized by the prescriber to prepare the written prescription, and the hard-copy record of the facsimile transmission shall not be obscured or rendered illegible due to such security features.
	e. 	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 rule 657—10.24(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 10.26(2)“c.”
	f. 	The pharmacist shall notify the board and the DEA if the prescribing individual fails to deliver a written prescription. Failure of the pharmacist to so notify the board and the DEA, or failure of the prescribing individual to deliver the required written prescription as herein required, shall void the authority conferred by this subrule.
	g. 	Pursuant to federal law and subrule 10.27(3), the pharmacist may fill a partial quantity of an emergency prescription so long as the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed and that the remaining portions are filled no later than 72 hours after the prescription is issued.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.27(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 and federal regulations.
	10.27(1) Insufficient supply on hand. If the pharmacist is unable to supply the full quantity authorized 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.
	10.27(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 an LTCF or for 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 an LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system pursuant to rule 657—21.5(124,155A).
	10.27(3) Patient or prescriber request. At the request of the patient or prescriber, a prescription for a Schedule II controlled substance may be partially filled pursuant to this subrule and federal law. The total quantity dispensed in all partial fillings shall not exceed the total quantity prescribed. Except as provided in paragraph 10.26(2)“g,” the remaining portion of a prescription partially filled pursuant to this subrule may be filled within 30 days of the date the prescription was issued.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4455C, IAB 5/22/19, effective 6/26/19]
657—10.28(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—23.9(124,155A), as applicable.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 3859C, IAB 6/20/18, effective 7/25/18]
657—10.29(124) Schedule II—issuing multiple prescriptions. An individual prescriber may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance pursuant to the provisions and limitations of this rule.
	10.29(1) Refills prohibited. The issuance of refills for a Schedule II controlled substance is prohibited. The use of multiple prescriptions for the dispensing of Schedule II controlled substances, pursuant to this rule, ensures that the prescriptions are treated as separate dispensing authorizations and not as refills of an original prescription.
	10.29(2) Legitimate medical purpose. Each separate prescription issued pursuant to this rule shall be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of the prescriber’s professional practice.
	10.29(3) Dates and instructions. Each prescription issued pursuant to this rule shall be dated as of and manually or electronically signed by the prescriber on the day the prescription is issued. Each separate prescription, other than the first prescription if that prescription is intended to be filled immediately, shall contain written instructions indicating the earliest date on which a pharmacist may fill each prescription.
	10.29(4) Authorized fill date unalterable. Regardless of the provisions of rule 657—10.30(124), when a prescription contains instructions from the prescriber indicating that the prescription shall not be filled before a certain date, a pharmacist shall not fill the prescription before that date. The pharmacist shall not contact the prescriber for verbal authorization to fill the prescription before the fill date originally indicated by the prescriber pursuant to this rule.
	10.29(5) Number of prescriptions and authorized quantity. An individual prescriber may issue for a patient as many separate prescriptions, to be filled sequentially pursuant to this rule, as the prescriber deems necessary to provide the patient with adequate medical care. The cumulative effect of the filling of each of these separate prescriptions shall result in the receipt by the patient of a quantity of the Schedule II controlled substance not exceeding a 90-day supply.
	10.29(6) Prescriber’s discretion. Nothing in this rule shall be construed as requiring or encouraging an individual prescriber to issue multiple prescriptions pursuant to this rule or to see the prescriber’s patients once every 90 days when prescribing Schedule II controlled substances. An individual prescriber shall determine, based on sound medical judgment and in accordance with established medical standards, how often to see patients and whether it is appropriate to issue multiple prescriptions pursuant to this rule.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4580C, IAB 7/31/19, effective 9/4/19]
657—10.30(124) Schedule II—changes to a prescription. 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.
	10.30(1) Changes prohibited. 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.
	10.30(2) Changes authorized. After consultation with the prescriber or the prescriber’s agent 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.
	e. 	The date the prescription was issued.
	f. 	The prescriber’s address or DEA registration number.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 5346C, IAB 12/30/20, effective 2/3/21]
657—10.31  Reserved.
657—10.32(124) Schedule III, IV, or V prescription. 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. Beginning January 1, 2020, all prescriptions for controlled substances shall be transmitted electronically to a pharmacy pursuant to rule 657—21.6(124,155A), except as provided in rule 657—21.8(124,155A).
	10.32(1) Record. Each filling and refilling of a prescription shall be entered in a uniformly maintained and readily retrievable record in accordance with rule 657—10.25(124). If the pharmacist merely initials or affixes the pharmacist’s unique identifier and dates the back of the prescription, it shall be deemed that the full face amount of the prescription has been dispensed.
	10.32(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 an authorized individual at the pharmacy 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, pharmacist-intern, or technician who obtains the oral authorization from the prescriber who issued the original prescription documents, on or with the original prescription, the date authorized, the quantity of each refill, the number of additional refills authorized, and the unique identification of the authorized individual.
	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.
	10.32(3) 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 pursuant to subrule 10.32(1). The total quantity dispensed in all partial fills shall not exceed the total quantity prescribed.
	10.32(4) 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.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4580C, IAB 7/31/19, effective 9/4/19]
657—10.33(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, and excepting products containing ephedrine, pseudoephedrine, or phenylpropanolamine, may be dispensed or administered without a prescription by a pharmacist to a purchaser at retail pursuant to the conditions of this rule.
	10.33(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. This subrule does not prohibit, after the pharmacist has fulfilled the professional and legal responsibilities set forth in this rule and has authorized the dispensing of the substance, the completion of the actual cash or credit transaction or the delivery of the substance by a nonpharmacist.
	10.33(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 controlled 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.
	10.33(3) Age of purchaser. The purchaser shall be at least 18 years of age.
	10.33(4) Identification. The pharmacist shall require every purchaser under this rule who is not known by the pharmacist to present a government-issued photo identification, including proof of age when appropriate.
	10.33(5) Record. A bound record book (i.e., with pages sewn or glued to the spine) 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 unique identification of the pharmacist or pharmacist-intern who approved the dispensing of the substance to the purchaser.
	10.33(6) Prescription not required under other laws. No other federal or state law or regulation requires a prescription prior to distributing or dispensing the Schedule V controlled substance.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.34(124) Dispensing products containing ephedrine, pseudoephedrine, or phenylpropanolamine without a prescription. A product containing ephedrine, pseudoephedrine, or phenylpropanolamine, which substance is a Schedule V controlled substance and is not listed in another controlled substance schedule, may be dispensed or administered without a prescription by an authorized dispenser pursuant to 657—Chapter 100 to a purchaser at retail pursuant to the conditions of this rule.
	10.34(1) Who may dispense. Dispensing shall be by an authorized dispenser pursuant to 657—Chapter 100. This subrule does not prohibit, after the dispenser has fulfilled the professional and legal responsibilities set forth in this rule and has authorized the dispensing of the substance, the completion of the actual cash or credit transaction or the delivery of the substance by another pharmacy employee.
	10.34(2) Packaging of nonliquid forms. A nonliquid form of a product containing ephedrine, pseudoephedrine, or phenylpropanolamine includes gel caps. Nonliquid forms of these products to be sold pursuant to this rule shall be packaged either in blister packaging with each blister containing no more than two dosage units or, if blister packs are technically infeasible, in unit dose packets or pouches.
	10.34(3) Frequency and quantity. Dispensing without a prescription to the same purchaser within any 30-day period shall be limited to products collectively containing no more than 7,500 mg of ephedrine, pseudoephedrine, or phenylpropanolamine; dispensing without a prescription to the same purchaser within a single calendar day shall not exceed 3,600 mg.
	10.34(4) Age of purchaser. The purchaser shall be at least 18 years of age.
	10.34(5) Identification. The dispenser shall require every purchaser under this rule to present a current government-issued photo identification, including proof of age when appropriate. The dispenser shall be responsible for verifying that the name on the identification matches the name provided by the purchaser and that the photo image depicts the purchaser.
	10.34(6) Record. Purchase records shall be recorded in the real-time electronic pseudoephedrine tracking system (PTS) established and administered by the governor’s office of drug control policy pursuant to 657—Chapter 100. If the PTS is unavailable for use, the purchase record shall be recorded in an alternate format and submitted to the PTS as provided in 657—subrule 100.3(4).
	a. 	Alternate record contents. The alternate record shall contain the following:
	(1)	The name, address, and signature of the purchaser.
	(2)	The name and quantity of the product purchased, including the total milligrams of ephedrine, pseudoephedrine, or phenylpropanolamine contained in the product.
	(3)	The date and time of the purchase.
	(4)	The name or unique identification of the dispenser who approved the dispensing of the product.
	b. 	Alternate record format. The record shall be maintained using one of the following options:
	(1)	A hard-copy record.
	(2)	A record in the pharmacy’s electronic prescription dispensing record-keeping system that is capable of producing a hard-copy printout of a record.
	(3)	A record in an electronic data collection system that captures each of the data elements required by this subrule and that is capable of producing a hard-copy printout of a record.
	c. 	PTS records retrieval. Pursuant to 657—subrule 100.4(6), the pharmacy shall be able to produce a hard-copy printout of transactions recorded in the PTS by the pharmacy for one or more specific products for a specified period of time upon request by the board or its representative or to such other persons or governmental agencies authorized by law to receive such information.
	10.34(7) Notice required. The pharmacy shall ensure that the following notice is provided to purchasers of ephedrine, pseudoephedrine, or phenylpropanolamine products and that the notice is displayed with or on the electronic signature device or is displayed in the dispensing area and visible to the public:
“Warning: Section 1001 of Title 18, United States Code, states that whoever, with respect to the logbook, knowingly and willfully falsifies, conceals, or covers up by any trick, scheme, or device a material fact, or makes any materially false, fictitious, or fraudulent statement or representation, or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, shall be fined not more than $250,000 if an individual or $500,000 if an organization, imprisoned not more than five years, or both.”
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4701C, IAB 10/9/19, effective 11/13/19]
657—10.35  Reserved.
657—10.36(124,155A) Records. Every 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 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. Original records more than 12 months old may be maintained in a secure remote storage area unless such remote storage is prohibited under federal law. If the secure storage area is not located within the same physical structure as the registrant, the records must be retrievable within 48 hours of a request by the board or its authorized agent.
	10.36(1) Schedule I and II records. Records of controlled substances listed in Schedules I and II shall be maintained separately from all other records of the registrant.
	10.36(2) Schedule III, IV, and V records. Records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the required information is readily retrievable from the ordinary business records of the registrant.
	10.36(3) Date of record. The date on which a controlled substance is actually received, imported, distributed, exported, disposed of, or otherwise transferred shall be used as the date of receipt, importation, distribution, exportation, disposal, or transfer.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.37  Reserved.
657—10.38(124) Revision of controlled substances schedules.
	10.38(1) 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(4).
	10.38(2) 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(4).
	10.38(3) Cannabis-derived products. If a cannabis-derived product or investigational product approved as a prescription drug medication by the United States Food and Drug Administration is added to, eliminated from or revised in the federal schedule of controlled substances by the DEA and notice of the addition, elimination or revision is given to the board, the board shall similarly add, eliminate or revise the prescription drug medication in the schedule of controlled substances. Such action by the board shall be immediately effective upon the date of publication of the final regulation containing the addition, elimination or revision in the Federal Register.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 3743C, IAB 4/11/18, effective 5/16/18; ARC 5346C, IAB 12/30/20, effective 2/3/21]
657—10.39(124) Temporary designation of controlled substances.
	10.39(1) Amend Iowa Code section 124.204(2) by adding the following new paragraphs:
	bt. 	N-phenyl-N-(1-(2-phenylpropyl)piperidin-4-yl)propionamide. Other name: beta-methyl fentanyl.
	bu. 	N-(1-phenethylpiperidin-4-yl)-N,3-diphenylpropanamide. Other names: beta-phenyl fentanyl, 3-phenylpropanoyl fentanyl.
	bv. 	N-(1-(2-flourophenethyl)piperidin-4-yl)-N-(2-fluorophenyl)propionamide. Other name: 2’-Fluoro ortho-fluorofentanyl, 2’-fluoro 2-fluorofentanyl.
	bw. 	N-(1-(4-methylphenethyl)piperidin-4-yl)-N-phenylacetamide. Other name: 4’-Methyl acetyl fentanyl.
	bx. 	N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide. Other names: ortho-Fluorbutyryl fentanyl, 2-fluorobutyryl fentanyl.
	by. 	N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide. Other names: ortho-Methyl acetylfentanyl, 2-methyl acetylfentanyl.
	bz. 	2-methoxy-N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide. Other names: ortho-Methyl methoxyacetyl fentanyl, 2-methyl methoxyacetyl fentanyl.
	ca. 	N-(4-methylphenyl)-N-(1-phenethylpiperidin-4-yl)propionamide. Other names: para-Methylfentanyl, 4-methylfentanyl.
	cb. 	N-(1-phenethylpiperidin-4-yl)-N-phenylbenzamide. Other names: Phenyl fentanyl, benzoyl fentanyl.
	cc. 	N-(1-phenethylpiperidin-4-yl)-N-phenylthiophene-2-carboxamide. Other names: Thiofuranyl fentanyl, 2-thiofuranyl fentanyl, thiophene fentanyl.
	cd. 	Ethyl (1-phenethylpiperidin-4-yl)(phenyl)carbamate. Other name: fentanyl carbamate.
	ce. 	N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)acrylamide. Other name: ortho-Fluoroacryl fentanyl.
	cf. 	N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide. Other name: ortho-Fluoroisobutyryl fentanyl.
	cg. 	N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamide. Other name: para-Fluoro furanyl fentanyl.
	10.39(2) Amend Iowa Code section 124.204(9) by adding the following new paragraphs:
	j. 	4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-thienol[3,2-f][1,2,4]triazolo[4,3-alpha][1,4]diazepine, its salts, isomers, and salts of isomers. Other name: etizolam.
	k. 	8-chloro-6-(2-fluorophenyl)-1-methyl-4H-benzo[f][1,2,4]triazolo[4,3-alpha][1,4]diazepine, its salts, isomers, and salts of isomers. Other name: flualprazolam.
	l. 	6-(2-chlorophenyl)-1-methyl-8-nitro-4H-benzo[f][1,2,4]triazolo[4,3-alpha][1,4]diazepine, its salts, isomers, and salts of isomers. Other name: clonazolam.
	m. 	8-bromo-6-(2-fluorophenyl)-1-methyl-4H-benzo[f][1,2,4]triazolo[4,3-alpha][1,4]diazepine, its salts, isomers, and salts of isomers. Other name: flubromazolam.
	n. 	7-chloro-5-(2-chlorophenyl)-1-methyl-1,3-dihydro-2H-benzo[e][1,4]diazepin-2-one, its salts, isomers, and salts of isomers. Other name: diclazepam.
	10.39(3) Amend Iowa Code section 124.206(2)“a” by rescinding and replacing the introductory text as follows:
	a. 	Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate excluding apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, naldemedine, nalmefene, naloxegol, naloxone, 6beta-naltrexol, naltrexone, and samidorphan, and their respective salts, but including the following:
	10.39(4) Amend Iowa Code section 124.210(6) by adding the following new paragraph:
	n. 	Serdexmethylphenidate.
	10.39(5) Amend Iowa Code section 124.212(5) by adding the following new paragraph:
	g. 	Ganaxolone (3alpha-hydroxy-3beta-methyl-5alpha-pregnan-20-one).
	10.39(6) Amend Iowa Code section 124.204(4) by adding the following new paragraphs:
	cl. 	2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one. Other names: methoxetamine, MXE.
	cm. 	1-(1,3-benzodioxol-5-yl)-2-(ethylamino)butan-1-one. Other names: eutylone, bk-EBDB.
	10.39(7) Amend Iowa Code section 124.204(6) by adding the following new paragraphs:
j.Amineptine (7-[(10,11-dihydro-5H-dibenzo[alpha,delta]cyclohepten-5-yl)amino]heptanoic acid).
k.Mesocarb (N-phenyl-N’-(3-(1-phenylpropan-2-yl)-1,2,3-oxadiazol-3-ium-5-yl)carbamimidate).
l.Methiopropamine (N-methyl-1-(thiophen-2-yl)propan-2-amine).
	10.39(8) Amend Iowa Code section 124.210(3) by adding the following new paragraph:
	bg. 	Daridorexant.
	10.39(9) Amend Iowa Code section 124.206(2)“d” by adding the following new subparagraph:
	(3)	[\18\F]FP-CIT.
	10.39(10) Amend Iowa Code section 124.204(2) by adding the following new paragraph:
	cn. 	1-methoxy-3-[4-(2-methoxy-2-phenylethyl)piperazin-1-yl]-1-phenylpropan-2-ol. Other name: Zipeprol.
[ARC 5914C, IAB 9/22/21, effective 10/27/21; ARC 6074C, IAB 12/15/21, effective 1/19/22; ARC 6255C, IAB 3/23/22, effective 4/27/22; ARC 6521C, IAB 9/21/22, effective 10/26/22; ARC 6689C, IAB 11/30/22, effective 1/4/23; ARC 6843C, IAB 2/8/23, effective 3/15/23; ARC 7026C, IAB 5/31/23, effective 7/5/23; ARC 7128C, IAB 12/13/23, effective 1/17/24; ARC 7617C, IAB 2/7/24, effective 3/13/24]
657—10.40(124) Excluded and exempt substances. The Iowa board of pharmacy hereby excludes from all schedules the current list of “Excluded Nonnarcotic Products” identified in Title 21, CFR Part 1308, Section 22. With the exception of listed butalbital products, the board hereby excludes from all schedules the current list of “Exempted Prescription Products” described in Title 21, CFR Part 1308, Section 32. Copies of such lists may be obtained by written request to the board office at 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309-4688.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 4455C, IAB 5/22/19, effective 6/26/19]
657—10.41(124) Anabolic steroid defined. Anabolic steroid, as defined in Iowa Code section 126.2(2), includes any substance identified as such in Iowa Code section 124.208(6) or 126.2(2).
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.42(124B) Additional precursor substances. Rescinded ARC 5346C, IAB 12/30/20, effective 2/3/21.
657—10.43(124) Reporting discipline and criminal convictions. A registrant shall provide written notice to the board of any disciplinary or enforcement action imposed by any licensing or regulatory authority on any license or registration held by the registrant no later than 30 days after the final action. Discipline may include, but is not limited to, fine or civil penalty, citation or reprimand, probationary period, suspension, revocation, and voluntary surrender. A registrant shall provide written notice to the board of any criminal conviction of the registrant or of any owner that is related to the operation of the registered location no later than 30 days after the conviction. The term criminal conviction includes instances when the judgment of conviction or sentence is deferred.
[ARC 3345C, IAB 9/27/17, effective 11/1/17]
657—10.44(124) Discipline. Pursuant to 657—Chapter 36, the board may fine, suspend, revoke, or impose other disciplinary sanctions on a registration for any of the following:
	1.	Any violation of the federal Food, Drug, and Cosmetic Act or federal regulations promulgated under the Act.
	2.	Any conviction of a crime related to controlled substances committed by the registrant, or if the registrant is an association, joint stock company, partnership, or corporation, by any managing officer.
	3.	Refusing access to the registered location or registrant records to an agent of the board for the purpose of conducting an inspection or investigation.
	4.	Failure to maintain registration pursuant to 657—Chapter 10.
	5.	Any violation of Iowa Code chapter 124, 124B, 126, 155A, or 205, or any rule of the board, including the disciplinary grounds set forth in 657—Chapter 36.
[ARC 3345C, IAB 9/27/17, effective 11/1/17; ARC 3857C, IAB 6/20/18, effective 7/25/18]
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, 155A.13, 155A.17, 155A.26, 155A.37, and 205.3.
[Filed 9/29/71; amended 8/9/72, 12/15/72, 11/14/73, 8/14/74, 4/8/75]
[Filed 11/24/76, Notice 10/20/76—published 12/15/76, effective 1/19/77]
[Filed 11/9/77, Notice 8/24/77—published 11/30/77, effective 1/4/78]
[Filed 10/20/78, Notices 8/9/78, 9/6/78—published 11/15/78, effective 1/9/79]
[Filed 8/28/79, Notice 5/30/79—published 9/19/79, effective 10/24/79]
[Filed 2/12/81, Notice 12/24/80—published 3/4/81, effective 7/1/81]
[Filed 7/24/81, Notice 5/13/81—published 8/19/81, effective 9/23/81]
[Filed emergency 12/14/81—published 1/6/82, effective 1/6/82]
[Filed emergency 10/6/82—published 10/27/82, effective 10/27/82]
[Filed 6/16/83, Notice 5/11/83—published 7/6/83, effective 8/10/83]
[Filed 2/23/84, Notice 11/23/83—published 3/14/84, effective 4/18/84]
[Filed emergency 8/10/84—published 8/29/84, effective 8/10/84]
[Filed emergency 6/14/85—published 7/3/85, effective 6/14/85]
[Filed emergency 8/30/85—published 9/25/85, effective 9/6/85]
[Filed emergency 12/4/85—published 1/1/86, effective 12/5/85]
[Filed emergency 5/14/86—published 6/4/86, effective 5/16/86]
[Filed 5/14/86, Notice 4/9/86—published 6/4/86, effective 7/9/86]◊
[Filed 1/28/87, Notice 11/19/86—published 2/25/87, effective 4/1/87]
[Filed emergency 7/24/87—published 8/12/87, effective 7/24/87]
[Filed 8/5/87, Notice 6/3/87—published 8/26/87, effective 9/30/87]
[Filed emergency 1/21/88—published 2/10/88, effective 1/22/88]
[Filed 3/29/88, Notice 2/10/88—published 4/20/88, effective 5/25/88]
[Filed emergency 8/5/88—published 8/24/88, effective 8/5/88]
[Filed emergency 10/13/88—published 11/2/88, effective 10/13/88]
[Filed emergency 5/16/89—published 6/14/89, effective 5/17/89]
[Filed emergency 9/12/89—published 10/4/89, effective 9/13/89]
[Filed 1/19/90, Notice 11/29/89—published 2/7/90, effective 3/14/90]
[Filed 8/31/90, Notice 6/13/90—published 9/19/90, effective 10/24/90]
[Filed emergency 1/29/91—published 2/20/91, effective 2/27/91]
[Filed 1/29/91, Notice 9/19/90—published 2/20/91, effective 3/27/91]
[Filed emergency 2/27/91—published 3/20/91, effective 2/27/91]
[Filed 4/26/91, Notice 2/20/91—published 5/15/91, effective 6/19/91]
[Filed emergency 5/10/91—published 5/29/91, effective 5/10/91]
[Filed 7/30/91, Notice 5/29/91—published 8/21/91, effective 9/25/91]1
[Filed emergency 9/23/91—published 10/16/91, effective 9/23/91]
[Filed emergency 10/18/91—published 11/13/91, effective 10/21/91]
[Filed 3/12/92, Notice 1/8/92—published 4/1/92, effective 5/6/92]
[Filed 5/21/92, Notice 4/1/92—published 6/10/92, effective 7/15/92]
[Filed emergency 8/10/92—published 9/2/92, effective 8/10/92]
[Filed 10/22/92, Notice 9/2/92—published 11/11/92, effective 1/1/93]
[Filed 9/23/93, Notice 5/26/93—published 10/13/93, effective 11/17/93]
[Filed emergency 3/21/94—published 4/13/94, effective 3/23/94]
[Filed 3/21/94, Notice 10/13/93—published 4/13/94, effective 5/18/94]
[Filed 4/22/94, Notice 11/10/93—published 5/11/94, effective 6/15/94]
[Filed 6/24/94, Notice 4/13/94—published 7/20/94, effective 8/24/94]
[Filed 3/22/95, Notice 11/9/94—published 4/12/95, effective 5/31/95]
[Filed 12/6/95, Notice 8/16/95—published 1/3/96, effective 2/7/96]
[Filed 11/19/97, Notice 10/8/97—published 12/17/97, effective 1/21/98]
[Filed 4/24/98, Notice 3/11/98—published 5/20/98, effective 6/24/98]
[Filed 7/31/98, Notice 5/20/98—published 8/26/98, effective 9/30/98]
[Filed emergency 8/18/99—published 9/8/99, effective 8/18/99]
[Filed emergency 10/6/99—published 11/3/99, effective 10/11/99]
[Filed emergency 7/18/00—published 8/9/00, effective 7/18/00]
[Filed 8/14/02, Notice 6/12/02—published 9/4/02, effective 10/9/02]
[Filed emergency 12/13/02—published 1/8/03, effective 12/13/02]
[Filed emergency 7/16/04 after Notice 6/9/04—published 8/4/04, effective 7/16/04]
[Filed 10/22/04, Notice 3/31/04—published 11/10/04, effective 12/15/04]
[Filed emergency 5/3/05—published 5/25/05, effective 5/21/05]
[Filed emergency 6/30/05 after Notice 5/11/05—published 7/20/05, effective 7/1/05]
[Filed 8/9/05, Notice 5/25/05—published 8/31/05, effective 10/5/05]
[Filed 3/22/06, Notice 12/21/05—published 4/12/06, effective 5/17/06]
[Filed 3/22/06, Notice 1/18/06—published 4/12/06, effective 5/17/06]
[Filed 5/17/06, Notice 4/12/06—published 6/7/06, effective 7/12/06]
[Filed 2/7/07, Notice 10/25/06—published 2/28/07, effective 4/4/07]
[Filed 5/14/07, Notice 2/28/07—published 6/6/07, effective 7/11/07]
[Filed emergency 8/2/07—published 8/29/07, effective 8/2/07]
[Filed emergency 11/13/07 after Notice 8/29/07—published 12/5/07, effective 11/13/07]
[Filed ARC 7636B (Notice ARC 7448B, IAB 12/31/08), IAB 3/11/09, effective 4/15/09]
[Filed Emergency ARC 7906B, IAB 7/1/09, effective 6/22/09]
[Filed ARC 8172B (Notice ARC 7908B, IAB 7/1/09), IAB 9/23/09, effective 10/28/09]
[Filed Emergency ARC 8411B, IAB 12/30/09, effective 12/1/09]
[Filed ARC 8539B (Notice ARC 8269B, IAB 11/4/09), IAB 2/24/10, effective 4/1/10]
[Filed ARC 8892B (Notice ARC 8667B, IAB 4/7/10), IAB 6/30/10, effective 9/1/10]
[Filed Emergency ARC 8989B, IAB 8/11/10, effective 7/21/10]
[Filed Emergency ARC 9000B, IAB 8/11/10, effective 7/22/10]
[Filed Emergency ARC 9091B, IAB 9/22/10, effective 8/30/10]
[Filed ARC 9410B (Notice ARC 9196B, IAB 11/3/10), IAB 3/9/11, effective 4/13/11]
[Filed ARC 9912B (Notice ARC 9671B, IAB 8/10/11), IAB 12/14/11, effective 1/18/12]
[Filed ARC 0504C (Notice ARC 0351C, IAB 10/3/12), IAB 12/12/12, effective 1/16/13]
[Filed ARC 0749C (Notice ARC 0652C, IAB 3/20/13), IAB 5/29/13, effective 7/3/13]
[Filed Emergency ARC 0893C, IAB 8/7/13, effective 7/9/13]
[Filed Emergency ARC 1408C, IAB 4/2/14, effective 3/13/14]
[Filed ARC 1575C (Notice ARC 1407C, IAB 4/2/14), IAB 8/20/14, effective 9/24/14]
[Filed ARC 1787C (Notice ARC 1647C, IAB 10/1/14), IAB 12/10/14, effective 1/14/15]
[Filed ARC 2195C (Notice ARC 2064C, IAB 7/22/15), IAB 10/14/15, effective 11/18/15]
[Filed ARC 2407C (Notice ARC 2287C, IAB 12/9/15), IAB 2/17/16, effective 3/23/16]
[Filed ARC 2408C (Notice ARC 2285C, IAB 12/9/15), IAB 2/17/16, effective 3/23/16]
[Filed ARC 3100C (Notice ARC 2858C, IAB 12/7/16), IAB 6/7/17, effective 7/12/17]
[Filed ARC 3345C (Notice ARC 3136C, IAB 6/21/17), IAB 9/27/17, effective 11/1/17]
[Filed ARC 3743C (Notice ARC 3505C, IAB 12/20/17), IAB 4/11/18, effective 5/16/18]
[Filed ARC 3857C (Notice ARC 3506C, IAB 12/20/17), IAB 6/20/18, effective 7/25/18]
[Filed ARC 3859C (Notice ARC 3511C, IAB 12/20/17), IAB 6/20/18, effective 7/25/18]
[Filed ARC 3860C (Notice ARC 3701C, IAB 3/28/18), IAB 6/20/18, effective 7/25/18]
[Filed ARC 3984C (Notice ARC 3758C, IAB 4/25/18), IAB 8/29/18, effective 10/3/18]
[Filed Emergency ARC 4085C, IAB 10/24/18, effective 10/3/18]
[Filed ARC 4269C (Notice ARC 4086C, IAB 10/24/18), IAB 1/30/19, effective 3/6/19]
[Filed ARC 4455C (Notice ARC 4290C, IAB 2/13/19), IAB 5/22/19, effective 6/26/19]
[Filed ARC 4580C (Notice ARC 4386C, IAB 4/10/19), IAB 7/31/19, effective 9/4/19]
[Filed ARC 4701C (Notice ARC 4570C, IAB 7/31/19), IAB 10/9/19, effective 11/13/19]
[Filed ARC 4797C (Notice ARC 4592C, IAB 8/14/19), IAB 12/4/19, effective 1/8/20]
[Filed ARC 4904C (Notice ARC 4692C, IAB 10/9/19), IAB 2/12/20, effective 3/18/20]
[Filed ARC 5096C (Notice ARC 4837C, IAB 1/1/20), IAB 7/15/20, effective 8/19/20]
[Filed ARC 5346C (Notice ARC 5155C, IAB 8/26/20), IAB 12/30/20, effective 2/3/21]
[Filed ARC 5347C (Notice ARC 5195C, IAB 9/23/20), IAB 12/30/20, effective 2/3/21]
[Filed ARC 5349C (Notice ARC 5114C, IAB 7/29/20), IAB 12/30/20, effective 2/3/21]
[Filed ARC 5541C (Notice ARC 5365C, IAB 12/30/20), IAB 4/7/21, effective 5/12/21]
[Filed ARC 5914C (Notice ARC 5705C, IAB 6/16/21), IAB 9/22/21, effective 10/27/21]
[Filed ARC 6074C (Notice ARC 5837C, IAB 8/11/21), IAB 12/15/21, effective 1/19/22]
[Filed ARC 6255C (Notice ARC 6082C, IAB 12/15/21), IAB 3/23/22, effective 4/27/22]
[Filed ARC 6330C (Amended Notice ARC 6179C, IAB 2/9/22; Notice ARC 5834C, IAB 8/11/21), IAB 6/1/22, effective 7/6/22]
[Filed ARC 6521C (Notice ARC 6334C, IAB 6/1/22), IAB 9/21/22, effective 10/26/22]
[Filed ARC 6689C (Notice ARC 6425C, IAB 7/27/22), IAB 11/30/22, effective 1/4/23]
[Filed ARC 6843C (Notice ARC 6532C, IAB 9/21/22), IAB 2/8/23, effective 3/15/23]
[Filed ARC 7025C (Notice ARC 6906C, IAB 2/22/23), IAB 5/31/23, effective 7/5/23]
[Filed ARC 7026C (Notice ARC 6874C, IAB 2/8/23), IAB 5/31/23, effective 7/5/23]
[Filed ARC 7128C (Notice ARC 7048C, IAB 7/26/23), IAB 12/13/23, effective 1/17/24]
[Filed ARC 7617C (Notice ARC 7104C, IAB 11/1/23), IAB 2/7/24, effective 3/13/24]
◊	Two or more ARCs
1	Effective date delayed 70 days by the Administrative Rules Review Committee at its meeting held September 11, 1991.