CHAPTER 10CONTROLLED SUBSTANCES[Prior to 2/10/88, see Pharmacy Examiners[620] Ch 8]65710.1(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.Related ARC(s): 3345C65710.2(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" "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," "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.
Related ARC(s): 3345C, 4455C65710.3(124) Who shall register. The following persons or businesses shall register on forms provided by the board:- Manufacturers, distributors, importers, and exporters located in Iowa. Effective January 1, 2018, nonresident manufacturers, distributors, importers, and exporters distributing controlled substances into Iowa.
- Reverse distributors located in Iowa. Effective January 1, 2018, nonresident reverse distributors engaging in the transfer of controlled substances with registrants located in Iowa.
- 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.
- 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.
- 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.
- Emergency medical service programs that are administering controlled substances to patients located in Iowa.
- Care facilities that are located in Iowa.
- Researchers, analytical laboratories, and teaching institutions that are located in Iowa.
- Animal shelters and dog training facilities that are located in Iowa.
- 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).
- Documented audit and reconciliation of all controlled substances every six months.
- Routine documented cycle counts of substances, so long as all controlled substances are counted every 90 days and identified discrepancies are investigated and documented.
- Other measure preapproved by the board.
- Any violation of the federal Food, Drug, and Cosmetic Act or federal regulations promulgated under the Act.
- 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.
- Refusing access to the registered location or registrant records to an agent of the board for the purpose of conducting an inspection or investigation.
- Failure to maintain registration pursuant to 657—Chapter 10.
- 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.