Controlled Substances Act (CSA) Registrations are required for 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, unless exempt from registration pursuant to rule 657 IAC—10.8(124).
Every individual practitioner or researcher who administers, prescribes, stocks, or dispenses any controlled substance must be registered under both state and federal Controlled Substances Acts. Federal registration is with the Drug Enforcement Administration (DEA). State registration is with the Iowa Board of Pharmacy. These registrations must be renewed periodically; check the respective registration certificates for expiration dates. Registration certificates must be maintained at the registered location. Registration is for a specific practice location. Individual practitioners or researchers who personally procure and maintain a stock supply of controlled substances for dispensation or administration at multiple locations must obtain a separate registration for each location. Individuals who make a change in their practice location must notify both the state and federal offices.
To be eligible to register, individual practitioners must hold a current, active license to practice their profession. The following individuals, if procuring/stocking, prescribing, administer, or dispensing controlled substances in Iowa, are required to register:
The following businesses, if engaged in any activities involving controlled substances, are required to register:
New Applicants may check the status of their CSAR application at https://ibop.igovsolution.net/online/Lookups/Lookup_Individual.aspx. Search by License/Registration Type CSA-Individual or CSA-Business, as appropriate, and the applicant’s name. Do not enter a License/Registration number. If the status is pending approval, use the Application Status Check feature to see what information is still needed.
Existing registrants (individuals and businesses) may check the status of their CSAR at https://ibop.igovsolution.net/online/Lookups/Lookup_Individual.aspx. Search by License/Registration Type CSA-Individual or CSA-Business, as appropriate, and the registrant’s name and/or CSAR number.
Veterinarians and Researchers, skip to STEP TWO
Federal and state laws require all controlled substances registrants to inventory all stocks of controlled substances in the possession of the registrant on the date the registrant first engages in the manufacture, distribution, dispensing, administration, prescribing, or disposing of controlled substances. In the event the registrant commences business or practice with no controlled substances on hand, that fact shall be recorded as the initial inventory. After the initial inventory, a registrant shall take a new inventory every year. The annual inventory may be taken on any date that is within one year of the previous inventory.
A pharmacy located in Iowa that dispenses controlled substances listed in Schedule II of the Controlled Substances Act shall maintain a perpetual inventory system for each of those substances. Specific requirements for maintenance and periodic reconciliation of the perpetual inventory are found in Board rule 657 IAC--10.33(124,155A). See 657 IAC chapter 10.
All inventories shall be taken either as of opening for business or as of the close of business on the inventory date and the inventory record shall identify either “opening” or “close of business.” The person making the inventory record shall date and sign the bottom of the final page and shall initial and date the bottom of all other pages of the inventory record. The inventory record shall be maintained in written, typewritten, or electronically printed form at the registered location two years from the date of the inventory. An inventory record of substances listed in Schedule I or Schedule II of the Controlled Substances Act shall be maintained separately from an inventory of all other controlled substances.
Inventory records of controlled substances shall include the name of the substance, the strength and dosage form of the substance (e.g. 10 mg. tablet), and the quantity of the substance. An exact count shall be recorded for all substances, unless it is a liquid in a non-incremented container which can be estimated to the nearest quarter container.
It is the responsibility of both the current owner and the prospective owner to take an inventory of all controlled substances whenever there is a change in ownership of an establishment licensed by the Board. An owner may delegate the actual taking of such inventory.
It is the responsibility of the owner to take an inventory of all controlled substances whenever there is a change in the responsible individual or the pharmacist in charge, as appropriate, of any establishment licensed by the Board.
If you need additional information regarding these procedures, please contact Terry Witkowski or contact the compliance officer assigned to your area of the state.
Any person or business registered to handle controlled substances in Iowa shall dispose of such drugs as follows:
Disposal of Resource Conservation and Recovery Act (RCRA) hazardous pharmaceutical waste:
The U.S. Environmental Protection Agency (EPA) has identified the following controlled substances to be hazardous pharmaceutical waste:
In order to be exempt from the EPA regulations for disposal of these substances, the waste must be disposed of in a manner that is publicly deemed in writing as acceptable by DEA or by incineration. To date, DEA has not publicly deemed in writing that any particular method of disposal meets its non-retrievable standard; as such, this hazardous pharmaceutical waste must be disposed of via incineration.
Disposal of controlled substances from long-term care facility patients:
Controlled substances dispensed to a resident in a long-term care facility and subsequently requiring destruction due to discontinuance of the medication, death of the resident, or other reasons necessitating destruction shall be destroyed by one of the following methods:
All application fees are nonrefundable and nontransferable. Once an application is submitted and the fee is paid, the withdrawal of an application, determination of ineligibility based on prior criminal convictions, or discovery of the submission of an incorrect application type does not merit return or refund of the application fee. Do not submit an application if you are unsure of which application type to submit. Do not send cash.