Controlled Substance Inventory
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, or disposing of controlled substances. In the event the registrant commences business 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—10.33(124,155A).
All inventories shall be taken either as of opening of 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. If the substance is listed in Schedule I or Schedule II of the Controlled Substances Act and for all solid oral and injectable hydrocodone-containing products, an exact count or measure of the contents shall be recorded. For all other substances listed in Schedules III, IV or V of the Controlled Substances Act, if the container has been opened, the registrant may make an estimated count or measure of the substance unless the original unopened container held more than 100 tablets or capsules, in which case an exact count shall be recorded.
It is the responsibility of both the current pharmacy owner and the prospective pharmacy owner to take an inventory of all controlled substances whenever there is a change in ownership of a facility licensed by the Board. A pharmacy owner may delegate the actual taking of such inventory.
It is the responsibility of the pharmacy owner to take an inventory of all controlled substances whenever there is a change in the pharmacist in charge 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.