Starting January 1, 2023, California pharmacies will be required to have a new written policy and procedure addressing controlled substances inventory reconciliations. The amended California Code of Regulations 1715.65 now requires that pharmacies perform inventory reconciliation report:

– on all federal controlled substances;

– for federal Schedule II drugs at least once every three months;

– for products containing the followings substances in the following strengths per tablet, capsule, other unit, or specified volume, at least once every 12 months:

(A) Alprazolam, 1 milligram/unit.

(B) Alprazolam, 2 milligrams/unit.

(C) Tramadol, 50 milligrams/unit.

(D) Promethazine/codeine, 6.25 milligrams of promethazine and 10 milligrams of  codeine per 5 milliliters of product.

– for any other controlled substances no later than three months after discovery of the reportable loss of that controlled substance;

– for all controlled substances at least once every two years.

The new regulation also explains the record-keeping requirements of inventory reconciliation reports, how such reports should be prepared, and clarifies inventory requirements in hospital setting.

You can purchase this new policy and procedure customizable to your practice at our RxPolicy website. (If you are a subscriber, you should have already received this new policy and procedure from us and you will receive a revised Standard Operational Manual for 2023 – with all the updates and requirements for 2023 – in December 2022).