By Steven Funk
On September 17, 2021, the California Board of Pharmacy published notice of its intent to amend section 1715.65, Title 16 of the California Code of Regulations (CCR) to address frequent compliance questions the Board receives on the requirement for pharmacies and clinics to perform inventory reconciliation activities and to address the ongoing diversion of non-Schedule II controlled substances, which is set forth in the proposed language.
As stated in the Board’s initial statement of reasons, the proposal seeks to reduce the amount of controlled substances diverted from pharmacies and clinics and thereby reduce the amount of drugs being misused and abused without denying pain relief for those who need it. According to the National Council on Alcoholism and Drug Independence, Inc. (as cited by the Board), the availability of opioids is partly the cause of the epidemic misuse of prescription medication. The Board determined that focusing on the non-Schedule II controlled substances with the highest reported drug losses would have the most significant impact on the health and safety of the regulated public while also managing the pharmacy staff time necessary to complete the inventories.
Existing federal law (Title 21 of the Code of Federal Regulations section 1304.11), requires that pharmacies and clinics complete an inventory of all federal controlled substances at least once every two years. The proposed amendment adds the requirement that four non-Schedule II controlled substances (Alprazolam, 1 milligram/unit, Alprazolam 2 milligrams/unit, Tramadol 50 milligrams/unit, and Promethazine/codeine, 6.25 milligrams of promethazine and 10 milligrams of codeine per 5 milliliters of product) will require an inventory at least once every twelve months. These four non-Schedule II substances have the highest reported drug losses to the Board. They are also subject to abuse and misuse, making them a target for diversion by pharmacy and clinic employees. The Board reasoned that by requiring the inventory of the four non-Schedule II controlled substances yearly and of other non-Schedule II controlled substances biennially, pharmacists and pharmacies will be better equipped to spot and stop employee drug diversion from the pharmacy earlier and prevent excessive drug losses from occurring.
The proposed regulation will also require that all individuals involved in completing the inventory or preparing the report be identified, and that the individual who performs the inventory sign and date the form. The regulation will also clarify the inventory requirements for an inpatient hospital pharmacy where drugs are stored within a drug storage area under the pharmacy’s control, and for the inventory of an automated drug delivery system within the inpatient hospital.
At its January 29–30, 2020 meeting [Agenda Item (IX(a)], the Board voted to initiate a rulemaking for this proposed amendment. During the meeting, the Board stated that it had considered a suggestion to include buprenorphine products as one of the target drugs but decided it was unnecessary. The 45-day public comment period for this rulemaking action will conclude on November 1, 2021.