By Steven Funk
On June 4, 2021, the California Board of Pharmacy (BOP) published notice of its intent to amend section 1715.6, Title 16 of the CCR to reduce mandatory reporting of loss of controlled substances, which is set forth in the proposed language. According to the initial statement of reasons, the Drug Enforcement Administration (DEA) requires the reporting of any “significant” loss of a controlled substance, in contrast to existing state law which requires the reporting of all drug losses. The proposed regulation establishes a minimum reporting threshold that corresponds to what it deems to be a significant loss, depending on the type and amount of controlled substance lost. By establishing a minimum reporting threshold, the Board aims to bring its reporting requirement into closer alignment with the DEA’s requirements.
As stated in the initial statement of reasons, the regulation seeks to reduce the administrative burden for both licensees and the Board, who under existing state law must prepare, review, and document reports for all controlled substance losses, including single-dose losses. The proposed amendment would require that the owner of the licensed facility submit to the Board a report for loss of controlled substances when 99 dosage units of tablets, capsules, or other oral medication are lost; or when 10 dosage units of single-dose injectable medications, lozenges, film, such as oral, buccal, and sublingual, suppositories, or patches are lost; or when two or more multi-dose vials, infusion bags, or other containers of injectable multi-dose medications, medications administered by continuous infusion, or any other multi-dose unit are lost. The proposed regulation also permits the reporting of any additional drug losses the pharmacist-in-charge deems “significant” in their professional discretion.
The Board approximates in its fiscal impact estimate that this regulation would reduce the number of licensed facilities reporting a drug loss from approximately 10,000 reports per year to 6,667 per year. The Board states that an Associate Governmental Program Analyst typically takes five minutes to process each report at the cost of approximately $3 per report. Consequently, the Board approximates that the anticipated decrease of 3,333 reports received and processed by the Board each year would result in cost savings of approximately $10,000 per year.
At its January 30, 2020 meeting [Agenda Item IX(b)], the Board voted to approve the proposed text of this rulemaking package. During the meeting, the Board emphasized the proposal’s priorities of providing clarity on drug loss reporting requirements while also ensuring pharmacy workers can use professional judgment. The 45-day public comment period ended on July 19, 2021. At the time of this writing, the Board reported on its website that the proposed regulation is undergoing review by the Office of Administrative Law (OAL).