By Shannon Dart

At its February 6–7, 2023 meeting (at 10:11:15), the Board of Pharmacy approved the recommendations from the Licensing Committee to move forward with changing regulatory language related to the authority of a licensed pharmacist to furnish opioid antagonists to the public without a prescription. The proposed changes are consistent with provisions of Business and Professions Code section 4052.01, as amended in SB 1259 (Laird) (Chapter 245, Statutes of 2022), and include a proposed amendment to Title 16, of the California Code of Regulations (CCR) section 1746.3. A full text with the amended and revised language can be found on the Medical Board of California’s website.

The amendment replaces language, screening criteria, training requirements, and more.  First, the language in section 1746.3 of the CCR was changed from “naloxone hydrochloride,” a drug more commonly known as NARCAN, to “opioid antagonist.” This change shifts the view of opioid overdose drugs from the specific definition of “naloxone hydrochloride” to any opioid antagonist, which is a drug that is designed to quickly reverse an overdose by negating the effects of opioids. “Opioid antagonists” are used most commonly during heroin, morphine, and oxycodone overdoses. The amended language also replaces the former requirement to provide a Pharmacy Board-approved fact sheet with an FDA-approved medication guide.

These amendments update three major requirements in furnishing opioid antagonists. First, the training requirement for pharmacists is updated, so pharmacists must complete training in a school of pharmacy recognized by the Board. Second, the labeling requirements for opioid antagonists is updated so the labeling is consistent with other prescription medications dispensed. Third, the patient’s physician is notified when the patient requests so, and if the patient does not affiliate with a physician, a written record is made of the drug furnished plus a recommendation to consult with an appropriate health care provider.

In addition, the amendment removes the screening criteria for furnishing an opioid antagonist, so individuals seeking this drug have access similar to what is already provided in schools and libraries. The amendment also removes privacy and documentation language to promote uniformity with other pharmaceutical products.

Finally, the amendment allows a pharmacist to advise in the selection of an opioid antagonist and any additional items the pharmacist may recommend when appropriate.