Board of Pharmacy Adopts Emergency Regulation for PrEP and PEP Treatments

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By Catherine Santos

On July 26, 2024, the California State Board of Pharmacy published a Notification of Proposed Emergency Regulatory Action concerning its proposed amendment to section 1747 of Title 16, Division 17, Article 5 of the California Code of Regulations (CCR). Section 1747 discusses the provision of HIV preexposure prophylaxis (PrEP) and HIV postexposure prophylaxis (PEP) treatments. The notice states that section 4052.02 of the Business and Professions Code authorizes a pharmacist to provide PrEP treatment under certain conditions and requires the Board to enact emergency regulations complying with CDC guidelines by October 31, 2024. According to the Board’s Finding of Emergency, the legislature “deemed the adoption of the proposed emergency regulation to be an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare.”

After a five-day notice period and a five-day public comment period, on August 14, 2024, the Office of Administrative Law published a Notice of Approval for the action, establishing the emergency regulation as effective on the same day and to expire on February 11, 2025.

On July 12, 2024, the Board published notice to make its proposed regulatory changes to section 1747 permanent, allowing pharmacists to initiate and furnish PrEP and PEP for HIV prevention independently.  In addition, the proposed changes would amend section 1747 to require that the Pharmacist maintain documentation of PrEP furnished and services provided for at least three years to ensure compliance and facilitate patient care. According to the Board’s Initial Statement of Reasons, maintaining services compliant with CDC recommendations is “critical to the health, safety, and general welfare of California residents and helps save lives.” Further, by adding the documentation requirement, the Board hopes to ensure pharmacists have the necessary information to treat patients to the best of their ability.

Written comments must be submitted by November 4, 2024, and a public hearing may be scheduled if requested 15 days before the end of the comment period.

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