October 01, 2025
What You Need to Know: The California Board of Pharmacy’s final compounding regulations explicitly exempt physicians and other non-pharmacy providers. CMA’s advocacy ensured physician practices will not be subject to pharmacy-only requirements, such as having an on-site pharmacist. The new rules take effect October 1, 2025.
After more than a year of rulemaking, the California Board of Pharmacy has finalized new compounding regulations that explicitly exempt physicians and other non-pharmacy providers – a change the California Medical Association (CMA) persistently advocated for. The rules, undertaken in response to updates to the United States Pharmacopeia and National Formulary (USP-NF) standards, now make clear they apply only to licensees of the Board of Pharmacy.
Throughout the process, CMA raised concerns that the pharmacy board’s original proposal – unlike prior regulations – did not specify such a limitation. Without that clarity, physician practices may have believed they were subject to pharmacy-only requirements. Many of these standards, like the requirement to have a pharmacist on site, are impractical for a physician practice. CMA’s sustained advocacy led to revisions in the final regulations approved by the Office of Administrative law that clearly limit the application of the new regulations to compounding by licensees of the Board of Pharmacy, thus excluding physicians and other providers from their scope and protecting physicians from inappropriate burdens and regulation.
Among the updated standards, the approved regulations now expressly require pharmacists to verify and document that a compounded sterile or nonsterile drug preparation, when essentially a copy of a commercially available drug product, produces a clinically significant difference based on the medical need of a specific patient. According to the Board of Pharmacy, this addition was an explicit clarification of a preexisting requirement of pharmacist practice under state law. This requirement does not apply if the compounded drug product appears in an American Society of Health-System Pharmacists list or FDA Drug Shortages Database of drugs at the time of compounding and dispensing, or if the pharmacist is in a health care facility where the drug cannot be obtained from the manufacturer or wholesaler and documentation is maintained.
CMA argued that the language creates an undue burden if interpreted as requiring the pharmacist to contact the physician for verification in all cases. CMA will track implementation of the regulation to understand its impact on physician practices and patients’ access to medications.
The new regulations (California Code of Regulations, title 16, commencing at section 1735) take effect October 1, 2025. The language of the regulations is available on the Board of Pharmacy’s “Approved Regulations” webpage , under “Compounded Drug Preparations.”
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