On June 19, 2025, California’s Office of Administrative Law approved the California Board of Pharmacy’s updated regulations for pharmacy compounding. The updated regulations go into effect on October 1, 2025. The Board of Pharmacy will be providing a policy statement to assist pharmacies during the transition period. This article will highlight some important changes pharmacies should be aware of.
Use of FDA 503A Category 1 Bulk Drug Substances for Sterile Compounding
Under the current regulatory scheme, California does not permit compounding with substances on the 503A Bulks List. Beginning October 1, 2025, resident and nonresident sterile compounding pharmacies may compound with components from the Bulks List provided that the compounding pharmacy complies with USP 797 and other applicable federal laws and guidance.
Compounding Veterinarian Preparations
Currently, compounding pharmacies may only provide veterinarians with a 5-day supply of a compounded preparation intended for animal use. Beginning October 1, 2025, pharmacies may provide up to a 28-day supply of a compounded preparation, depending on its sterility and intended use. Specifically:
- Pharmacies can provide a veterinarian with up to a 14-day supply of a nonsterile compound.
- Pharmacies can provide a veterinarian with up to a 7-day supply of a sterile, non-ophthalmic compound.
- Pharmacies can provide a veterinarian with up to a 28-day supply of a sterile ophthalmic compound.
Addition of Flavoring Agents to Oral Liquid Dosage Forms of FDA Approved Drugs
Pharmacies whose only compounding consists of adding a flavoring agent to a prescribed FDA approved drug will be exempt from certain requirements. The request to add the flavoring agent need not come from the prescriber or the prescriber’s agent, the patient or the patient’s agent may also request that the pharmacy add the flavoring.
Handling of Hazardous Drugs
Updated regulations apply to facilities that compound hazardous drugs and those that open hazardous drug capsules or crush hazardous drug tablets. Sterile preparation mats are no longer required. Additional updates regarding engineering controls and workflow management will also take effect on October 1, 2025.
Compounding in Hospitals
The updated regulations contain several changes related to compounding in hospitals:
- More flexibility to compound medications that are commercially available products.
- More flexibility on how to document rate of infusion.
- Additional provisions for immediate use compounding.
- Additional provisions around competency assessments.
It is vital that pharmacies impacted by these updates review and—if necessary—adjust their practices to ensure compliance with the Board’s updated regulations.
How Frier Levitt Can Help
Frier Levitt has represented numerous licensees across the country in the pharmacy industry, including in the State of California and nonresident pharmacies licensed in California. Frier Levitt has worked with pharmacies to ensure compliance when compounding sterile and nonsterile products, including when mailing/shipping compounded products across state lines. Contact us if you are contemplating or currently compounding medications in California or shipping compounded products into California.
