California State Board of Pharmacy staff presented draft amendments to multiple Business and Professions Code sections to align the state's statutory language for outsourcing facilities with federal definitions and recent legislative changes.

Staff told the Enforcement and Compounding Committee that the proposed omnibus edits would add the phrase "geographic location or address" to the BPC definition of an outsourcing facility, remove the phrase "non-patient specific" from existing text, and replace instances of the word "licensed" with "registered" where the federal Food and Drug Administration maintains a registration (rather than a license). The proposed changes were presented as technical alignments intended to mirror Title 21 of the Code of Federal Regulations and AB1533, which staff said allows some outsourcing facilities to perform patient-specific compounding.

The committee reviewed Attachment 2, which contains the draft language recommended by staff. Members generally described the proposed edits as "small but mighty" alignment changes intended to reduce ambiguity for 503B outsourcing facilities. Committee members asked staff to ensure cross-references are added so that when the FDA cancels, revokes, or suspends an outsourcing facility's registration, corresponding California references (including provisions that address nonresident outsourcing facilities) would be treated consistently.

No members raised substantive objections during the committee discussion. Staff advised the committee that referring draft statutory language to the full board does not require a committee motion; the committee consented to have the matter brought forward for full-board consideration and possible action.

What's next: staff will prepare the referral materials and draft language for the full board to consider, including the proposed replacements of "licensed" with "registered," the addition of geographic-location language, and the suggested cross-references to nonresident facility provisions.