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Board staff proposes BPC edits to align outsourcing-facility rules with FDA language
Summary
Committee reviewed draft Business and Professions Code edits suggested by staff to align California's outsourcing-facility definitions and terminology (e.g., adding “geographic location or address” and replacing "licensed" with "registered") to match FDA/Title 21 language and AB1533 changes.
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…
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