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Comments on the FDA’s Draft Guidances on the Prescription Requirement Under Section 503A and the Facilities Definition Under Section 503B

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Public Citizen supports policies contained in these two recent FDA guidances, which generally serve to clarify the line between traditional pharmacy compounding and drug manufacturing. In particular, we agree that Section 503A limits traditional compounding pharmacies from selling “office stock” in bulk to healthcare practitioners, approve of clear limitations on anticipatory compounding, and approve of the requirement that all products produced by outsourcing facilities comply with current good manufacturing practices.

Read more about our work on pharmacy compounding