Pharmacy and drug forms

USP <797>

Compounded vs FDA-approved, 503A vs 503B, and the accreditation programs that distinguish them.

Definition

The United States Pharmacopeia chapter governing sterile compounding for human use, covering air quality, personnel garbing, surface sampling, and beyond-use dating for compounded preparations. 503A pharmacies must demonstrate USP <797> compliance to dispense sterile injectables like compounded semaglutide. Inspections typically check ISO Class 5 primary engineering controls, anteroom pressure differentials, and operator media-fill testing.

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Definition curated by Weight Loss Rankings — sourced from FDA labels and peer-reviewed PubMed literature, never AI-generated summaries.

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