Pharmacy and drug forms

503A pharmacy

Where a compounded drug parts company with an FDA-approved one, where 503A parts company with 503B, and which accreditation programs tell them apart.

Definition

A state-licensed compounding pharmacy making preparations for named individual patients against a prescription. Held to USP <797> for sterile work, but its finished products are not FDA pre-approved. ⚠ If a seller will not name the 503A filling your vial, you cannot check its inspection history — and that is the single most common gap in this register.

PCAB accreditation investigation

GLP Watchdog writes these definitions from FDA labels and peer-reviewed PubMed literature. Not one of them is an AI-generated summary.

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