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503A pharmacy (traditional compounding pharmacy)

A 503A pharmacy is an ordinary state-licensed pharmacy (or a doctor) that makes compounded medicines under section 503A of US law. State pharmacy boards are the main watchdog. It follows different, lighter rules than a drug factory.

For experts

Section 503A of the FD&C Act covers compounding by licensed pharmacists in state-licensed pharmacies or federal facilities and by physicians. Bulk drug substances must meet an applicable USP/NF monograph, be a component of an FDA-approved drug, or appear on the 503A bulks list, and must be accompanied by a valid certificate of analysis and made by an FDA-registered establishment. State boards of pharmacy have primary day-to-day oversight, and CGMP requirements do not apply to 503A compounding, although other federal law such as the prohibition on insanitary conditions does.

Sources (2)

  1. 01Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29
  2. 02Compounding and the FDA: Questions and AnswersU.S. Food and Drug Administration · 2025-09-16 · accessed 2026-09-29