Primary regulatory
Compounding Quality Act: Sections 503A and 503B of the FD&C Act
FDA overview of the Drug Quality and Security Act (DQSA), which established sections 503A (traditional compounding pharmacies, state-regulated) and 503B (outsourcing facilities, FDA-registered, cGMP) of the FD&C Act, defining different regulatory requirements for each compounding category.
U.S. Food and Drug AdministrationPublished 2013-11-27Accessed 2026-07-08
Registry record
Source metadata
- Publisher
- U.S. Food and Drug Administration
- Source type
- Primary regulatory
- Registry ID
fda-503a-503b-compounding
Source usage
Linked from 19 pages
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GuidePeptide Terminology Glossary
GuideState-by-State Peptide Regulation: Research Chemicals, Compounding, Syringes, and Telehealth Prescribing
GuideSterile vs Bacteriostatic Water: What Changes After the Seal Is Broken
Research hubCompounded Peptides Explained: 503A vs 503B
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Research hubRUO vs Telehealth: How People Access Peptides
Research hubWhat Does 'Research Use Only' Actually Mean?
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