Overview of the federal and state framework governing compounded medication production in the U.S.
Federal authority
The Food, Drug, and Cosmetic Act (FD&C Act) Sections 503A and 503B, refined by the Drug Quality and Security Act of 2013 (DQSA), establish the two pathways for legal compounded medication.
State authority
State pharmacy boards license individual pharmacies, inspect facilities, and have primary authority over 503A compounding. State boards can investigate, suspend, or revoke licenses independently of federal action.
Standards bodies
USP (United States Pharmacopeia) sets specific compounding standards: USP <797> (sterile preparations), USP <800> (hazardous drugs), USP <71> (sterility testing), USP <85> (bacterial endotoxin testing). These are referenced in both 503A and 503B regulation.
How the framework changes with shortage status
When a drug is on FDA's shortage list, both 503A (patient-specific) and 503B (bulk) compounding of that drug are broadly permitted. When the drug is removed from shortage list, 503B bulk production of that drug is generally restricted; 503A patient-specific continues. This dynamic shaped the entire compounded GLP-1 supply landscape through 2024–2026.
Recent inflection points
- August 2024: FDA declared tirzepatide shortage resolved. 503B bulk production transition restrictions followed.
- February 2025: FDA declared semaglutide shortage resolved. Similar transition.
- April 14, 2026: FDA action restricting unapproved salt-form API for compounded GLP-1. See detailed analysis.