federal
United States federal
U.S. federal peptide regulation is split among FDA approval, compounding exemptions under FD&C Act sections 503A and 503B, drug-shortage authorities, enforcement discretion, and (for sport) WADA rules.
Federal law preempts certain state requirements for approved drugs but leaves much compounding oversight to state boards of pharmacy. This page covers FDA, DEA, FTC, and WADA sport-rule status only.
Key agencies
Substances covered
Key documents
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
U.S. Food and Drug Administration · Agency list · FDA-2015-N-3534
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503B
U.S. Food and Drug Administration · Agency list · FDA-2015-N-0030
- WADA 2025 Prohibited List
World Anti-Doping Agency · Sport prohibited list