Regulatory Tightening: FDA Bulk Substance Policy Redefines Peptide Compounding
Why it matters The U.S. FDA is moving from a period of discretionary enforcement to active restriction of unlisted bulk drug substances used in compounding. This shift directly impacts how pharmacies, clinics, and research suppliers can handle many well-known peptides—including BPC-157, TB-500, and Epitalon—used historically under gray-zone exemptions. Study snapshot / Policy background Key findings…