FDA Removes 12 Therapeutic Peptides From Category 2 — What the April 15 Action Means

On April 15, 2026, the U.S. Food and Drug Administration formally removed twelve therapeutic peptides from Category 2 of the 503A bulk drug substances evaluation framework. The action clears a multi-year regulatory freeze on compounding these peptides and sets up the category’s most consequential regulatory decision point in a decade — the Pharmacy Compounding Advisory Committee meeting on July 23–24.

The twelve peptides affected are BPC-157, TB-500, KPV, MOTS-c, DSIP, Semax, Epitalon, GHK-Cu, Melanotan II, LL-37, Dihexa, and PEG-MGF. Each had been placed in Category 2 — the “pending nomination with safety concerns” tier — which in practical terms acted as a freeze on large-scale compounding pharmacy preparation.

The April 15 action moves these peptides to an interim evaluation tier. Licensed 503A compounding pharmacies may now legally prepare them under valid patient-specific prescriptions. The FDA has committed to a final Bulks List decision in July.

What it does not do. The reclassification does not make these peptides FDA-approved drugs. It does not endorse their efficacy. It does not legalize the gray-market research-chemical channel, which continues to operate outside the legal drug supply chain. And it does not create a uniform national access regime — state pharmacy board rules continue to vary.

What happens next. The July PCAC meeting will recommend final 503A Bulks List placement. Industry expectation is that seven to nine of the twelve will receive clean approval; Melanotan II, Dihexa, and PEG-MGF are the likeliest candidates for restriction or deferred decision.

For the full breakdown of the April 15 action and what the PCAC meeting is expected to decide, see our FDA timeline tracker and the 2026 Peptide Law Playbook.