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In September 2023 FDA placed roughly 17 to 19 peptides into Category 2 of the 503A interim bulks guidance, meaning substances that raise significant safety concerns. That effectively stopped compounding pharmacies from preparing them. FDA cited immunogenicity, impurity and the absence of rigorous human trials.
In September 2024 a settlement with compounders required FDA to stop acting unilaterally and instead submit key peptides to the Pharmacy Compounding Advisory Committee in public meetings. That is the process that produced the July 2026 hearing.
FDA removed 12 peptides from Category 2 after the original nominators withdrew their nominations. This included BPC-157, TB-500, MOTS-c and injectable GHK-Cu.
Removal from Category 2 is not authorisation. It moved these compounds back into an unresolved state pending review. Several sellers presented it as a green light. It was not.
| Compound | Vote | Outcome |
|---|---|---|
| BPC-157 | 8 to 6 | Recommended |
| KPV | passed | Recommended |
| TB-500 | passed | Recommended |
| MOTS-c | passed | Recommended |
| Semax | 8 to 5 | Recommended |
| Epitalon | 7 to 5 | Recommended |
| Emideltide (DSIP) | 6 to 7 | Rejected |
Notably, the committee recommended six of seven over the objection of FDA's own scientific staff, who had found the evidence insufficient for most of them. FDA reviewers noted that BPC-157's effectiveness case rested on a single trial of 46 people, and that they found no human studies at all for KPV.
None of these compounds is legal to compound today. Advisory committee votes are recommendations. Adding a substance to the 503A bulks list requires formal notice and comment rulemaking, which takes months at minimum. FDA is not bound by the recommendation and has gone against advisory panels before, which is a live possibility here given its own reviewers dissented.
Within 48 hours of the vote, sites began advertising these compounds as newly legal. They are not. A seller who either does not understand the difference between a recommendation and a rule, or does understand and is counting on you not to, has told you something useful about how they handle everything else.
Different track, opposite direction. The tirzepatide shortage resolved in October 2024 and semaglutide in February 2025, closing the compounding exemption for both. In April 2026 FDA moved to bar semaglutide, tirzepatide and liraglutide from the 503B bulks list entirely, and issued more than 50 warning letters during 2026. See semaglutide and tirzepatide.
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Regulatory status current as of the page date. This area is changing quickly and this page is reviewed monthly. [set review reminder]