In July 2026 the FDA's Pharmacy Compounding Advisory Committee spent two days reviewing seven peptides that had been nominated for the list of bulk substances that compounding pharmacies may use. The headlines called it a win for peptides. The reality is more measured.
Update, October 31, 2026: On October 28, HHS announced an interim policy for the six peptides the committee backed. The sections below explain the vote and what the new policy does and doesn't change.
What the committee voted
- BPC-157, KPV and TB-500: recommended, each by a vote of 8 to 6 with one abstention.
- MOTS-c: recommended, 7 to 5 with two abstentions.
- Semax and Epithalon: recommended by similarly narrow margins.
- DSIP (emideltide): not recommended, 7 to 6.
FDA staff had recommended against all seven, so the committee went against the agency's own reviewers on six of them.
What HHS did on October 28
On October 28, 2026, the Department of Health and Human Services announced an interim enforcement discretion policy for BPC-157, Epithalon, KPV, MOTS-c, Semax and TB-500. HHS said it does not intend to take action against state-licensed pharmacies, federal facilities or licensed physicians that compound these six under section 503A, as long as strict conditions are met:
- The bulk material comes from an FDA-registered manufacturer and has a certificate of analysis.
- The product contains only one active ingredient and uses only the routes of administration the policy lists.
- The label states that it is a compounded drug product and not for resale.
- Serious adverse events are reported to the FDA.
DSIP, the one peptide the committee voted against, is not covered. Neither are 503B outsourcing facilities. Comments on the policy are open for two weeks after its publication in the Federal Register.
What did not change
Enforcement discretion is not approval. None of the six is an FDA-approved drug, and none has been added to the 503A bulks list. Adding them would still take formal rulemaking, which can take months or years. HHS also said it may revisit the policy if safety signals or quality problems appear. And the policy is about compounded products made by pharmacies; it does not change the status of research-grade material sold for laboratory use.
Why the margins matter
Votes of 8 to 6 and 7 to 5 tell you the experts in the room were split. The disagreement was mostly about evidence: most of the research on these compounds comes from animal studies, and the human data are small or come from a single research group. That gap is exactly what any future rule will have to address.
What to watch next
Look for changes to the interim policy after the comment period closes, and for any FDA proposal to add some or all of the six peptides to the bulks list through notice-and-comment rulemaking. We will update the briefs for BPC-157, TB-500, KPV, MOTS-c, Semax and Epithalon when the status changes.