On July 23 and 24, 2026 the FDA's Pharmacy Compounding Advisory Committee (PCAC) met to consider seven peptides nominated for the 503A bulks list, the list of bulk drug substances that 503A compounding pharmacies may use even though the substances are not components of approved drugs and have no USP monograph. For clinics that have watched BPC-157 and TB-500 sit in regulatory limbo since 2023, the votes were the most significant development in years. They were also only a recommendation.
The votes
The committee voted to recommend six of the seven peptides for inclusion:
| Peptide | Vote | Outcome |
|---|---|---|
| BPC-157 | 8 to 6, 1 abstention | Recommended |
| KPV | 8 to 6, 1 abstention | Recommended |
| TB-500 | 8 to 6, 1 abstention | Recommended |
| MOTS-c | 7 to 5, 2 abstentions | Recommended |
| Semax | Majority | Recommended |
| Epitalon | Majority | Recommended |
| DSIP (emideltide) | Majority against | Not recommended |
FDA career staff had recommended against including all seven, citing the thin safety and effectiveness record for substances that have never been through an approval process. The committee voted over those objections, which is unusual and is one reason the outcome drew attention.
How the peptides got here
Most of these peptides were placed in Category 2 of the FDA's interim 503A bulks list in 2023, the category for nominated substances the agency identified as raising significant safety risks. Category 2 substances may not be compounded. On April 15, 2026 the FDA removed a group of peptides, including BPC-157 and TB-500, from Category 2 ahead of the committee review. That step was procedural: it did not place them in Category 1, approve them, or authorize compounding. The BPC-157 and TB-500 provider guides cover the history in more detail.
What the votes mean
PCAC is an advisory committee. Its recommendations go to the FDA, which decides whether to add a substance to the 503A bulks list through notice-and-comment rulemaking. Reporting on the meeting indicates the additions would also require approval from the Secretary of Health and Human Services. As of October 2026, no final listing has been published for any of the six.
Until that happens, the compounding eligibility of BPC-157, TB-500 and the others remains unsettled. In practice:
- Some pharmacies read the April removal and the July votes as enough to resume compounding under the interim policy; others will not compound until a final listing. Partner pharmacies on ScriptLinkRx make that call for themselves.
- State boards of pharmacy have their own positions and are not bound by the committee.
- A favorable vote is not a safety finding. The FDA's own staff recommended against listing.
What a clinic should watch
- The Federal Register. A proposed rule adding substances to the 503A bulks list is the signal that changes the legal position. Nothing before that does.
- The next PCAC meeting. Injectable GHK-Cu and other peptides removed from Category 2 are expected to come before the committee in 2027; see the GHK-Cu guide.
- Your pharmacy's current position. Ask the dispensing pharmacy how it is treating each peptide's eligibility today, and document the answer.
- Research-chemical sellers. The votes do not make "research use only" products lawful to administer. They are not pharmaceuticals and remain subject to FDA enforcement.
For how peptide sourcing works through licensed pharmacies on the platform, see the peptide sourcing guide for clinics.
Sources
- FDA: Pharmacy Compounding Advisory Committee
- FDA: Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
- NCPA: FDA advisory committee nominates six peptides for pharmacies to compound (July 31, 2026)
- McDermott Will & Emery: PCAC backs majority of peptides in two-day public meeting
- AJMC: FDA Panel Backs 6 Peptides for Compounding