RegulationSILVER SPRING, Md. · Event July 24, 2026
FDA advisers back six peptides for 503A list, reject DSIP
The votes are advisory. Nothing can be legally compounded under 503A because of them until FDA acts.
FDA’s Pharmacy Compounding Advisory Committee (PCAC) ended a two-day meeting on July 24, 2026 having voted to recommend six of the seven peptides before it for the 503A bulks list, the list of bulk drug substances that state-licensed pharmacies may use to compound drugs for individual prescriptions. The only substance it voted down was emideltide, also called delta sleep-inducing peptide (DSIP).
FDA announced the meeting in a Federal Register notice published April 16, 2026 (91 FR 20465). The agenda covered BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax and Epitalon.
The votes
| Substance | Date | Reported vote (yes-no) | Outcome |
|---|---|---|---|
| BPC-157 | Jul 23 | 8-6, 1 abstention | Recommended |
| KPV | Jul 23 | 8-6, 1 abstention | Recommended |
| TB-500 | Jul 23 | 8-6, 1 abstention | Recommended |
| MOTS-c | Jul 23 | 7-5, 2 abstentions | Recommended |
| Semax | Jul 24 | 8-5 | Recommended |
| Epitalon | Jul 24 | Reported as 7-4 and as 7-5 | Recommended |
| Emideltide (DSIP) | Jul 24 | 6-7, 1 abstention | Not recommended |
Tallies are as reported by AJMC and the SSRP Institute. The sources agree on every figure except Epitalon, so we show both versions until FDA posts the official minutes.
Against staff advice
AJMC reported that FDA’s briefing documents recommended against all seven substances. It said the reviewers found the available studies, including five trials of BPC-157, too short and too small to establish safety or effectiveness for the indications nominated. Those indications ranged from ulcerative colitis to wound healing, obesity, osteoporosis and opioid withdrawal. The Associated Press, in its report carried by PBS News, wrote that the committee “narrowly recommended easing access to six out of seven peptides … despite warnings from government scientists.”
What the vote does not do
The committee is advisory, and AP noted that its votes “aren’t binding.” A favorable vote does not authorize compounding. For a substance to join the 503A bulks list, FDA must publish a proposed rule, take public comment and issue a final rule.
The votes also say nothing about products sold online as “research use only.” Those are not compounded drugs. FDA has continued to treat them as unapproved new drugs when the seller’s marketing shows they are meant for people (see our warning-letter explainer).
What came next
The panel’s recommendations fed directly into the policy debate that followed. In October, a document titled “Interim Access Policy for Compounding Using Certain Peptides” reached OMB for review (our report). When FDA announced the July meeting in April, it also planned a further PCAC meeting before the end of February 2027, according to the law firm Orrick. Of the 12 peptides removed from Category 2, the five not on the July agenda are LL-37, injectable GHK-Cu, dihexa, Melanotan II and PEG-MGF.
What changed: key dates
| Date | What happened |
|---|---|
| SSRP Institute: FDA Announces Change in Status of 12 Peptides | |
| Federal Register: Federal Register notice of the meeting, 91 FR 20465 | |
| Orrick: FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings | |
| Associated Press via PBS News: FDA advisory panel recommends easing access to 6 out of 7 popular peptides (AP) | |
| SSRP Institute: PCAC Meeting Vote Summary | |
| Event date for this report | |
| Office of Information and Regulatory Affairs (Reginfo.gov): Pending EO 12866 Regulatory Review: RIN 0910-ZD94 | |
| Amino Wire published this report | |
| Update: Re-verified. The AP quotation now cites AP's report as carried by PBS News, which we could check. We removed a quotation from a Buchanan Ingersoll & Rooney analysis we could not re-check, and attributed the February 2027 meeting to Orrick instead of Polsinelli. |
Update log
- Re-verified. The AP quotation now cites AP's report as carried by PBS News, which we could check. We removed a quotation from a Buchanan Ingersoll & Rooney analysis we could not re-check, and attributed the February 2027 meeting to Orrick instead of Polsinelli.
Sources
10 linked records- [1] July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee U.S. FDA Primary record
- [2] 2026 Meeting Materials, Pharmacy Compounding Advisory Committee U.S. FDA Primary record
- [3] Federal Register notice of the meeting, 91 FR 20465 Federal Register · Primary record
- [4] FDA Panel Backs 6 Peptides for Compounding AJMC
- [5] FDA reviews BPC-157, TB-500 and other peptides favored by RFK Jr. Associated Press
- [6] FDA advisory panel recommends easing access to 6 out of 7 popular peptides (AP) Associated Press via PBS News ·
- [7] Pending EO 12866 Regulatory Review: RIN 0910-ZD94 Office of Information and Regulatory Affairs (Reginfo.gov) · Primary record
- [8] FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings Orrick ·
- [9] FDA Announces Change in Status of 12 Peptides SSRP Institute ·
- [10] PCAC Meeting Vote Summary SSRP Institute ·
Amino Wire reports regulatory and court records. Nothing here is medical or legal advice, and we do not provide dosing information. Named companies may respond; see right of reply.
