BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon. The draft policy is published in today's Federal Register. It is not FDA approval, and public comments are open until Nov 14.
FDA is reviewing 12 peptides for the list of ingredients pharmacies may compound from. On Oct 30, HHS published a draft policy saying it will not take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound six of them, under conditions that include a patient-specific prescription and quality testing. The policy is not binding, and HHS says it may revisit it if a safety or quality problem arises. The other six are not covered.
| COVERED BY THE HHS ENFORCEMENT PAUSE · OCT 30, 2026 | |||
|---|---|---|---|
| PEPTIDE | JULY PANEL VOTE | FEDERAL ENFORCEMENT | NEXT STEP |
| BPC-157 | RECOMMENDED | PAUSED · CONDITIONS APPLY | FDA rulemaking on the compounding list |
| TB-500 | RECOMMENDED | PAUSED · CONDITIONS APPLY | FDA rulemaking on the compounding list |
| KPV | RECOMMENDED | PAUSED · CONDITIONS APPLY | FDA rulemaking on the compounding list |
| MOTS-c | RECOMMENDED | PAUSED · CONDITIONS APPLY | FDA rulemaking on the compounding list |
| Semax | RECOMMENDED | PAUSED · CONDITIONS APPLY | FDA rulemaking on the compounding list |
| Epitalon | RECOMMENDED | PAUSED · CONDITIONS APPLY | FDA rulemaking on the compounding list |
| VOTED · NOT COVERED | |||
| PEPTIDE | JULY PANEL VOTE | FEDERAL ENFORCEMENT | NEXT STEP |
| Emideltide (DSIP) | NOT RECOMMENDED | NOT PAUSED | None scheduled |
| AWAITING NEXT PANEL · DUE BY END OF FEB 2027 | |||
| PEPTIDE | PANEL VOTE | FEDERAL ENFORCEMENT | NEXT STEP |
| LL-37 (cathelicidin) | NOT YET VOTED | NOT PAUSED | Panel meeting; no public docket yet |
| GHK-Cu | NOT YET VOTED | NOT PAUSED | Panel meeting; no public docket yet |
| Dihexa | NOT YET VOTED | NOT PAUSED | Panel meeting; no public docket yet |
| Melanotan II | NOT YET VOTED | NOT PAUSED | Panel meeting; no public docket yet |
| PEG-MGF | NOT YET VOTED | NOT PAUSED | Panel meeting; no public docket yet |