FDA advisory committee recommends adding six peptides to the pharmacy compounding list
FDA advisory committee recommends adding six peptides to the pharmacy compounding list
On July 23–24, an FDA advisory committee recommended adding BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax to the list of bulk drug substances that may be used in prescription compounding under section 503A. Emideltide did not receive the committee’s support. The FDA will make the final decision.
Section 503A allows a pharmacy to compound a drug under a prescription for an identified individual patient. The 503A list determines which active substances a pharmacy may use as starting materials. The vote therefore concerns a potential legal route for peptides that longevity clinics and overseas websites already sell as substances intended for “research use.”
Three weeks before the vote, FDA staff recommended rejecting all seven candidates. For Epitalon, they cited the absence of published evidence of efficacy for insomnia, the risk of an immune response and impurities introduced during peptide synthesis. The committee reached a different conclusion: Epitalon received 7 votes in favor and 5 against, with one abstention, while Semax received 8 votes in favor and 5 against. Emideltide was rejected by 6 votes to 7, with one abstention.
At the PCAC meeting on July 23–24, the committee discussed the quality of the substances, the clinical evidence and the respective roles of physicians and pharmacists in making treatment decisions for individual patients. Committee member David Pope, a pharmacist at XiFin Pharmacy Solutions, explained his vote in favor of Epitalon as follows: “The physician and pharmacist assess the risks and decide whether the peptide is appropriate for a particular patient.”
A majority of PCAC members recommended adding six substances to the 503A list. The FDA will now prepare a proposed rule, solicit public comments and decide whether pharmacies may use these substances to compound drugs under prescriptions for individual patients.