Facts
- HHS and the FDA are weighing an interim policy on compounded peptides that would let pharmacies temporarily make several unapproved peptides, according to the Regulatory Affairs Professionals Society (RAPS), in a report dated October 23, 2026. The agencies sent the interim access policy to the Office of Management and Budget, RAPS reported. It would apply until permanent rules are in place. RAPS described the move as potential, so nothing is final.
- The six peptides are BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. An FDA advisory committee recommended in the summer adding them to the 503A compounding list, according to RAPS.
- HHS Secretary Robert F. Kennedy Jr. said on a Tuesday that the administration aims to establish ‘a state-regulated marketplace for certain unapproved peptides.’ He argued that compounding pharmacies would offer safety protections that gray- and black-market sellers do not, RAPS reported.
- Becker’s Hospital Review, citing an October 7 Washington Post report, said the FDA had been weighing seven peptides for conditions such as insomnia, obesity and wound healing. FDA scientists said there is ‘not enough evidence on their safety and effectiveness.’ The advisory panel, which was reshaped with wellness clinic physicians before its meeting, voted in July to recommend six of the seven and against emideltide, a proposed treatment for opioid withdrawal and insomnia. The FDA is not required to follow the panel’s advice.
- The safety groups ECRI and ISMP warned after the vote that ‘gaps in safety and efficacy data remain unresolved.’
- Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said his group asked the FDA for interim enforcement discretion so state-licensed pharmacies could prepare the drugs for patients with a prescription. He wants enhanced patient disclosures, serious adverse event reporting and data collection, and described that as better than illicit markets, Becker’s reported.
- The Partnership for Safe Medicines filed a citizen petition asking the FDA ‘to stop the compounding of certain peptides,’ arguing it is illegal and carries safety hazards, RAPS reported, citing Politico.
- These reports are from October 8 and October 23. I could not confirm whether HHS or the FDA has since finalized any policy.
Quotes
HHS Secretary Robert F. Kennedy Jr., as reported by RAPS, said the aim is “a state-regulated marketplace for certain unapproved peptides.”
Ilisa Bernstein, a former deputy director of the FDA’s drug compliance office, has concerns about the lack of safety data, but believes, in Becker’s paraphrase, that “broader access seems inevitable and guardrails could help identify safety problems.”
Source Read RAPS’s report here.
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