The Trump administration is preparing a stopgap that would allow certain previously restricted peptides to be sold temporarily while federal health officials write new regulations, according to an Oct. 7 Washington Post report citing two people familiar with the matter.
The move would let some compounding pharmacies dispense peptides marketed as medical treatments and wellness products, even though the claims for what they treat have not been fully safety tested. The plan has not been announced, and the Post reported that its timing is unclear, it could still change and it is not known which peptides would be included. The sources said federal officials are seeking guardrails around the policy, and HHS did not comment.
The FDA has been weighing whether to let compounding pharmacies produce seven peptides for conditions such as insomnia, obesity and wound healing. FDA scientists said there is not enough evidence on their safety and effectiveness, but the agency’s Pharmacy Compounding Advisory Committee, which was reshaped with wellness clinic physicians before the meeting, voted in July to recommend six of the seven. It voted against emideltide, a proposed treatment for opioid withdrawal and insomnia.
The FDA is not required to follow the panel’s advice, and the Post said it is not clear when formal rulemaking will be released. 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, told the Post his group has asked the FDA for interim enforcement discretion, which would let state-licensed compounding pharmacies prepare the drugs for patients with a prescription. He said the group wants conditions that include enhanced patient disclosures, serious adverse event reporting and data collection on peptide use and called it a better approach than illicit markets.
Ilisa Bernstein, a former deputy director of the FDA’s drug compliance office, told the Post she has concerns about the lack of safety data but that broader access seems inevitable and guardrails could help identify safety problems.
The proposal comes as the FDA has moved in the opposite direction on compounded GLP-1s, which are also peptides. In April, the agency proposed excluding semaglutide, tirzepatide and liraglutide from the bulks list for outsourcing facilities as part of a monthslong crackdown.
