HHS Eases Rules on Six Peptides
The move allows small compounding pharmacies to produce unapproved wellness substances that were previously restricted by the FDA.
By Amina Howard ·
The Department of Health and Human Services announced on Tuesday a new policy that grants enforcement discretion for six peptides, effectively allowing small compounding pharmacies to manufacture these unapproved substances. The peptides have long been sought for wellness purposes but lacked formal FDA approval, leaving them in a legal gray market.
Peptides are short chains of amino acids that can influence bodily functions. While some occur naturally, the six targeted by the new rule are synthetic variations often promoted by influencers and clinicians for conditions ranging from insomnia to metabolic health. The specific compounds and their marketed uses include BPC-157 for ulcerative colitis, Epitalon for insomnia, KPV for wound healing, MOTS-c for metabolic health, Semax for migraine, and TB-500 for wound healing.
The policy shift follows a July meeting where an FDA advisory panel voted to expand access to these peptides through compounding pharmacies. That vote occurred despite recommendations from FDA scientists who advised against unwinding existing restrictions due to sparse evidence regarding safety and effectiveness. HHS argues that compounding offers a safer alternative to illicit research-use-only peptides, which are frequently sourced from overseas suppliers.
The new rule applies only to 503A compounding pharmacies, which are smaller facilities, and does not cover 503B outsourcing facilities that produce higher volumes. Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, noted that his company had previously avoided making the peptides due to their illegal status. Under the new policy, his smaller facility can produce them, but only in limited quantities. He stated that he does not believe all 503A pharmacies in the country could meet current consumer demand.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said the decision provides a more accountable alternative for patients. He emphasized that the policy brings these products under pharmacy standards and regulatory oversight, including adverse event reporting. However, he warned that it may take time for pharmacies to begin dispensing the products because ingredient suppliers must verify that active ingredients meet the policy's requirements.
Critics argue the policy bypasses standard procedures. Dr. Robert Steinbrook of Public Citizen said Health Secretary Robert F. Kennedy Jr. acted unilaterally, undermining the FDA. Steinbrook advised clinicians to inform patients about the risks of contamination and adverse effects, noting that all peptide substances should ideally go through the standard FDA approval process. Shabbir Safda of the Partnership for Safe Medicines wrote that the decision leaves Americans in a gray area regarding safety, especially since FDA scientists had previously voted against the substances due to evidence concerns.
