HHS Eases Rules on Six Popular Peptides

Small pharmacies across the country are preparing to mix compounds that were effectively banned for years.

The Department of Health and Human Services announced a new policy on Tuesday that grants enforcement discretion for six specific peptides. This move allows 503A compounding pharmacies to produce these substances despite their lack of formal FDA approval. The peptides include BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500.

Health Secretary Robert F. Kennedy Jr., a vocal supporter of these treatments, has stated that he has used some of them personally. The administration argues that compounding by licensed pharmacies is safer than the current gray market, where consumers often buy unverified products from overseas suppliers labeled for research use only. The policy specifically targets smaller 503A facilities and does not apply to larger 503B outsourcing facilities that produce high volumes of medicine.

The regulatory shift follows a July vote by an FDA advisory panel. That panel voted in favor of expanded access to the six peptides through compounding pharmacies. However, FDA scientists at the same meeting recommended against removing existing restrictions due to sparse evidence regarding safety and effectiveness.

Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, said his company has received years of requests for these compounds but avoided making them due to legal constraints. Under the new rules, only his smaller facility can produce them, and likely in limited quantities. "We won't be able to meet demand," Fritzler said. He noted that Olympia will likely compound only one of the six peptides and must first update its facility. He predicted that the collective capacity of all 503A pharmacies in the country would be insufficient to satisfy consumer interest.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, welcomed the decision in a statement. He described the move as a more accountable alternative for patients and emphasized that it brings these products under pharmacy standards and adverse event reporting. He cautioned, however, that pharmacies may take time to begin dispensing the drugs because suppliers must verify that active ingredients meet the new policy requirements.

Consumer advocacy groups raised concerns about the decision. Dr. Robert Steinbrook, Health Research Group Director at Public Citizen, wrote that the policy undermines the FDA by allowing unproven substances to be manufactured without concern for federal enforcement. He advised clinicians to inform patients about contamination risks. Shabbir Safda, executive director of the Partnership for Safe Medicines, filed a citizen petition last week urging the FDA to ignore the advisory committee's recommendation. He wrote that the decision leaves Americans in a gray area regarding safety, particularly since FDA scientists had voiced concerns about the evidence.