HHS lets small pharmacies produce six popular peptides

The Department of Health and Human Services issued a new policy that grants small compounding pharmacies the authority to manufacture six specific peptides.

These compounds, which have circulated in the wellness market despite lacking formal approval, will now be produced under a policy of enforcement discretion. The directive applies specifically to 503A compounding facilities. It does not extend to 503B outsourcing facilities, which operate on a larger scale. Health Secretary Robert F. Kennedy Jr. has previously stated that he uses some of these peptides himself. The agency argues that regulated compounding offers a safer alternative to the illicit online market, where products are often labeled for research use only and sourced from overseas suppliers.

The six peptides covered by the new rule are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. Proponents cite various unproven benefits, including treatment for ulcerative colitis, insomnia, wound healing, metabolic health, and migraines. These substances are chains of amino acids that are shorter than proteins. They can have strong effects on the body, but the scientific evidence regarding their safety and effectiveness remains limited. In July, an FDA advisory panel voted to support expanded access to these compounds. At the same meeting, FDA scientists recommended against lifting existing restrictions due to concerns about the available evidence.

Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, notes that customers have requested these peptides for years. His company previously avoided producing them because they were technically illegal to compound. Under the new guidelines, only his smaller facility can make the products, and only in limited quantities. Fritzler stated that Olympia will likely produce only one of the six peptides initially. He expressed skepticism that the national network of 503A pharmacies could satisfy market demand. "We won't be able to meet demand," he said.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, welcomed the decision in a statement. He described the change as a more accountable alternative for patients. Brunner noted that the policy brings these products under pharmacy standards and regulatory oversight. However, he warned that pharmacies need time to verify that their ingredient suppliers meet the new requirements before dispensing the drugs to patients.

Critics argue the policy bypasses standard safety checks. Dr. Robert Steinbrook, a health research group director at Public Citizen, wrote that the move undermines the FDA. He stated that allowing unproven peptides to be marketed without federal enforcement concerns threatens public health. Steinbrook advised clinicians to inform patients about the risks of contamination and adverse effects. Shabbir Safda, executive director of the Partnership for Safe Medicines, said the decision leaves Americans in a gray area regarding safety. His organization filed a citizen petition last week urging the FDA to disregard the July advisory committee recommendation.

The new policy takes effect immediately for eligible 503A facilities. Pharmacists must now verify that their active ingredients comply with the HHS specifications before beginning production.