HHS Will Let Small Pharmacies Compound Six Popular Peptides Without Enforcement, Over Objections From FDA Scientists

The Department of Health and Human Services said it will exercise "enforcement discretion" for six peptides popular in wellness circles, effectively allowing small compounding pharmacies to make them even though they have not gone through FDA review, NPR reported Wednesday.

Peptides are short chains of amino acids that can have powerful effects in the body. Some occur naturally; others are synthetic. Influencers and some clinicians promote them for a range of uses, though evidence of safety and effectiveness is sparse. The six have been sold on a gray market as "research-use-only" chemicals, often from overseas suppliers. The new policy says compounding is a safer alternative.

Health Secretary Robert F. Kennedy Jr. has supported broader access and has said he has used some peptides himself. In July, an FDA advisory panel voted in favor of expanded compounding access to the six, but at the same meeting the FDA's own scientists recommended against loosening the restrictions, NPR reported.

The policy does not change the peptides' legal status. It applies to 503A compounding pharmacies, which make medicines for individual patients, not to 503B outsourcing facilities that produce larger volumes. Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in Florida, said only his company's smaller facility will qualify and that it will likely compound just one of the six at first. "We won't be able to meet demand," he said. "I don't think all the [503]As in the country could meet the demand."

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, called the policy a "more accountable alternative" that "brings patients into a system where pharmacy standards, regulatory oversight, and serious adverse event reporting apply." He said it may take time before pharmacies can dispense the products, because ingredient suppliers and pharmacies must verify the active ingredients meet the policy's requirements.

Consumer advocates objected. Dr. Robert Steinbrook of Public Citizen said Kennedy acted unilaterally rather than through rulemaking. "By allowing unproven and potentially unsafe peptides to be manufactured, marketed and prescribed without concern about potential federal enforcement actions, Kennedy has undermined the FDA and threatened public health," he said. The Partnership for Safe Medicines, which filed a citizen petition last week urging the FDA to reject its advisers' recommendation, said the decision "leaves Americans in a grey area."

Still unclear: when the first compounded products will reach patients, and how HHS will track adverse events tied to them.