HHS grants enforcement discretion for six specific peptides

The Department of Health and Human Services announced on Tuesday that it will exercise enforcement discretion for six specific peptides, effectively permitting small compounding pharmacies to manufacture them. The policy targets 503A compounding facilities, which operate on a smaller scale than the 503B outsourcing facilities that produce high volumes of medicine. Larger 503B facilities remain subject to the existing restrictions.

Health Secretary Robert F. Kennedy Jr. has previously stated that he has used peptides himself and is a vocal supporter of the compounds. The new guidance allows small pharmacies to prepare these substances even though they have not undergone the rigorous drug review and approval process required by the Food and Drug Administration. The administration argues that regulated compounding is a safer alternative to the illicit "research-use-only" peptides often sold by overseas suppliers.

The six peptides covered by the policy include BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. Proponents have marketed these amino acid strings for various conditions, including ulcerative colitis, insomnia, wound healing, metabolic health, and migraines. While some peptides occur naturally, the versions discussed in the policy are often synthetic variations. Evidence for their safety and effectiveness in these specific uses remains sparse.

The decision follows a July meeting where an FDA advisory panel voted in favor of expanded access to these peptides through compounding pharmacies. At the same meeting, however, FDA scientists recommended against unwinding the current restrictions. Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, noted that his company had not produced the peptides for years because they were illegal to compound. Under the new rules, only his smaller facility will be eligible to make them, and only in limited quantities.

Fritzler expressed concern that the supply will not match the consumer interest. He stated that his company will likely compound only one of the six peptides initially and needs to prepare its facility. He added that he does not believe all 503A pharmacies in the country could meet the total demand.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said his group is pleased with the decision. In a statement, Brunner described the move as offering a more accountable alternative for patients currently seeking gray market peptides. He noted that the policy brings patients into a system where pharmacy standards and regulatory oversight apply, including serious adverse event reporting. Brunner warned that it may take time for pharmacies to begin dispensing these products while ingredient suppliers verify that their active ingredients meet the policy requirements.

Consumer advocacy groups have raised concerns about the speed and method of the policy change. Public Citizen, a nonprofit organization, stated that Secretary Kennedy appears to have acted unilaterally rather than following the typical rulemaking process. Dr. Robert Steinbrook, Health Research Group Director at Public Citizen, wrote that the move undermines the FDA and threatens public health by allowing unproven substances to be manufactured without concern for federal enforcement actions. Steinbrook advised clinicians to inform patients of the risks of contamination and other adverse effects.

The Partnership for Safe Medicines, which includes various pharmacy and pharmacist organizations, filed a citizen petition with the FDA last week. The petition urges the agency to ignore the advisory committee's July recommendation. Shabbir Safda, the group's executive director, wrote in a statement that the decision leaves Americans in a grey area regarding safety. He highlighted that FDA scientists recommended against the substances due to concerns with the available evidence.