HHS allows pharmacies to compound six peptides

The Department of Health and Human Services issued a new policy on Tuesday allowing small compounding pharmacies to produce six specific peptides.

The agency stated it will use enforcement discretion for these compounds, effectively permitting their manufacture without full Food and Drug Administration approval.

Health Secretary Robert F. Kennedy Jr., a vocal proponent of the compounds, announced the move.

Peptides are short chains of amino acids that can have strong effects on the body.

While some occur naturally, the six covered by this policy are often synthetic and have gained popularity among wellness influencers.

Until now, these specific compounds existed in a gray market, sold online as research-use-only products despite an official ban.

The policy targets small 503A compounding pharmacies.

It does not apply to larger 503B outsourcing facilities that produce higher volumes of medicine.

This distinction limits supply, as only smaller operations can legally create the products under the new rules.

Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, said his company had not made the peptides previously because they were illegal to compound.

Under the new guidance, only his smaller facility can produce them, and only in limited quantities.

Fritzler said the company likely will compound just one of the six peptides initially and must first prepare its facility for the process. "We won't be able to meet demand," he said. He added that he does not believe all 503A facilities in the country could satisfy consumer demand. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, welcomed the decision. He said the move provides a more accountable alternative for patients seeking these compounds. Brunner noted that the policy places patients within a system where pharmacy standards and adverse event reporting apply. However, he warned that pharmacies need time to begin dispensing the products. Ingredient suppliers must first ensure their active materials meet policy requirements, and pharmacies must verify those ingredients. In July, an FDA advisory panel voted to expand access to these six peptides through compounding pharmacies. At the same meeting, FDA scientists recommended against lifting existing restrictions on the substances. Consumer advocacy groups have criticized the new approach. Public Citizen, a nonprofit, said Kennedy acted unilaterally rather than following the standard rulemaking process. Robert Steinbrook, a health research director at Public Citizen, wrote that the move undermines the FDA and threatens public health. Steinbrook stated that all peptide substances should go through the standard FDA approval process for new drugs. He advised clinicians to inform patients about the risks of contamination and other adverse effects. The Partnership for Safe Medicines filed a citizen petition last week urging the FDA to ignore the July advisory committee recommendation. Shabbir Safda, the group's executive director, said the decision leaves Americans in a gray area regarding the safety of these peptides. Safda noted that FDA scientists had recommended against allowing the substances due to concerns about the evidence. The six peptides covered by the policy are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. Proponents have promoted them for uses including ulcerative colitis, insomnia, wound healing, metabolic health, and migraines.