US Health Secretary Kennedy pledges to forgo enforcement against pharmacies compounding drugs from six unapproved peptides despite FDA scientists’ objections

US Health Secretary Kennedy pledges to forgo enforcement against pharmacies compounding drugs from six unapproved peptides despite FDA scientists’ objections

On October 28, the US Department of Health and Human Services (HHS) released a draft policy signed by Kennedy: until a rule establishes the list of substances pharmacies may use to compound drugs, the department intends to forgo enforcement against state-licensed pharmacies and physicians compounding drugs from BPC-157, TB-500, MOTS-c, Epitalon, Semax and KPV. The draft will appear in the Federal Register on October 30, followed by a two-week comment period.

Peptides are short chains of amino acids; these six are marketed for healing, sleep and longevity. Under section 503A of federal law, a pharmacy may compound a drug on prescription for an individual patient only from a substance that is an ingredient in an approved drug, is described in a pharmacopeia (a collection of standards), or appears on an FDA list. The six peptides meet none of these criteria. According to AP, many users buy vials labeled “for research use only” online from chemical manufacturers; HHS describes the policy as a more closely controlled alternative to that market.

Adding a substance to the list requires a rulemaking process with public comment; the law firm Frier Levitt estimates that this takes 12–24 months. In July, an FDA advisory committee voted to add the six peptides to the list, but the FDA’s Center for Drug Evaluation and Research recommended against including each one. Citing six people familiar with the matter, AP reports that FDA scientists opposed the policy. Two of the sources said HHS initially wanted the FDA to draft a rule establishing the list, but agency officials warned that scientists would not support such a rule, and the department shifted to a pledge to forgo enforcement.

The pledge is subject to ten conditions. The raw material must come from an FDA-registered manufacturer, with a certificate of analysis for each batch. Pharmacies must report serious adverse events to the FDA and state authorities. Each preparation may contain a single active ingredient, with no mixtures, making it easier to link an adverse event to a particular peptide. The department may revisit the policy, for example if evidence of harm emerges.

HHS disputes the Center for Drug Evaluation and Research’s assessment: it says batch certificates of analysis address gaps in quality data and that the center’s safety concerns about TB-500 are speculative, with no observed harm. By the July meeting, the FDA had identified human studies of BPC-157 administered by enema, intravenously, into a joint and into the bladder, but none involving subcutaneous or oral administration; the policy permits both routes (oral administration requires demonstrated absorption). A trial of subcutaneous BPC-157 injections is planned at the University of Arkansas starting in January 2027. The FDA found no human administration data for TB-500, KPV or MOTS-c; for MOTS-c, HHS cites a placebo-controlled trial of an analog that reported no serious adverse events.

Former FDA official Peter Lurie told AP ahead of the midterm elections: “This is a wink to the MAHA faithful in the hope that they will turn out at the polls.” MAHA is Kennedy’s “Make America Healthy Again” movement.

According to Reuters, analysts estimate that the peptide market could be worth 2–3 billion dollars if legalized. The policy covers small pharmacies operating under section 503A, NPR reports. Joshua Fritzler of Olympia and Wesley Pharmaceuticals says the company would most likely compound one of the six peptides, in small quantities: “I don’t think all the 503A pharmacies in the country could meet that demand.”