HHS lets compounding pharmacies make six unapproved peptides

In a notice filed Wednesday, the Department of Health and Human Services said compounding pharmacies may make six unapproved peptide drugs under enforcement discretion while the agency continues work on a formal rule. The notice covers TB-500, BPC-157, epitalon, semax, MOTS-c and KPV, none of which is FDA approved or on the bulk drug substances list that normally limits compounding. Reuters reported on Oct. 15 that the FDA had submitted to the White House for review a temporary policy that would allow compounding with certain peptides.

Under the policy, the FDA will not take legal action against qualifying pharmacies for a period. Buchanan Ingersoll & Rooney, a law firm, said conditions could require pharmacies to hold state licenses, receive valid prescriptions and report adverse events. The notice also requires pharmacies to certify the identity and purity of each peptide and to file side effect reports, a requirement that did not exist before.

HHS pressed ahead despite objections from most FDA scientific staff members, six people familiar with the development told The Associated Press. Most FDA scientific staff members opposed the plan and had only limited input in drafting it, the people said. The department first sought a formal FDA regulation that would list BPC-157 and other peptides as safe for compounding, two of the people said. After FDA officials warned that scientific staff had major safety concerns and would refuse to support a regulation declaring the peptides safe, HHS took the enforcement discretion route aimed at specialty pharmacies selling substances that lack FDA clearance and would ordinarily be treated as illegal drugs because they have not completed the agency's safety and effectiveness review.

The FDA has already described BPC-157, one of the six substances, as posing possible immunogenicity risks and peptide-related impurities, with no or only limited safety information for the ways people use it. An FDA advisory committee gave narrow support in July to adding six peptides to the bulk drug substances list, but the vote was nonbinding and formal rulemaking could take years. NBC News reported that the advisory panel included six recently appointed members with peptide-industry ties and a member whose father, a member of Congress, had urged Kennedy to expand peptide access.

Kennedy has described himself as a 'big fan' of peptides and has said he used BPC-157 to treat a muscle injury. International sports bodies classify both BPC-157 and TB-500 as doping agents. Supporters including Kennedy say permitting pharmacies to compound these products could shift purchases away from unregulated sellers that offer peptides labeled 'for research use only,' and toward a more controlled supply chain.

In August, the agency issued warning letters to four internet-based peptide sellers and classified their products as unapproved new drugs regardless of 'research use only' disclaimers, according to the law firm Sheppard. HHS spokesperson Emily Hilliard said in a statement that the department is prioritizing prevention and patient safety while addressing risks from black-market peptides.

Critics said the policy does not confer proof of safety or effectiveness. Peter Lurie, a former FDA official who runs the consumer advocacy group Center for Science in the Public Interest, said the agency was essentially 'turning a blind eye' by widening access to drugs with no demonstrated benefit. Shabbir Safdar, who leads the Partnership for Safe Medicines, said both the interim non-enforcement stance and a future rule change would put Americans in contact with 'untested dangerous substances'. He said the FDA's announcement amounts to saying it will not enforce rules against makers of unproven compounds. Shawn Hamilton, a board-certified internist, told Blavity Health that enforcement discretion does not mean a product has been studied or that consistent dosing is established for these substances. Reuters reported that Hims & Hers has already said it plans to offer peptides if regulations allow.

Update, October 28, 2026

The Partnership for Safe Medicines said on Oct. 28 that it had formally petitioned the FDA to set aside the advisory committee vote and refuse to allow compounding of the six unapproved peptides. In a statement, the group argued that the evidence is too weak to support the products' safety, that several newly appointed Pharmacy Compounding Advisory Committee members appeared to have conflicts of interest tied to those peptides, and that the committee's composition violated federal conflict-of-interest rules. The petition contends the committee was assembled in a way that breached the Federal Advisory Committee Act and the Ethics in Government Act. Executive Director Shabbir Imber Safdar said the administration should reverse course and instead prosecute "the bad actors who have been illegally producing and distributing dangerous products to the public".

Update, November 2, 2026

DataMEDS AI said on Monday that its subsidiary Corexa Health has entered a commercial supply agreement for bulk drug substance and active pharmaceutical ingredients for the six peptides named in the HHS enforcement discretion policy, and that Corexa Pharmacy intends to begin dispensing compounded peptide prescriptions in November. The company said it plans to use its Health Lives Here mobile app to collect and report safety data under the policy. DataMEDS noted that the peptide products are compounded and have not received FDA approval or undergone FDA safety and efficacy review.