HHS Lets Compounding Pharmacies Make Six Unapproved Peptides While Formal Rule Change Proceeds

The Department of Health and Human Services is allowing compounding pharmacies to begin making six peptides right away, even as the agency works on a formal change to the rules that govern what those pharmacies can produce.

In a notice filed Wednesday, the agency said it would use "enforcement discretion," which means it will not pursue legal action against pharmacies that make the unapproved products. The peptides are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. None of them is yet on the Food and Drug Administration's list of ingredients that compounding pharmacies may use.

The peptides have been promoted online for a wide range of supposed benefits, including faster healing, younger-looking skin and a longer lifespan. The FDA has not approved any of them, and the agency's own scientists concluded there is not enough data to show they are safe and effective.

The FDA said pharmacies must certify the identity and purity of the compounds. They must also now report side effects, something that was not previously required.

The step comes amid a growing "gray market" for peptides, in which sellers label products "for research use only" as a legal workaround that lets them say the items are not intended for human use. Health Secretary Robert F. Kennedy Jr. and others have argued that allowing compounding would steer people away from that market and toward safer products. HHS spokesperson Emily Hilliard said in a statement that the department is working to put prevention and patient safety at the center of health care, "and that includes confronting the risks of black-market peptides."

Compounding pharmacies generally can use only ingredients the FDA has placed on its bulk drug substances list. Adding one requires the agency to propose a rule, take public comment and issue a final rule, a process that can take several months.

The FDA moved toward that process in July, when an advisory panel narrowly voted to recommend adding the six peptides to the list. The panel included six new appointees with ties to the peptide industry, along with another member who is the son of a U.S. representative who has urged Kennedy to widen access to peptides. During that meeting, some members worried the recommendation could make it harder for the FDA to refuse other unapproved drugs in the future.

Critics were sharply negative about the latest move. Dr. Peter Lurie, a former FDA official who now leads the watchdog group Center for Science in the Public Interest, said the agency was essentially "turning a blind eye" to expand access to drugs not proven to work.

Shabbir Safdar, executive director of the Partnership for Safe Medicines, which researches the dangers of counterfeit medicines, said both the enforcement discretion and the coming rule change would expose Americans to "untested dangerous substances." He added: "Imagine what it means for the nation's top drug regulator to announce they won't enforce the laws on people making completely untested compounds and distributing them to the public."

According to Reginfo.gov, a federal site that tracks regulations, the FDA was scheduled to meet on Tuesday and Wednesday with outside groups, including Medivant Healthcare, a compounding pharmacy that offers peptides.