HHS Allows Immediate Production of Six Unapproved Peptides

Six peptides are now legally safe for compounding pharmacies to manufacture, according to a notice filed by the Department of Health and Human Services on Wednesday. The agency stated it will exercise enforcement discretion, meaning it will not pursue legal action against facilities producing these specific compounds. The peptides involved are BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500. None of these ingredients currently appear on the Food and Drug Administration's list of bulk drug substances permitted for use in compounding.

The move allows pharmacies to begin production immediately while HHS works toward a formal regulatory change. Under standard procedures, adding a new ingredient requires the FDA to propose a rule, solicit public comment, and issue a final rule, a process that often takes several months. By using enforcement discretion, the department is effectively bypassing this timeline for these six products.

The peptides have gained popularity through online marketing, with sellers promoting potential benefits such as faster healing, improved skin appearance, and increased longevity. However, the FDA has not approved any of the six compounds. Agency scientists have concluded that there is insufficient data to demonstrate that these substances are safe or effective for their intended uses.

New requirements accompany this permission. Pharmacies must now certify the identity and purity of the compounds. They are also required to report side effects, a step that was not previously mandatory for these products. HHS spokesperson Emily Hilliard said the department aims to center patient safety in health care, noting that the move includes "confronting the risks of black-market peptides."

Proponents, including Health Secretary Robert F. Kennedy Jr., argue that formalizing access through compounding will steer consumers away from a growing gray market. In that market, sellers often label products "for research use only" to avoid regulations regarding human consumption. Critics question whether this approach adequately protects patients.

Dr. Peter Lurie, former FDA official and head of the Center for Science in the Public Interest, described the agency's action as "turning a blind eye" to expand access to unproven drugs. Shabbir Safdar, executive director of the Partnership for Safe Medicines, warned that the move exposes Americans to "untested dangerous substances." He noted that the nation's top drug regulator is announcing it will not enforce laws on those making completely untested compounds.

The FDA had already moved toward formal approval in July when an advisory panel narrowly voted to recommend adding these peptides to the bulk drug list. That panel included six new appointees with ties to the peptide industry. One other member is the son of a U.S. representative who has urged Kennedy to widen access to these compounds. Some panel members expressed concern that the recommendation could complicate future FDA decisions on other unapproved drugs. According to Reginfo.gov, the FDA is scheduled to meet with outside groups, including Medivant Healthcare, a compounding pharmacy that offers peptides.