HHS grants temporary enforcement discretion for six unapproved peptides

The U.S. Department of Health and Human Services announced Wednesday that it will exercise enforcement discretion for compounding pharmacies that prepare six peptides—BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. The policy allows pharmacies to compound these substances without immediate legal action, even though the FDA has not approved them for human use.

Under the new guidance, pharmacies must certify the identity and purity of each peptide and report any adverse effects, requirements that were not previously mandatory. The move aims to shift sales from the “gray market,” where peptides are often labeled “for research use only,” toward products that meet the agency’s reporting standards.

"Under President Trump’s leadership, HHS is working to put prevention and patient safety at the center of health care—and that includes confronting the risks of black-market peptides," said Emily Hilliard, an HHS spokesperson.

Critics argue the policy could expose patients to untested compounds. Dr. Peter Lurie, a former FDA official now leading the Center for Science in the Public Interest, described the approach as the agency “turning a blind eye” to drugs lacking proven safety and efficacy. Shabbir Safdar, executive director of the Partnership for Safe Medicines, warned that the discretion could allow distribution of “untested dangerous substances.”

The FDA is concurrently working on a formal rule change that would add the six peptides to the bulk drug substances list, a process that typically involves a proposal, public comment and final rule issuance. An advisory panel voted narrowly in July to recommend the addition, though some members expressed concern about future regulatory flexibility.

The agency scheduled meetings with industry groups, including Medivant Healthcare, a compounding pharmacy that offers peptides, as part of the rulemaking process.