HHS allows pharmacies to compound six unapproved peptides

The Department of Health and Human Services is allowing compounding pharmacies to make six unapproved peptides while it works on a formal rule change, giving patients another way to obtain products promoted for healing and other benefits despite unresolved safety questions.

In a notice posted Wednesday, HHS said it would exercise “enforcement discretion,” meaning it will not take legal action against pharmacies that compound the substances. The six are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. None has been approved by the Food and Drug Administration, whose scientists have found insufficient evidence to establish their safety and effectiveness.

The policy includes conditions. Pharmacies must certify the identity and purity of the compounds and report side effects, according to NBC News. The Guardian reported that pharmacies must also obtain peptide ingredients from FDA-registered factories.

Most FDA scientific staff members opposed HHS’s approach and had limited input in developing it, The Guardian reported, citing six people familiar with the process who spoke to the Associated Press on condition of anonymity. Two of those people said HHS had initially sought a regulation adding peptides to a list of substances compounding pharmacies could use. FDA officials warned that scientific staff had major safety concerns and would not support a regulation deeming the substances safe. FDA staff ultimately provided technical assistance on the plan, including safety measures, The Guardian reported.

Compounding pharmacies generally may use only ingredients on the FDA’s bulk drug substances list. Adding one requires a proposed rule, public comment and a final rule, a process that can take months. An FDA advisory panel narrowly voted in July in favor of adding six peptides to the list, NBC News reported. The Guardian reported that FDA staff reiterated at a July meeting that more than half a dozen peptides brought forward for reconsideration remained unproven in terms of safety and effectiveness.

According to NBC News, the panel included six new appointees with ties to the peptide industry and another member who is the son of a U.S. representative who had pushed Health Secretary Robert F. Kennedy Jr. to make peptides more available.

Kennedy, who has called himself a “big fan” of peptides and said he used BPC-157 for a muscle injury, argues that pharmacy access could draw Americans away from a gray market. Online sellers offer peptides labeled “for research use only,” while promoting them for uses ranging from faster healing to a longer lifespan.

“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,” HHS spokesperson Emily Hilliard told NBC News.

Critics say the policy widens access to unproven products. Dr. Peter Lurie, a former FDA official who leads the Center for Science in the Public Interest, told NBC News the agency was essentially “turning a blind eye.” Shabbir Safdar, executive director of the Partnership for Safe Medicines, said the decision would expose Americans to “untested dangerous substances.”

In 2023, the FDA placed more than a dozen peptides, including BPC-157 and TB-500, on a list of substances that should not be compounded because of risks including allergic reactions, kidney damage and tumor growth, The Guardian reported.