HHS Temporarily Allows Compounding Pharmacies To Make Six Peptides

The Department of Health and Human Services (HHS) has announced that compounding pharmacies across the United States can temporarily make and distribute six peptides, even though these substances have not yet been formally approved by the Food and Drug Administration (FDA). According to a notice filed Wednesday (October 28), the agency will use “enforcement discretion,” meaning it will not take legal action against pharmacies compounding these peptides while a formal rule change is under consideration. This decision makes the peptides available sooner than if HHS waited for the usual rulemaking process to finish.

The six peptides covered by the new policy are BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500. These substances have been promoted as potential treatments for faster healing, younger-looking skin, and even a longer lifespan, but none of them are approved by the FDA. The FDA said that compounding pharmacies must now certify the identity and purity of these compounds and report any side effects, a requirement that was not previously in place. The FDA advisory panel had previously voted in July to recommend allowing compounding pharmacies to manufacture these peptides, though some of the committee members expressed concerns about the safety and future implications of the move.

The new HHS policy comes as a response to a growing “gray market” where peptides are sold online as “for research use only,” allowing sellers to avoid FDA regulation. Health Secretary Robert F. Kennedy Jr. has argued that changing the rules for compounding pharmacies could move people away from unregulated products and toward safer, pharmacy-made compounds. An HHS spokesperson told NBC News, “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.”

The HHS plan includes some safety measures, such as requiring pharmacies to source peptide ingredients from FDA-regulated factories, collect information on side effects, and verify the chemical identity of the compounds. These guardrails were suggested by FDA staffers and accepted by HHS as part of the compromise.

Going forward, the FDA will continue working on a formal rule change regarding compounding pharmacies and peptides. For now, pharmacies can legally make and sell the six peptides, while the agency gathers more data and public comment before issuing a final ruling.