HHS allows compounding of six unapproved peptides under interim policy

HHS said it does not intend to take enforcement action against pharmacies that compound the six while the FDA reviews the substances. The policy covers BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.

The policy applies to state-licensed pharmacies, federal facilities and physicians compounding for a patient with a prescription, Allure reported. Pharmacies must report serious adverse events to the FDA and label the products as compounded drugs not for resale, according to the report.

Conditions in the interim policy

Raw ingredients must come from FDA-registered manufacturers following good manufacturing practice, with a certificate of analysis covering identity, purity, endotoxins and contaminants such as heavy metals.

Each product may contain only one peptide, and some allow only particular forms, such as intranasal use for Semax. Sales are prescription-only.

HHS said the aim is to discourage use of research-use-only peptides from foreign manufacturers, which it called a safety risk to US patients. None of the six is FDA-approved, and the FDA does not review their safety, effectiveness or quality before they are marketed, HHS said.

FDA staff opposed the change

For the six peptides in the policy, the Center for Drug Evaluation and Research recommended against loosening restrictions, BioXconomy reported. It cited poorly characterized chemical structure, a lack of safety information and contamination risk during formulation.

HHS said a change in circumstances since the July hearing led to the policy shift. It pointed to documented historical use, multiple human studies and a lot-specific certificate from an FDA-registered facility. BioXconomy reported that none of that evidence had been provided as of publication. HHS also did not cite any recorded adverse events, saying CDER's concerns were inferential or mechanistic rather than based on observed harm.

Allure reported that the Associated Press, citing six people familiar with the policy, said FDA scientific staff had little input on the decision and opposed the changes.

The July vote behind the policy

The policy follows the Pharmacy Compounding Advisory Committee's meeting on 23 and 24 July 2026. The panel recommended six of the seven nominated peptides for the Section 503A Bulks List. BPC-157 passed 8-6 with one abstention. Epitalon passed 7-5 with one abstention and Semax 8-5; emideltide failed 6-7 with one abstention.

CSPI said in a JAMA Viewpoint that every favorable vote came from the newly appointed permanent members. It said the FDA restricted compounding of the same seven peptides in September 2023, citing significant safety risks.

Evidence gap

BPC-157 has been tested in about 30 humans, NYU Langone's Rachel Pessah-Pollack told CBS News. GLP-1 drugs were tested in hundreds of thousands of patients, she said.

CSPI argued that following the committee's advice would expose the public to unproven peptides and threaten the integrity of the advisory committee system. James LaValle, chair of the International Peptide Society, said the recommendation was not FDA approval, did not change the substances' legal status and did not authorize compounding. He said a blanket rejection would push patients toward unregulated research-chemical markets.

What happens next

The FDA said after the July vote it will consider the PCAC's recommendations, consult USP and issue a proposed rule. A public comment period would precede a final rule. The FDA ordinarily makes additions to the 503A Bulks List through notice-and-comment rulemaking. CSPI said the FDA has forwarded to the Office of Management and Budget a proposal that could allow compounding of certain peptides.