The American Medical Association has adopted a policy urging the Department of Health and Human Services, the FDA and related federal authorities to immediately rescind administrative policies that ease compounding and distribution of synthetic peptides lacking FDA approval, announced Nov. 9 at the group's interim meeting in Orlando. The AMA also said it plans to work with federal agencies, state medical boards and pharmacy boards to pursue enforcement against compounding pharmacies, direct-to-consumer telehealth platforms and online sellers.

The policy at issue is an HHS interim measure issued Oct. 28 that allows pharmacies to compound six unapproved peptides: BPC-157, TB-500, KPV, MOTS-c, semax and epitalon. Public comments close Nov. 13 under docket HHS-OASH-2026-0496, according to Holland & Knight, which means organized medicine put itself on record with days to spare.

What HHS actually allowed

HHS says the policy gives patients a more controlled alternative to "research use only" peptides made by foreign suppliers. Pharmacies must source ingredients from FDA-registered manufacturers following good manufacturing practices, obtain a certificate of analysis, use a single peptide per product and report serious side effects to the FDA.

Crucially, the policy does not approve anything. The peptides remain unapproved, HHS can revoke the measure, and products sold online as "not for human use" fall outside it entirely.

The evidence gap

Dr. Ilse Levin, an AMA board member, said that by allowing pharmacies to compound unapproved synthetic peptides, "patients are at increased risk of serious harm," noting the substances have not undergone the testing required of approved drugs. FDA briefing materials reached a similar conclusion, finding the available research, including five studies of BPC-157, short, small and insufficient to establish safety or effectiveness.

The FDA's own 2023 restriction on BPC-157 cited possible immune reactions, impurity concerns and very limited safety information. The advisory committee that preceded the current policy voted 8-6 with one abstention to back BPC-157, KPV and TB-500, against the advice of FDA career scientists, AJMC reported.

Who else is objecting

Public Citizen's Health Research Group criticized the advisory panel vote, and patient safety organizations ECRI and the Institute for Safe Medication Practices have warned against relaxing peptide restrictions. The New York Times reported that Health Secretary Robert F. Kennedy Jr.'s office named eight new panel members ahead of the July meeting, six of whom had sold peptide products; HHS says all passed the standard ethics review.

An AMA policy carries no legal force, and Becker's Hospital Review noted the release did not name the HHS policy directly. The leverage is indirect: state pharmacy boards, not the FDA, oversee traditional compounding pharmacies.

Use is climbing regardless

The FDA's adverse event system has logged 10 serious reports tied to BPC-157 since 2021, eight of them in 2026, AJMC reported, though such reports do not establish that the peptide caused the problem. A preprint analysis of clinical notes from one database found newly documented BPC-157 users rose about 33-fold from early 2020 to early 2026.

Bottom line

After comments close Nov. 13, HHS can keep, revise or withdraw the interim policy. What the AMA vote changes is the pressure downstream, where state regulators decide whether a licensed pharmacy in their jurisdiction fills the prescription at all.