Health Department Proposes Easier Rules for Six Wellness Peptides
A new draft policy would require prescriptions for six unapproved peptides, moving them from online marketplaces to licensed compounding pharmacies.
By James Brooks ·
The U.S. Department of Health and Human Services released a draft policy on Wednesday that would allow licensed pharmacies to compound six specific peptides for individual patients.
The move creates a legal pathway for compounds like BPC-157 and TB-500, which are currently popular among wellness influencers and athletes but lack formal Food and Drug Administration approval.
HHS Secretary Robert F. Kennedy Jr. acted on a recommendation from the FDA’s Pharmacy Compounding Advisory Committee, which voted in July to support the easing of restrictions on these substances.
The six peptides covered by the draft are BPC-157 for ulcerative colitis, KPV for wound healing, TB-500 for wound healing, MOTS-c for obesity and osteoporosis, Semax for neurological disorders, and Epitalon for insomnia.
Under the current system, many consumers purchase these injectables from unregulated websites without seeing a doctor. The new interim policy would require a physician’s prescription and mandate that the drug be prepared by a licensed compounding pharmacy or physician.
HHS spokesperson Emily Hilliard stated that the policy does not grant FDA approval or establish clinical safety and effectiveness. It instead requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable.
The department has a 14-day comment period for the draft policy. After this period, HHS is expected to issue a final policy that will determine enforcement discretion for these substances.
The FDA does not review compounded drugs for safety, effectiveness, or quality before they are marketed. HHS argues that the new rules provide a more controlled alternative to the unregulated gray market where foreign manufacturers currently supply many of these products.
Supporters of the policy argue it brings necessary clarity to the market. Jeff Cohen, co-founder of the American Peptide Association, called the move a bold step outside the usual pharmaceutical pathway.
Critics, however, question the scientific basis for the decision. Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, noted that the FDA’s own scientists recommended against voting in favor of these substances due to concerns with evidence.
Safdar filed a citizen petition last week urging the FDA to block the compounding of peptides. He said the administration’s decision overlooks potential conflicts of interest among committee members and places their interests above patient safety.
Dr. Hal Mohammed, a committee member who voted in favor, said the gray market pipeline poses a greater risk than regulated pharmacy compounding. He stated that his mandate as a physician is to keep patients as safe as possible by avoiding harm from unregulated sources.
