HHS Draft Policy Would Allow Compounding Pharmacies to Mix Six Popular Peptides

Six injectable peptides used by wellness influencers and athletes will soon be available through licensed compounding pharmacies under a new draft policy from the US Department of Health and Human Services. The rule, posted Wednesday, targets the unregulated market where consumers currently buy substances like BPC-157 and TB-500 without medical oversight. HHS stated the policy is designed to replace foreign, research-use-only products with domestic versions that meet specific safety standards.

The push for this change began in July when the FDA’s Pharmacy Compounding Advisory Committee voted to support the compounding of these specific compounds. The six substances include 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. These drugs have not received full FDA approval, meaning the agency has not evaluated them for safety, quality, or effectiveness through the standard pathway.

Previously, patients often sourced these peptides from unregulated websites without consulting a physician. Under the draft interim policy, a doctor must write a prescription for a patient to receive the medication from a licensed compounding pharmacy. The policy asserts that HHS will not take enforcement action against state-licensed pharmacies or physicians who compound these specific drugs, even though the ingredients are not officially on the list of substances compounders can prepare.

HHS spokesperson Emily Hilliard said in an email that the policy requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting. "The policy does not grant FDA approval or establish clinical safety and effectiveness," Hilliard said. "It requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers."

Supporters argue this route is safer than the current status quo. Dr. Hal Mohammed, a committee member and global chief medical officer of Gameday Men’s Health, stated that the gray market pipeline is the primary risk. "Myself as a physician, I have to make sure that I’m keeping patients as safe as possible. That’s my mandate: Do no harm," he said. Jeff Cohen, co-founder of the American Peptide Association, called the move a bold step that provides clarity the industry has sought for years.

Critics, however, warn that the move lacks a strong scientific foundation. Dr. Elizabeth Rebello of the University of Texas MD Anderson Cancer Center expressed concern that the decision responds to market demand rather than solid science. Shabbir Imber Safdar, executive director of Partnership for Safe Medicines, noted that the FDA’s own scientists had recommended against voting in favor of these substances due to evidence gaps. Last week, his coalition filed a citizen petition urging the FDA to block the compounding of peptides.

For consumers already using these drugs, the shift could mean higher prices. Jay Campbell, co-founder of BioLongevity Labs, said that while the policy is good news for prescription users, it may hurt those buying from direct-to-consumer marketplaces. "As demand rises, these peptides could get substantially more expensive, especially if access at the direct-to-consumer level is restricted or cut off," Campbell wrote in an email. He added that pharmacies will pass costs for FDA-registered manufacturers and quality testing directly to patients.

The draft policy opens a 14-day comment period, after which HHS is expected to issue a final rule. The Alliance for Pharmacy Compounding welcomed the move, noting it includes safeguards like extensive testing and adverse event reporting. CEO Scott Brunner said the alliance would seek clarification on how the federal policy will coordinate with state boards of pharmacy and when it takes effect. "A credible federal policy with meaningful patient-safety safeguards gives states a sound basis for their own oversight," Brunner said.