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HHS says it will not act against compounding of six peptides, with conditions

HHS will not act against 503A compounding of BPC-157, TB-500, MOTS-c, KPV, epitalon and semax under ten conditions. None is FDA-approved.

· Policy

The Department of Health and Human Services announced on October 28, 2026 that it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding six peptides, as long as ten conditions are met. The notice was published in the Federal Register on October 30.

What changed. The policy covers BPC-157, TB-500, MOTS-c and epitalon by injection under the skin or into muscle, BPC-157 by mouth or on the skin as well, KPV by mouth or on the skin only, and semax as a nasal product only. It lasts until a final rule decides whether each peptide goes on the 503A bulks list. Each product may hold a single active ingredient, must start from a tested, registered source, and needs a prescription for a named patient. Serious side effects must be reported to FDA. This is the policy that went to White House review on October 14.

What it means. A pharmacy that follows the conditions should not expect federal action for compounding these six. HHS says one aim is to steer people away from research-use-only products from foreign suppliers, which it calls a safety risk. If you are considering one of these peptides, the practical questions are for a prescriber: what the evidence shows, whether the pharmacy meets the conditions, and what your state allows.

What has not changed. None of the six is FDA-approved, none is on the 503A bulks list, and no rule has been proposed. FDA has not reviewed any compounded version for safety, effectiveness or quality, and the evidence behind each peptide is the same as it was before. The notice says the policy creates no rights and is not binding, HHS may revisit it if a safety signal appears, and comments are open until November 13, 2026. Multi-peptide blends such as Wolverine, Glow and Klow fall outside it, because each product may contain only one active ingredient. Peptides not on the list, including CJC-1295, ipamorelin, selank and GHK-Cu, are unaffected. Products sold “for research use only” are still not legal to use on people. The FDA status tracker shows where each peptide stands.

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