Reports differ on its status. Most describe it as an interim enforcement discretion policy that HHS has already issued. CNN calls it a draft posted for a 14-day comment period, with a final rule expected afterward. The notice was scheduled for formal publication in the Federal Register on Friday, with comments accepted for two weeks after that. HHS says it can revise or withdraw the policy if safety signals or product-quality concerns emerge. HHS spokesperson Emily Hilliard told CNN that the policy is not FDA approval and does not establish that the peptides are safe or effective.

The conditions are specific. The bulk substance must come from an FDA-registered establishment that follows Current Good Manufacturing Practice and supplies a valid certificate of analysis. The drug must be compounded under a patient-specific prescription and contain a single active ingredient. Labels must read "This is a compounded drug product. Not for resale." Serious adverse events and quality problems must be reported to the FDA's MedWatch program and to state authorities. Routes are limited by peptide: BPC-157 may be given by injection, orally or topically, Semax only intranasally, and KPV only in topical and oral forms. TB-500, Epitalon and MOTS-c are limited to subcutaneous or intramuscular injection. Oral products need documentation of adequate bioavailability in humans, and the only co-packaged device allowed is an FDA-cleared syringe. The policy does not cover outsourcing facilities under Section 503B, or products sold as research chemicals or dietary supplements.

HHS presents the policy as a "controlled alternative" to a gray market of foreign-supplied or "research use only" peptides, and says it supports "patient choice and freedom." Reason reports that the department wants to steer buyers away from sellers on platforms such as AliExpress. CNN says the peptides are popular with wellness influencers and athletes for purported benefits such as less inflammation and faster recovery, and are now sold without FDA approval. Scott Brunner, chief executive of the Alliance for Pharmacy Compounding, said the policy aims to move buyers away from gray-market sellers. The American Peptide Association also backs it. Dr. Bob Baravarian, a foot and ankle surgeon who owns Alpha Bioscience Labs, called it "a great step in the right direction" because it allows U.S.-made peptides with certification, testing and purity verification. Jay Campbell of BioLongevity Labs said it offers a regulated path but may raise prices for people who now buy directly.

Critics point to the evidence. Medical Daily reports that FDA career scientists found it insufficient: the five clinical studies of BPC-157 were short and small, and there were no human safety studies for KPV, TB-500, MOTS-c or Epitalon. The advertised benefits, including tissue repair, healthier skin and longevity, remain scientifically unproven, according to IBTimes, which adds that federal reviewers have previously raised concerns about impurities, unwanted immune responses and gaps in human safety data. Shabbir Imber Safdar of the Partnership for Safe Medicines said the evidence for effectiveness and safety is lacking and alleged conflicts of interest among advisory committee members.

The policy follows a July meeting of the FDA's Pharmacy Compounding Advisory Committee, which recommended placing the substances on the 503A bulks list. Reason says the committee considered seven substances and voted to list six. The vote is non-binding, and the FDA has issued no final decision. The Alliance for Safe Biologic Medicines alleges that eight panelists added by Kennedy formed the entire affirmative bloc in votes that Medical Daily reports as 8-6. BPC-157 and TB-500 remain banned by the World Anti-Doping Agency, and the policy is not expected to be covered by insurance.