HHS Issues Interim Enforcement-Discretion Policy for Six Peptide Compounding Substances, Including BPC-157; Notice Publishes Oct. 30
The U.S. Department of Health and Human Services (HHS) on Oct. 28 filed an enforcement-discretion policy with the Federal Register for publication on Oct. 30 (Docket No. HHS-OASH-2026-0496), signed by Secretary Robert F. Kennedy, Jr. The policy states that, while the Food and Drug Administration's list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act is developed through rulemaking, HHS does not intend to take enforcement action against a state-licensed pharmacy, a federal facility, or a licensed physician compounding a drug product using a peptide bulk drug substance listed in the policy's appendix.
The policy covers six peptides. According to the policy appendix, as summarized by several specialist outlets, the six and their permitted routes are BPC-157 (subcutaneous, intramuscular, oral and topical forms), TB-500 (subcutaneous or intramuscular injection), epitalon (subcutaneous or intramuscular injection, dispensed in intermittent courses), semax (intranasal use), KPV (topical and oral forms) and MOTS-c (subcutaneous or intramuscular injection). The discretion applies under conditions that include sourcing the peptides from FDA-registered manufacturers that comply with current good manufacturing practice, obtaining certificates of analysis documenting identity and quality, compounding only under patient-specific prescriptions, limiting products to a single active ingredient, and reporting serious adverse events and product-quality problems.
In the notice, HHS explains that compounding is the practice in which a licensed pharmacist or physician combines, mixes or alters ingredients to create a medication tailored to an individual patient. The notice states plainly that compounded drugs are not FDA-approved, meaning FDA does not review their safety, effectiveness or quality before they are marketed, and that while compounded drugs can serve an important medical need, they may also pose risks to patients. HHS said that, based on Pharmacy Compounding Advisory Committee meetings and data on peptide utilization, there is significant interest in using these peptides in compounding given the lack of approved products, and that the interim step is meant to expand and improve patient access. Future FDA rulemaking may propose adding some or all of the peptides to the 503A bulks list based on the available evidence.
The policy followed disagreement inside FDA. According to Associated Press reporting, an FDA advisory panel voted in July to recommend allowing compounding of the same six peptides, while FDA's own scientists recommended against unwinding the existing restrictions, concluding the evidence was insufficient to establish their safety and effectiveness. The HHS notice also states that the draft policy does not establish any rights for any person and is not binding on HHS or the public, and that HHS may revisit the interim policy in whole or in part if a safety signal or a product-quality issue arises.
Written comments can be submitted via the federal regulations portal under Docket No. HHS-OASH-2026-0496 until two weeks after the notice is published in the Federal Register. The full policy document is available through the HHS website.
Source: GSM · USA (original Chinese edition)
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