Wire reporting: (AP, via Anchorage Daily News)

The Department of Health and Human Services posted a draft enforcement-discretion policy on compounding six unapproved peptide drugs, Ars Technica and the BBC reported, with Federal Register publication dated Oct. 30 and a two-week public comment window^1,3.

The peptides named by Ars Technica are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500¹. The BBC listed a similar set without Epitalon³. None are FDA-approved as safe and effective, AP accounts carried by Anchorage Daily News and The Philadelphia Inquirer said^4,6.

The notice does not change the peptides' regulatory status, Ars Technica said; it states HHS will not take enforcement action against compounding pharmacies that make them¹. The BBC said the draft came from the secretary's office rather than FDA, which the BBC called unusual³.

AP, citing six people familiar with the process who were not named, said FDA scientific staff had little input and opposed the plan, warning it could undercut the agency's role of keeping unsafe products off the market^4,6. Those accounts said HHS first sought a regulation adding the substances to the compounding list, then shifted to non-enforcement after FDA staff would not back a safety finding^4,6.

In 2023, FDA listed more than a dozen peptides, including BPC-157 and TB-500, as substances that should not be compounded because of risks such as allergic reactions, kidney damage, and tumor growth, AP reported^4,6. A July advisory panel voted to ease restrictions on the six peptides; Ars Technica said Kennedy had appointed several panel members with peptide-business ties, and AP said the panel included people who work in the peptide field^1,4.

HHS argues the policy will steer patients away from research-use-only products from foreign makers toward licensed U.S. compounders, Ars Technica and AP said^1,4. An HHS spokesperson told AP the agency is confronting black-market peptide risks with a more controlled alternative^4,6. Kennedy has called himself a big fan and has described using BPC-157 for a muscle injury, those outlets said^1,3,4.

Lee Rosebush of the American Academy of Peptide Medicine, which represents people who prescribe or sell peptides, praised the move, Ars Technica and AP reported^1,4. Peter Lurie of the Center for Science in the Public Interest, a former FDA official, said FDA-approved drugs already exist for the conditions peptides are marketed for and warned of diversion from proven treatments^4,6. Fred Mills of Americans for Safe and Effective Medicines said the policy does not fix untested products or weak oversight, according to Ars Technica¹.

AP said compounders are directed to use ingredients from FDA-registered factories, check purity, and collect side-effect data, but Lurie said FDA lacks authority to enforce those pharmacy requirements^4,6. The Alliance for Pharmacy Compounding told AP that timing and state-board overlap still need clarifying⁴. Telehealth firm Hims & Hers has said it plans to offer wellness peptides if policy changes, AP reported^4,6.

Whether the draft becomes final after comments, and whether any of the six peptides will later be added to the 503A bulks list by rulemaking, is not yet known^1,3. Not medical advice.