HHS Enforcement Discretion for Six Compounded Peptides
HHS says it will not enforce against 503A compounding of six peptides including BPC-157 if a detailed set of conditions is met, but the substances still are not on FDA's bulks list and the policy is open for comment.
On October 28, 2026, HHS issued an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances," according to a Foley & Lardner alert; comments close two weeks after Federal Register publication, which the firm lists as November 13, 2026. The policy states HHS does not intend to enforce against state-licensed pharmacies, federal facilities, or licensed physicians compounding from six bulk substances — BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 — provided roughly ten conditions are met, including sourcing from an FDA-registered facility with a certificate of analysis, CGMP-compliant manufacturing, MedWatch adverse event reporting, single-ingredient products, bioavailability documentation for oral formulations and 510(k)-cleared syringes.
The policy does not add the substances to FDA's 503A bulks list or approve the compounded products. The six peptides fail the statutory bulk drug substance eligibility tests, and the Pharmacy Compounding Advisory Committee's narrow July 2026 recommendation (over FDA career scientists' objection) still awaits notice-and-comment rulemaking that may take months or years.
Why counsel should care: compounders, telehealth prescribers, API suppliers and wellness investors must test each condition line by line, preserve documentation, and monitor FDA's rulemaking and any safety-signal-driven revisit.