HHS Interim Enforcement Discretion for Six Peptides in 503A Compounding
HHS's October 30, 2026 Federal Register notice shields 503A compounding of BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 while FDA builds the bulks list, but state boards may still restrict.
On October 30, 2026, HHS published in the Federal Register an interim, non-binding enforcement discretion policy covering Section 503A compounding with six peptide bulk drug substances: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. HHS states it does not intend to enforce against state-licensed pharmacies, federal facilities and licensed physicians compounding with those peptides while FDA finishes rulemaking to build the 503A bulks list. Each peptide had been in Category 2 since September 2023, and CDER had recommended against listing all of them; HHS justified inclusion citing characterization data, documented historical use and policy safeguards, and framed the policy as a way to displace research-use-only peptides from foreign manufacturers.
Counsel should note three features. First, the policy is described as HHS's, not FDA's, unlike most compounding discretion policies, and it runs counter to FDA's recent stricter approach to bulk compounding; ASHP has criticized the lack of clinical and safety data and guardrails. Second, the policy is interim and may be revisited on a safety signal or quality issue, and FDA may later propose adding some or all six peptides to the bulks list. Third, 503A compounders remain subject to state licensure, and boards of pharmacy may impose additional restrictions or decline to recognize the discretion.
Watch for state board actions, compounding-related safety developments and any FDA bulks-list proposal.