US: HHS will not act against pharmacies compounding six peptides — BPC-157, TB-500, KPV, MOTS-c, semax, epitalon
The policy that went to the White House on 14 October is now public. An "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances", signed by the Secretary of Health and Human Services and announced in the Federal Register (91 FR 68526), says HHS "does not intend to take enforcement action" against a state-licensed pharmacy, federal facility or licensed physician that compounds any of the six under ten conditions: an FDA-registered source with a full certificate of analysis, one active ingredient, a patient-specific prescription, MedWatch reporting, a fixed label and route limits per peptide. It is interim, not binding, revocable on a safety signal, and not approval; the FDA's 503A list itself is unchanged and its own reviewers recommended against listing each of them. Comments for two weeks. The US regulation page and all six compound pages are rewritten from the document.



































































