U.S. Food and Drug Administration (FDA)
Is Epitalon legal in United States?
Not approvedNo FDA approval; an advisory panel voted in July 2026 to recommend considering it, but the vote is not binding
Not approved as a medicine here.
Epitalon is not approved for any use. FDA's Category 2 page lists it among withdrawn nominations and says FDA has no safety information on the proposed route. The Pharmacy Compounding Advisory Committee reviewed epitalon for insomnia on 24 July 2026 and, per a law-firm report, voted 7 to 4 with one abstention to recommend it for the 503A bulks list. FDA has not acted, so epitalon is not on the list and cannot rely on FDA's Category 1 policy.
Last verified 2026-09-29 · how we verify
Epitalon elsewhere
Sources (3)
- 01Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)U.S. Food and Drug Administration · 2026-04-22 · accessed 2026-09-29
- 02July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration · 2026-08-06 · accessed 2026-09-29
- 03Bulk list bound? PCAC backs majority of peptides in two-day public meetingMcDermott Will & Schulte · 2026-07-27 · accessed 2026-09-29