Epitalon FDA & Regulatory Status (2026)
Published reporting only; not an independently verified live regulatory determination. Sources and review dates are shown for each field.
Author: Chad E. · Last reviewed: 2026-10-17
- FDA compounding category
- Reported removed from Category 2 effective April 22, 2026. This report does not establish a later Category 1 placement. Source post
Reviewed: 2026-10-17 - PCAC review and vote
- July 24, 2026: recommended for inclusion, 7–5 with one abstention. The vote is advisory. Source post
Reviewed: 2026-10-17 - 503A bulks list status
- The cited coverage describes an advisory recommendation, not completed FDA rulemaking or a final bulks-list addition. Source post
Reviewed: 2026-10-17 - FDA-approved drug
- Not yet reviewed
- WADA status
- Listed in our 2026 WADA coverage as prohibited under S0. Source post
Reviewed: 2026-10-17
Recent developments
- RFK Jr. Just Changed the Peptide Industry Forever. Here's What It Actually Means.
- Apex Peptides, Federal Agents, and What the September 23 Raid Actually Tells Us About the RUO Sector
- PEPTIDES for Veterans Act 2026: Nancy Mace, the VA, and How Everything Changed
- The FDA Voted. Now What? The Complete Road Map to What Happens After the PCAC Peptide Decision
- FDA Advisory Panel Day 2 Results: Semax and Epitalon Recommended, Emideltide Rejected: Full Two-Day Scorecard
- FDA Advisory Panel Votes to Recommend BPC-157, TB-500, KPV, and MOTS-c for Compounding (2026)
- WADA and Peptides in 2026: The Complete Guide to What's Banned, What's Monitored, and Why It Matters
- 503A vs. 503B: How Peptides Fit Into the U.S. Compounding Framework in 2026 and Beyond
Sourced questions
What FDA category is Epitalon in?
Reported removed from Category 2 effective April 22, 2026. This report does not establish a later Category 1 placement.
What did the PCAC vote on Epitalon?
July 24, 2026: recommended for inclusion, 7–5 with one abstention. The vote is advisory.
Is Epitalon on the 503A bulks list?
The cited coverage describes an advisory recommendation, not completed FDA rulemaking or a final bulks-list addition.
Is Epitalon banned by WADA?
Listed in our 2026 WADA coverage as prohibited under S0.
Encyclopedia entry · State-law reference
Research use only. Not for human consumption. This page summarizes public regulatory information and is not legal advice.