The short answer. Epitalon, also sold as epithalon, is not FDA-approved and, as of September 26, 2026, has no lawful compounding pathway. Both nominators withdrew in April 2026, which moved it out of Category 2 into no category. FDA’s briefing for the July 24, 2026 advisory committee recommended against listing it.
| FDA approved | No. No USP monograph, and not a component of any approved drug. |
|---|---|
| 503A pharmacy | No pathway. Not on 21 CFR 216.23 and in no category since Apr 22, 2026. |
| 503B outsourcing facility | No pathway. Never in a 503B category. |
| Latest FDA action | Advisory committee, Jul 24, 2026 (insomnia). FDA’s briefing recommended against listing both forms. |
| Enforcement | Named in an FDA warning letter to a Florida outsourcing facility, Jan 20, 2026. |
| MDside position | Our providers do not prescribe it. |
| Last verified | 2026-09-26 |
What happened, in order
| Date | What happened |
|---|---|
| Sep 2, 2010 | Orphan designation for retinitis pigmentosa, revoked Jan 6, 2016, according to FDA’s briefing. |
| Sep 29, 2023 | FDA placed epitalon in 503A Category 2. |
| Apr 14, 2026 | Withdrawal letters from both nominators, Wells Pharmacy Network and LDT Health Solutions, posted to the docket. |
| Apr 22, 2026 | Removed from Category 2. It now sits in no category. |
| Jul 24, 2026 | The advisory committee reviewed the free base and the acetate for insomnia. FDA proposed that neither be listed. |
An old orphan designation is not an approval
Vendor pages sometimes cite epitalon’s orphan designation. FDA’s briefing records that the designation, granted in 2010 for retinitis pigmentosa, was revoked in 2016. An orphan designation never approves a drug. It marks a product as eligible for development incentives, and for epitalon even that has lapsed. FDA also treats epitalon, a synthetic tetrapeptide, as a different substance from epithalamin, a pineal gland extract.
What FDA told the committee
FDA’s briefing found no applicable monograph and no approved drug containing epitalon, and its safety-risk page cites a possible immunogenicity risk from aggregation and peptide-related impurities. FDA proposed that neither epitalon free base nor epitalon acetate be added to the 503A list.
Market reports say the committee voted in favor. FDA had not posted minutes as of September 26, 2026, so we cannot confirm the tally from an FDA source. Each compound also had two separate votes, one for the free base and one for the acetate. A committee vote is advice to FDA. Only notice-and-comment rulemaking adds a substance to 21 CFR 216.23, and none has started.
Enforcement has reached outsourcing facilities
FDA’s January 20, 2026 warning letter to GenoGenix, a Florida outsourcing facility, cited “Epithalon” among products whose labels lacked required statements, including that the product was compounded and was not for resale. The firm had stopped production and started a recall in July 2025. FDA also named epitalon as ineligible for 503A in its 2020 warning letter to Tailor Made Compounding.
What this means for you
Take epitalon off your menu, including any longevity bundle that contains it. If a supplier cites the orphan designation or the July committee meeting as authority, neither one creates a pathway. Check this page before any change. For how we build compliant longevity offerings, see peptide programs.
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Frequently asked questions
Is epitalon legal to compound?
No. As of September 26, 2026 epitalon is not on the 503A bulks list, is in no FDA category, has no monograph and is not part of an approved drug. It left Category 2 in April 2026 because both nominators withdrew, which did not open any route for a pharmacy to compound it.
Is epitalon the same as epithalamin?
No. FDA treats them as different substances. Epitalon is a synthetic four amino acid peptide. Epithalamin is an extract of the pineal gland. Research or history cited for one does not carry over to the other, and neither has a compounding pathway in the United States as of September 2026.
Does epitalon have FDA orphan drug status?
Not anymore. FDA’s July 2026 briefing records an orphan designation for retinitis pigmentosa granted in 2010 and revoked in 2016. Even while it stood, an orphan designation was never an approval. It only made a product eligible for development incentives, and it gave no basis for compounding.
Primary sources. Last verified September 26, 2026. Corrections are welcome: contact us.
- FDA, 503A bulk drug substance categories (updated May 14, 2026)
- FDA, Certain bulk drug substances that may present significant safety risks (updated Apr 22, 2026)
- FDA, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Jan 2025)
- 21 CFR 216.23, the 503A bulks list
- FDA, Pharmacy Compounding Advisory Committee, July 23-24, 2026
- 91 FR 20465 (Apr 16, 2026), Pharmacy Compounding Advisory Committee meeting notice, Docket FDA-2025-N-6895
- FDA briefing document, epitalon (July 2026 PCAC)
- FDA, voting questions, July 2026 PCAC
- Regulations.gov, withdrawal of nominations by Wells Pharmacy Network, FDA-2015-N-3534-0484 (posted Apr 14, 2026)
- Regulations.gov, withdrawal of nominations by LDT Health Solutions, FDA-2015-N-3534-0485 (posted Apr 14, 2026)
- FDA warning letter, GenoGenix LLC (Jan 20, 2026)
- FDA warning letter, Tailor Made Compounding (Apr 1, 2020)
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.