Epitalon: where it stands with the FDA, and what it costs
No FDA-approved drug contains it.
Go to clinicLowest per monthEpitalon injection
EllieMD · $58.33/mo
Go to clinicLowest at a clinic we link toEpitalon injection (10mg)
Pepti · $249/mo (≈ $267 per 30 days with its fees)
Where Epitalon stands today
No FDA-approved drug contains epitalon. FDA had it in 503A Category 2 from September 29, 2023 until April 22, 2026 (nominations withdrawn). On July 24, 2026 the advisory committee voted 7-4 (1 abstention, per law-firm reports) to recommend listing it, against FDA staff's proposal. HHS's October 30, 2026 interim policy covers epitalon acetate for subcutaneous or intramuscular injection dispensed in intermittent courses, single-ingredient, under ten conditions; it does not cover 503B facilities.
For pharmacies compounding one patient's prescription (section 503A)
Not on the 503A bulks list and in no FDA category (removed from Category 2 on April 22, 2026 after its nominations were withdrawn). Since Oct 30, 2026 it is one of six peptides in HHS's interim enforcement discretion policy for 503A compounding, limited to the form and routes below and ten conditions.
“Bulk drug substances nominated but withdrawn ... Epitalon Compounded drugs containing epitalon may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities.”
““Epitalon” has been removed from category 2 because the nominations were withdrawn by the nominators.”
HHS interim enforcement discretion policy (Office of the Secretary, not FDA)
“HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a bulk drug substance in Appendix A.”
Form and routes HHS covers
“Based on the identified updated information, enforcement discretion for epitalon acetate is appropriate subcutaneous or intramuscular injectable dosage forms that are dispensed in intermittent courses that are compounded from API accompanied by a CoA meeting the conditions of this policy.”
“Epitalon was in Category 2 from September 29, 2023, until April 22, 2026, and neither the placement nor the removal changed its status under section 503A; CDER recommended against listing either form, and the PCAC voted in favor of inclusion.”
One of the ten conditions: single-ingredient products only (no blends)
“The compounded drug product contains only a single Active Pharmaceutical Ingredient (API) listed in Appendix A.”
The Federal Register notice calls the policy a draft; written comments closed two weeks after publication
“HHS is announcing the availability of a draft”
21 CFR 216.23(a), the 503A bulks list itself: six substances (Brilliant Blue G, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester, thymol iodide); none of the compounds in this file
“The following bulk drug substances can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act.”
For outsourcing facilities (section 503B)
Not on the 503B bulks list and not in any 503B category (FDA's 503B nominations list, updated March 21, 2025, does not name it)
“Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless: The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or”
The 503B bulks list holds five substances (diphenylcyclopropenone, glycolic acid, quinacrine HCl oral, squaric acid dibutyl ester, trichloroacetic acid); none of the compounds in this file
“FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:”
The HHS policy names 503A compounders only; it does not cover 503B outsourcing facilities
“HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician”
The FDA's compounding advisory committee
24 July 2026: Should epitalon (free base) and epitalon acetate be placed on the 503A bulks list? (use FDA reviewed: insomnia). Vote: 7 yes, 4 no, 1 abstention (both forms), per law-firm reports. Committee recommended inclusion, against FDA staff's proposal; no FDA rule yet; HHS cited the vote in its Oct 30, 2026 interim policy
“VOTE: Should Epitalon (free base) be placed on the list? ... VOTE: Should Epitalon acetate be placed on the list?”
FDA warnings, recalls and letters
21 October 2025: Recall of epitalon injection. Class II; recall initiated 2025-07-30, classified 2025-10-21, distributed nationwide. (GenoGenix LLC, Boca Raton, FL (registered 503B outsourcing facility)).
“Epithalon for Injection, 20mg, all presentations ... Lack of Assurance of Sterility”
20 January 2026: Same warning letter; epithalon among products missing required outsourcing-facility label statements. (GenoGenix LLC, Boca Raton, FL (registered 503B outsourcing facility)).
“Examples include Glutathione Magnesium, Reconstitution Solution, and Epithalon.”
Our reading
A 503A pharmacy can compound epitalon acetate injections, in intermittent courses, for a patient-specific prescription under HHS's enforcement discretion if every condition is met; nasal or oral epitalon, continuous dosing and blends fall outside it.
Every source above was checked again on 14 November 2026.
What 48 clinics charge
- EllieMDEpitalon injection$58.33/mo
- Optimize Health & PerformanceEpitalon injection (50mg)$57.50/mosupply not stated, counted as 4 weeks: ≈ $62 per 30 days
- Optimize Health & PerformanceEpitalon injection (100mg)$100/mosupply not stated, counted as 4 weeks: ≈ $107 per 30 days
- EnhancedEpitalon injectionfrom $109/mo
- ArgoEpitalon injection$125/mo
What Epitalon is
- What it is
- Synthetic tetrapeptide
- How it works
- A four-amino-acid peptide modelled on a pineal gland extract.
- How it is given
- Subcutaneous injection
- Also called
- epithalon, epithalamin
Epitalon side by side
About Epitalon
Is Epitalon FDA-approved?
No. No FDA-approved drug contains Epitalon. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is Epitalon legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. No FDA-approved drug contains epitalon. FDA had it in 503A Category 2 from September 29, 2023 until April 22, 2026 (nominations withdrawn). On July 24, 2026 the advisory committee voted 7-4 (1 abstention, per law-firm reports) to recommend listing it, against FDA staff's proposal. HHS's October 30, 2026 interim policy covers epitalon acetate for subcutaneous or intramuscular injection dispensed in intermittent courses, single-ingredient, under ten conditions; it does not cover 503B facilities.
How much does Epitalon cost?
48 clinics publish a price. The lowest that compares per month is $58.33/mo at EllieMD, and the middle of 35 clinics' lowest monthly prices is about $213. What a month buys differs by clinic, so each price lists what it includes. every Epitalon price
What forms does Epitalon come in?
Clinics sell it as injection (47 prices), other (5 prices).