Is there an FDA-approved Epitalon product?
No FDA-approved product
The record found no FDA-approved product. A label that says research use only does not make a product approved for people.
What the record says: No FDA-approved epitalon drug product
Legal status · Record reviewed
Is Epitalon legal in the U.S.?
Short answer
Epitalon has no single legal status. It depends on the product and how it is supplied.
No FDA-approved epitalon drug product. A research use only label does not make a product approved for people.
Pharmacy mixing (compounding): FDA had placed it in Category 2 for possible safety risks, and the request was then withdrawn (FDA page dated April 22, 2026).
Sports: we have no current sports-rule review for it yet.
Rules for buying, selling, and prescribing also depend on how a product is made and sold, and on state law.
This is not legal advice.
Whether you may buy, sell, or use a product also depends on pharmacy (compounding) rules, a prescription, and state law. Read how U.S. peptide law works.
Have a product in hand? Check if it is a prescription, compounded, or research-only product.
The three records behind this answer
Is it on FDA's compounding safety list?
Nomination withdrawn
FDA had placed it in Category 2 for possible safety risks. The person who asked FDA to allow it in compounding then withdrew the request. FDA still lists its safety concerns and has not made a final decision. A withdrawn request is neither a ban nor an approval.
Source: FDA's page of bulk drug substances that may present significant safety risks. FDA marks it current as of . We checked it on .
Do sports rules ban Epitalon?
Not assessed
This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.
Check the current World Anti-Doping Agency list and your sport's rules before you compete.
Other names in this record: Epithalon, AEDG, epitalon acetate.
Go further
Read the full Epitalon record
What it is, what studies in people show, and what is still unknown.
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