vialauditThe Roundup
SS-31·US LEGAL STATUS·LAST CHECKED 12 OCT 2026

Is SS-31 legal?

Yes, as a prescription drug: FDA has approved it (Forzinity). A vial sold as a 'research peptide' is not the approved product, and selling it for human use breaks federal drug law. Pharmacies may compound it only when the product is not a copy of the approved drug.

RESEARCH-LABELLED SALE
Unapproved copy of an Rx drug
PHARMACY COMPOUNDING
Only if not a copy
PRESCRIPTION
FDA-approved (Forzinity)
WADA 2026
Not listed

DESCRIBES THE LAW · NOT LEGAL ADVICE · NO DOSING INFORMATION

Federal, compounding and sport status

CHECKED 12 OCT 2026

Federal status

FDA approval
approved as drug · brand: Forzinity · NDA 215244 · approved Sep 19, 2025
Indications: improve muscle strength in adult and pediatric patients (≥30 kg) with Barth syndrome
DEA scheduling
not scheduled
503A compounding
FDA interim category: Component of an FDA-approved drug
503A Bulks List: not on list
Elamipretide is the active ingredient of Forzinity (accelerated approval, 19 Sep 2025). 503A rules on approved components and 'essentially a copy' apply.
FDA Warning Letters
none on record for this compound
Shortage status
not currently on shortage list
Sale framing
Research-use-only posture: CRITICAL CROSS-REFERENCE: SS-31 = elamipretide = Bendavia = Forzinity. All four names refer to the same molecule. Any 'SS-31 research peptide' sold by a research-chemical vendor is diversion of Forzinity, an approved drug.
Personal possession: Not federally criminalized.

Sport-body status

WADA 2026
not prohibited
Elamipretide is an approved drug (Forzinity) and is not listed.
USADA
not banned
NCAA
unknown

What we couldn’t verify

State rules

NONE FOUND

We found no state statute, board rule or enforcement action that names SS-31. The federal position above applies in all 50 states and DC.

Questions

3 ANSWERS
Is SS-31 legal in the US?

Yes, as a prescription drug: FDA has approved it (Forzinity). A vial sold as a 'research peptide' is not the approved product, and selling it for human use breaks federal drug law. Pharmacies may compound it only when the product is not a copy of the approved drug.

Can a pharmacy compound SS-31?

Elamipretide is the active ingredient of Forzinity (accelerated approval, 19 Sep 2025). 503A rules on approved components and 'essentially a copy' apply.

Is SS-31 banned in sport?

It is not on the WADA 2026 Prohibited List. Elamipretide is an approved drug (Forzinity) and is not listed.

Sources

4 DOCUMENTS
  1. FDA approval record
  2. DEA controlled-substance schedules
  3. FDA 503A compounding position
  4. WADA 2026 Prohibited List
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