vialauditThe Roundup
THYMOSIN ALPHA-1·US LEGAL STATUS·LAST CHECKED 12 OCT 2026

Is Thymosin Alpha-1 legal?

Not as a drug. Thymosin Alpha-1 has no FDA approval, so selling it for human use breaks federal drug law, and a 'research use only' label does not protect a seller whose site signals human use. It is not a controlled substance, and possessing it is not a federal crime. It is approved in several countries (Zadaxin), which has no effect in the US. Pharmacies cannot compound it.

RESEARCH-LABELLED SALE
Unapproved drug
PHARMACY COMPOUNDING
No · PCAC voted against
PRESCRIPTION
Not in US · approved in several countries (Zadaxin)
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
no approval · brand: Zadaxin (international)
DEA scheduling
not scheduled
503A compounding
FDA interim category: Nominated but withdrawn (off Category 2, not eligible)
503A Bulks List: voted no
Not eligible. The PCAC voted 17-4 against it on 4 Dec 2024. FDA now lists it under 'nominated but withdrawn' (no longer Category 2), which does not permit compounding.
PCAC review history
  • Dec 4, 2024 · voted against · 17 no, 4 yes · SOURCE ↗
FDA Warning Letters
none on record for this compound
Shortage status
not currently on shortage list
Sale framing
Research-use-only posture: PCAC-rejected. International approval gap is the story — US sale is FDCA §505 violation despite EMA-equivalent foreign approval.
Personal possession: Not federally criminalized.

Sport-body status

WADA 2026
not prohibited
Not named. Approved abroad as Zadaxin, so S0 does not apply; thymosin beta-4 (TB-500) is a different molecule.
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 Thymosin Alpha-1. The federal position above applies in all 50 states and DC.

What changed at the last check

1 CHANGES
DateFieldWasNowWhy
12 Oct 2026FDA Category 2 (safety risk)on listnot on listFDA's Category 2 page lists it under 'nominated but withdrawn', not in Category 2. source ↗

Questions

3 ANSWERS
Is Thymosin Alpha-1 legal in the US?

Not as a drug. Thymosin Alpha-1 has no FDA approval, so selling it for human use breaks federal drug law, and a 'research use only' label does not protect a seller whose site signals human use. It is not a controlled substance, and possessing it is not a federal crime. It is approved in several countries (Zadaxin), which has no effect in the US. Pharmacies cannot compound it.

Can a pharmacy compound Thymosin Alpha-1?

Not eligible. The PCAC voted 17-4 against it on 4 Dec 2024. FDA now lists it under 'nominated but withdrawn' (no longer Category 2), which does not permit compounding.

Is Thymosin Alpha-1 banned in sport?

It is not on the WADA 2026 Prohibited List. Not named. Approved abroad as Zadaxin, so S0 does not apply; thymosin beta-4 (TB-500) is a different molecule.

Sources

5 DOCUMENTS
  1. FDA approval record
  2. DEA controlled-substance schedules
  3. FDA 503A compounding position
  4. PCAC review, 4 Dec 2024
  5. WADA 2026 Prohibited List
THE ROUNDUP · MONTHLY

Receipts in your inbox. Once a month.

New audits, expired coupons pruned, lab notes from vials still on the bench. No marketing. No lifestyle copy. Unsubscribe in one click.

14,200 SUBSCRIBERS·0 SPONSORED ITEMS·11 ISSUES SINCE LAUNCH