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Glutathione regulatory status

Current status of Glutathione in the United States: Under FDA review. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Glutathione?

Regulatory: Under FDA reviewWADA: Not WADA prohibitedVerified: Verified Sep 22, 2026
FDA and compounding
Glutathione is not an FDA approved drug. Oral glutathione is sold lawfully as a dietary supplement. Injectable glutathione is compounded from a bulk substance that was nominated for the FDA 503A bulks list and appears on the nominated substances lists pending a final determination; compounding continues under FDA's interim enforcement policy where state boards permit. FDA has issued warnings about compounded glutathione products containing high levels of endotoxin and about glutathione injections marketed for skin lightening, which is not an approved use.
WADA
Not WADA prohibited
Access path
  1. Over the counter dietary supplement, no prescription needed.
  2. Prescription from a licensed provider filled by a 503A compounding pharmacy for injectable glutathione, where the state board permits it.
  3. Clinic or telehealth programs offering IV or injectable glutathione.

Full Glutathione page: evidence, dosing in the literature, and sources

How has the status of Glutathione changed over time?

No dated regulatory event has been recorded for Glutathione. That usually means no FDA, PCAC, Federal Register, or WADA action has named it specifically. Category-wide actions are listed on the tracker hub.

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Glutathione and the source of each dated event.

  1. [1]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
  2. [2]FDA: Compounding and the FDA, questions and answers (including risks of compounded drugs and enforcement policy for nominated bulk substances)FDA, 2026
  3. [3]WADA Prohibited List (including section M2 on intravenous infusions)WADA, 2026