Is Glutathione legal in the US?
No. It is not approved as a drug, though pharmacies may make it up.
Glutathione is not approved by the FDA as a drug for any indication. Oral glutathione is sold as a dietary supplement, intravenous and inhaled forms are made by compounding pharmacies, and glutathione sits in Category 1 of the FDA's list of nominated compounding substances, meaning it may be compounded while the agency evaluates it. In August 2026 the agency warned compounders not to use supplement grade glutathione in injectables after a cluster of adverse events. 16
No. It is sold as a dietary supplement by mouth. Pharmacies compound it for intravenous or inhaled use. The FDA lists it in Category 1 of nominated compounding substances. That permits compounding while the agency decides whether to add it to the approved bulk substances list. 1
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Citations
- FDA: bulk drug substances nominated for use in compounding under section 503A, category list fda.gov
- Arjinpathana 2012, Journal of Dermatological Treatment: glutathione as an oral whitening agent, randomised placebo-controlled study doi.org
- Hauser 2009, Movement Disorders: randomised double-blind pilot of intravenous glutathione in Parkinson's disease doi.org
- Richie 2015, European Journal of Nutrition: randomised controlled trial of oral glutathione on body stores pubmed.ncbi.nlm.nih.gov
- Griese 2013, American Journal of Respiratory and Critical Care Medicine: inhaled glutathione in cystic fibrosis, randomised trial pubmed.ncbi.nlm.nih.gov
- FDA 2026: FDA reminds compounders not to use dietary supplement grade glutathione in injectables fda.gov
- FDA 2026: Greenwich Rx voluntary nationwide recall of compounded glutathione due to elevated endotoxin levels fda.gov
Reference information only, not medical advice. Drawn from the Glutathione article, fact-checked against the cited sources. No dosing anywhere on this site.