Regulatory record
- August 2026
- Listed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues.
Status verified for this index · August 2026
Definition
Glutathione is a tripeptide of glutamate, cysteine, and glycine, the body's most abundant intracellular antioxidant; it is synthesized in every cell rather than obtained primarily from outside.
The injectable market sells it chiefly for skin tone and general wellness, uses that sit far from the molecule's textbook biochemistry.
Evidence
Systematic reviews of glutathione for skin outcomes find limited, short-term, and mixed evidence: a 2019 review reported some skin-tone effects in small trials with oral and topical use, and a 2025 review in melasma reached guarded conclusions about efficacy and durability [1, 2]. Evidence specifically for intravenous or intramuscular glutathione is thinner than for the oral forms the reviews mostly cover.
No glutathione product is FDA-approved for cosmetic indications, and the trials that exist are small enough that a confident claim in either direction outruns the data.
Lawful access
Glutathione is listed in Category 1 of the FDA's interim 503A bulks list; licensed pharmacies may compound it with a valid prescription while review continues. No telehealth supplier is listed in this index yet; programs carrying glutathione are under review.
References
- Journal of Cosmetic Dermatology. The clinical effect of glutathione on skin color and other related skin conditions: a systematic review. 2019. PMID 30895708
- International Journal of Dermatology. Glutathione as a skin-lightening agent and in melasma: a systematic review. 2025. PMID 39444151