Glutathione injections: legal status

Short answer: glutathione is in FDA’s Category 1 for 503A compounding: a substance under evaluation [1]. FDA says it does not intend to take action against a state-licensed pharmacy, federal facility or licensed physician that compounds with a Category 1 substance, if the conditions in its guidance are met [2]. Glutathione injections are not FDA-approved, and FDA has warned that injectable skin-lightening products, some of which contain glutathione, may be unsafe [3].

At a glance

Glutathione	FDA Category 1, under evaluation [1]
503A compounding	FDA does not intend to act, if its guidance conditions are met [2]
Skin lightening	No injectable drug is FDA-approved for it; FDA warns these products may be unsafe [3]
FDA-approved	No
Last checked	November 6, 2026

What Category 1 means

Category 1 substances may be eligible for the 503A bulks list, were nominated with enough information for FDA to evaluate them, and do not appear on any other list [2]. They stay under FDA’s interim policy until FDA decides on them, or until FDA removes them from Category 1, for example because of safety information [2].

FDA’s warning on injectable skin-lightening products

FDA says it has not approved any injectable drug for skin whitening or lightening, and that these products may be unsafe or ineffective and may contain unknown ingredients or contaminants [3]. Glutathione is one of the ingredients FDA names in these products [3].

How to check a source

A legal compounded product comes from a licensed pharmacy with a prescription in your name. See how to check a compounding pharmacy.

What is not known

FDA has not finished its evaluation of glutathione for the 503A bulks list [1], [2]. Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed. Talk to a licensed clinician before you use it.

Change log

• November 6, 2026: page created.