No FDA-approved drug product has reduced glutathione as an active ingredient. One approved product carries an ingredient bearing the name, and it is the oxidised form, glutathione disulfide. Everywhere else glutathione sits in a queue: Category 1 on both of FDA's compounding lists, absent from 21 CFR 216, and the subject of a 2022 advisory committee vote that has produced no rulemaking. This is the status as of September 23, 2026.

Is glutathione FDA approved?

Not as reduced glutathione. A Drugs@FDA query for products whose active ingredient is named glutathione returns no exact match for "GLUTATHIONE". The only glutathione-bearing active ingredient term in the database is "GLUTATHIONE DISULFIDE", with two records.

The approved product is BSS PLUS, NDA 018469, sponsored by Alcon, an intraocular irrigating solution whose generic name is recorded as "balanced salt solution enriched with bicarbonate, dextrose, and glutathione". Its label lists "glutathione disulfide (oxidized glutathione) 4.6 mg" in each millilitre of the concentrate part. A second, discontinued application, NDA 020079, carries the identical formulation; its brand-name field in Drugs@FDA is inconsistent with FDA's own description of that application elsewhere, so no brand name is given for it here.

The distinction matters because GSSG is a different substance from GSH, not a variant of it, with its own substance code, CAS number and mass, as set out in GSH, GSSG and total glutathione. FDA's summary of the reduced form's position is one sentence:

There is not an applicable United States Pharmacopeia (USP) or National Formulary (NF) drug monograph, glutathione is not a component of an FDA-approved drug.FDA Briefing Information, Pharmacy Compounding Advisory Committee, June 8, 2022

Where glutathione sits on FDA's compounding lists

Glutathione appears in Category 1 on both nomination lists and nowhere else on either: the 503A list updated May 14, 2026, and the 503B list updated March 21, 2025, in each case under the heading "Bulk Drug Substances Under Evaluation". In the 503A document the word occurs exactly once, in the Category 1 bullet list between glutaraldehyde and glycolic acid, so it is in neither Category 2 nor Category 3. Category 1 means FDA has said it does not intend to act against a compounder using the substance while it evaluates, subject to the conditions in its guidance; it is not approval and it is not the bulks list. The categories are set out in Category 1, Category 2 and the 503A bulks list in 2026.

The 503B list carries one further detail: its footnote marker is defined as "Designates bulk drug substances that are components of FDA approved drugs", and the glutathione entry carries no such marker, consistent with FDA's position that the reduced form, unlike the disulfide, is not a component of any approved product.

The codified list is the one that would change the legal position, and glutathione is not on it: 21 CFR part 216, retrieved in full for the September 21, 2026 issue date, contains zero occurrences of the word.

The reason it is in the queue is statutory. Under section 503A a bulk substance must comply with an applicable USP or NF monograph, or, where none exists, be a component of an approved drug, or appear on the bulks list. Glutathione has no USP or NF monograph and the reduced form is not a component of an approved drug, so the third route is the only one left. FDA notes that glutathione "is listed in the Japanese and European Pharmacopoeia", which is why a certificate may cite a foreign monograph method while no US monograph exists. What each category of supplier may lawfully do is covered in Compounding pharmacy, outsourcing facility or research supplier.

The 2022 notice, the committee vote, and the rulemaking that never came

FDA announced the review in the Federal Register on May 6, 2022, at 87 FR 27163, docket FDA-2021-N-0357. The agenda names the substances plainly: "The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: Ammonium tetrathiomolybdate, enclomiphene citrate, ferric subsulfate, and glutathione." The meeting was held on June 8, 2022, and the docket closed the day before. The notice also tabulates the nominated uses, which are not reproduced here.

FDA's staff position, in a briefing memo dated May 2, 2022, was against listing:

For the reasons discussed below, we believe the evaluation criteria weigh against placing glutathione on the 503A Bulks List.FDA Briefing Information, Pharmacy Compounding Advisory Committee, June 8, 2022

The committee disagreed. The minutes record the question, "Should glutathione be placed on the list?", and the vote: 8 yes, 5 no, 1 abstention.

A majority of committee members voted in favor of adding glutathione to the 503A Bulks List... Several members stated that the data and information presented demonstrated that glutathione has physical and chemical stability.Minutes, Pharmacy Compounding Advisory Committee, June 8, 2022

Committee recommendations are not binding, and adding a substance to the bulks list requires rulemaking. A Federal Register search of all FDA documents for "glutathione" returns 19 items, of which the May 6, 2022 notice is the only one about compounding. As of September 23, 2026 no proposed or final rule has named it for the 503A list. FDA said no, the committee said yes, and four years later the substance is still in Category 1.

What FDA's two alerts say, and what they are about

Two entries on FDA's compounding risk alerts index name glutathione. Both concern sterile preparations made from material labelled for supplement use, and both turn on endotoxin. The first is dated June 7, 2019, and followed a February 1, 2019 warning about L-glutathione powder distributed by a repackager in Decatur, Alabama:

FDA contacted the L-glutathione manufacturer, which confirmed that its L-glutathione is only marketed in the U.S. for use in dietary supplements, and that the ingredient is not intended for use in sterile drugs.FDA, compounding alert, June 7, 2019

The second, dated August 27, 2026, FDA frames as a reminder:

[8/27/2026] FDA is aware of reports of at least 30 patients who experienced adverse events... The glutathione was compounded by different compounding pharmacies, all of which obtained their glutathione (Lot #229536) from Medisca Inc., U.S. headquarters in Plattsburgh, N.Y. The glutathione was labeled as dietary supplement grade, which is not an appropriate ingredient to make injectable drugs.FDA, compounding alert, August 27, 2026

FDA states its general expectation in the same notice:

Ingredients labeled for dietary supplement use may contain impurities and contaminants, including endotoxins, that may be harmful when administered as an injectable drug.FDA, compounding alert, August 27, 2026

Read precisely, neither alert says anything about glutathione as a chemical. Both say that material graded for one purpose was used to make a sterile preparation for another, and that the grade did not carry the endotoxin control the second purpose demands. The subject is the starting material's grade, not the molecule's identity, and neither alert concerns research material labelled for laboratory use. Glutathione is also absent from FDA's page listing bulk substances that "may present significant safety risks".

Drug, supplement or food?

FDA describes the oral article as a supplement as a matter of observed fact: "Oral glutathione is marketed in the United States as a dietary supplement formulated as a capsule, tablet, or liquid." The 2019 and 2026 alerts use the same vocabulary, calling glutathione a "dietary ingredient" and the material "dietary supplement grade".

There is also a food clearance. GRAS notice GRN 293, filed by Kohjin Co., Ltd. on July 2, 2009 for glutathione as a food ingredient, closed on December 22, 2009 with FDA's standard response, "FDA has no questions". A GRAS conclusion concerns a food use under the food-additive provisions. It is not a determination about supplement legality and not an approval of anything.

One gap should be stated rather than papered over. The statutory basis on which glutathione is a lawful dietary ingredient could not be verified from any primary source: no new dietary ingredient notification was located, and glutathione does not appear in FDA's Dietary Supplement Ingredient Directory. So we assert no basis, and nothing was found in which FDA excludes it from the dietary-ingredient definition either.

What the warning letters naming glutathione actually charge

In each of the letters to pharmacies reviewed here, the violation charged is a labelling or facility-conditions matter, and glutathione is named only as one product on a list. A letter issued April 7, 2026 cites products that "did not include the following statement on the label: the statement 'Not for Resale'". One issued May 5, 2025 cites products that omitted adverse-event reporting information from the container.

None of them charges glutathione itself as an unapproved drug substance. Separately, letters to supplement sellers charge unapproved-new-drug violations based on the claims made about glutathione on a website, not on the substance in the bottle. Claims rather than chemistry is the same pattern that drives FDA action against research-product sellers.

Glutathione and the WADA 2026 Prohibited List

Glutathione does not appear anywhere on the World Anti-Doping Agency's 2026 Prohibited List, in effect from January 1, 2026: a text search of all 26 pages returns zero occurrences. It is likewise absent from the 2026 Monitoring Program.

Absence is not clearance. Section S0 is a catch-all covering "any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use". Whether any anti-doping organisation has applied S0 to glutathione could not be verified, and athletes take their determinations from their federation, not from a supplier's article. The wider picture is in Where research peptides sit on the WADA Prohibited List.

Status as of September 23, 2026

We sell glutathione as a lyophilized vial and a glutathione liquid spray, both labelled research use only and neither offered as a drug, a supplement or a food. The table is what the primary documents say; anything not in them is not stated here.

Sources

• Bulk Drug Substances Nominated for Use in Compounding Under Section 503A, FDA, updated May 14, 2026
• Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA, content current as of May 14, 2026
• Bulk Drug Substances Nominated for Use in Compounding Under Section 503B, FDA, updated March 21, 2025
• 21 CFR part 216, Pharmacy Compounding, eCFR
• Pharmacy Compounding Advisory Committee; Notice of Meeting, 87 FR 27163, Federal Register, May 6, 2022
• Evaluation of Glutathione for Inclusion on the 503A Bulk Drug Substances List, FDA Briefing Information, Pharmacy Compounding Advisory Committee, June 8, 2022
• Minutes, Pharmacy Compounding Advisory Committee meeting, FDA, June 8, 2022
• FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables, FDA, June 7, 2019
• FDA reminds compounders not to use dietary supplement grade glutathione for injectables, FDA, August 27, 2026
• GRAS Notice GRN 293, Glutathione, FDA GRAS Notice Inventory, closed December 22, 2009
• Warning letter to ProRx LLC, FDA, April 7, 2026
• The 2026 Prohibited List, World Anti-Doping Agency, effective January 1, 2026