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Glutathione is a naturally occurring antioxidant tripeptide that compounding pharmacies prepare by prescription as sterile injections, oral forms and topical preparations.
Glutathione is a small peptide built from three amino acids: glutamate, cysteine and glycine. Cells make it themselves and use it as a primary antioxidant, cycling between a reduced form (GSH) and an oxidized form (GSSG) to neutralize reactive oxygen species. Its sulfur group also binds copper at the active site of tyrosinase, the enzyme that drives melanin production, which is the proposed basis for its study as a skin lightening agent. No FDA-approved drug contains glutathione as an active ingredient for oral, injectable, nasal or topical use; the only approved product that includes a glutathione form is an intraocular irrigating solution used during eye surgery, which contains oxidized glutathione. Oral glutathione is sold as a dietary supplement with GRAS status for food use. Because nothing is manufactured as a drug for these routes, any prescription glutathione, whether injectable, oral, nasal or topical, is compounded. Compounded preparations are not FDA-approved and require a prescription.
Because no manufactured glutathione drug exists for these routes, there is no FDA label for them and no boxed warning. FDA has warned about compounded intravenous glutathione twice, in 2019 and 2026, after patients developed fever, chills, body aches, nausea, vomiting, low blood pressure and sepsis-like symptoms within minutes to hours of an infusion, some requiring hospital care; FDA attributed these to excessive endotoxin in dietary supplement grade powder that was not suitable for injection. Reported side effects of oral glutathione include gas, loose stools, flushing and weight gain; nebulized glutathione has caused cough and airway tightening in people with asthma, and reversible severe liver injury has been reported with intravenous use. Glutathione may interact with chemotherapy, and its use in people with cancer is theoretically contraindicated. Safety in pregnancy and breastfeeding has not been established, and no LactMed entry was found. If you notice side effects, talk to your prescriber or pharmacist.
Glutathione (gamma-glutamyl-cysteinyl-glycine) is the predominant intracellular thiol and maintains redox balance; proposed pigment effects include copper chelation at tyrosinase, interference with tyrosinase transport to premelanosomes, ROS quenching and a shift from eumelanin to pheomelanin synthesis (Sonthalia et al., 2016). Oral bioavailability data conflict: hepatic gamma-glutamyl transferase hydrolyzes the peptide, some single-dose studies show no plasma rise, longer trials show inconsistent increases, and neither cited source reports a clearance route or half-life. There is no labeled indication for any route a compounding pharmacy would prepare. In June 2022 FDA proposed that glutathione not be added to the 503A bulks list; the Pharmacy Compounding Advisory Committee voted 8 to 5, with one abstention, to recommend inclusion, a non-binding vote, and the minutes record no final decision. Prescribers have ordered compounded glutathione for skin lightening (Sonthalia et al., 2016), and it has been studied in Parkinson disease, cystic fibrosis and HIV with inconsistent results (Drugs.com monograph); the IJDVL review advises against intravenous use for skin lightening. Dosing and route are per prescriber. Sterile preparations require API manufactured for injectable use with endotoxin limits set from the maximum intended dose. Monitor liver function with repeated intravenous use. Glutathione is not a controlled substance.
Compounded at Bayview
Patient guides for the preparations we make most often. Each one is compounded to order and requires a prescription.
We do not have a patient page for this ingredient yet. That does not mean we cannot make it. Bayview compounds this ingredient to a prescriber's order, and our full compounding formulary lists every preparation we make. Viewing the formulary requires a prescriber account.
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Every preparation in our formulary that contains this ingredient. Strength, base and dose form are set by the prescription.
Other salt forms of this molecule, and ingredients commonly compounded alongside it.
This page describes an active pharmaceutical ingredient, not a finished drug product. Bayview Pharmacy compounds preparations containing it only on a prescriber's order for an individual patient.
Compounded preparations are not FDA-approved, and the FDA has not evaluated them for safety, effectiveness, or manufacturing quality. Nothing on this page is a claim that any preparation is effective for any condition.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
Our pharmacists work with prescribers to build preparations around a patient's dose, form and tolerances. Ask us what is possible with this ingredient.
