In short. Glutathione is compounded from a bulk drug substance that FDA lists as under evaluation for 503A compounding. A compounded glutathione preparation is not FDA-approved. In TrueRoute it is ordered as a patient prescription that the prescriber signs.
What it is
Glutathione is a tripeptide. A pharmacy compounds it from a bulk drug substance, so the federal rules on which bulk substances a 503A pharmacy may use apply to it. FDA says a 503A compounder may use a bulk substance that complies with an applicable USP or NF monograph, that is a component of a drug product FDA has approved, or that appears on FDA’s 503A bulks list.
FDA status
FDA lists glutathione in category 1 of the bulk drug substances nominated for use in compounding under section 503A: substances under evaluation (FDA’s list, updated May 14, 2026). FDA says a category 1 substance may be eligible for inclusion on the 503A bulks list, and that it does not intend to take action against a compounder for compounding with one, provided the conditions of its interim policy are met.
A substance can leave category 1, for example because of new safety information, so check FDA’s current list before you rely on it.
Compounded medications are not FDA-approved, and FDA does not review them for safety, effectiveness or quality.
How it is ordered in TrueRoute
Glutathione is ordered as a patient prescription. The prescriber names the patient, chooses the product from your catalogue at your account’s price, reviews the order total and signs. Before anything is charged, TrueRoute checks what it can check, such as the prescriber’s licence in the patient’s state as attested and whether the product can be sent there, and selects the route under its written routing policy. Orders are filled by licensed pharmacies in our network.
Office-use and physician-use purchasing is a separate purchase-order flow with no patient attached, available once your account holds that program.
The forms and strengths your account can order, with their prices for your ship-to state, are shown in your catalogue once your account is set up. This page lists none, because what is carried changes.
What the prescriber decides
The prescription is the prescriber’s. They decide whether glutathione is appropriate for the patient and set the product, quantity and directions. TrueRoute is software: it does not recommend a medication, a dose or a product, it does not dispense, and it does not practice medicine.
Every medication reference page · Medical spa purchasing · How it works