FDA Glutathione Injection Reminder: MOS Quality & Safety
On August 27, 2026, the U.S. Food and Drug Administration issued an important reminder to all compounders regarding the use of dietary supplement‑grade glutathione in injectable preparations.
FDA emphasized that dietary supplement-grade ingredients are not appropriate for making injectable drugs and may contain impurities or contaminants, including endotoxins, that can present significant health risks when administered by injection.
For physicians considering Glutathione Injection from McGuff Outsourcing Solutions (MOS), we want to answer two important questions clearly.
Does MOS use dietary supplement-grade glutathione Active Pharmaceutical Ingredient (API)?
MOS does not use dietary supplement-grade glutathione API in the manufacture of Glutathione Injection.
Our quality program begins with the sourcing and qualification of API appropriate for its intended pharmaceutical use. Suppliers and incoming materials are evaluated under our established quality systems before an API is released for manufacturing.
Does MOS test Glutathione Injection for bacterial endotoxins?
Each finished batch of MOS Glutathione Injection is tested for bacterial endotoxins against established acceptance criteria before release.
Finished-product testing also includes sterility, potency, impurities, particulate matter, and other applicable quality attributes. Each batch is released only after review and approval by the MOS Quality Unit.
Quality Starts at the Source
FDA’s recent communication reinforces an important principle: finished-product testing alone cannot assure the quality of an injectable drug. Quality must be built into the entire process—from appropriate API sourcing and supplier qualification through manufacturing, testing, and final batch release.
That principle is fundamental to how McGuff Outsourcing Solutions manufactures sterile medications.
In Short
No dietary supplement-grade glutathione API.
Every finished batch tested for bacterial endotoxins.
Quality built into the process from API sourcing through final release.
McGuff Outsourcing Solutions is an FDA-registered 503B outsourcing facility.
