FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables

FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables

The FDA’s mission is to protect the public health by ensuring the safety and efficacy of human and veterinary drugs. It is a mission that should be lauded by healthcare practitioners and patients alike. However, when it comes to compounding pharmacies, the FDA needs to ensure the safety and efficacy of compounded drugs without stifling therapeutic innovations that often are the reasons why practitioners and patients seek out knowledgeable compounding pharmacies—to provide drug formulations that currently do not exist in the commercial market!

It is difficult to fault recent FDA’s seemingly anti-compounding actions when less capable pharmacies are releasing questionable preparations.

In the recently reported adverse events due to high endotoxin loads associated with Letco’s glutathione, is the appropriate FDA response to eliminate glutathione (and by association all dietary supplements) from pharmacy compounding? Very few raw materials for pharmacy compounding are ensured by the manufacturer to be suitable for sterile compounding, regardless of whether the material is a dietary supplement or not. The question that should be asked by FDA is what quality system did the pharmacies that compounded with Letco’s glutathione have in place to screen for endotoxin of each batch of raw material and what Quality Control (QC) tests were performed to ensure the safety of the finished preparation prior to release for patient use?

Highly skilled and conscientious compounding pharmacies like McGuff Compounding Pharmacy Services, have a robust quality system to address formulation issues such as homogeneity, potency, endotoxin, sterility, and other QC parameters prior to the release of compounded preparations beyond just reviewing the raw material’s certificate of analysis. By doing our own due diligence, we are living up to our own uncompromising passion for quality pharmaceuticals.

FDA should enforce sanitary guidelines on all sterile fill compounding pharmacies and not restrict access to medically needed preparations.

For more information on this matter, please see the FDA article: