Compounders are mandated to stop using dietary supplement grade glutathione for compounding injectable drugs due to associated patient safety risks.
This prohibition is crucial as the use of inappropriate ingredients can result in severe adverse events, including shock and symptoms consistent with sepsis-like conditions, highlighting significant patient safety concerns within compounded drugs.
Compounding pharmacies must verify that all components used in injectable drugs are suitable for their intended use and discontinue the use of any glutathione labeled for dietary supplement purposes, particularly if sourced from Medisca.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Compounding pharmacies must verify that all components used in injectable drugs are suitable for their intended use and discontinue the use of any glutathione labeled for dietary supplement purposes, particularly if sourced from Medisca.
The FDA has issued a reminder to compounding pharmacies to refrain from using dietary supplement grade glutathione for injectable preparations. This is in response to reports of adverse events among patients who received intravenous glutathione, indicating serious health risks associated with elevated endotoxin levels in these products. Compounders must ensure that all components for injectable drugs are appropriate for their use, avoiding contaminants that could led to harmful effects.
What changed: Compounders are mandated to stop using dietary supplement grade glutathione for compounding injectable drugs due to associated patient safety risks.
Why it matters: This prohibition is crucial as the use of inappropriate ingredients can result in severe adverse events, including shock and symptoms consistent with sepsis-like conditions, highlighting significant patient safety concerns within compounded drugs.
Practical implication: Compounding pharmacies must verify that all components used in injectable drugs are suitable for their intended use and discontinue the use of any glutathione labeled for dietary supplement purposes, particularly if sourced from Medisca.
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