TOPIC: FDA Reminds Compounders to Use Ingredients Suitable for Sterile Compounding - CDER Alert
AUDIENCE: Patient, Health Care Professional, Pharmacy
ISSUE: FDA is reminding compounders to only produce sterile drugs using components that are suitable for compounding drugs intended to be sterile. The agency also reminds compounders to only use appropriate ingredients when compounding drugs intended to be sterile to help ensure patient safety.
FDA urges manufacturers, including repackagers, to clearly identify any ingredients intended for use in foods or dietary supplements on the label. Providing this information on ingredient labels could help prevent compounders from using ingredients that are not appropriate for sterile drugs and may help prevent patient harm.
FDA has received adverse event reports following use of NAD+ injectable drugs, including severe chills, shaking, vomiting and fatigue with some requiring medical treatment. These reactions are consistent with excessive levels of endotoxins.
Previously, FDA highlighted concerns with using dietary ingredient glutathione to compound sterile injectables.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: FDA is aware of compounders using food-grade nicotinamide adenine dinucleotide (NAD+) sold by repackagers to make intravenous products. Ingredients identified as food grade are not suitable for compounding sterile drugs without appropriate processing, due to the high risk of contamination with microbes and endotoxins, which can harm patients.
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