FDA Alert: FDA Reminds Compounders to Use Appropriate and Sterile Ingredients

FDA reminds compounders to use ingredients suitable for sterile compounding

FDA is reminding compounders to only produce sterile drugs using components that are suitable for compounding drugs intended to be sterile.

The agency 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.

FDA also reminds compounders to only use appropriate ingredients when compounding drugs intended to be sterile to help ensure patient safety.

The agency 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.

The agency encourages compounders to know your bulks and excipient suppliers and know whether the ingredient is appropriate for use in drugs. Additionally, repackagers should ask compounders about whether the ingredient is intended for use in drugs to help ensure the ingredient is used appropriately.

Previously, FDA highlighted concerns with using dietary ingredient glutathione to compound sterile injectables.

The agency encourages health care professionals, compounders and patients report adverse events to the FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178