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# FDA: Compounders Should Use ‘Suitable’ Ingredients
- URL: https://www.fdaweb.com/fda-compounders-should-use-suitable-ingredients/
- Published: 2024-10-31T12:00:00.000Z
- Updated: 2026-09-14T14:45:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158093

FDA is reminding drug 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,” an agency [statement](https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-use-ingredients-suitable-sterile-compounding?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. “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.”

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

“FDA has received adverse event reports following use of NAD+ injectable drugs, including severe chills, shaking, vomiting, and fatigue with some requiring medical treatment,” the notice says. “These reactions are consistent with excessive levels of endotoxins.”

The statement says FDA encourages manufacturers, including repackagers, to clearly identify any ingredients intended for use in foods or dietary supplements on the label. “Providing that information on ingredient labels could help prevent compounders from using ingredients that are not appropriate for sterile drugs and may help prevent patient harm,” it says.