FDA: Emerging Scientific and Technical Information on Leachable Nitrosamines in Infusion Bags
- Date
- August 20, 2025
- Category
US Regulations
- Description
On 18 August 2025, FDA issued a new notification titled ‘Emerging Scientific and Technical Information on Leachable NDBA and Other Small-Molecule Nitrosamines in Infusion Bags’, see https://www.fda.gov/media/188238/download. This highlights a newly identified concern regarding nitrosamine impurities in drug products packaged in infusion bags. CDER generally does not intend to object to the distribution of drug products in infusion bags because the drug products contain leachable nitrosamines while the Agency investigates this issue.
The FDA has identified N-nitroso-dibutylamine (NDBA) and other small-molecule nitrosamines as potential leachables from infusion bag materials into drug products. This issue is considered emerging, with limited data currently available.
CDER is recommending that manufacturers and marketing authorization holders conduct risk assessments on drug products packaged in infusion bags to determine if NDBA and other small-molecule nitrosamines may form from packaging and leach into their drug products.
If they conclude that there is a risk, or if CDER identifies a potential risk, then manufacturers are asked to test at least three batches of their drug products within expiry. This testing should focus on the strength(s) with the greatest risk of nitrosamine leaching. Test results, including method validation data, must be submitted to CDER as general correspondence within 90 days—by November 16, 2025.