Drugs

Test and Report Leachable Nitrosamines: FDA

FDA has published a guidance, Emerging Scientific and Technical Information on Leachable NDBA and Other Small-Molecule Nitrosamines in Infusion Bags, asking manufacturers and applicants to obtain better data and applicants to report data in their applications so the agency can better understand the emerging issue of the detection of N-nitroso-dibutylamine (NDBA) in certain drug products packaged in infusion bags. The document says FDA expects the data being requested will help inform CDER as to the appropriate next steps for addressing leachable nitrosamines in infusion bags.

The guidance says FDA generally does not intend to object to manufacturers and applicants distributing drug products in infusion bags containing leachable nitrosamines while the agency investigates the issue. “As CDER’s understanding of the root cause of this issue evolves and potential practices that can remediate or eliminate this concern develop, the agency may inform application holders of an increase or decrease in the adjustment factor or in the recommended acceptable intake limit for these impurities,” it says.

The guidance says CDER is recommending that approved applicants, manufacturers of approved or marketed products, and pending applicants 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 manufacturers and applicants conclude there is a risk, or if CDER identifies a potential risk, it says, then manufacturers and applicants should test their products to determine the presence of and, if present, the amounts of leachable nitrosamine impurities.

Currently, the guidance says, it appears that leachable nitrosamines found in drug products packaged in infusion bags are associated with printed overwraps and pouches. It says that packaging components such as polymeric raw materials, inks, and nitrocellulose in overwraps/pouches may be sources of nitrosamine impurities.

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