FDA: Adjustment of Nitrosamine Limits for Short-Term Use Medicines
The FDA has updated its recommendations on Acceptable Intake (AI) limits for nitrosamine impurities. Under certain conditions, the Agency now accepts a Less-Than-Lifetime (LTL) adjustment of AI limits for medicinal products that are not intended for lifetime use. This also represents an alignment with the LTL concept of ICH M7(R2).
Depending on the intended duration of treatment, lifetime AI limits may be multiplied by a factor of 80 (up to 1 month), 13.3 (more than 1 to 12 months), or 6.67 (more than 1 to 10 years). No LTL adjustment is provided for treatment lasting more than ten years.
This represents a change in FDA's previous position, under which LTL adjustments for nitrosamines were not recommended. The reassessment is based on new scientific evidence regarding the dose-response relationship. The LTL approach does not apply to the Interim AI Limits established by FDA.
The new recommendations were published on 24 September 2026.
Source:
FDA: Application of Less-Than-Lifetime Adjustment to Nitrosamine Impurities
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