2018年在一种药品中发现亚硝胺杂质，导致美国食品和药物管理局（FDA）、加拿大卫生部和其他国际监管机构开始调查其他药物中是否存在这种污染物。2019年，随着更多的药品被确认导致召回，FDA和加拿大卫生部要求公司制定计划，对其生产的药品和用于存在亚硝胺的活性药物成分进行风险分析。如果发现亚硝胺存在，公司必须确保其含量不超过建议的可接受摄入量限值。在美国和加拿大，医用气体都被归类为药物，因此CGA评估了常用医用气体的生产投入和产出。 CGA成员还收到了关于制药公司在生产其产品时使用的气体的亚硝胺污染的询问。本立场声明和相关技术报告反映了CGA进行的评估结果，并与CGA于2020年3月26日致加拿大卫生部的信函一致，该信函是对关于亚硝胺的第57号DEL公告的回复。

The discovery of nitrosamine impurity in one type of drug product in 2018, led the United States Food and Drug Administration (FDA), Health Canada, and other international regulators to begin to investigate the presence of this contaminant in other drugs. With additional drug products being identified leading to recalls in 2019, the FDA and Health Canada required firms to establish plans to conduct risk analysis of their manufactured drug products and the active pharmaceutical ingredients they used for the presence of nitrosamines. If nitrosamines were found to be present, firms were required to ensure that levels did not exceed recommended acceptable intake limits. Medical gases are classified as drugs in both the United States and Canada, therefore CGA evaluated the production inputs and outputs of common medical gases. CGA members have also received inquiries regarding nitrosamine contamination of gases used by pharmaceutical firms in the manufacture of their products. This position statement and the associated technical report reflect the results of the evaluation CGA performed and is consistent with CGA's March 26, 2020 letter to Health Canada in response to DEL Bulletin No 57 regarding nitrosamines.