Fed Regist. 2004 Apr 8;69(68):18727-67.
The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.
美国食品药品监督管理局（FDA）正在修订其关于补充剂的法规以及对已批准申请的其他变更，以实施1997年《食品药品监督管理局现代化法案》（《现代化法案》）中的生产变更条款。最终规则要求制造商评估生产变更对药品或生物制品的特性、强度、质量、纯度和效力的影响，因为这些因素与产品的安全性或有效性相关。最终规则规定了在使用变更生产的产品分发前需要提交补充申请并获得批准的变更要求、在产品分发前至少30天需要提交补充申请的变更要求、在分发时需要提交补充申请的变更要求以及需在年度报告中描述的变更要求。
