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首页> 美国政府科技报告 >Guidance for Industry Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages. Final Guidance
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Guidance for Industry Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages. Final Guidance

机译：确保药品供应链的行业标准指南 - 处方药包装的标准化数字识别。最终指导

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摘要

This guidance is intended to address provisions set forth in Section 505D of the Federal Food, Drug, and Cosmetic Act (the Act) regarding development of standardized numerical identifiers (SNIs) for prescription drug packages. In this guidance, FDA is identifying package-level SNIs, as an initial step in FDAs development and implementation of additional measures to secure the drug supply chain. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

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