美國食品藥品管理局（FDA）于2018年9月發(fā)布了供企業(yè)用"藥品供應(yīng)鏈安全法（DSCSA）規(guī)定的產(chǎn)品標(biāo)識符問答指導(dǎo)原則（草案）"，回答了藥品包裝上粘貼或印刷產(chǎn)品標(biāo)識符的許多具體問題，指出了對不同容器上產(chǎn)品標(biāo)識符的類型（線性條形碼和2D數(shù)據(jù)矩陣條形碼）的不同要求。詳細(xì)介紹該指導(dǎo)原則，期望對我國藥品包裝這方面的進(jìn)一步規(guī)范和完善有所啟發(fā)。

FDA issued Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers Guidance for Industry (draft),in September 2018. This document answers many specific questions about product identifiers affixed or imprinted on drug packaging, and points out the different requirements for the types of product identifiers (linear bar code and 2D data matrix bar code) on different containers. This paper introduces the guidance in detail and is expects to be enlightening to the further development and perfection of this aspect in our country.