美國(guó)食品藥品管理局（FDA）于2018年10月發(fā)布了《供企業(yè)用的藥品供應(yīng)鏈安全法規(guī)定的某些處方藥核查系統(tǒng)指導(dǎo)原則》（草案）。該指導(dǎo)原則介紹了FDA對(duì)藥品供應(yīng)鏈中的企業(yè)建立非法處方藥核查系統(tǒng)（包括可疑產(chǎn)品的隔離和調(diào)查以及非法產(chǎn)品的隔離、處置和通知等）的具體要求。我國(guó)目前尚無(wú)類似指導(dǎo)原則，詳細(xì)介紹該指導(dǎo)原則的主要內(nèi)容，以期對(duì)我國(guó)藥品供應(yīng)鏈中的企業(yè)發(fā)現(xiàn)和清除非法藥品有參考價(jià)值，對(duì)藥政部門的管理有益。

FDA issued Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry (draft)in October, 2018.The guidance introduces the specific requirements of FDA for enterprises in the drug supply chain to establish illegitimate prescription drug verification system, including quarantine and investigation of suspect products as well as quarantine, disposition, and notification of illegal products, etc. There is no similar guidance at present in our country. The guidance of FDA is introduced in detail, which is of great reference value to the enterprises in the drug supply chain of our country to discover and eliminate the illegitimate drugs, and it is beneficial to the management of the drug administration department in this respect.