5/15付（5/19付追記更新）GMP Platformトピック「米国FDA／医薬品供給を確保しながら医薬品調剤に取り組む州間の覚書を締結を頑張ります。 」でお伝えした、米国内の医薬品調剤の州間覚書に関して。
10/26付で米国FDAから、この件に関する「Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products 」と題して覚書が発出されています。
同時に、10/27付発効のFederal Register「Memorandum of Understanding: Certain Distributions of Compounded Human Drug Products between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration」が出ています。
合せて、10/26付でFDA長官よるFDA in Brief「FDA Announces Significant Milestone in Compounding Program to Protect Public Health Through Collaboration with States」がでいます。
また本件について、10/26付のRAPSが「FDA-state compounding MOU now available for signing 」と題して記事に取り上げています。
本邦にはあまり関係しませんが、一部の関係者および興味のある方は、下記URLsの通知等をご参照ください。
l10/26付「Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products」
https://www.fda.gov/media/143283/download
l10/26付FDA in Brief「FDA Announces Significant Milestone in Compounding Program to Protect Public Health Through Collaboration with States」
https://www.fda.gov/news-events/fda-brief/fda-brief-fda-announces-significant-milestone-compounding-program-protect-public-health-through
l10/27発効Federal Register「Memorandum of Understanding: Certain Distributions of Compounded Human Drug Products between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration」
https://www.federalregister.gov/public-inspection/2020-23687/memorandum-of-understanding-certain-distributions-of-compounded-human-drug-products-between-the
l10/26付RAPS「FDA-state compounding MOU now available for signing」
https://www.raps.org/news-and-articles/news-articles/2020/10/fda-state-compounding-mou-now-available-for-signin
10/26付で米国FDAから、この件に関する「Memoran
同時に、10/27付発効のFederal Register「Memorandum of Understanding: Certain Distributions of Compounded Human Drug Products between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration」が出ています。
合せて、10/26付でFDA長官よるFDA in Brief「FDA Announces Significant Milestone in Compounding Program to Protect Public Health Through Collaboration with States」がでいます。
また本件について、10/26付のRAPSが「FDA-
本邦にはあまり関係しませんが、一部の関係者および興味のある方
l10/26付「Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products」
https://www.fda.gov/media/
l10/26付FDA in Brief「FDA Announces Significant Milestone in Compounding Program to Protect Public Health Through Collaboration with States」
https://www.fda.gov/news-
l10/27発効Federal Register「Memorandum of Understanding: Certain Distributions of Compounded Human Drug Products between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration」
https://www.federalregister.
l10/26付RAPS「FDA-state compounding MOU now available for signing」
https://www.raps.org/news-and-
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