동향
동향 내용
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
분류 GMP, Guidance 조회 2723
발행년도 2015 등록일 2015-10-02
출처 FDA (바로가기)
This guidance sets forth the Food and Drug Administration’s (“FDA” or “the Agency”) policy regarding repackaging by state-licensed pharmacies, Federal facilities, and facilities that register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act).
 
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리스트 이전글과 다음글
이전글이전글 Mixing, Diluting, or Repackiaging Biological Products Outside the Scope of an Approved Biologics
다음글다음글 Request for Quality Metrics Guidance for Industry