Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities | |||
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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).
(후략)
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이전글 | Mixing, Diluting, or Repackiaging Biological Products Outside the Scope of an Approved Biologics |
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다음글 | Request for Quality Metrics Guidance for Industry |