FDA 发布州许可药房与外包设施重新包装特定人用药品的正式指南

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

AI 导读

FDA 发布正式指南，说明州许可药房、联邦设施和 503B 外包设施重新包装人用处方药时，FDA 在哪些条件下不拟对违反特定条款的行为采取行动。该指南于 2017 年 1 月发布，文件编号为 FDA-2014-D-1524，涉及 FD&C Act 第 505、502(f)(1)、582 条及特定情形下的第 501(a)(2)(B) 条。

推荐理由

文件列出了 FDA 对州许可药房、联邦设施和 503B 外包设施重新包装人用处方药不拟采取执法行动的条件，可用于核对适用对象与条款范围。

正文 · 原文

GUIDANCE DOCUMENT

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities Guidance for Industry January 2017

Final

Docket Number:

FDA-2014-D-1524

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This guidance sets forth the FDA's policy regarding repackaging by State-licensed pha1macies, 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). This guidance describes the conditions under which FDA does not intend to take action for violations of sections 505, 502(f)(l ), 582, and where specified, section 501(a)(2)(B) of the Act, when a State licensed pharmacy, a Federal facility, or an outsourcing facility repackages human prescription drug products.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-1524.