FDA 发布 503B 条款下人用药品配制外包设施 CGMP 修订草案指南

Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

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FDA 发布 503B 条款下人用药品配制外包设施 CGMP 指南修订草案，文件属 Level 1 草案、不用于实施且仅为非约束性建议。修订基于利益相关方反馈和初始草案的评议意见，部分体现为结合外包设施的运营规模与范围来考虑 CGMP 要求的适用。评议可通过 Docket FDA-2014-D-0779 随时提交。

推荐理由

该修订草案说明 FDA 在 CGMP 要求适用上进一步考虑外包设施的运营规模与范围，可用于对照初始草案核对变化。

正文 · 原文

GUIDANCE DOCUMENT

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:

FDA-2014-D-0779

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” This revised draft guidance describes FDA's policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations. Based on feedback from stakeholders and comments received on the initial draft guidance, the guidance is being revised, in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility's operations.

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-0779.