首页 > 资讯 > FDA发布一系列配药指南文件

出自识林

2015-02-16 FDA

2月14日FDA发布了一系列共5份指南文件，旨在帮助配药房遵守新的影响药房、联邦机构、外包机构和医生法令、规则和制度。5份指南文件罗列如下，并针对各文件涉及的主要领域做了简要介绍：

• 指南草案：实体根据《联邦食品、药品和化妆品法案》503B节考虑是否注册为外包设施
  

该文件讨论了，企业何时应该或不应该注册为外包药房，取决于设施所实施活动的类型。

• 行业指南草案：某些人用药产品通过配药房和外包设施的重新包装
  

该文件涉及已获批药品的重新包装。FDA正发布指南说明计划如何解决在州政府许可药房、联邦设施或外包设施实施的重新包装问题。

• 行业指南草案：生物制品在已获批生物制品许可申请（BLA）范围外的混合、稀释或重新包装
  

“该指南草案说明了，当州政府许可药房、联邦设施或外包设施在没有已获批BLA的情况下，混合、稀释或重新包装特殊生物制品时，或当这类设施或医生在没有已获批BLA的情况下，配置致敏物处方集（用于治疗过敏）时，依据何种条件，FDA不会采取违反公共健康服务法案（PHS法案）和FD&C法案的行动。”请注意，在已获批BLA的标签规定范围外混合、稀释或重新包装生物制品，被认为是未经批准的药品，需要在其自己的BLA下获批。

• 行业指南草案：根据《联邦食品、药品和化妆品法案》503B节的外包设施不良反应报告
  

外包配药设施必须符合不良反应（ADE）报告要求，该指南文件解释了对于这类设施的ADE报告制度。
该草案已于，2015年10月定稿。

• 州和美国食品药品管理局有关某些人用药配药产品分销的合作备忘录草案（MOU）
  

该文件说明了签署MOU的州所承担的责任，包括有关调查投诉，监控运输产品到州外和在州内过量分销产品的配药设施。

任何涉及配药、重新包装和外包的设施应认真研读这些文件内容，因为配药是一个高风险领域，且近几年FDA已经显示了其意义重大的执法行动。FDA相关新闻稿请见此处。

Lachman CONSULTANTS - Bob Pollock先生 2015-02-13
编译：识林-椒 2015-02-16
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Trying Not to Compound the Problem – FDA Releases a Series of Guidance/ Policy Documents
Written by Bob Pollock • February 13, 2015

Today, FDA released a set of 5 guidance documents designed to help compounders comply with new statutes, rules and regulations that can impact pharmacies, federal facilities, outsourcing facilities and physicians. The 5 guidance documents are listed below and the major areas they address are described briefly:

• Draft Guidance: For Entities Considering Whether to Register As Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act
  

This document discusses when a firm should or should not register as an outsourcing pharmacy depending on the type of activities conducted by the facility

• Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
  

This document addresses repackaging of already approved drugs. FDA is issuing guidance to describe how it intends to address repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility.

• Draft Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (BLA)
  

“The draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and the FD&C Act when state-licensed pharmacies, federal facilities or outsourcing facilities mix, dilute or repackage specific biological products without an approved BLA, or when such facilities or physicians prepare prescription sets of allergenic extracts (used to treat allergies) without an approved BLA.” Note that a biologic product that is mixed, diluted or repackaged outside of the express provisions of the approved BLA is considered an unapproved drug that requires approval under its own BLA.

• Draft Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act
  

This may seem too obvious, but outsourcing compounding facilities must meet adverse event (ADE) reporting requirements, and this guidance document explains the ADE reporting scheme for such facilities.

• Draft Memorandum of Understanding Between A State and the U.S. Food and Drug Administration Addressing Certain Distributions of Compounded Human Drug Products
  

This document describes the responsibilities of the states that sign the MOU in regard to investigation of complaints and monitoring of compounding facilities that ship product out of state and those that dispense inordinate amounts of product intrastate.

Anyone involved in compounding, repackaging, and outsourcing facilities should be well versed in the content of these documents, as compounding is a high priority risk area that FDA has shown significant enforcement action in recent years. The full set of documents along with the FDA press release on their issuance can be found here.