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:
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
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.
“The draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and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.
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.
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.
【文件概要】
该文件依据《联邦食品、药品和化妆品法案》（FD&C法案）第503B章节，针对注册为外包设施（outsourcing facilities）的药品配制企业提出不良事件报告要求。指南规定外包设施必须按照21 CFR 310.305的内容和格式要求，向FDA报告与其配制的处方药相关的所有严重且非预期的不良药物事件（serious, unexpected adverse drug experiences）。报告需包含四个核心数据要素：可识别患者、可识别报告者、可疑药品和严重不良事件，并在15个日历日内提交初始报告。指南还建议（非强制）报告所有严重不良事件（无论预期与否），以帮助识别潜在产品质量问题。外包设施需通过电子途径（安全报告门户SRP或电子提交网关ESG）提交报告，并保留相关记录10年供FDA审查。FDA可通过检查验证合规性，未报告不良事件将构成FD&C法案下的禁止行为。
