首页 > 资讯 > FDA发布待包装原料药用于配药的临时执法政策

出自识林

2015-10-27 Lachman CONSULTANTS

FDA今日发布两份指南规定，关于在外包设施和/或配药房使用待包装原料药时的临时执法政策。FDA还明确了在药品配药中可用的待包装原料药清单的历史沿革，说明了其在联邦食品药品和化妆品法案503A（对待配药房）和503B（对待外包设施）下关于药品配药的临时执法政策。两份指南见Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act，Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act。

503A和503B待包装原料药必须在FDA已获批药品或在适当的NF专论的USP标准中。如果没有，待包装原料药必须出现在指定列表上。在503A药品的情况下，药房配药委员会还必须权衡包含在清单上的未包装原料药的可接受性。

FDA已要求提名符合法案503A和503B两节配药的包含在待包装原料药清单上的药品，并将已提名的包含在清单中的药品（除现包含在FDA已获批药品或适当的NF专论的USP标准中的待包装原料药）分成四类。

表单1 – 有可以用于评估药品是否可以配药的充分信息递交到FDA的待包装原料药（指南文件中有概述标准）
表单2 – 引发安全问题的待包装原料药
表单3 – 没有充分支持的已提名待包装原料药
表单4 – FDA已确定不得用于配药的待包装原料药

FDA还没有最终敲定这些清单，所以临时政策被用于防止破坏患者获得所需产品。

底线是，除包含FDA已获批药品或适当的NF专论的USP标准的待包装原料药的配药药品，在FDA最终决定之前，如果503A或503B提名的待包装原料药的药品出现在表单1上，FDA将行使强制执法自由裁量权。此外，所有未包装原料药原始必须在FDCA 510下注册的并且拥有有效分析报告单的设施中生产。使用这些未包装原料药的配药药品还必须分别符合所有其它FDCA 503A或503B申请要求。

此时，FDA期望没有表单2-4中列出的未包装原料药用于配药。FDA清单请见：503A清单，503B清单。

有了这份指南，配药药房和外包设施现在可能可以更好的了解他们可以在配药操作中使用哪些未包装原料药而不会引发FDA的执法行动，至少目前是这样。

Lachman CONSULTANTS - Bob Pollock先生 2015-10-27
编译：识林-椒
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To Compound or Not to Compound? That is the Question!
By Bob Pollock | October 26, 2015

FDA has issued two guidance documents today (here) and (here) that outline the FDA’s interim enforcement policy relative to the use of bulk drug substances in outsourcing facilities and/or pharmacy compounding. The Agency identifies the historical evolution of the list of bulk drug substances acceptable for use in the compounding of drug products and has described its interim enforcement policy regarding drugs compounded under Section 503 A (dealing with pharmacy compounding) and Section 503 B (dealing with outsourcing facilities) of the Federal Food Drug and Cosmetic Act.

503 A and 503 B bulk drug substances must either be found in an FDA approved drug product or in an applicable USP of NF monograph. If not, the bulk drug substance must appear on a specified list. In the case of the 503 A drugs, a pharmacy compounding advisory committee must also weigh in on the bulk drug’s acceptability for inclusion on the list.

FDA has asked for nominations for drugs to be included on the bulk API lists for both drugs subject to compounding under both sections of the Act and has broken down the drugs nominated for inclusion in those lists (with the exception of bulk drug substances currently contained in FDA approved drug products or for which there is an applicable USP or NF monograph) into four categories.

List 1 – bulk drug substances for which there is adequate information submitted to the Agency for evaluation as to whether the drug may be compounded (criteria outlined in the guidance documents)
List 2 – bulk drug substances which raise safety concerns
List 3 – bulk drug substances nominated without adequate support
List 4 – bulk drug substances for which the FDA has already made a determination that may not be used in compounding.

The FDA has not yet finalized these lists, so an interim policy is being used to prevent disruption to patient access to needed products.

The bottom line is that in addition to compounded drugs that contain bulk drug substances that are already contained in FDA approved products or that have an appropriate USP or NF monograph, FDA will exercise enforcement discretion if the drugs appear on List 1 of the 503 A or 503 B nominated bulk drug substances prior to FDA’s final determinations. In addition, all bulk drug substances must be originally manufactured in a facility that is registered under 510 of the Act and is accompanied by a valid Certificate of Analysis (COA). The compounded product using the bulk drug substance must also meet all other application requirements for Section 503 A or Section 503 B of the Act, respectively.

FDA expects that no bulk drug substance on lists 2-4 may be used in compounding at this time. The FDA lists may be found here for section 503 A and here for section 503 B.

With this guidance, compounding pharmacies and outsourcing facilities may now have a better picture of what bulk drug substances they can use in their compounding operations without FDA enforcement action – at least for now!