FDA发布用于配药的待包装原料药定稿指南
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FDA发布用于配药的待包装原料药定稿指南
笔记 2016-06-12 Lachman CONSULTANTS 【相关资讯】：FDA发布待包装原料药用于配药的临时执法政策 2015-10-27 随着大量活动仍围绕着配药药房和外包设施，以及执法行动仍在增加，6月9日FDA发布两份定稿指南文件描述了可以根据503A（药房）和503B（外包设施）用于配药而不采取FDA执法行动的待包装原料药类型（FDA官网通知）。指南文件假设设施按照州或联邦机构的相应控制运营。 指南对于根据503A和503B用于配药的待包装原料药描述了以下三类待包装产品： 类别1 – 这些原料药符合列入根据503A或503B用于配药的待包装原料药列表的条件，拥有充分的信息供评估这些原料药并且此时在配药时没有出现显著安全性风险而被提名。FDA不打算对根据503A或503B（以适用为准）使用类别1所列待包装原料药配药的配药机构采取行动，类别1所列待包装原料药提供了满足指南文件和其它FD&C法案相关要求的条件。 类别2 – 这些待包装原料药拥有充分的支持信息供FDA评估而被提名，但会引发显著的安全性问题，不符合适用于类别1的原料药的政策。除非FDA发布最终规定（503A (b)(1)(A)(i)(III)）或最终联邦公报通告（503B(a)(2)(A)）准许特定原料药在配药中使用，这些待包装原料药不能用于配药。请参见FDA网页：与提名用于配药的某些待包装原料药相关的安全性风险，查看原料药清单和已识别安全性风险概述。 类别3 – 这些待包装原料药被提名列入待包装原料药清单，没有充分的支持性信息供FDA评估，不符合适用于类别1的原料药政策。这些待包装原料药不能用于配药，并且除非原料药拥有充分的支持性信息通过以下卷宗被重新提名，FDA将不会考虑这些待包装原料药。
Lachman CONSULTANTS - Bob Pollock先生 Compounding Guidance Finalized by FDA With much activity still surrounding compounding pharmacies and outsourcing facilities, and with enforcement action still on the rise, today FDA issued two final Guidance documents that describe the types of bulk drug substances that can be used for compounding for section 503A (pharmacies) and 503B (outsourcing facilities) without FDA enforcement action. This also obviously assumes that the facility is operating in accordance with the appropriate controls by state or federal agencies. The Guidance on bulk substances for compounding under section 503A (here Category 1 – These substances may be eligible for inclusion on the list of bulk drug substances that can be used in compounding under section 503A or 503B, were nominated with sufficient information for FDA to evaluate them and do not appear to present a significant safety risk in compounding at this time. FDA does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in Category 1 of either 503A or 503B, whichever is applicable, provided that the conditions described in the guidance documents and all other applicable requirements of the FD&C Act are met. Category 2 – These are bulk drug substances that were nominated with sufficient supporting information for FDA to evaluate them, but raise significant safety concerns, and are not eligible for the policy that applies to substances in Category 1. These bulk drug substances cannot be used in compounding unless FDA publishes a final rule (section 503A (b)(1)(A)(i)(III)) or final Federal Register notice (section 503B(a)(2)(A)) authorizing the particular substance's use in compounding. See Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding for a list of the substances and a summary of the identified safety risks. Category 3 – These are bulk drug substances that were nominated for inclusion on the bulk drug substances lists without sufficient supporting information for FDA to evaluate them and are not eligible for the policy that applies to substances in Category 1. These bulk drug substances cannot be used in compounding, and FDA will not consider them for the bulk drug substances lists unless the substances are re-nominated with sufficient supporting information through the following dockets:
Other information specific to 503A and 503B can be gleaned from the two Guidance documents referenced above. Also please see the FDA notice announcing the availability of these final Guidance documents describing the FDA's interim policy here. |
) and those that are permissible under section 503B (