首页 > 资讯 > 单个患者使用 – 肠道外药品的新标签术语

出自识林

2015-10-21 Lachman CONSULTANTS

FDA发布新的指南草案，题为《人用多剂量、单剂量和单个患者使用包装的注射药品标签之合适包装类型术语的选择和建议》。这份指南草案增加了FDA长期用于肠道外产品的两个具体术语 – 单剂量容器和多剂量容器，但调整了这些术语，修订定义如下：

单剂量容器：单剂量容器是无菌药品用于肠道外给药（注射或输注），不需满足抗菌效能试验要求的容器。单剂量容器设计用于单个患者单次注射/输注。当空间允许时，单剂量容器应按此标识，并应在标签上包括适当的丢弃声明。单剂量容器举例有：小瓶、安瓿和预充针。

多剂量容器：多剂量容器是无菌药品用于肠道外给药（注射或输注），已满足抗菌效能试验要求的容器，或根据FDA规定排除这类试验要求的容器。多剂量容器用于盛纳一个剂量以上的药品。当空间允许时，多剂量容器应按此标识。多剂量容器通常预期不超过30mL或更少药品。已开封或已输入（例如，针穿孔）的多剂量容器使用期限是28天，除非生产商在标签上另有规定。多剂量容器举例有：小瓶。

由于长期不恰当使用一些肠道外产品已导致显著的不良卫生事件（指南文件中有陈述），FDA推出一个新的名词 – 单个患者使用容器 – 更准确地描述了对于多剂量但应仅用于单个患者的产品的使用。

单个患者使用容器：单个患者使用容器是无菌药品用于肠道外给药（注射或输注），对单个患者多次使用的容器。当空间允许时，单个患者使用容器应按此标识，并应在标签上包括适当的丢弃声明。单个患者使用容器举例有：患者自控镇痛盒和某些注射笔。

对于包装类型指定的变更，NDA和BLA的递交类型与ANDA不同。除了从“一次性使用”到“单剂量”的变更可以在年报中递交，其它根据本指南对NDA和BLA的变更必须递交已获批申请的补充申请。经批准，ANDA申请人可以在CBE-0中提交变更。

Lachman CONSULTANTS - Bob Pollock先生 2015-10-22
编译：识林-椒
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Single Patient Use – A New Label Term for Parenteral Products
By Bob Pollock | October 21, 2015 原文地址

FDA published a new draft Guidance (with a name that might take up half of this blog post) entitled, “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use”. Go ahead- say THAT in one breath!

Anyway, this draft Guidance adds to the two specific terms that FDA has long use for parenteral products – single-dose container and multiple-dose container- but they have even tweaked those terms and now define them as follows:

Single-Dose Container: A single-dose container is a container of a sterile medication for parenteral administration (injection or infusion) that is not required to meet the antimicrobial effectiveness testing requirements. A single-dose container is designed for use with a single patient as a single injection/infusion. When space permits, a single-dose container is labeled as such and should include on the label appropriate discard statements. Examples of single-dose containers are vials, ampules, and prefilled syringes.

Multiple-Dose Container: A multiple-dose container is a container of a sterile medication for parenteral administration (injection or infusion) that has met antimicrobial effectiveness testing requirements, or is excluded from such testing requirements by FDA regulation. A multiple-dose container is intended to contain more than one dose of the drug product. When space permits, a multiple-dose container is labeled as such. Multiple-dose containers are generally expected to contain 30 mL or less of medication. The beyond-use date for an opened or entered (e.g., needle-punctured) multiple-dose container is 28 days, unless otherwise specified by the manufacturer in the label. An example of a multiple-dose container is a vial.

Due to the long history of inappropriate use of some parenteral products that have resulted in significant adverse health events (as described in the Guidance document), the Agency is introducing a new term – Single Patient Use Container – that more accurately describes the use of a product that has multiple doses, but should be used only for a single patient.

Single-Patient-Use Container: A single-patient-use container is a container of a sterile medication for parenteral administration (injection or infusion) that is intended to be used multiple times for a single patient. When space permits, a single-patient-use container is labeled as such and should include on the label appropriate discard statements. Examples of single-patient-use containers are patient controlled analgesia cartridges and certain pens for injection.

The types of submissions differ for NDAs and BLAs than for ANDAs for changes to package type designation. With the exception of the change from “single use” to “single dose,” which may be submitted in an Annual Report, other changes under this Guidance for NDAs and BLAs must be submitted as Prior Approval Supplements. Following approval, ANDA applicants may submit the change in a CBE-0. To view the draft Guidance in its entirety, please click here.