留在家里 / 我的图书馆 / 20170830 ECA新闻:FDA对单位剂量重新包装...

0 0


20170830 ECA新闻:FDA对单位剂量重新包装的固体口服剂型有效期计算指南草案

2017-10-23  留在家里


FDA Draft Guidance on Expiration Dating ofUnit-Dose repackaged Solid Oral Dosage Forms


The U.S. Food and Drug Administration(FDA) proposed to tighten the previously proposed expirationdates for oral solid drugs from one year to just six months after they arerepackaged into unit doses, except under certain circumstances. This is inline with USP (United States Pharmacopeia) standards on expiration dating.


The FDA states that this action was taken in responseto 'an increasing demand in various health care settings for solid oraldosage form drug products repackaged into unit-dose containers, which hold aquantity of drug for administration as a single dose. The increase in unit-doserepackaging has led to questions regarding stability studies and appropriateexpiration dates for these repackaged products'.


The draft guideline Expiration Datingof Unit-Dose Repackaged Solid Oral Dosage Form Drug Products was announced on August 8, 2017, and replaces thedraft guidance for industry Expiration Datingof Unit-Dose Repackaged Drugs: Compliance Policy Guide (2005). In addition, once final, it will supersede Compliance PolicyGuide 480.200 Expiration Dating of Unit-Dose Repackaged Drugs (1995). Comments regarding the draft document should besubmitted within 60 days of publication.


In the previous draft guidance on expiration datingissued in May 2005, the FDA had proposed to set the expiration date for nonsterile,unit-dose repackaged drugs to one year, which was also aligned with USPstandards at the time for beyond use dating for unit-dose repackaging bydispensers.


According to the FDA, the present draft guidance'addresses repackaging of prescription and over-the-counter solidoral dosage form drugs into unit-dose containers by commercialpharmaceutical repackaging firms that are required to register with FDAunder section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)and to comply with current good manufacturing practice (cGMP) regulations in 21CFR parts 210 and 211'.


The 7-paged guidance does not cover


  • Other dosage forms (e.g., sterile, liquid, topical),

  • 其它剂型(例如,无菌、液体、局部)

  • Products repackaged by State-licensed pharmacies, Federal facilities,     and outsourcing facilities as defined under section 503B of the FD&C     Act.

  • 由国家批准的药房、联邦场所和FDCA503B部分定义的外包场所进行重新包装的药品

Background: 背景

FDA’s cGMP regulations for finished productsrequire that 'each drug product bear an expiration date determined byappropriate stability testing and that the date must be related to any storageconditions stated on the labeling, as determined by stability studies'.Samples used for stability testing must be in the same container-closure systemas the marketed drug to ensure the drug product’s safety and efficacy over itsintended shelf life.


Additionally, United States Pharmacopeia (USP) GeneralChapter <7> Labeling states that “the label of an official drug product …shall bear an expiration date.” For unit-dose repackaged products, USP GeneralChapter <1178> Good Repackaging Practices recommends that the expirationdate “not exceed


  • 6 months from the date of repackaging; or

  • 重新包装日起算6个月;或

  • the manufacturer’s expiration date; or

  • 生产商的有效日期;或

  • 25% of the time between the date of repackaging and the expiration     date shown on the manufacturer’s bulk article container of the drug being     repackaged,

  • 重新包装日与显示在生产商的等分装药品散装容器上标示有效期之间25%的时间

whichever is earlier.” 取其短者

FDA will not enforce certain stability studyrequirements for repackaged drug products in the following cases:


  • if an expiration date that does not exceed 6 months from the date of     repackaging is assigned, or

  • 如果有效期不超过重新包装后6个月;或

  • if 25 percent of the time between the date of repackaging and the     expiration date on the container of the original manufacturer’s product is     used as expiration date, whichever time period is shorter, and if the     following conditions are met:

  • 如果使用重新包装与原始生产商在在容器上给定的药品有效期之间25%时长作为有效期,取其短者,并且符合以下条件时:

  • The unit dose container complies with Class A or Class B standards as     described in USP General Chapter <671> Containers – Performance Testing, “Packaging System     Classification for Single-Unit Containers and Unit-Dose Containers for     Solid Oral Dosage Forms”;

  • 单位剂量容器符合USP通论<671>“容器----性能测试”、“固体口服制剂单位剂量容器和单次剂量容器包装系统分类”中A类或B类标准;

  • The unit-dose repacking container provides light protection equal to     or greater than that of the drug product’s original container closure     system if the drug product is sensitive to light;

  • 药品对光敏感,单位剂量重新包装容器的光保护性能等同或优于药品原始容器包装系统;

  • The drug product’s original container has not been opened before and     the entire contents are repackaged in one operation;

  • 药品的原始容器之前未打开,一个容器中所有药品在一次操作中全部重新包装完成;

  • Repackaging and storage occur in an environment that is consistent     with the conditions described in the original drug product’s labeling     (e.g. temperature and humidity, otherwise, if not specified in the     original labeling, refer to definitions for “controlled room temperature”     and “dry place” in USP <659> Packaging and Storage Requirements);     and

  • 重新包装和存贮的环境与原始药品的标示所述条件一致(例如,温度和湿度,如原始标签未指定,可参见USP<659>“包装和存贮要求”中“受控室温”和“干燥处”的定义);以及

  • The drug product’s labeling does not caution against repackaging.

  • 药品的标示没有重新包装注意事项。

The FDA also proposes to permit the expiration date toexceed the ones described above, provided the above-listed conditions aremet and if repackagers have supportive data from appropriate studies (includinga risk-based assessment), using an adequate number of samples. Thesesamples need to demonstrate that the container closure system used forrepackaging is at least as protective for the drug product as the originalpackaging. However, 'the expiration date of the repackaged product doesnot exceed the original manufacturer’s expiration date'


    本站是提供个人知识管理的网络存储空间,所有内容均由用户发布,不代表本站观点。如发现有害或侵权内容,请点击这里 或 拨打24小时举报电话:4000070609 与我们联系。




    请遵守用户 评论公约

    类似文章 更多
    喜欢该文的人也喜欢 更多