FDA发布含苯生产卡波姆药品重新配方的最终指南FDA-2023-D-5408
Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
FDA发布最终指南FDA-2023-D-5408，为使用以苯生产的卡波姆的药品重新配方提供应做检测及应提交或备查资料的建议。指南指出部分美国药典卡波姆各论目前允许不可接受的苯水平并引发安全担忧，FDA已要求USP删除这些各论，申请人和生产商可能需要重新配方。指南结合受影响药品的不同给药途径和剂型给出建议，并为申请持有人列出通报此类变更的适当提交类型。
指南说明部分美国药典卡波姆各论允许的苯水平带来的安全关注，并列出重新配方所需的检测与提交资料方向。
GUIDANCE DOCUMENT
Final Level 1 Guidance
- Docket Number:
- FDA-2023-D-5408
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
The purpose of this guidance is to provide recommendations for applicants and manufacturers on what tests should be performed and what documentation should be submitted or available to FDA to support the reformulation of drug products that use carbomers manufactured with benzene. Certain United States Pharmacopeia (USP) carbomer monographs currently allow for unacceptable levels of benzene, which raises safety concerns. FDA has requested that the USP omit (or remove) these monographs, and applicants and manufacturers may need to reformulate their drug products to avoid using these carbomers. This guidance provides recommendations for testing and documentation related to reformulation, taking into consideration the various routes of administration and dosage forms of affected drug products. For application holders, this guidance also recommends appropriate submission types to notify the Agency of such changes.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2023-D-5408.
来源：FDA Pharmaceutical Quality Documents · fda.gov