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Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, and Carbomer 1342

Type of Posting: Notice of Intent to Revise
Posting Date: 18-Nov-2022
Targeted Official Date:01-Aug-2025; USP-NF 2025 Issue 2
Expert Committee: Complex Excipients

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Complex Excipients Expert Committee (EC) intends to omit the Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, and Carbomer 1342 monographs, with a targeted official date of August 1, 2025.  These are documentary standards for carbomers manufactured with the use of benzene.

The proposed omissions are consistent with a request documented in a letter from the U.S. Food and Drug Administration dated November 1, 2022, that describes concern about the use of benzene, one of the Class 1 solvents, in manufacturing of these excipients. The proposed omissions are also consistent with the concerns described by FDA in a communication titled: “FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs” released on June 9, 2022, in which FDA provided a list of products, mostly hand sanitizers and aerosols drug products (sunscreens, deodorants, and antiperspirants), that “have been recalled due to benzene contamination” and asked USP to omit the above-mentioned carbomer monographs that “allow for levels of benzene of 100 ppm or greater.” The proposed omissions would address FDA’s safety concerns associated with these specified levels of benzene in their communication.

The Complex Excipients EC convened a Steering Committee of impacted stakeholders including application and nonapplication drug manufacturers/organizations, carefully reviewed the FDA request for omission of the above-mentioned carbomer monographs and assessed the potential impact of the omissions on application and nonapplication drug products, including an assessment of time necessary to switch to non-benzene containing carbomers. The EC looked at the number of products that use these carbomers, possible timelines for reformulation and changing the label information of impacted application and nonapplication drug products (stakeholder input). The EC also considered the points raised by FDA in its letter dated November 1, 2022. In the letter FDA requested that the monographs be omitted by 2025 to address the FDA’s safety concerns.  

The EC aims to publish the omission proposals for Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, and Carbomer 1342 monographs in PF 49(2) [Mar. – Apr. 2023] with a targeted official date of August 1, 2025, giving stakeholders a one-year period for extended implementation. The EC believes that the targeted official date will provide the time needed for manufacturers and users to make necessary changes. The information about the targeted official date will also be provided in the monograph proposals. 

USP encourages stakeholders to comment on the proposed monograph omissions and provide feedback on any impact that may result from these proposed omissions and the proposed implementation timeline by May 31, 2023. Please direct any such feedback to the email address below.

Should you have any questions, please contact Galina Holloway, Principal Scientist (