Type of Posting: Notice of Intent to Revise
Posting Date: 03-Feb–2025
Targeted Official Date: 01–Aug–2025
Expert Committee: Various
In accordance with the 2020–2025 Rules and Procedures of the Council of Experts, this Compendial Notice is to indicate that USP and its Expert Committees, as applicable, intend to revise four General Chapters following a revision of General Notices and Requirements, 5.60. Impurities and Contaminants in Official Articles.
The aforementioned revision to General Notices and Requirements was proposed for comment in PF 50(2) and will become official on August 1, 2025. USP has identified four General Chapters containing references to General Notices and Requirements that are impacted by the revisions in PF 50(2). These references were updated on Feb. 3, 2025, and become official on August 1, 2025.
The impacted standards are as follows:
- <1> INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS
- <2> ORAL DRUG PRODUCTS—PRODUCT QUALITY TESTS
- <4> MUCOSAL DRUG PRODUCTS—PRODUCT QUALITY TESTS
- <1086> IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS
Interested stakeholders are encouraged to alert USP staff to any impact they recognize related to the update of those monographs.
Should you have any questions or comments, please contact Gabriel I. Giancaspro, Distinguished Scientific Fellow (gig@usp.org), or the affected monograph’s liaisons.