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General Chapters <1> Injections and <788> Particulate Matter in Injections

Type of Posting: Notice of Intent to Revise

Posting Date: 26–Aug–2011

Official Date: <1>: USP 36–NF 31, 01–May–2013; <788>: Revision Bulletin, 01–Oct–2011

Expert Committee: General Chapters—Dosage Forms

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the USP General Chapters—Dosage Forms Expert Committee intends to revise General Chapters <1> Injections and <788> Particulate Matter in Injections to include an exemption for the testing requirement for veterinary products administered through intramuscular and subcutaneous routes. USP is engaged in ongoing discussions regarding animal health products and will consider revising the chapter based on the outcome.

The proposed revision to General Chapter <788> Particulate Matter in Injections will be published as a Revision Bulletin at a date to be determined. The revision to General Chapter <1> Injections is expected to appear as an In-Process Revision in Pharmacopeial Forum 37(6) [Nov–Dec 2011] and become official in USP 36–NF 31 on 01 May 2013. The comment deadline for this proposal will be 31 Jan 2012.

Should you have any questions, please contact Desmond Hunt (301-816-8341 or