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General Chapter <1> Injections: Labeling on Ferrules and Cap Overseals

Type of Posting: General Announcement

Posting Date: 08–May–2009

USP announces that the Nomenclature Expert Committee will be reviewing and considering possible changes to the "Labeling on Ferrules and Cap Overseals" section of General Chapter <1> Injections in the United States Pharmacopeia (USP) at its next meeting, June 29–30, 2009. There will be both open and closed sessions on this topic during the meeting, and USP will announce the agenda for the meeting through the calendar section of the USP website to enable observer participation at the meeting.

The standard is stated in a section of General Chapter Injections <1> published in USP 32. Pursuant to a General Chapter <1> Injections Revision Bulletin dated August 22, 2008, the official date of the standard was postponed to May 10, 2010.

The review of the section of General Chapter Injections <1> is the result of continuing interest by USP in advancing an optimal labeling standard that promotes safe medication use through cautionary statements while recognizing the potential need to provide additional useful information on ferrules and cap overseals. USP and the Nomenclature Expert Committee will continue to collaborate on this standard with the Food and Drug Administration, other involved Expert Committees of the Council of Experts, and interested stakeholders.

Should the Nomenclature Expert Committee reach a decision to change the standard, USP intends to provide stakeholders with a period of at least twelve (12) months before the standard becomes official to allow sufficient time for implementation.

Should you have any questions, please contact Shawn C. Becker, M.S., R.N., Director, Healthcare Quality and Safety (