Type of Posting: Notice of Intent to Revise
Posting Date: 30–Apr–2010
Official Date: Interim Revision Announcement in PF 36(6)
Expert Committee: Monograph Development–Ophthalmology, Oncology, and Dermatology
In accordance with the 2005–2010 Rules and Procedures of the Council of Experts the Monograph Development—Ophthalmology, Oncology, and Dermatology Expert Committee, at the recommendation of the Safe Medication Use Expert Committee, intends to revise the labeling of Vincristine Sulfate Injection and Vincristine Sulfate for Injection monographs to harmonize with the World Health Organization’s (WHO) recent labeling changes. WHO changed their standards based on reported deaths due to confusion about and the resultant injection of these anticancer drugs directly into the spine (intrathecally) instead of the vein (intravenously). The revised monograph labeling will now say "For Intravenous Use Only – Fatal if Given by Other Routes."
This revision proposal will be published as a proposed Interim Revision Announcement in Pharmacopeial Forum (PF) 36(4) July–August 2010. The comment period for this proposal will be from July 1 through August 30, 2010. This revision would normally become official in the Interim Revision Announcement that appears in PF 36(6) November–December 2010.
USP is seeking advice from manufacturers on the official date of the labeling change for this important yet potentially dangerous medication. If manufacturers are already complying with the WHO standards, USP would like to use the December 1, 2010 official date that would result from the November–December 2010 publishing in PF. If not, USP would like manufacturers to indicate how much time they would need to implement this urgent patient safety labeling change. The official date will be published in PF 36(4) with the proposed IRA. Submit this information to Ms. Shawn Becker at the e-mail address below.
Should you have any questions, please contact Feiwen Mao, M.S., Scientific Liaison to the Monograph Development: Ophthalmology, Oncology, and Dermatology Expert Committee (301-816-8320 or fm@usp.org) or Shawn C. Becker, M.S., R.N., Director, Healthcare Quality Standards and Liaison to the Safe Medication Use Expert Committee (301-816-8216 or scb@usp.org).