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Fosphenytoin Sodium Injection

Type of Posting: Revision Bulletin

Posting Date: 30–Jan–2015

Official Date: 01–Feb–2015

Expert Committee: Monographs—Small Molecules 4

Reason for Revision: Safety, Urgent

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Fosphenytoin Sodium Injection monograph. The purpose for the revision is to remove the word “prominently” from the Labeling section of the monograph per request of the U.S. FDA.

The Fosphenytoin Sodium Injection Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 38–NF 33.

Should you have any questions, please contact Heather Joyce, Ph.D., (301–998–6792 or hrj@usp.org).