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Fexofenadine Hydrochloride and Fexofenadine Hydrochloride Capsules

Type of Posting: Revision Bulletin: POSTPONEMENT

Posting Date: 06–Apr–2005

USP has postponed indefinitely the official dates of the Fexofenadine Hydrochloride and Fexofenadine Hydrochloride Capsules monographs, which were published in the First Supplement to USP 28–NF 23 on pages 3227 and 3228 respectively. These monographs were originally slated to become official on April 1, 2005. The postponements are to provide additional time to further evaluate some of the tests, procedures, and acceptance criteria provided in the proposed monographs.

The Pharmaceutical Analysis 1 Expert Committee is presently reviewing comments received concerning these monographs. The USP intends to publish, if necessary, additional proposed revisions in a future issue of Pharmacopeial Forum for further public review and comment. USP proposes that these monograph revisions go forward to official text once the public comments have been considered.

Should you have any questions, please contact Karen A. Russo, Ph.D., Associate Director Noncomplex Actives and Excipients and liaison to the Pharmaceutical Analysis 1 Expert Committee (301-816-8379 or kar@usp.org).