FDA exempts l-desoxyephedrine from final rule exemption while USP completes monograph.
This article was originally published in The Tan Sheet
Executive Summary
FDA EXEMPTS L-DESOXYEPHEDRINE FROM NASAL DECONGESTANT FINAL RULE until Dec. 31, 1996 while the U.S. Pharmacopeia completes a monograph for the ingredient. Responding to an Aug. 2 citizen petition from Leiner Health Products requesting the stay, OTC Monograph Review Staff Director William Gilbertson, PharmD, in an Aug. 31 letter, called the petition "reasonable" and said the effective date would be delayed "to permit time for USP processing."