Pseudoephedrine citizen petition
This article was originally published in The Tan Sheet
Executive Summary
FDA is "unable to provide a response...at this time" to Pharmacists Planning Service's petition requesting the agency switch pseudoephedrine to a "pharmacists-only" drug class requiring consultation, patient history review, identification and registration for purchase. In a FDL-1letter dated Dec. 9, Center for Drug Evaluation & Research Director Steve Galson, MD, acknowledges failing to provide an answer within FDA's standard 180-day review period, but says the agency will respond "as soon as we have made a decision on your request." PPS, a non-profit advocacy group, submitted the petition June 23 based on claims the drug is used as a performance enhancer, citing its pharmacological relationship to ephedrine (1"The Tan Sheet" Aug. 9, 2004, p. 6)...