OTC drugs of abuse tests
This article was originally published in The Tan Sheet
Executive Summary
FDA's proposed rule to reclassify OTC sample collection systems for drugs of abuse test kits will be discussed at a public hearing June 19. Under the March 5 proposed rule, urine sample collection systems for OTC drugs of abuse testing would be downclassified from Class III to Class I and exempted from premarket review ("The Tan Sheet" March 9, p. 14). Slated from 9 a.m. to 5 p.m. at 5600 Fishers Lane, conference rooms D and E, Rockville, Md., the one-day meeting is intended to "solicit input on the proposed rule in addition to comments being submitted to the docket," FDA says...