OTC drugs of abuse urine test kits downclassified under FDA proposal.
This article was originally published in The Tan Sheet
Executive Summary
OTC URINE SAMPLE DRUG TEST KITS CLASS I 510(k)-EXEMPT UNDER FDA PROPOSAL to downclassify the home collection urine sampling kits for drugs of abuse testing published in the March 5 Federal Register. To help manufacturers meet labeling requirements, FDA "plans to develop a guidance on issues such as how to label the test sample collection system so that the consumer can understand the test results and how to ensure that the specimen and the container remain properly identified and intact during mailing to the laboratory." In addition, the guidance would "address methods for providing consumers with adequate professional assistance in interpreting/understanding test results and providing counseling referrals, if needed," the notice states.
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning