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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.
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