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From the Food and Drug Administration
May 6, 1998

New Rule Proposed for Home Drug Abuse Test Kits

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JAMA. 1998;279(17):1339. doi:10.1001/jama.279.17.1339

The FDA has issued for public comment a proposed rule that would make it easier for manufacturers to market over-the-counter (OTC) drug abuse specimen collection kits, while ensuring that safeguards are in place so the kits are accurate and reliable for use in a nonprofessional setting. The home drug abuse test kits are sold directly to the general public, employers, and insurance companies for use in collecting and mailing a urine specimen to a designated laboratory to test for drugs of abuse. The results are communicated by telephone by the product's manufacturer to the person who sent in the specimen. The proposed rule implements existing FDA policy.

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