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JAMA. 1998;279:1339.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Under the proposed rule, the agency will allow companies to market OTC drug abuse specimen collection kits without first obtaining premarket approval or clearance if certain criteria are met: (1) The test used by the laboratory to identify the existence of illegal drugs . . . [Full Text of this Article]

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