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FDA approves over-the-counter drug test

FDA graphic January 21, 1997
Web posted at: 8:50 p.m. EST

WASHINGTON (CNN) -- The Food and Drug Administration cleared an over-the-counter drug test kit Tuesday, the first such test to win federal approval.

The urine test can detect illegal drugs such as marijuana, PCP, amphetamines, cocaine and heroin, and is expected to be popular with parents and families of drug-rehabilitation patients.

Dr. Brown's Home Drug Testing System, made by Personal Health and Hygiene Inc., has equipment for urine collection, storage and mailing, and instructions for getting results and referrals.

Test creator J. Theodore Brown Jr., a Silver Spring, Maryland, psychologist, said his kits will reach drugstores within six weeks and will cost less than $30.

Consumers will mail a urine sample in a tamper-proof package to a government-certified laboratory which uses FDA-approved drug tests, including confirmatory retests to minimize false results. Consumers anonymously telephone a toll-free number for results.

All drug tests can give false-positive as well as false-negative results. For example, they can miss abuse when the urine is sampled too late, and can falsely signal abuse if the person ate foods that mimic the metabolites drug tests measure.

Last year, the FDA allowed some similar products to be marketed without its approval under a so-called interim ruling.

The agency did so after being criticized in September for cracking down on an Atlanta woman who sold 1,000 home drug-test kits without the FDA's knowledge. The FDA said it did not know if her test was accurate, but congressional critics argued the agency was preventing parents from getting tests employers can use.

The FDA relented, letting home drug tests to be sold temporarily while it reevaluated how strictly such kits should be regulated.

 
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