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Date: March 3, 1998
FOR IMMEDIATE RELEASE
Contact: FOOD AND DRUG ADMINISTRATION, Sharon Snider: 301­827­6242,
Broadcast Media: 301­827­3434, Consumer Inquiries:  800­532­4440

FDA Proposes New Policy For Home Drug Abuse Test Kits

The agency will now allow all test kits to be marketed without prior approval as long as they meet certain criteria. In the past, the agency has required that it approve such products prior to marketing unless they were used in workplace, insurance or other controlled settings. Because of the new, more flexible policy, the Agency will apply it virtually across the board, including

to tests used in workplace, insurance, and other controlled settings. It would not apply, however, to tests used in connection with law enforcement purposes.

"The proposal balances the need to assure the accuracy of tests for drugs of abuse and the goal of simplifying the regulatory requirements so that these tests are made available to parents and others as soon as feasible," said William B. Schultz, FDA Deputy Commissioner for Policy.

Drug abuse specimen collection kits are sold directly to parents, employers, and insurance companies. The testing procedures require that a specimen from the body, such as urine, be collected and mailed to a designated laboratory for testing for drugs of abuse such as marijuana, PCP, or cocaine. The results are then communicated back to the parent (or other person who sent in the test specimen) by phone by the product's manufacturer.

FDA is proposing that these specimen collection kits be allowed to be marketed without prior agency approval as long as they meet the following criteria:

1. The test used by the laboratory to identify the existence of illegal drugs must be approved or otherwise recognized by FDA as accurate and reliable for laboratory use. FDA has already cleared more than 200 laboratory urine tests to detect drugs of abuse. This will ensure the accuracy of the test.
2. The laboratory performing the test must be certified to do the necessary screening and confirmatory test. Some 70 laboratories certified by the Substance Abuse and Mental Health Services Administration would meet this requirement, as well as numerous laboratories certified by other agencies and organizations. This will ensure the qualifications of the laboratory to perform the test.
3. The collection kits must be accurately labeled so consumers can easily use them, and samples must be clearly identified to avoid mix­ups. Accurate labeling will enable the lay person to understand what drugs the test can and cannot identify, the time frame within which drugs can be detected, how to properly collect the test specimen and mail it to the laboratory, how to interpret test results, and how to obtain professional counseling, if needed.