New Labeling Guidance for OTC Drug Testing Kits

FDA specifies what a kit's labeling must say if it is to be marketed without prior agency approval.


Labeling is playing a crucial role in FDA's proposal to allow over-the-counter (OTC) sample collection systems for drugs of abuse to be marketed without prior approval from the agency.

In a document issued December 21, "Draft Guidance for Labeling of Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing," the agency's Center for Devices and Radiological Health (CDRH) wrote that "adequate labeling and methods of communicating test results to consumers" make up one of the three criteria required for test marketing without prior approval. The others are the accuracy and reliability of the laboratory test and the experience and competency of the laboratory performing the test.

The comment period on the draft ends March 22.

"Accurate labeling," the document states, "will enable the layperson to understand what drugs the test can identify, the time frame within which the 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."

As a result, the package insert needs to certify that the test is as accurate as those used in hospitals and other professional settings and that it is reliable for home use.

There must be clear and simple instructions on how to collect, prepare, and mail the sample as well as on where to send it. The use of drawings and diagrams is encouraged.

An identification system must be in place to ensure that samples are not mixed up or misidentified at the laboratory, while ensuring anonymity.

Each drug that can be detected by the system must be clearly identified by all its scientific as well as common names.

In lay terms, the degree of accuracy that can be expected must be described. Clear and simple explanations of how false positives and false negatives could result must be included. Any foods or OTC or prescription drugs that could cause an erroneous result must be identified. The package should also state how long after ingestion a particular drug remains in one's urine. All of these statements must be supported by science and must be truthful and balanced.

Labeling also must state clearly that all samples that initially test positive will be tested further to confirm the result.

Instructions on how and when to obtain test results must be enclosed. These should include how to contact a trained health professional if further interpretation of the results is needed or if counseling is needed.

The test results should be delivered in a simple, easy-to-understand format. Reports should include the probability of false positives and false negatives and restate the known sources of potential errors.

Any customer who receives either positive or negative results should receive instructions on how to obtain professional counseling or medical assistance.

The labeling on the device should mention that one's physician can be contacted about how to identify and treat substance-abuse problems. It should also mention that information for talking to children about drug use and abuse can be obtained from the National Clearinghouse for Drug and Alcohol Information at 800/729-4889.

Warnings and precautions for users appropriate to the particular device must be included. Warnings include:

  • Urine specimens may be infectious.
  • Some medicines and foods may cause false positives.
  • Hands must be washed before and after handling the specimens.

Information on mechanisms for detecting or dealing with sample tampering should be included.

All promotions, advertising, and labeling should reflect scientific facts and be balanced.

The labeling should be written in accordance with existing guidances, including FDA's "Write It Right" (1993) and "Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostics (IVDs)—Guidance Regarding Premarket Submissions" (1988) and the National Committee for Clinical Laboratory Standards' (NCCLS; Wayne, PA) "Labeling of Home-Use In Vitro Testing Products: Approved Guidelines" (1996).

Comments and suggestions should be sent to Docket No. 99D-5125, Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, FDA, 5630 Fishers Ln., Rm. 1061, (HFA-305), Rockville, MD 20852.

For further information, contact Joseph Hackett, CDRH (HFZ-440), FDA, 9200 Corporate Blvd., Rockville, MD 20850, 301/594-3084.

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