FDA Issues Draft Guidance on OTC Sample

Collection System Labeling

 

The Food and Drug Administration (FDA) announced the availability of a draft guidance entitled "Guidance on Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing." The guidance, which is not final or in effect at this time, proposes to reclassify OTC sample collection systems for drugs of abuse testing into Class I. FDA is proposing that these specimen collection systems be allowed to be marketed without prior agency approval as long as they meet the following criteria:

1. The underlying laboratory test(s) are accurate and reliable;

2. The laboratory performing the test(s) has adequate experience and competency;

3. The product has adequate labeling and methods of communicating test results to consumers.

Accurate labeling will enable the lay person 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 the test results and how to obtain professional counseling if needed.


If the proposed rule becomes final, adequate labeling and methods of communicating test results to consumers will be a restriction required under section 520(e) of the Federal Food, Drug and Cosmetic Act, even though manufacturers of these collection systems will be exempt from premarket review. The guidance presents FDA's direction on ways to fulfill this proposed requirement, as well as helping manufacturers currently marketing these products under CDRH's interim policy regarding "Parent's Access to Tests for Drugs of Abuse."


To obtain a copy of the draft guidance, visit http://www.fda.gov/cdrh/ggpmain.html#docs or contact DATIA at (800) 355-1257 for a copy.