[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR809.40]

[Page 90]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE--Table of Contents
 
         Subpart C--Requirements for Manufacturers and Producers
 
Sec. 809.40  Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.

    (a) Over-the-counter (OTC) test sample collection systems for drugs 
of abuse testing (Sec. 864.3260 of this chapter) are restricted devices 
under section 520(e) of the Act subject to the restrictions set forth in 
this section.
    (b) Sample testing shall be performed in a laboratory using 
screening tests that have been approved, cleared, or otherwise 
recognized by the Food and Drug Administration as accurate and reliable 
for the testing of such specimens for identifying drugs of abuse or 
their metabolites.
    (c) The laboratory performing the test(s) shall have, and shall be 
recognized as having, adequate capability to reliably perform the 
necessary screening and confirmatory tests, including adequate 
capability to perform integrity checks of the biological specimens for 
possible adulteration.
    (d) All OTC test sample collection systems for drugs of abuse 
testing shall be labeled in accordance with Sec. 809.10(f) and shall 
provide an adequate system to communicate the proper interpretation of 
test results from the laboratory to the lay purchaser.

[65 FR 18234, Apr. 7, 2000]