[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR809.40]



[Page 91]

 

                        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]