CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE > SUBPART C—Requirements for Manufacturers and Producers (§809.20 to §809.40) > 809.40—Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.

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 ( § 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 § 809.10(f) and shall provide an adequate system to communicate the proper interpretation of test results from the laboratory to the lay purchaser.

Code of Federal Regulations

[65 FR 18234, Apr. 7, 2000]