[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.2]

[Page 51]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 312_INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 312.2  Applicability.

    (a) Applicability. Except as provided in this section, this part 
applies to all clinical investigations of products that are subject to 
section 505 of the Federal Food, Drug, and Cosmetic Act or to the 
licensing provisions of the Public Health Service Act (58 Stat. 632, as 
amended (42 U.S.C. 201 et seq.)).
    (b) Exemptions. (1) The clinical investigation of a drug product 
that is lawfully marketed in the United States is exempt from the 
requirements of this part if all the following apply:
    (i) The investigation is not intended to be reported to FDA as a 
well-controlled study in support of a new indication for use nor 
intended to be used to support any other significant change in the 
labeling for the drug;
    (ii) If the drug that is undergoing investigation is lawfully 
marketed as a prescription drug product, the investigation is not 
intended to support a significant change in the advertising for the 
product;
    (iii) The investigation does not involve a route of administration 
or dosage level or use in a patient population or other factor that 
significantly increases the risks (or decreases the acceptability of the 
risks) associated with the use of the drug product;
    (iv) The investigation is conducted in compliance with the 
requirements for institutional review set forth in part 56 and with the 
requirements for informed consent set forth in part 50; and
    (v) The investigation is conducted in compliance with the 
requirements of Sec. 312.7.
    (2)(i) A clinical investigation involving an in vitro diagnostic 
biological product listed in paragraph (b)(2)(ii) of this section is 
exempt from the requirements of this part if (a) it is intended to be 
used in a diagnostic procedure that confirms the diagnosis made by 
another, medically established, diagnostic product or procedure and (b) 
it is shipped in compliance with Sec. 312.160.
    (ii) In accordance with paragraph (b)(2)(i) of this section, the 
following products are exempt from the requirements of this part: (a) 
blood grouping serum; (b) reagent red blood cells; and (c) anti-human 
globulin.
    (3) A drug intended solely for tests in vitro or in laboratory 
research animals is exempt from the requirements of this part if shipped 
in accordance with Sec. 312.160.
    (4) FDA will not accept an application for an investigation that is 
exempt under the provisions of paragraph (b)(1) of this section.
    (5) A clinical investigation involving use of a placebo is exempt 
from the requirements of this part if the investigation does not 
otherwise require submission of an IND.
    (6) A clinical investigation involving an exception from informed 
consent under Sec. 50.24 of this chapter is not exempt from the 
requirements of this part.
    (c) Bioavailability studies. The applicability of this part to in 
vivo bioavailability studies in humans is subject to the provisions of 
Sec. 320.31.
    (d) Unlabeled indication. This part does not apply to the use in the 
practice of medicine for an unlabeled indication of a new drug product 
approved under part 314 or of a licensed biological product.
    (e) Guidance. FDA may, on its own initiative, issue guidance on the 
applicability of this part to particular investigational uses of drugs. 
On request, FDA will advise on the applicability of this part to a 
planned clinical investigation.

[52 FR 8831, Mar. 19, 1987, as amended at 61 FR 51529, Oct. 2, 1996; 64 
FR 401, Jan. 5, 1999]