[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR320.31]

[Page 189]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS--Table of Contents
 
      Subpart B--Procedures for Determining the Bioavailability or 
                     Bioequivalence of Drug Products
 
Sec. 320.31  Applicability of requirements regarding an ``Investigational New Drug Application.''

    (a) Any person planning to conduct an in vivo bioavailability or 
bioequivalence study in humans shall submit an ``Investigational New 
Drug Application'' (IND) if:
    (1) The test product contains a new chemical entity as defined in 
Sec. 314.108(a) of this chapter; or
    (2) The study involves a radioactively labeled drug product; or
    (3) The study involves a cytotoxic drug product.
    (b) Any person planning to conduct a bioavailability or 
bioequivalence study in humans using a drug product that contains an 
already approved, non-new chemical entity shall submit an IND if the 
study is one of the following:
    (1) A single-dose study in normal subjects or patients where either 
the maximum single or total daily dose exceeds that specified in the 
labeling of the drug product that is the subject of an approved new drug 
application or abbreviated new drug application.
    (2) A multiple-dose study in normal subjects or patients where 
either the single or total daily dose exceeds that specified in the 
labeling of the drug product that is the subject of an approved new drug 
application or abbreviated new drug application.
    (3) A multiple-dose study on a extended release product on which no 
single-dose study has been completed.
    (c) The provisions of parts 50, 56, and 312 of this chapter are 
applicable to any bioavailability or bioequivalence study in humans 
conducted under an IND.
    (d) A bioavailability or bioequivalence study in humans other than 
one described in paragraphs (a) through (c) of this section is exempt 
from the requirements of part 312 of this chapter if the following 
conditions are satisfied:
    (1) If the study is one described under Sec. 320.38(b) or 
Sec. 320.63, the person conducting the study, including any contract 
research organization, shall retain reserve samples of any test article 
and reference standard used in the study and release the reserve samples 
to FDA upon request, in accordance with, and for the period specified 
in, Sec. 320.38; and
    (2) An in vivo bioavailability or bioequivalence study in humans 
shall be conducted in compliance with the requirements for institutional 
review set forth in part 56 of this chapter, and informed consent set 
forth in part 50 of this chapter.

[57 FR 18000, Apr. 28, 1992, as amended at 58 FR 25927, Apr. 28, 1993; 
67 FR 77674, Dec. 19, 2002]

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