[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: 21CFR312.40]

[Page 66-67]
 
                        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 C_Administrative Actions
 
Sec. 312.40  General requirements for use of an investigational new 
drug in a clinical investigation.


    (a) An investigational new drug may be used in a clinical 
investigation if the following conditions are met:
    (1) The sponsor of the investigation submits an IND for the drug to 
FDA; the IND is in effect under paragraph (b) of this section; and the 
sponsor complies with all applicable requirements in this part and parts 
50 and 56 with respect to the conduct of the clinical investigations; 
and
    (2) Each participating investigator conducts his or her 
investigation in compliance with the requirements of this part and parts 
50 and 56.
    (b) An IND goes into effect:
    (1) Thirty days after FDA receives the IND, unless FDA notifies the 
sponsor that the investigations described in the IND are subject to a 
clinical hold under Sec. 312.42; or
    (2) On earlier notification by FDA that the clinical investigations 
in the IND may begin. FDA will notify the sponsor in writing of the date 
it receives the IND.

[[Page 67]]

    (c) A sponsor may ship an investigational new drug to investigators 
named in the IND:
    (1) Thirty days after FDA receives the IND; or
    (2) On earlier FDA authorization to ship the drug.
    (d) An investigator may not administer an investigational new drug 
to human subjects until the IND goes into effect under paragraph (b) of 
this section.