[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.36]

[Page 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 B_Investigational New Drug Application (IND)
 
Sec.  312.36  Emergency use of an investigational new drug (IND).

    Need for an investigational drug may arise in an emergency situation 
that does not allow time for submission of an IND in accordance with 
Sec.  312.23 or Sec.  312.34. In such a case, FDA may authorize shipment 
of the drug for a specified use in advance of submission of an IND. A 
request for such authorization may be transmitted to FDA by telephone or 
other rapid communication means. For investigational biological drugs 
regulated by the Center for Biologics Evaluation and Research, the 
request should be directed to the Office of Communication, Training and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research, 301-827-2000. For all other investigational drugs, the request 
for authorization should be directed to the Division of Drug Information 
(HFD-240), Center for Drug Evaluation and Research, 301-827-4570. After 
normal working hours, eastern standard time, the request should be 
directed to the FDA Office of Emergency Operations (HFA-615), 301-443-
1240. Except in extraordinary circumstances, such authorization will be 
conditioned on the sponsor making an appropriate IND submission as soon 
as practicable after receiving the authorization.

[69 FR 17927, Apr. 6, 2004]