[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.36]

[Page 74]
 
                        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.

    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, 
the request should be directed to the Division of Biological 
Investigational New Drugs (HFB-230), Center for Biologics Evaluation and 
Research, 8800 Rockville Pike, Bethesda, MD 20892, 301-443-4864. For all 
other investigational drugs, the request for authorization should be 
directed to the Document Management and Reporting Branch (HFD-53), 
Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, 
MD 20857, 301-443-4320. After normal working hours, eastern standard 
time, the request should be directed to the FDA Division of Emergency 
and Epidemiological Operations, 202-857-8400. 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.

(Collection of information requirements approved by the Office of 
Management and Budget under control number 0910-0014)

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 55 
FR 11579, Mar. 29, 1990]