[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: 21CFR312.110]

[Page 90-91]
 
                        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 F--Miscellaneous
 
Sec. 312.110  Import and export requirements.


    (a) Imports. An investigational new drug offered for import into the 
United States complies with the requirements of this part if it is 
subject to an IND that is in effect for it under Sec. 312.40 and: (1) 
The consignee in the United States is the sponsor of the IND; (2) the 
consignee is a qualified investigator named in the IND; or (3) the 
consignee is the domestic agent of a foreign sponsor, is responsible for 
the control and distribution of the investigational drug, and the IND 
identifies the consignee and describes what, if any, actions the 
consignee will take with respect to the investigational drug.
    (b) Exports. An investigational new drug intended for export from 
the United States complies with the requirements of this part as 
follows:
    (1) If an IND is in effect for the drug under Sec. 312.40 and each 
person who receives the drug is an investigator named in the 
application; or
    (2) If FDA authorizes shipment of the drug for use in a clinical 
investigation. Authorization may be obtained as follows:
    (i) Through submission to the International Affairs Staff (HFY-50), 
Associate Commissioner for Health Affairs, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, of a written request from the 
person that seeks to export the drug. A request must provide adequate 
information about the drug to satisfy FDA that the drug is appropriate 
for the proposed investigational use in humans, that the drug will be 
used for investigational purposes only, and that the drug may be legally 
used by that consignee in the importing country for the proposed 
investigational use. The request shall specify the quantity of the drug 
to be shipped per shipment and the frequency of expected shipments. If 
FDA authorizes exportation under this paragraph, the agency shall 
concurrently notify the government of the importing country of such 
authorization.
    (ii) Through submission to the International Affairs Staff (HFY-50), 
Associate Commissioner for Health Affairs, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, of a formal request from an 
authorized official of the government of the country to which the drug 
is proposed to be shipped. A request must specify that the foreign 
government has adequate information about the drug and the proposed 
investigational use, that the drug will be used for investigational 
purposes only, and that the foreign government is satisfied that the 
drug may legally be used by the intended

[[Page 91]]

consignee in that country. Such a request shall specify the quantity of 
drug to be shipped per shipment and the frequency of expected shipments.
    (iii) Authorization to export an investigational drug under 
paragraph (b)(2)(i) or (ii) of this section may be revoked by FDA if the 
agency finds that the conditions underlying its authorization are not 
longer met.
    (3) This paragraph applies only where the drug is to be used for the 
purpose of clinical investigation.
    (4) This paragraph does not apply to the export of new drugs 
(including biological products, antibiotic drugs, and insulin) approved 
or authorized for export under section 802 of the act (21 U.S.C. 382) or 
section 351(h)(1)(A) of the Public Health Service Act (42 U.S.C. 
262(h)(1)(A)).

(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; 64 
FR 401, Jan. 5, 1999]