[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR207.40]

[Page 127-128]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 207_REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN 
COMMERCIAL DISTRIBUTION--Table of Contents
 
           Subpart D_Procedure for Foreign Drug Establishments
 
Sec.  207.40  Establishment registration and drug listing requirements 
for foreign establishments.


    (a) Foreign drug establishments whose drugs are imported or offered 
for import into the United States shall comply with the establishment 
registration and drug listing requirements in subpart C of this part, 
unless exempt under subpart B of this part or unless the drugs enter a 
foreign trade zone and are re-exported from that foreign trade zone 
without having entered U. S. commerce.
    (b) No drug may be imported or offered for import into the United 
States unless it is listed as required in subpart

[[Page 128]]

C of this part and manufactured, prepared, propagated, compounded, or 
processed at a registered foreign drug establishment; however, this 
restriction does not apply to a drug imported or offered for import 
under the investigational use provisions in part 312 of this chapter, or 
the investigational new animal drug use provisions in part 511 of this 
chapter, or to a component of a drug imported under section 801(d)(3) of 
the act. Foreign drug establishments shall submit all listing 
information, including labels and labeling, and registration information 
in the English language.
    (c) Each foreign drug establishment required to register under 
paragraph (a) of this section shall submit the name, address, and phone 
number of its United States agent as part of its initial and updated 
registration information in accordance with subpart C of this part. Each 
foreign drug establishment shall designate only one United States agent.
    (1) The United States agent shall reside or maintain a place of 
business in the United States.
    (2) Upon request from FDA, the United States agent shall assist FDA 
in communications with the foreign drug establishment, respond to 
questions concerning the foreign drug establishment's products that are 
imported or offered for import into the United States, and assist FDA in 
scheduling inspections of the foreign drug establishment. If the agency 
is unable to contact the foreign drug establishment directly or 
expeditiously, FDA may provide information or documents to the United 
States agent, and such an action shall be considered to be equivalent to 
providing the same information or documents to the foreign drug 
establishment.
    (3) The foreign drug establishment or the United States agent shall 
report changes in the United States agent's name, address, or phone 
number to FDA within 10-business days of the change.

[66 FR 59157, Nov. 27, 2001]