[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR607.40]

[Page 64-65]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 607_ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF 
 
      Subpart C_Procedures for Foreign Blood Product Establishments
 
Sec. 607.40  Establishment registration and blood product listing requirements 


for foreign blood product establishments.

    (a) Every foreign establishment shall comply with the establishment 
registration and blood product listing requirements contained in subpart 
B of this part, unless exempt under subpart D of this part or unless the 
blood product enters a foreign trade zone and is re-exported from that 
foreign trade zone without having entered U. S. commerce.
    (b) No blood product may be imported or offered for import into the 
United States unless it is the subject of a blood product listing as 
required under subpart B of this part and is manufactured, prepared, 
propagated, compounded, or processed at a registered foreign 
establishment; however, this restriction does not apply to a blood 
product imported or offered for import under the investigational use 
provisions of part 312 of this chapter or to a blood product imported 
under section 801(d)(4) of the act. The establishment registration and 
blood product listing information shall be in the English language.
    (c) Each foreign establishment required to register under paragraph 
(a) of this section shall, as part of the establishment registration and 
blood product listing, submit the name and address of the establishment 
and the name of the individual responsible for submitting establishment 
registration and blood product listing information. Any changes in this 
information shall be reported to the Food and Drug Administration at the 
intervals specified for updating establishment registration information 
in Sec. 607.26 and blood product listing information in Sec. 
607.30(a).

[[Page 65]]

    (d) Each foreign 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 B of this part. Each foreign 
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 establishment, respond to questions 
concerning the foreign establishment's products that are imported or 
offered for import into the United States, and assist FDA in scheduling 
inspections of the foreign establishment. If the agency is unable to 
contact the foreign 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 establishment.
    (3) The foreign 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 59159, Nov. 27, 2001]