[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR607.40]

[Page 59]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
     Subpart C--Procedures for Foreign Blood Product Establishments
 
Sec. 607.40  Blood product listing requirements for foreign blood product establishments.


    (a) Every foreign establishment shall comply with the blood product 
listing requirements contained in Subpart B of this part, unless exempt 
under Subpart D of this part, whether or not it is also registered.
    (b) No blood product may be imported from a foreign establishment 
into the United States except a blood product imported or offered for 
import pursuant to the investigational use provisions of part 312 of 
this chapter, unless it is first the subject of a blood product listing 
as required in Subpart B of this part. The blood product listing 
information shall be in the English language.
    (c) Foreign establishments shall submit, as part of the blood 
product listing, the name and address of the establishment and the name 
of the individual responsible for submitting blood product listing 
information. Any changes in this information shall be reported to the 
Food and Drug Administration at the intervals specified for updating 
blood product listing information in Sec. 607.30(a).

[40 FR 52788, Nov. 12, 1975, as amended at 55 FR 11014, Mar. 26, 1990]