[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR207.40]

[Page 109]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
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  Drug listing requirements for foreign drug establishments.


    (a) Every foreign drug establishment whose drugs are imported or 
offered for import into the United States shall comply with the drug 
listing requirements in subpart C of this part, unless exempt under 
subpart B of this part, whether or not it is also registered.
    (b) No drug, unless it is listed as required in subpart C of this 
part, may be imported from a foreign drug establishment into the United 
States except a drug imported or offered for import under the 
investigational use provisions of part 312 of this chapter. Foreign drug 
establishments shall submit the drug listing information in the English 
language.
    (c) Every foreign drug establishment shall submit, as part of drug 
listing, the name and address of the establishment and the name of the 
individual responsible for submitting drug listing information. The 
establishment shall report to FDA any changes in this information at the 
intervals specified in Sec. 207.30(a) for updating drug listing 
information.

[45 FR 38043, June 6, 1980, as amended at 55 FR 11577, Mar. 29, 1990]