(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 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]