Sec. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS
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## SEC. 702 REGISTRATION OF FOREIGN ESTABLISHMENTS ###
(a)Enforcement of Registration of Foreign Establishments Section 502(o) (21 U.S.C. 352(o)) is amended by striking “in any State”. ###
(b)Registration of Foreign Drug Establishments **[**[21 U.S.C. 360](/us/usc/t21/s360)**]** Section 510(i) (U.S.C. 360(i)) is amended— ####
(1)in paragraph (1)— #####
(A)by amending the matter preceding subparagraph
(A)to read as follows: “Every person who owns or operates any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States shall, through electronic means in accordance with the criteria of the Secretary—”; #####
(B)by amending subparagraph
(A)to read as follows: > > ##### “(A) > > upon first engaging in any such activity, immediately submit a registration to the Secretary that includes— > > > ###### “(i) > > with respect to drugs, the name and place of business of such person, all such establishments, the unique facility identifier of each such establishment, a point of contact e-mail address, the name of the United States agent of each such establishment, the name of each importer of such drug in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug to the United States for purposes of importation; and > > > ###### “(ii) > > with respect to devices, the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such device in the United States that is known to the establishment, and the name of each person who imports or offers for import such device to the United States for purposes of importation; and” > ; and #####
(C)by amending subparagraph
(B)to read as follows: > > ##### “(B) > > each establishment subject to the requirements of subparagraph
(A)shall thereafter register with the Secretary during the period beginning on October 1 and ending on December 31 of each year.” > ; and ####
(2)by adding at the end the following: > > #### “(4) > > The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph
(1)with respect to drugs. The requirement to include a unique facility identifier in a registration under paragraph
(1)with respect to drugs shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence.” > .
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