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Code · STATUTE-COMPILATIONS · Food and Drug Administration Safety and Innovation Act · Sec. 701

Sec. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS

260 words·~1 min read·/statute-compilations/comps-9932/sec-701

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## SEC. 701 REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS Section 510 (21 U.S.C. 360) is amended— ####
(1)in subsection (b)— #####
(A)in paragraph (1), by striking “ On or before ” and all that follows through the period at the end and inserting the following: > “During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address.; and > > > ##### “(B) > > by adding at the end the following: > > > #### “(3) > > The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph
(1)shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence.” > ; and ####
(2)in subsection (c), by striking “ with the Secretary his name, place of business, and such establishment ” and inserting > “with the Secretary— > > > #### “(1) > > with respect to drugs, the information described under subsection (b)(1); and > > > #### “(2) > > with respect to devices, the information described under subsection (b)(2).” > .
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Sec. 701
REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS
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