<section xmlns="http://xml.house.gov/schemas/uslm/1.0" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dcterms="http://purl.org/dc/terms/" style="-uslm-lc:I80" id="id6f4ec6db-6123-11e3-9d46-8388bf8dcc60" identifier="/us/usc/t21/s384e"><num value="384e">§ 384e.</num><heading> Recognition of foreign government inspections</heading><subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="id6f4ec6dc-6123-11e3-9d46-8388bf8dcc60" identifier="/us/usc/t21/s384e/a"><num value="a" class="bold">(a)</num><heading class="bold"> Inspection</heading><chapeau>The Secretary—</chapeau><paragraph style="-uslm-lc:I12" class="indent1" id="id6f4ec6dd-6123-11e3-9d46-8388bf8dcc60" identifier="/us/usc/t21/s384e/a/1"><num value="1">(1)</num><content> may enter into arrangements and agreements with a foreign government or an agency of a foreign government to recognize the inspection of foreign establishments registered under <ref href="/us/usc/t21/s360/i">section 360(i) of this title</ref> in order to facilitate risk-based inspections in accordance with the schedule established in <ref href="/us/usc/t21/s360/h/3">section 360(h)(3) of this title</ref>;</content>
</paragraph>
<paragraph style="-uslm-lc:I12" class="indent1" id="id6f4ec6de-6123-11e3-9d46-8388bf8dcc60" identifier="/us/usc/t21/s384e/a/2"><num value="2">(2)</num><content> may enter into arrangements and agreements with a foreign government or an agency of a foreign government under this section only with a foreign government or an agency of a foreign government that the Secretary has determined as having the capability of conduction inspections that meet the applicable requirements of this chapter; and</content>
</paragraph>
<paragraph style="-uslm-lc:I12" class="indent1" id="id6f4ec6df-6123-11e3-9d46-8388bf8dcc60" identifier="/us/usc/t21/s384e/a/3"><num value="3">(3)</num><content> shall perform such reviews and audits of drug safety programs, systems, and standards of a foreign government or agency for the foreign government as the Secretary deems necessary to determine that the foreign government or agency of the foreign government is capable of conducting inspections that meet the applicable requirements of this chapter.</content>
</paragraph>
</subsection>
<subsection style="-uslm-lc:I19" class="indent2 firstIndent-2" id="id6f4ec6e0-6123-11e3-9d46-8388bf8dcc60" identifier="/us/usc/t21/s384e/b"><num value="b" class="bold">(b)</num><heading class="bold"> Results of inspection</heading><chapeau>The results of inspections performed by a foreign government or an agency of a foreign government under this section may be used as—</chapeau><paragraph style="-uslm-lc:I12" class="indent1" id="id6f4ec6e1-6123-11e3-9d46-8388bf8dcc60" identifier="/us/usc/t21/s384e/b/1"><num value="1">(1)</num><content> evidence of compliance with <ref href="/us/usc/t21/s351/a/2/B">section 351(a)(2)(B) of this title</ref> or <ref href="/us/usc/t21/s381/r">section 381(r) of this title</ref>; and</content>
</paragraph>
<paragraph style="-uslm-lc:I12" class="indent1" id="id6f4ec6e2-6123-11e3-9d46-8388bf8dcc60" identifier="/us/usc/t21/s384e/b/2"><num value="2">(2)</num><content> for any other purposes as determined appropriate by the Secretary.</content>
</paragraph>
</subsection>
<sourceCredit id="id6f4ec6e3-6123-11e3-9d46-8388bf8dcc60">(<ref href="/us/act/1938-06-25/ch675/s809">June 25, 1938, ch. 675, § 809</ref>, as added <ref href="/us/pl/112/144/s712">Pub. L. 112–144, title VII, § 712</ref>, <date date="2012-07-09">July 9, 2012</date>, <ref href="/us/stat/126/1072">126 Stat. 1072</ref>.)</sourceCredit>
</section>