HR 2715 — Destruction of Hazardous Imports Act

changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italics and existing law in which no change is 
proposed is shown in roman):

 FEDERAL FOOD, DRUG, AND COSMETIC ACT

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 CHAPTER III--PROHIBITED ACTS AND PENALTIES

 prohibited acts

 Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
 (a) The introduction or delivery for introduction into 
interstate commerce of any food, drug, device, tobacco product, 
or cosmetic that is adulterated or misbranded.
 (b) The adulteration or misbranding of any food, drug, 
device, tobacco product, or cosmetic in interstate commerce.
 (c) The receipt in interstate commerce of any food, drug, 
device, tobacco product, or cosmetic that is adulterated or 
misbranded, and the delivery or proffered delivery thereof for 
pay or otherwise.
 (d) The introduction or delivery for introduction into 
interstate commerce of any article in violation of section 404, 
415, 505,, 564, or 607.
 (e) The refusal to permit access to or copying of any record 
as required by section 412, 414, 417(j), 416, 504, 564, 
605,703, 704(a), 760, or 761; or the failure to establish or 
maintain any record, or make any report, required under section 
412, 414(b), 417, 416, 504, 505 (i) or (k), 512(a)(4)(C), 512 
(j), (l) or (m), 572(i), 515(f), 519, 564, 605,611, 760, 761, 
909, or 920 or the refusal to permit access to or verification 
or copying of any such required record; or the violation of any 
recordkeeping requirement under section 204 of the FDA Food 
Safety Modernization Act (except when such violation is 
committed by a farm).
 (f) The refusal to permit entry or inspection as authorized 
by section 704.
 (g) The manufacture within any Territory of any food, drug, 
device, tobacco product, or cosmetic that is adulterated or 
misbranded.
 (h) The giving of a guaranty or undertaking referred to in 
section 303(c)(2), which guaranty or undertaking is false, 
except by a person who relied upon a guaranty or undertaking to 
the same effect signed by, and containing the name and address 
of, the person residing in the United States from whom he 
received in good faith the food, drug, device, tobacco product, 
or cosmetic; or the giving of a guaranty or undertaking 
referred to in section 303(c)(3), which guaranty or undertaking 
is false.
 (i)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, 
stamp, tag, label, or other identification device authorized or 
required by regulations promulgated under the provisions of 
section 404 or 721.
 (2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, 
stone, or other thing designed to print, imprint, or reproduce 
the trademark, trade name, or other identifying mark, imprint, 
or device of another or any likeness of any of the foregoing 
upon any drug or container or labeling thereof so as to render 
such drugs a counterfeit drug.
 (3) The doing of any act which causes a drug to be a 
counterfeit drug, or the sale or dispensing, or the holding for 
sale or dispensing, of a counterfeit drug.
 (j) The using by any person to his own advantage, or 
revealing, other than to the Secretary or officers or employees 
of the Department, or to the courts when relevant in any 
judicial proceeding under this Act, any information acquired 
under authority of section 404, 409, 412, 414, 505, 510, 512, 
513, 514, 515, 516, 518, 519, 520, 571, 572, 573, 704, 708, 
721, 904, 905, 906, 907, 908, 909, or 920(b) concerning any 
method or process which as a trade secret is entitled to 
protection; or the violating of section 408(i)(2) or any 
regulation issued under that section.. This paragraph does not 
authorize the withholding of information from either House of 
Congress or from, to the extent of matter within its 
jurisdiction, any committee or subcommittee of such committee 
or any joint committee of Congress or any subcommittee of such 
joint committee.
 (k) The alteration, mutilation, destruction, obliteration, or 
removal of the whole or any part of the labeling of, or the 
doing of any other act with respect to, a food, drug, device, 
tobacco product, or cosmetic, if such act is done while such 
article is held for sale (whether or not the first sale) after 
shipment in interstate commerce and results in such article 
being adulterated or misbranded.
 (m) The sale or offering for sale of colored oleomargarine or 
colored margarine, or the possession or serving of colored 
oleomargarine or colored margarine in violation of section 
407(b) or 407(c).
 (n) The using, in labeling, advertising or other sales 
promotion of any reference to any report or analysis furnished 
in compliance with section 704.
 (o) In the case of a prescription drug distributed or offered 
for sale in interstate commerce, the failure of the 
manufacturer, packer, or distributor thereof to maintain for 
transmittal, or to transmit, to any practitioner licensed by 
applicable State law to administer such drug who makes written 
request for information as to such drug, true and correct 
copies of all printed matter which is required to be included 
in any package in which that drug is distributed or sold, or 
such other printed matter as is approved by the Secretary. 
Nothing in this paragraph shall be construed to exempt any 
person from any labeling requirement imposed by or under other 
provisions of this Act.
 (p) The failure to register in accordance with section 510 or 
905, the failure to provide any information required by section 
510(j), 510(k), 905(i), or 905(j), or the failure to provide a 
notice required by section 510(j)(2) or 905(i)(3).
 (q)(1) The failure or refusal--
 (A) to comply with any requirement prescribed under 
 section 518, 520(g), 903(b), 907, 908, or 915;
 (B) to furnish any notification or other material or 
 information required by or under section 519, 520(g), 
 904, 909, or 920; or
 (C) to comply with a requirement under section 522 or 
 913.
 (2) With respect to any device or tobacco product, the 
submission of any report that is required by or under this Act 
that is false or misleading in any material respect.
 (3) The failure to comply with any requirement under section 
524B(b)(2) (relating to ensuring device cybersecurity).
 (r) The movement of a device, drug, or tobacco product in 
violation of an order under section 304(g) or the removal or 
alteration of any mark or label required by the order to 
identify the device, drug, or tobacco product as detained.
 (s) The failure to provide the notice required by section 
412(c) or 412(e), the failure to make the reports required by 
section 412(f)(1)(B), the failure to retain the records 
required by section 412(b)(4), or the failure to meet the 
requirements prescribed under section 412(f)(3).
 (t) The importation of a drug in violation of section 
801(d)(1), the sale, purchase, or trade of a drug or drug 
sample or the offer to sell, purchase, or trade a drug or drug 
sample in violation of section 503(c), the sale, purchase, or 
trade of a coupon, the offer to sell, purchase, or trade such a 
coupon, or the counterfeiting of such a coupon in violation of 
section 503(c)(2), the distribution of a drug sample in 
violation of section 503(d) or the failure to otherwise comply 
with the requirements of section 503(d), the distribution of 
drugs in violation of section 503(e), failure to comply with 
the requirements under section 582, the failure to comply with 
the requirements under section 584, as applicable, or the 
failure to otherwise comply with the requirements of section 
503(e).
 (u) The failure to comply with any requirements of the 
provisions of, or any regulations or orders of the Secretary, 
under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).
 (v) The introduction or delivery for introduction into 
interstate commerce of a dietary supplement that is unsafe 
under section 413.
 (w) The making of a knowingly false statement in any 
statement, certificate of analysis, record, or report required 
or requested under section 801(d)(3); the failure to submit a 
certificate of analysis as required under such section; the 
failure to maintain records or to submit records or reports as 
required by such section; the release into interstate commerce 
of any article or portion thereof imported into the United 
States under such section or any finished product made from 
such article or portion, except for export in accordance with 
section 801(e) or 802, or with section 351(h) of the Public 
Health Service Act; or the failure to so export or to destroy 
such an article or portions thereof, or such a finished 
product.
 (x) The falsification of a declaration of conformity 
submitted under section 514(c) or the failure or refusal to 
provide data or information requested by the Secretary under 
paragraph (3) of such section.
 (y) In the case of a drug, device, or food--
 (1) the submission of a report or recommendation by a 
 person accredited under section 523 that is false or 
 misleading in any material respect;
 (2) the disclosure by a person accredited under 
 section 523 of confidential commercial information or 
 any trade secret without the express written consent of 
 the person who submitted such information or secret to 
 such person; or
 (3) the receipt by a person accredited under section 
 523 of a bribe in any form or the doing of any corrupt 
 act by such person associated with a responsibility 
 delegated to such person under this Act.
 (z) The dissemination of information in violation of section 
551.
 (aa) The importation of a prescription drug in violation of 
section 804, the falsification of any record required to be 
maintained or provided to the Secretary under such section, or 
any other violation of regulations under such section.
 (bb) The transfer of an article of food in violation of an 
order under section 304(h), or the removal or alteration of any 
mark or label required by the order to identify the article as 
detained.
 (cc) The importing or offering for import into the United 
States of an article of food or a drug by, with the assistance 
of, or at the direction of, a person debarred from such 
activity under section 306(b)(3).
 (dd) The failure to register in accordance with section 415.
 (ee) The importing or offering for import into the United 
States of an article of food in violation of the requirements 
under section 801(m).
 (ff) The importing or offering for import into the United 
States of a drug or device with respect to which there is a 
failure to comply with a request of the Secretary to submit to 
the Secretary a statement under section 801(o).
 (gg) The knowing failure to comply with paragraph (7)(E) of 
section 704(g); the knowing inclusion by a person accredited 
under paragraph (2) of such section of false information in an 
inspection report under paragraph (7)(A) of such section; or 
the knowing failure of such a person to include material facts 
in such a report.
 (hh) The failure by a shipper, carrier by motor vehicle or 
rail vehicle, receiver, or any other person engaged in the 
transportation of food to comply with the sanitary 
transportation practices prescribed by the Secretary under 
section 416.
 (ii) The falsification of a report of a serious adverse event 
submitted to a responsible person (as defined under section 
604,760, or 761) or the falsification of a serious adverse 
event report (as defined under section 760 or 761 or required 
under section 605(a)) submitted to the Secretary.
 (jj)(1) The failure to submit the certification required by 
section 402(j)(5)(B) of the Public Health Service Act, or 
knowingly submitting a false certification under such section.
 (2) The failure to submit clinical trial information required 
under subsection (j) of section 402 of the Public Health 
Service Act.
 (3) The submission of clinical trial information under 
subsection (j) of section 402 of the Public Health Service Act 
that is false or misleading in any particular under paragraph 
(5)(D) of such subsection (j).
 (kk) The dissemination of a television advertisement without 
complying with section 503B.
 (ll) The introduction or delivery for introduction into 
interstate commerce of any food to which has been added a drug 
approved under section 505, a biological product licensed under 
section 351 of the Public Health Service Act, or a drug or a 
biological product for which substantial clinical 
investigations have been instituted and for which the existence 
of such investigations has been made public, unless--
 (1) such drug or such biological product was marketed 
 in food before any approval of the drug under section 
 505, before licensure of the biological product under 
 such section 351, and before any substantial clinical 
 investigations involving the drug or the biological 
 product have been instituted;
 (2) the Secretary, in the Secretary's discretion, has 
 issued a regulation, after notice and comment, 
 approving the use of such drug or such biological 
 product in the food;
 (3) the use of the drug or the biological product in 
 the food is to enhance the safety of the food to which 
 the drug or the biological product is added or applied 
 and not to have independent biological or therapeutic 
 effects on humans, and the use is in conformity with--
 (A) a regulation issued under section 409 
 prescribing conditions of safe use in food;
 (B) a regulation listing or affirming 
 conditions under which the use of the drug or 
 the biological product in food is generally 
 recognized as safe;
 (C) the conditions of use identified in a 
 notification to the Secretary of a claim of 
 exemption from the premarket approval 
 requirements for food additives based on the 
 notifier's determination that the use of the 
 drug or the biological product in food is 
 generally recognized as safe, provided that the 
 Secretary has not questioned the general 
 recognition of safety determination in a letter 
 to the notifier;
 (D) a food contact substance notification 
 that is effective under section 409(h); or
 (E) such drug or biological product had been 
 marketed for smoking cessation prior to the 
 date of the enactment of the Food and Drug 
 Administration Amendments Act of 2007; or
 (4) the drug is a new animal drug whose use is not 
 unsafe under section 512.
 (mm) The failure to submit a report or provide a notification 
required under section 417(d).
 (nn) The falsification of a report or notification required 
under section 417(d).
 (oo) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
 (pp) The introduction or delivery for introduction into 
interstate commerce of a tobacco product in violation of 
section 911.
 (qq)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp 
(including tax stamp), tag, label, or other identification 
device upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
 (2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, 
stone, or other item that is designed to print, imprint, or 
reproduce the trademark, trade name, or other identifying mark, 
imprint, or device of another or any likeness of any of the 
foregoing upon any tobacco product or container or labeling 
thereof so as to render such tobacco product a counterfeit 
tobacco product.
 (3) The doing of any act that causes a tobacco product to be 
a counterfeit tobacco product, or the sale or dispensing, or 
the holding for sale or dispensing, of a counterfeit tobacco 
product.
 (rr) The charitable distribution of tobacco products.
 (ss) The failure of a manufacturer or distributor to notify 
the Attorney General and the Secretary of the Treasury of their 
knowledge of tobacco products used in illicit trade.
 (tt) Making any express or implied statement or 
representation directed to consumers with respect to a tobacco 
product, in a label or labeling or through the media or 
advertising, that either conveys, or misleads or would mislead 
consumers into believing, that--
 (1) the product is approved by the Food and Drug 
 Administration;
 (2) the Food and Drug Administration deems the 
 product to be safe for use by consumers;
 (3) the product is endorsed by the Food and Drug 
 Administration for use by consumers; or
 (4) the product is safe or less harmful by virtue 
 of--
 (A) its regulation or inspection by the Food 
 and Drug Administration; or
 (B) its compliance with regulatory 
 requirements set by the Food and Drug 
 Administration;
 including any such statement or representation 
 rendering the product misbranded under section 903.
 (uu) The operation of a facility that manufactures, 
processes, packs, or holds food for sale in the United States 
if the owner, operator, or agent in charge of such facility is 
not in compliance with section 418.
 (vv) The failure to comply with the requirements under 
section 419.
 (ww) The failure to comply with section 420.
 (xx) The refusal or failure to follow an order under section 
423.
 (yy) The knowing and willful failure to comply with the 
notification requirement under section 417(h).
 (zz) The importation or offering for importation of a food if 
the importer (as defined in section 805) does not have in place 
a foreign supplier verification program in compliance with such 
section 805.
 (aaa) The failure to register in accordance with section 
801(s).
 (bbb) The failure to notify the Secretary in violation of 
section 568.
 (ccc)(1) The resale of a compounded drug that is labeled 
``not for resale'' in accordance with section 503B.
 (2) With respect to a drug to be compounded pursuant to 
section 503A or 503B, the intentional falsification of a 
prescription, as applicable.
 (3) The failure to report drugs or adverse events by an 
entity that is registered in accordance with subsection (b) of 
section 503B.
 (ddd)(1) The manufacture or the introduction or delivery for 
introduction into interstate commerce of a rinse-off cosmetic 
that contains intentionally-added plastic microbeads.
 (2) In this paragraph--
 (A) the term ``plastic microbead'' means any solid 
 plastic particle that is less than five millimeters in 
 size and is intended to be used to exfoliate or cleanse 
 the human body or any part thereof; and
 (B) the term ``rinse-off cosmetic'' includes 
 toothpaste.
 (eee) The failure to comply with any order issued under 
section 569D.
 (fff)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, 
stamp, tag, label, or other identification upon any device or 
container, packaging, or labeling thereof so as to render such 
device a counterfeit device.
 (2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, 
stone, or other thing designed to print, imprint, or reproduce 
the trademark, trade name, or other identifying mark or imprint 
of another or any likeness of any of the foregoing upon any 
device or container, packaging, or labeling thereof so as to 
render such device a counterfeit device.
 (3) The doing of any act which causes a device to be a 
counterfeit device, or the sale or dispensing, or the holding 
for sale or dispensing, of a counterfeit device.
 (ggg) The failure of a sponsor of a product approved under 
accelerated approval pursuant to section 506(c)--
 (1) to conduct with due diligence any postapproval 
 study required under section 506(c) with respect to 
 such product; or
 (2) to submit timely reports with respect to such 
 product in accordance with section 506B(a)(2).
 (hhh) The failure to register or submit listing information 
in accordance with section 607.
 (iii) The refusal or failure to follow an order under section 
611.
 (jjj) The unauthorized movement, or introduction or delivery 
for introduction into interstate commerce, including export, of 
an article that is subject to an order for destruction under 
section 801(v).

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 CHAPTER VIII--IMPORTS AND EXPORTS

 imports and exports

 Sec. 801. (a) The Secretary of the Treasury shall deliver to 
the Secretary of Health and Human Services, upon his request, 
samples of food, drugs, devices, tobacco products, and 
cosmetics which are being imported or offered for import into 
the United States, giving notice thereof to the owner or 
consignee, who may appear before the Secretary of Health and 
Human Services and have the right to introduce testimony. The 
Secretary of Health and Human Services shall furnish to the 
Secretary of the Treasury a list of establishments registered 
pursuant to subsection (i) of section 510 or section 905(h) and 
shall request that if any drugs, devices, or tobacco products 
manufactured, prepared, propagated, compounded, or processed in 
an establishment not so registered are imported or offered for 
import into the United States, samples of such drugs, devices, 
or tobacco products be delivered to the Secretary of Health and 
Human Services, with notice of such delivery to the owner or 
consignee, who may appear before the Secretary of Health and 
Human Services and have the right to introduce testimony. If it 
appears from the examination of such samples or otherwise that 
(1) such article has been manufactured, processed, or packed 
under insanitary conditions or, in the case of a device, the 
methods used in, or the facilities or controls used for, the 
manufacture, packing, storage, or installation of the device do 
not conform to the requirements of section 520(f), or (2) such 
article is forbidden or restricted in sale in the country in 
which it was produced or from which it was exported, or (3) 
such article is adulterated, misbranded, or in violation of 
section 505 or the importer (as defined in section 805) is in 
violation of such section 805, or prohibited from introduction 
or delivery for introduction into interstate commerce under 
section 301(ll), or is a controlled substance subject to an 
order under section 569D, or (4) the recordkeeping requirements 
under section 204 of the FDA Food Safety Modernization Act 
(other than the requirements under subsection (f) of such 
section) have not been complied with regarding such article or 
(5) such article is being imported or offered for import in 
violation of section 301(cc), then any such article described 
in any of clauses (1) through (5) shall be refused admission, 
except as provided in subsection (b) of this section. If it 
appears from the examination of such samples or otherwise that 
the article is a counterfeit drug or counterfeit device, such 
article shall be refused admission. With respect to an article 
of food, if importation of such food is subject to, but not 
compliant with, the requirement under subsection (q) that such 
food be accompanied by a certification or other assurance that 
the food meets applicable requirements of this Act, then such 
article shall be refused admission. If such article is subject 
to a requirement under section 605, 760, or 761 and if the 
Secretary has credible evidence or information indicating that 
the responsible person (as defined in section 604, 760, or 761) 
has not complied with a requirement of such section 605, 760, 
or 761 with respect to any such article, or has not allowed 
access to records described in such section 605, 760, or 761, 
then such article shall be refused admission, except as 
provided in subsection (b) of this section. The Secretary of 
the Treasury shall cause the destruction of any such article 
refused admission unless such article is exported, under 
regulations prescribed by the Secretary of the Treasury, within 
90 days of the date of notice of such refusal or within such 
additional time as may be permitted pursuant to such 
regulations, except that the Secretary of Health and Human 
Services may destroy, without the opportunity for export, any 
drug, device, or tobacco product refused admission under this 
section, if such drug, device, or tobacco product is valued at 
an amount that is $2,500 or less (or such higher amount as the 
Secretary of the Treasury may set by regulation pursuant to 
section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 
1498(a)(1))) and was not brought into compliance as described 
under subsection (b). The Secretary of Health and Human 
Services shall issue regulations providing for notice and an 
opportunity to appear before the Secretary of Health and Human 
Services and introduce testimony, as described in the first 
sentence of this subsection, on destruction of a drug, device, 
or tobacco product under the seventh sentence of this 
subsection. The regulations shall provide that prior to 
destruction, appropriate due process is available to the owner 
or consignee seeking to challenge the decision to destroy the 
drug, device, or tobacco product. Where the Secretary of Health 
and Human Services provides notice and an opportunity to appear 
and introduce testimony on the destruction of a drug, device, 
or tobacco product, the Secretary of Health and Human Services 
shall store and, as applicable, dispose of the drug, device, or 
tobacco product after the issuance of the notice, except that 
the owner and consignee shall remain liable for costs pursuant 
to subsection (c). Such process may be combined with the notice 
and opportunity to appear before the Secretary and introduce 
testimony, as described in the first sentence of this 
subsection, as long as appropriate notice is provided to the 
owner or consignee. Neither clause (2) nor clause (5) of the 
third sentence of this subsection shall be construed to 
prohibit the admission of narcotic drugs, the importation of 
which is permitted under the Controlled Substances Import and 
Export Act.
 (b) Pending decision as to the admission of an article being 
imported or offered for import, the Secretary of the Treasury 
may authorize delivery of such article to the owner or 
consignee upon the execution by him of a good and sufficient 
bond providing for the payment of such liquidated damages in 
the event of default as may be required pursuant to regulations 
of the Secretary of the Treasury. If it appears to the 
Secretary of Health and Human Services that (1) an article 
included within the provisions of clause (3) of subsection (a) 
of this section can, by relabeling or other action, be brought 
into compliance with the Act or rendered other than a food, 
drug, device, or cosmetic, or (2) with respect to an article 
described in subsection (a) relating to the requirements of 
section 605, 760, or 761, the responsible person (as defined in 
section 604, 760, or 761) can take action that would assure 
that the responsible person is in compliance with section 605, 
760, or 761, as the case may be, final determination as to 
admission of such article may be deferred and, upon filing of 
timely written application by the owner or consignee and the 
execution by him of a bond as provided in the preceding 
provisions of this subsection, the Secretary may, in accordance 
with regulations, authorize the applicant, or, with respect to 
clause (2), the responsible person, to perform such relabeling 
or other action specified in such authorization (including 
destruction or export of rejected articles or portions thereof, 
as may be specified in the Secretary's authorization). All such 
relabeling or other action pursuant to such authorization shall 
in accordance with regulations be under the supervision of an 
officer or employee of the Department of Health and Human 
Services designated by the Secretary, or an officer or employee 
of the Department of the Treasury designated by the Secretary 
of the Treasury.
 (c) All expenses (including travel, per diem or subsistence, 
and salaries of officers or employees of the United States) in 
connection with the destruction provided for in subsection (a) 
of this section and the supervision of the relabeling or other 
action authorized under the provisions of subsection (b) of 
this section, the amount of such expenses to be determined in 
accordance with regulations, and all expenses in connection 
with the storage, cartage, or labor with respect to any article 
refused admission under subsection (a) of this section, shall 
be paid by the owner or consignee and, in default of such 
payment, shall constitute a lien against any future 
importations made by such owner or consignee.
 (d)(1)(A) Except as provided in paragraph (2) and section 
804, no drug subject to section 503(b) or composed wholly or 
partly of insulin which is manufactured in a State and exported 
may be imported into the United States unless the drug is 
imported by the manufacturer of the drug.
 (B) Except as authorized by the Secretary in the case of a 
drug that appears on the drug shortage list under section 506E 
or in the case of importation pursuant to section 804, no drug 
that is subject to section 503(b)(1) may be imported into the 
United States for commercial use if such drug is manufactured 
outside the United States, unless the manufacturer has 
authorized the drug to be marketed in the United States and has 
caused the drug to be labeled to be marketed in the United 
States.
 (2) The Secretary may authorize the importation of a drug the 
importation of which is prohibited by paragraph (1) if the drug 
is required for emergency medical care.
 (3)(A) Subject to subparagraph (B), no component of a drug, 
no component part or accessory of a device, or other article of 
device requiring further processing, which is ready or suitable 
for use for health-related purposes, and no article of a food 
additive, color additive, or dietary supplement, including a 
product in bulk form, shall be excluded from importation into 
the United States under subsection (a) if each of the following 
conditions is met:
 (i) The importer of such article of a drug or device 
 or importer of such article of a food additive, color 
 additive, or dietary supplement submits to the 
 Secretary, at the time of initial importation, a 
 statement in accordance with the following:
 (I) Such statement provides that such article 
 is intended to be further processed by the 
 initial owner or consignee, or incorporated by 
 the initial owner or consignee, into a drug, 
 biological product, device, food, food 
 additive, color additive, or dietary supplement 
 that will be exported by the initial owner or 
 consignee from the United States in accordance 
 with subsection (e) or section 802, or with 
 section 351(h) of the Public Health Service 
 Act.
 (II) The statement identifies the 
 manufacturer of such article and each 
 processor, packer, distributor, or other entity 
 that had possession of the article in the chain 
 of possession of the article from the 
 manufacturer to such importer of the article.
 (III) The statement is accompanied by such 
 certificates of analysis as are necessary to 
 identify such article, unless the article is a 
 device or is an article described in paragraph 
 (4).
 (ii) At the time of initial importation and before 
 the delivery of such article to the importer or the 
 initial owner or consignee, such owner or consignee 
 executes a good and sufficient bond providing for the 
 payment of such liquidated damages in the event of 
 default as may be required pursuant to regulations of 
 the Secretary of the Treasury.
 (iii) Such article is used and exported by the 
 initial owner or consignee in accordance with the 
 intent described under clause (i)(I), except for any 
 portions of the article that are destroyed.
 (iv) The initial owner or consignee maintains records 
 on the use or destruction of such article or portions 
 thereof, as the case may be, and submits to the 
 Secretary any such records requested by the Secretary.
 (v) Upon request of the Secretary, the initial owner 
 or consignee submits a report that provides an 
 accounting of the exportation or destruction of such 
 article or portions thereof, and the manner in which 
 such owner or consignee complied with the requirements 
 of this subparagraph.
 (B) Notwithstanding subparagraph (A), the Secretary may 
refuse admission to an article that otherwise would be imported 
into the United States under such subparagraph if the Secretary 
determines that there is credible evidence or information 
indicating that such article is not intended to be further 
processed by the initial owner or consignee, or incorporated by 
the initial owner or consignee, into a drug, biological 
product, device, food, food additive, color additive, or 
dietary supplement that will be exported by the initial owner 
or consignee from the United States in accordance with 
subsection (e) or section 802, or with section 351(h) of the 
Public Health Service Act.
 (C) This section may not be construed as affecting the 
responsibility of the Secretary to ensure that articles 
imported into the United States under authority of subparagraph 
(A) meet each of the conditions established in such 
subparagraph for importation.
 (4) The importation into the United States of blood, blood 
components, source plasma, or source leukocytes or of a 
component, accessory, or part thereof is not permitted pursuant 
to paragraph (3) unless the importation complies with section 
351(a) of the Public Health Service Act or the Secretary 
permits the importation under appropriate circumstances and 
conditions, as determined by the Secretary. The importation of 
tissue or a component or part of tissue is not permitted 
pursuant to paragraph (3) unless the importation complies with 
section 361 of the Public Health Service Act.
 (e)(1) A food, drug, device, tobacco product or cosmetic 
intended for export shall not be deemed to be adulterated or 
misbranded under this Act, and a tobacco product intended for 
export shall not be deemed to be in violation of section 
906(e), 907, 911, or 920(a), if it--
 (A) accords to the specifications of the foreign 
 purchaser,
 (B) is not in conflict with the laws of the country 
 to which it is intended for export,
 (C) is labeled on the outside of the shipping package 
 that it is intended for export, and
 (D) is not sold or offered for sale in domestic 
 commerce.
 (2) Paragraph (1) does not apply to any device--
 (A) which does not comply with an applicable 
 requirement of section 514 or 515,
 (B) which under section 520(g) is exempt from either 
 such section, or
 (C) which is a banned device under section 516,
unless, in addition to the requirements of paragraph (1), 
either (i) the Secretary has determined that the exportation of 
the device is not contrary to public health and safety and has 
the approval of the country to which it is intended for export 
or (ii) the device is eligible for export under section 802.
 (3) A new animal drug that requires approval under section 
512 shall not be exported pursuant to paragraph (1) if such 
drug has been banned in the United States.
 (4)(A) Any person who exports a food, drug, animal drug, or 
device may request that the Secretary--
 (i) certify in writing that the exported food, drug, 
 animal drug, or device meets the requirements of 
 paragraph (1) or section 802; or
 (ii) certify in writing that the food, drug, animal 
 drug, or device being exported meets the applicable 
 requirements of this Act upon a showing that the food, 
 drug or device meets the applicable requirements of 
 this Act.
The Secretary shall issue such a certification within 20 days 
of the receipt of a request for such certification.
 (B) If the Secretary issues a written export certification 
within the 20 days prescribed by subparagraph (A), a fee for 
such certification may be charged but shall not exceed $175 for 
each certification. Fees collected for a fiscal year pursuant 
to this subparagraph shall be credited to the appropriation 
account for salaries and expenses of the Food and Drug 
Administration and shall be available in accordance with 
appropriations Acts until expended without fiscal year 
limitation. Such fees shall be collected in each fiscal year in 
an amount equal to the amount specified in appropriations Acts 
for such fiscal year and shall only be collected and available 
for the costs of the Food and Drug Administration.
 (C) For purposes of this paragraph, a certification by the 
Secretary shall be made on such basis, and in such form 
(including a publicly available listing) as the Secretary 
determines appropriate.
 (D) With regard to fees pursuant to subparagraph (B) in 
connection with written export certifications for food:
 (i) Such fees shall be collected and available solely 
 for the costs of the Food and Drug Administration 
 associated with issuing such certifications.
 (ii) Such fees may not be retained in an amount that 
 exceeds such costs for the respective fiscal year.
 (E)(i)(I) If the Secretary denies a request for certification 
under subparagraph (A)(ii) with respect to a device 
manufactured in an establishment (foreign or domestic) 
registered under section 510, the Secretary shall provide in 
writing to the person seeking such certification the basis for 
such denial, and specifically identify the finding upon which 
such denial is based.
 (II) If the denial of a request as described in subclause (I) 
is based on grounds other than an injunction proceeding 
pursuant to section 302, seizure action pursuant to section 
304, or a recall designated Class I or Class II pursuant to 
part 7, title 21, Code of Federal Regulations, and is based on 
the facility being out of compliance with part 820 of title 21, 
Code of Federal Regulations, the Secretary shall provide a 
substantive summary of the specific grounds for noncompliance 
identified by the Secretary.
 (III) With respect to a device manufactured in an 
establishment that has received a report under section 704(b), 
the Secretary shall not deny a request for certification as 
described in subclause (I) with respect to a device based 
solely on the issuance of that report if the owner, operator, 
or agent in charge of such establishment has agreed to a plan 
of correction in response to such report.
 (ii)(I) The Secretary shall provide a process for a person 
who is denied a certification as described in clause (i)(I) to 
request a review that conforms to the standards of section 
517A(b).
 (II) Notwithstanding any previous review conducted pursuant 
to subclause (I), a person who has been denied a certification 
as described in clause (i)(I) may at any time request a review 
in order to present new information relating to actions taken 
by such person to address the reasons identified by the 
Secretary for the denial of certification, including evidence 
that corrective actions are being or have been implemented to 
address grounds for noncompliance identified by the Secretary.
 (III) Not later than 1 year after the date of enactment of 
the FDA Reauthorization Act of 2017, the Secretary shall issue 
guidance providing for a process to carry out this 
subparagraph. Not later than 1 year after the close of the 
comment period for such guidance, the Secretary shall issue 
final guidance.
 (F)(i) This paragraph applies to requests for certification 
under this subparagraph of a device manufactured by a device 
establishment located outside of the United States that is 
registered under section 510, if the device is listed pursuant 
to section 510(j), the device has been cleared, approved, or is 
not required to submit a premarket report pursuant to 
subsection (l) or (m) of section 510, and the device is 
imported or offered for import into the United States.
 (ii) The Secretary shall issue the certification as described 
in clause (iii) if the device or devices for which 
certification is requested under this subparagraph meet the 
applicable requirements of this Act.
 (iii)(I) A certification for a device described in clause (i) 
shall be subject to the fee described in subparagraph (B).
 (II) Notwithstanding subparagraph (C), a certification for a 
device described in clause (i) shall address and include the 
same material information as a ``Certificate to Foreign 
Government'' and shall have a document title including the 
words ``Certificate to Foreign Government''.
 (iv) The requirements and procedures of subparagraph (E) 
shall apply to a denial of a certification under this 
subparagraph.
 (f)(1) If a drug (other than insulin, an antibiotic drug, an 
animal drug, or a drug exported under section 802) being 
exported in accordance with subsection (e) is being exported to 
a country that has different or additional labeling 
requirements or conditions for use and such country requires 
the drug to be labeled in accordance with those requirements or 
uses, such drug may be labeled in accordance with such 
requirements and conditions for use in the country to which 
such drug is being exported if it also is labeled in accordance 
with the requirements of this Act.
 (2) If, pursuant to paragraph (1), the labeling of an 
exported drug includes conditions for use that have not been 
approved under this Act, the labeling must state that such 
conditions for use have not been approved under this Act. A 
drug exported under section 802 is exempt from this section.
 (g)(1) With respect to a prescription drug being imported or 
offered for import into the United States, the Secretary, in 
the case of an individual who is not in the business of such 
importations, may not send a warning notice to the individual 
unless the following conditions are met:
 (A) The notice specifies, as applicable to the 
 importation of the drug, that the Secretary has made a 
 determination that--
 (i) importation is in violation of section 
 801(a) because the drug is or appears to be 
 adulterated, misbranded, or in violation of 
 section 505;
 (ii) importation is in violation of section 
 801(a) because the drug is or appears to be 
 forbidden or restricted in sale in the country 
 in which it was produced or from which it was 
 exported;
 (iii) importation is or appears to be in 
 violation of section 801(d)(1); or
 (iv) importation otherwise is or appears to 
 be in violation of Federal law.
 (B) The notice does not specify any provision 
 described in subparagraph (A) that is not applicable to 
 the importation of the drug.
 (C) The notice states the reasons underlying such 
 determination by the Secretary, including a brief 
 application to the principal facts involved of the 
 provision of law described in subparagraph (A) that is 
 the basis of the determination by the Secretary.
 (2) For purposes of this section, the term ``warning 
notice'', with respect to the importation of a drug, means a 
communication from the Secretary (written or otherwise) 
notifying a person, or clearly suggesting to the person, that 
importing the drug for personal use is, or appears to be, a 
violation of this Act.
 (h)(1) The Secretary shall give high priority to increasing 
the number of inspections under this section for the purpose of 
enabling the Secretary to inspect food offered for import at 
ports of entry into the United States, with the greatest 
priority given to inspections to detect the intentional 
adulteration of food.
 (2) The Secretary shall give high priority to making 
necessary improvements to the information management systems of 
the Food and Drug Administration that contain information 
related to foods imported or offered for import into the United 
States for purposes of improving the ability of the Secretary 
to allocate resources, detect the intentional adulteration of 
food, and facilitate the importation of food that is in 
compliance with this Act.
 (3) The Secretary shall improve linkages with other 
regulatory agencies of the Federal Government that share 
responsibility for food safety, and shall with respect to such 
safety improve linkages with the States and Indian tribes (as 
defined in section 4(e) of the Indian Self-Determination and 
Education Assistance Act (25 U.S.C. 450b(e))).
 (i)(1) For use in inspections of food under this section, the 
Secretary shall provide for research on the development of 
tests and sampling methodologies--
 (A) whose purpose is to test food in order to rapidly 
 detect the adulteration of the food, with the greatest 
 priority given to detect the intentional adulteration 
 of food; and
 (B) whose results offer significant improvements over 
 the available technology in terms of accuracy, timing, 
 or costs.
 (2) In providing for research under paragraph (1), the 
Secretary shall give priority to conducting research on the 
development of tests that are suitable for inspections of food 
at ports of entry into the United States.
 (3) In providing for research under paragraph (1), the 
Secretary shall as appropriate coordinate with the Director of 
the Centers for Disease Control and Prevention, the Director of 
the National Institutes of Health, the Administrator of the 
Environmental Protection Agency, and the Secretary of 
Agriculture.
 (4) The Secretary shall annually submit to the Committee on 
Energy and Commerce of the House of Representatives, and the 
Committee on Health, Education, Labor, and Pensions of the 
Senate, a report describing the progress made in research under 
paragraph (1), including progress regarding paragraph (2).
 (j)(1) If an officer or qualified employee of the Food and 
Drug Administration has credible evidence or information 
indicating that an article of food presents a threat of serious 
adverse health consequences or death to humans or animals, and 
such officer or qualified employee is unable to inspect, 
examine, or investigate such article upon the article being 
offered for import at a port of entry into the United States, 
the officer or qualified employee shall request the Secretary 
of Treasury to hold the food at the port of entry for a 
reasonable period of time, not to exceed 24 hours, for the 
purpose of enabling the Secretary to inspect, examine, or 
investigate the article as appropriate.
 (2) The Secretary shall request the Secretary of Treasury to 
remove an article held pursuant to paragraph (1) to a secure 
facility, as appropriate. During the period of time that such 
article is so held, the article shall not be transferred by any 
person from the port of entry into the United States for the 
article, or from the secure facility to which the article has 
been removed, as the case may be. Subsection (b) does not 
authorize the delivery of the article pursuant to the execution 
of a bond while the article is so held.
 (3) An officer or qualified employee of the Food and Drug 
Administration may make a request under paragraph (1) only if 
the Secretary or an official designated by the Secretary 
approves the request. An official may not be so designated 
unless the official is the director of the district under this 
Act in which the article involved is located, or is an official 
senior to such director.
 (4) With respect to an article of food for which a request 
under paragraph (1) is made, the Secretary, promptly after the 
request is made, shall notify the State in which the port of 
entry involved is located that the request has been made, and 
as applicable, that such article is being held under this 
subsection.
 (k)(1) If an article of food is being imported or offered for 
import into the United States, and the importer, owner, or 
consignee of the article is a person who has been debarred 
under section 306(b)(3), such article shall be held at the port 
of entry for the article, and may not be delivered to such 
person. Subsection (b) does not authorize the delivery of the 
article pursuant to the execution of a bond while the article 
is so held. The article shall be removed to a secure facility, 
as appropriate. During the period of time that such article is 
so held, the article shall not be transferred by any person 
from the port of entry into the United States for the article, 
or from the secure facility to which the article has been 
removed, as the case may be.
 (2) An article of food held under paragraph (1) may be 
delivered to a person who is not a debarred person under 
section 306(b)(3) if such person affirmatively establishes, at 
the expense of the person, that the article complies with the 
requirements of this Act, as determined by the Secretary.
 (l)(1) If an article of food is being imported or offered for 
import into the United States, and such article is from a 
foreign facility for which a registration has not been 
submitted to the Secretary under section 415 (or for which a 
registration has been suspended under such section), such 
article shall be held at the port of entry for the article, and 
may not be delivered to the importer, owner, or consignee of 
the article, until the foreign facility is so registered. 
Subsection (b) does not authorize the delivery of the article 
pursuant to the execution of a bond while the article is so 
held. The article shall be removed to a secure facility, as 
appropriate. During the period of time that such article is so 
held, the article shall not be transferred by any person from 
the port of entry into the United States for the article, or 
from the secure facility to which the article has been removed, 
as the case may be.
 (m)(1) In the case of an article of food that is being 
imported or offered for import into the United States, the 
Secretary, after consultation with the Secretary of the 
Treasury, shall by regulation require, for the purpose of 
enabling such article to be inspected at ports of entry into 
the United States, the submission to the Secretary of a notice 
providing the identity of each of the following: The article; 
the manufacturer and shipper of the article; if known within 
the specified period of time that notice is required to be 
provided, the grower of the article; the country from which the 
article originates; the country from which the article is 
shipped; any country to which the article has been refused 
entry; and the anticipated port of entry for the article. An 
article of food imported or offered for import without 
submission of such notice in accordance with the requirements 
under this paragraph shall be refused admission into the United 
States. Nothing in this section may be construed as a 
limitation on the port of entry for an article of food.
 (2)(A) Regulations under paragraph (1) shall require that a 
notice under such paragraph be provided by a specified period 
of time in advance of the time of the importation of the 
article of food involved or the offering of the food for 
import, which period shall be no less than the minimum amount 
of time necessary for the Secretary to receive, review, and 
appropriately respond to such notification, but may not exceed 
five days. In determining the specified period of time required 
under this subparagraph, the Secretary may consider, but is not 
limited to consideration of, the effect on commerce of such 
period of time, the locations of the various ports of entry 
into the United States, the various modes of transportation, 
the types of food imported into the United States, and any 
other such consideration. Nothing in the preceding sentence may 
be construed as a limitation on the obligation of the Secretary 
to receive, review, and appropriately respond to any notice 
under paragraph (1).
 (B)(i) If an article of food is being imported or offered for 
import into the United States and a notice under paragraph (1) 
is not provided in advance in accordance with the requirements 
under paragraph (1), such article shall be held at the port of 
entry for the article, and may not be delivered to the 
importer, owner, or consignee of the article, until such notice 
is submitted to the Secretary, and the Secretary examines the 
notice and determines that the notice is in accordance with the 
requirements under paragraph (1). Subsection (b) does not 
authorize the delivery of the article pursuant to the execution 
of a bond while the article is so held. The article shall be 
removed to a secure facility, as appropriate. During the period 
of time that such article is so held, the article shall not be 
transferred by any person from the port of entry into the 
United States for the article, or from the secure facility to 
which the article has been removed, as the case may be.
 (ii) In carrying out clause (i) with respect to an article of 
food, the Secretary shall determine whether there is in the 
possession of the Secretary any credible evidence or 
information indicating that such article presents a threat of 
serious adverse health consequences or death to humans or 
animals.
 (3)(A) This subsection may not be construed as limiting the 
authority of the Secretary to obtain information under any 
other provision of this Act.
 (B) This subsection may not be construed as authorizing the 
Secretary to impose any requirements with respect to a food to 
the extent that it is within the exclusive jurisdiction of the 
Secretary of Agriculture pursuant to the Federal Meat 
Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products 
Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products 
Inspection Act (21 U.S.C. 1031 et seq.).
 (n)(1) If a food has been refused admission under subsection 
(a), other than such a food that is required to be destroyed, 
the Secretary may require the owner or consignee of the food to 
affix to the container of the food a label that clearly and 
conspicuously bears the statement: ``UNITED STATES: REFUSED 
ENTRY''.
 (2) All expenses in connection with affixing a label under 
paragraph (1) shall be paid by the owner or consignee of the 
food involved, and in default of such payment, shall constitute 
a lien against future importations made by such owner or 
consignee.
 (3) A requirement under paragraph (1) remains in effect until 
the Secretary determines that the food involved has been 
brought into compliance with this Act.
 (o) If an article that is a device is being imported or 
offered for import into the United States, and the importer, 
owner, or consignee of such article does not, at the time of 
offering the article for import, submit to the Secretary a 
statement that identifies the registration under section 510(i) 
of each establishment that with respect to such article is 
required under such section to register with the Secretary, the 
article may be refused admission. If the article is refused 
admission for failure to submit such a statement, the article 
shall be held at the port of entry for the article, and may not 
be delivered to the importer, owner, or consignee of the 
article, until such a statement is submitted to the Secretary. 
Subsection (b) does not authorize the delivery of the article 
pursuant to the execution of a bond while the article is so 
held. The article shall be removed to a secure facility, as 
appropriate. During the period of time that such article is so 
held, the article shall not be transferred by any person from 
the port of entry into the United States for the article, or 
from the secure facility to which the article has been removed, 
as the case may be.
 (p)(1) Not later than 36 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act, and 
annually thereafter, the Secretary shall submit to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives, a report regarding--
 (A) the nature, extent, and destination of United 
 States tobacco product exports that do not conform to 
 tobacco product standards established pursuant to this 
 Act;
 (B) the public health implications of such exports, 
 including any evidence of a negative public health 
 impact; and
 (C) recommendations or assessments of policy 
 alternatives available to Congress and the executive 
 branch to reduce any negative public health impact 
 caused by such exports.
 (2) The Secretary is authorized to establish appropriate 
information disclosure requirements to carry out this 
subsection.
 (q) Certifications Concerning Imported Foods.--
 (1) In general.--The Secretary may require, as a 
 condition of granting admission to an article of food 
 imported or offered for import into the United States, 
 that an entity described in paragraph (3) provide a 
 certification, or such other assurances as the 
 Secretary determines appropriate, that the article of 
 food complies with applicable requirements of this Act. 
 Such certification or assurances may be provided in the 
 form of shipment-specific certificates, a listing of 
 certified facilities that manufacture, process, pack, 
 or hold such food, or in such other form as the 
 Secretary may specify.
 (2) Factors to be considered in requiring 
 certification.--The Secretary shall base the 
 determination that an article of food is required to 
 have a certification described in paragraph (1) on the 
 risk of the food, including--
 (A) known safety risks associated with the 
 food;
 (B) known food safety risks associated with 
 the country, territory, or region of origin of 
 the food;
 (C) a finding by the Secretary, supported by 
 scientific, risk-based evidence, that--
 (i) the food safety programs, 
 systems, and standards in the country, 
 territory, or region of origin of the 
 food are inadequate to ensure that the 
 article of food is as safe as a similar 
 article of food that is manufactured, 
 processed, packed, or held in the 
 United States in accordance with the 
 requirements of this Act; and
 (ii) the certification would assist 
 the Secretary in determining whether to 
 refuse or admit the article of food 
 under subsection (a); and
 (D) information submitted to the Secretary in 
 accordance with the process established in 
 paragraph (7).
 (3) Certifying entities.--For purposes of paragraph 
 (1), entities that shall provide the certification or 
 assurances described in such paragraph are--
 (A) an agency or a representative of the 
 government of the country from which the 
 article of food at issue originated, as 
 designated by the Secretary; or
 (B) such other persons or entities accredited 
 pursuant to section 808 to provide such 
 certification or assurance.
 (4) Renewal and refusal of certifications.--The 
 Secretary may--
 (A) require that any certification or other 
 assurance provided by an entity specified in 
 paragraph (2) be renewed by such entity at such 
 times as the Secretary determines appropriate; 
 and
 (B) refuse to accept any certification or 
 assurance if the Secretary determines that such 
 certification or assurance is not valid or 
 reliable.
 (5) Electronic submission.--The Secretary shall 
 provide for the electronic submission of certifications 
 under this subsection.
 (6) False statements.--Any statement or 
 representation made by an entity described in paragraph 
 (2) to the Secretary shall be subject to section 1001 
 of title 18, United States Code.
 (7) Assessment of food safety programs, systems, and 
 standards.--If the Secretary determines that the food 
 safety programs, systems, and standards in a foreign 
 region, country, or territory are inadequate to ensure 
 that an article of food is as safe as a similar article 
 of food that is manufactured, processed, packed, or 
 held in the United States in accordance with the 
 requirements of this Act, the Secretary shall, to the 
 extent practicable, identify such inadequacies and 
 establish a process by which the foreign region, 
 country, or territory may inform the Secretary of 
 improvements made to such food safety program, system, 
 or standard and demonstrate that those controls are 
 adequate to ensure that an article of food is as safe 
 as a similar article of food that is manufactured, 
 processed, packed, or held in the United States in 
 accordance with the requirements of this Act.
 (r)(1) The Secretary may require, pursuant to the regulations 
promulgated under paragraph (4)(A), as a condition of granting 
admission to a drug imported or offered for import into the 
United States, that the importer electronically submit 
information demonstrating that the drug complies with 
applicable requirements of this Act.
 (2) The information described under paragraph (1) may 
include--
 (A) information demonstrating the regulatory status 
 of the drug, such as the new drug application, 
 abbreviated new drug application, or investigational 
 new drug or drug master file number;
 (B) facility information, such as proof of 
 registration and the unique facility identifier;
 (C) indication of compliance with current good 
 manufacturing practice, testing results, certifications 
 relating to satisfactory inspections, and compliance 
 with the country of export regulations; and
 (D) any other information deemed necessary and 
 appropriate by the Secretary to assess compliance of 
 the article being offered for import.
 (3) Information requirements referred to in paragraph (2)(C) 
may, at the discretion of the Secretary, be satisfied--
 (A) through representation by a foreign government, 
 if an inspection is conducted by a foreign government 
 using standards and practices as determined appropriate 
 by the Secretary;
 (B) through representation by a foreign government or 
 an agency of a foreign government recognized under 
 section 809; or
 (C) other appropriate documentation or evidence as 
 described by the Secretary.
 (4)(A) Not later than 18 months after the date of enactment 
of the Food and Drug Administration Safety and Innovation Act, 
the Secretary shall adopt final regulations implementing this 
subsection. Such requirements shall be appropriate for the type 
of import, such as whether the drug is for import into the 
United States for use in preclinical research or in a clinical 
investigation under an investigational new drug exemption under 
505(i).
 (B) In promulgating the regulations under subparagraph (A), 
the Secretary--
 (i) may, as appropriate, take into account 
 differences among importers and types of imports, and, 
 based on the level of risk posed by the imported drug, 
 provide for expedited clearance for those importers 
 that volunteer to participate in partnership programs 
 for highly compliant companies and pass a review of 
 internal controls, including sourcing of foreign 
 manufacturing inputs, and plant inspections; and
 (ii) shall--
 (I) issue a notice of proposed rulemaking 
 that includes the proposed regulation;
 (II) provide a period of not less than 60 
 days for comments on the proposed regulation; 
 and
 (III) publish the final regulation not less 
 than 30 days before the effective date of the 
 regulation.
 (C) Notwithstanding any other provision of law, the Secretary 
shall promulgate regulations implementing this subsection only 
as described in subparagraph (B).
 (s) Registration of Commercial Importers.--
 (1) Registration.--The Secretary shall require a 
 commercial importer of drugs--
 (A) to be registered with the Secretary in a 
 form and manner specified by the Secretary; and
 (B) subject to paragraph (4), to submit, at 
 the time of registration, a unique identifier 
 for the principal place of business for which 
 the importer is required to register under this 
 subsection.
 (2) Regulations.--
 (A) In general.--The Secretary, in 
 consultation with the Secretary of Homeland 
 Security acting through U.S. Customs and Border 
 Protection, shall promulgate regulations to 
 establish good importer practices that specify 
 the measures an importer shall take to ensure 
 imported drugs are in compliance with the 
 requirements of this Act and the Public Health 
 Service Act.
 (B) Procedure.--In promulgating a regulation 
 under subparagraph (A), the Secretary shall--
 (i) issue a notice of proposed 
 rulemaking that includes the proposed 
 regulation;
 (ii) provide a period of not less 
 than 60 days for comments on the 
 proposed regulation; and
 (iii) publish the final regulation 
 not less than 30 days before the 
 regulation's effective date.
 (C) Restrictions.--Notwithstanding any other 
 provision of Federal law, in implementing this 
 subsection, the Secretary shall only promulgate 
 regulations as described in subparagraph (B).
 (D) Effective date.--In establishing the 
 effective date of the regulations under 
 subparagraph (A), the Secretary shall, in 
 consultation with the Secretary of Homeland 
 Security acting through U.S. Customs and Border 
 Protection, as determined appropriate by the 
 Secretary of Health and Human Services, provide 
 a reasonable period of time for an importer of 
 a drug to comply with good importer practices, 
 taking into account differences among importers 
 and types of imports, including based on the 
 level of risk posed by the imported product.
 (3) Discontinuance of registration.--The Secretary 
 shall discontinue the registration of any commercial 
 importer of drugs that fails to comply with the 
 regulations promulgated under this subsection.
 (4) Unique facility identifier.--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.
 (5) Exemptions.--The Secretary, by notice in the 
 Federal Register, may establish exemptions from the 
 requirements of this subsection.
 (t) Single Source Pattern of Imported Illegal Drugs.--If the 
Secretary determines that a person subject to debarment as a 
result of engaging in a pattern of importing or offering for 
import controlled substances or drugs as described in section 
306(b)(3)(D), and such pattern is identified by the Secretary 
as being offered for import from the same manufacturer, 
distributor, or importer, the Secretary may by order determine 
all drugs being offered for import from such person as 
adulterated or misbranded, unless such person can provide 
evidence otherwise.
 (u) Illicit Articles Containing Active Pharmaceutical 
Ingredients.--
 (1) In general.--For purposes of this section, an 
 article that is being imported or offered for import 
 into the United States may be treated by the Secretary 
 as a drug if the article--
 (A) is not--
 (i) accompanied by an electronic 
 import entry for such article submitted 
 using an authorized electronic data 
 interchange system; and
 (ii) designated in such a system as 
 an article regulated by the Secretary 
 (which may include regulation as a 
 drug, a device, a dietary supplement, 
 or other product that is regulated 
 under this Act); and
 (B) is an ingredient that presents 
 significant public health concern and is, or 
 contains--
 (i) an active ingredient in a drug--
 (I) that is approved under 
 section 505 or licensed under 
 section 351 of the Public 
 Health Service Act; or
 (II) for which--
 (aa) an 
 investigational use 
 exemption has been 
 authorized under 
 section 505(i) of this 
 Act or section 351(a) 
 of the Public Health 
 Service Act; and
 (bb) a substantial 
 clinical investigation 
 has been instituted, 
 and such investigation 
 has been made public; 
 or
 (ii) a substance that has a chemical 
 structure that is substantially similar 
 to the chemical structure of an active 
 ingredient in a drug or biological 
 product described in subclause (I) or 
 (II) of clause (i).
 (2) Effect.--This subsection shall not be construed 
 to bear upon any determination of whether an article is 
 a drug within the meaning of section 201(g), other than 
 for the purposes described in paragraph (1).
 (v) Destruction of Refused Articles Presenting Significant 
Public Health Concerns.--
 (1) In general.--If the Secretary of Health and Human 
 Services finds that an article that has been refused 
 admission under subsection (a) presents a significant 
 public health concern, the Secretary may issue to the 
 owner or consignee of the article an order to destroy 
 the article, without the opportunity for export.
 (2) Deadline; costs.--Not later than 90 days after 
 the issuance of an order under paragraph (1), the owner 
 or consignee of the article shall destroy the article. 
 The owner or consignee shall be responsible for the 
 costs of such destruction.
 (3) Due process.--The Secretary of Health and Human 
 Services shall provide to the owner or consignee of an 
 article subject to an order under paragraph (1) 
 appropriate due process prior to the destruction of the 
 article. Such due process shall be specified in 
 regulations and include notice and an opportunity to 
 appear before the Secretary and introduce testimony on 
 the destruction--
 (A) in combination with the notice and 
 opportunity to appear and introduce testimony 
 on the refusal of admission of the article 
 under subsection (a); or
 (B) separately.

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 MINORITY, ADDITIONAL, OR DISSENTING VIEWS