[House Report 116-512]
[From the U.S. Government Publishing Office]


116th Congress    }                                  {         Report
                        HOUSE OF REPRESENTATIVES
 2d Session       }                                  {         116-512

======================================================================



 
                     SAFEGUARDING THERAPEUTICS ACT

                                _______
                                

 September 17, 2020.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 5663]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 5663) to amend the Federal Food, Drug, and 
Cosmetic Act to give authority to the Secretary of Health and 
Human Services, acting through the Commissioner of Food and 
Drugs, to destroy counterfeit devices, having considered the 
same, reports favorably thereon with an amendment and 
recommends that the bill as amended do pass.

                                CONTENTS

                                                                   Page
  I.  Purpose and Summary.............................................2
 II.  Background and Need for the Legislation.........................3
III.  Committee Hearings..............................................4
 IV.  Committee Consideration.........................................4
  V.  Committee Votes.................................................5
 VI.  Oversight Findings..............................................5
VII.  New Budget Authority, Entitlement Authority, and Tax Expenditure5
VIII. Federal Mandates Statement......................................5

 IX.  Statement of General Performance Goals and Objectives...........5
  X.  Duplication of Federal Programs.................................6
 XI.  Committee Cost Estimate.........................................6
XII.  Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.....6
XIII. Advisory Committee Statement....................................6

XIV.  Applicability to Legislative Branch.............................6
 XV.  Section-by-Section Analysis of the Legislation..................6
 XVI. Changes in Existing Law Made by the Bill, as Reported...........7

    The amendment is as follows:
    Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

   This Act may be cited as the ``Safeguarding Therapeutics Act''.

SEC. 2. AUTHORITY TO DESTROY COUNTERFEIT DEVICES.

  (a) In General.--Section 801(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)) is amended--
          (1) in the fourth sentence, by inserting ``or counterfeit 
        device'' after ``counterfeit drug''; and
          (2) by striking ``The Secretary of the Treasury shall cause 
        the destruction of'' and all that follows through ``liable for 
        costs pursuant to subsection (c).'' and inserting the 
        following: ``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 or device refused admission 
        under this section, if such drug or device 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 or device 
        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 or device. Where the 
        Secretary of Health and Human Services provides notice and an 
        opportunity to appear and introduce testimony on the 
        destruction of a drug or device, the Secretary of Health and 
        Human Services shall store and, as applicable, dispose of the 
        drug or device after the issuance of the notice, except that 
        the owner and consignee shall remain liable for costs pursuant 
        to subsection (c).''.
  (b) Definition.--Section 201(h) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(h)) is amended--
          (1) by redesignating subparagraphs (1), (2), and (3) as 
        clauses (A), (B), and (C), respectively; and
          (2) after making such redesignations--
                  (A) by striking ``(h) The term'' and inserting 
                ``(h)(1) The term''; and
                  (B) by adding at the end the following:
          ``(2) The term `counterfeit device' means a device which, or 
        the container, packaging, or labeling of which, without 
        authorization, bears a trademark, trade name, or other 
        identifying mark, imprint, or symbol, or any likeness thereof, 
        or is manufactured using a design, of a device manufacturer, 
        packer, or distributor other than the person or persons who in 
        fact manufactured, packed, or distributed such device and which 
        thereby falsely purports or is represented to be the product 
        of, or to have been packed or distributed by, such other device 
        manufacturer, packer, or distributor.
          ``(3) For purposes of subparagraph (2)--
                  ``(A) the term `manufactured' refers to any of the 
                following activities: manufacture, preparation, 
                propagation, compounding, assembly, or processing; and
                  ``(B) the term `manufacturer' means a person who is 
                engaged in any of the activities listed in clause 
                (A).''.

                         I. Purpose and Summary

    H.R. 5663, the ``Safeguarding Therapeutics Act'', was 
introduced on January 21, 2020, by Representatives Brett 
Guthrie (R-KY) and Eliot L. Engel (D-NY). H.R. 5663, as 
reported, will extend the administrative destruction authority 
of the U.S. Food and Drug Administration (FDA) to medical 
devices. This authority allows the agency to destroy drugs or 
devices that have been refused admission without providing the 
owner or consignee with the opportunity to export the 
product.\1\ This authority helps the agency to ensure that 
counterfeit or otherwise violative products cannot enter the 
United States.
---------------------------------------------------------------------------
    \1\U.S. Food and Drug Admin., FDA's Administrative Destruction 
Authority, https://www.fda.gov/industry/import-program-resources/fdas-
administrative-destruction-authority (May 15, 2018).
---------------------------------------------------------------------------

                II. Background and Need for Legislation

    In 2012, Congress granted FDA the authority to destroy a 
refused drug valued at $2,500 or less (or a higher amount as 
the Secretary of the Treasury may determine in regulation) 
without the opportunity for further export.\2\ This Committee 
passed legislation granting this authority to help prevent 
further export of violative products, such as products that are 
counterfeit, contaminated, or contain illegal or toxic 
ingredients. Prior to the authority granted in 2012, if FDA 
refused a drug's admission because the agency believed it was 
adulterated or misbranded, the drug could be further exported 
after refusal of admission, and may have found its way into the 
United States drug supply chain through mail facilities.\3\ As 
the volume of drugs shipped to the United States increased, 
violative drugs were less likely to receive reviews due to 
resource constraints of FDA, increasing the possibility of 
previously-refused drugs entering the United States' drug 
market.\4\ In 2019, FDA used the administrative destruction 
authority to destroy more than 17,000 violative drugs, ensuring 
that illicit or dangerous drugs did not enter the United States 
drug supply.\5\
---------------------------------------------------------------------------
    \2\Id.
    \3\U.S. Food and Drug Admin., Administrative Destruction of Certain 
Drugs Refused Admission to the United States, Final Rule, available at 
https://www.fda.gov/media/93525/download.
    \4\Id.
    \5\U.S. Food and Drug Admin., FDA in Brief: Readout of Acting FDA 
Commissioner Ned Sharpless, M.D., Visit to JFK/Seacaucus Int'l Mail 
Facilities, https://www.fda.gov/news-events/fda-brief/fda-brief-
readout-acting-fda-commissioner-ned-sharpless-md-visit-jfksecaucus-
international-mail (Oct. 19, 2019).
---------------------------------------------------------------------------
    Currently, the administrative destruction authority only 
extends to drug products. According to the agency, expanding 
administrative destruction authority to counterfeit or illegal 
medical devices could be extremely useful to FDA's ability to 
protect public health during public health emergencies, like 
the COVID-19 outbreak, where large numbers of illegal test kits 
are being imported into the United States.\6\ Currently, FDA is 
limited to refusing illegal COVID-19 test kits and other 
devices, and the importers are given the opportunity to export 
them.\7\ Extending administrative destruction authority to 
violative medical devices would prevent shippers from sending 
violative devices back to the United States in the hope of 
avoiding detection, and could help to deter future shipments of 
counterfeit or illegal medical devices.\8\
---------------------------------------------------------------------------
    \6\FDA , Proposal to Expand Food and Drug Administration (FDA) 
801(a) Authority and Oversight of Counterfeit Devices.
    \7\FDA, Proposal to Expand Food and Drug Administration (FDA) 
801(a) Authority and Oversight of Counterfeit Devices.
    \8\FDA , Proposal to Expand Food and Drug Administration (FDA) 
801(a) Authority and Oversight of Counterfeit Devices.
---------------------------------------------------------------------------
    H.R. 5663 amends section 801(a) of the Federal Food, Drug, 
and Cosmetic Act to authorize FDA to destroy a device refused 
admission if the device is valued at an amount less than $2,500 
and amends the Act to include a definition of a counterfeit 
device.

                        III. Committee Hearings

    For the purposes of section 103(i) of H. Res. 6 of the 
116th Congress, the following hearing was used to develop or 
consider H.R. 5663:
    The Subcommittee on Health held a legislative hearing on 
January 29, 2020, entitled, ``Improving Safety and Transparency 
in America's Food and Drugs.'' The hearing focused on H.R. 
5663, the ``Safeguarding Therapeutics Act'', and nine other 
bills. The Subcommittee received testimony from the following 
witnesses:

Panel I:

           Jeff Allen, Ph.D., President and CEO, 
        Friends of Cancer Research;
           Richard Kaeser, Vice President, Global Brand 
        Protection, Johnson & Johnson;
           Fernando Muzzio, Ph.D., Distinguished 
        Professor, Chemical and Biochemical Engineering, 
        Rutgers, the State University of New Jersey; and
           Kao-Ping Chua, M.D., Ph.D., Assistant 
        Professor, Department of Pediatrics, University of 
        Michigan Medical School.

Panel II:

           Melanie Benesh, Legislative Attorney, 
        Environmental Working Group;
           Tom Balmer, Executive Vice President, 
        National Milk Producers Federation;
           J. David Carlin, Senior Vice President of 
        Legislative Affairs and Economic Policy, International 
        Dairy Foods Association;
           Douglas Corey, D.V.M., Past President, 
        American Association of Equine Practitioners;
           Talia Day, Patient Advocate;
           Paul C. DeLeo, Ph.D., Principal, Integral 
        Consulting, Inc.;
           Mardi Mountford, President, Infant Nutrition 
        Council of America;
           Nancy Perry, Senior Vice President, 
        Government Relations, American Society for the 
        Prevention of Cruelty to Animals; and
           Sara Sorscher, Deputy Director of Regulatory 
        Affairs, Center for Science in the Public Interest.

                      IV. Committee Consideration

    Representatives Guthrie (R-KY) and Engel (D-NY) introduced 
H.R. 5663, the ``Safeguarding Therapeutics Act'', on January 
21, 2020, and the bill was referred to the Committee on Energy 
and Commerce. Subsequently, H.R. 5663 was referred to the 
Subcommittee on Health on January 22, 2020. A legislative 
hearing was held by the Subcommittee on January 29, 2020.
    On March 11, 2020, the Subcommittee on Health met in open 
markup session, pursuant to notice, to consider H.R. 5663. No 
amendments were offered during consideration of the bill. The 
Subcommittee on Health then agreed to a motion by Ms. Eshoo, 
Chairwoman of the subcommittee, to forward favorably H.R. 5663, 
without amendment, to the full Committee on Energy and Commerce 
by a voice vote.
    On July 15, 2020, the full Committee met in virtual open 
markup session, pursuant to notice, to consider the bill H.R. 
5663. During consideration of the bill, an amendment in the 
nature of a substitute offered by Mr. Guthrie, on behalf of 
himself and Mr. Engel, was agreed to by a voice vote. Upon 
conclusion of the bill's consideration, the full Committee 
agreed to a motion on final passage by Mr. Pallone, Chairman of 
the committee, to order H.R. 5663 reported favorably to the 
House, amended, by a voice vote, a quorum being present.

                           V. Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that there were no record votes taken on H.R. 
5663, including the motion for final passage of the bill.

                         VI. Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
oversight findings and recommendations of the Committee are 
reflected in the descriptive portion of the report.

 VII. New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.
    The Committee has requested but not received from the 
Director of the Congressional Budget Office a statement as to 
whether this bill contains any new budget authority, spending 
authority, credit authority, or an increase or decrease in 
revenues or tax expenditures.

                    VIII. Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

       IX. Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to extend 
the authority of the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, to destroy 
counterfeit medical devices.

                   X. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 5663 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                      XI. Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

    XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 5663 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                   XIII. Advisory Committee Statement

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                XIV. Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

           XV. Section by Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates that the bill may be cited as the 
``Safeguarding Therapeutics Act''.

Sec. 2. Authority to destroy counterfeit devices

    Section 2 amends section 801(a) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA) to authorize the Secretary of Health 
and Human Services to destroy any article that is refused 
admission, including medical devices.
    Further, the section amends section 201 of the FFDCA to 
include a definition of `counterfeit device'. As defined in the 
bill, the term `counterfeit device' means a device which, or 
the container, packaging, or labeling of which, bears a 
trademark, trade name, identifying mark, imprint, symbol, or 
any likeness thereof that is not authorized, or is manufactured 
using a design of a device manufacturer, packer, or distributor 
other than the person who in fact manufactured, packed, or 
distributed such device, and falsely purports or represents to 
be the product or the device manufacturer, packer, or 
distributed.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, 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




           *       *       *       *       *       *       *
                        CHAPTER II--DEFINITIONS

  Sec. 201. For the purposes of this Act--
  (a)(1) The term ``State'', except as used in the last 
sentence of section 702(a), means any State or Territory of the 
United States, the District of Columbia, and the Commonwealth 
of Puerto Rico.
  (2) The term ``Territory'' means any Territory or possession 
of the United States, including the District of Columbia, and 
excluding the Commonwealth of Puerto Rico and the Canal Zone.
  (b) The term ``interstate commerce'' means (1) commerce 
between any State or Territory and any place outside thereof, 
and (2) commerce within the District of Columbia or within any 
other Territory not organized with a legislative body.
  (c) The term ``Department'' means the Department of Health 
and Human Services.
  (d) The term ``Secretary'' means the Secretary of Health and 
Human Services.
  (e) The term ``person'' includes individual, partnership, 
corporation, and association.
  (f) The term ``food'' means (1) articles used for food or 
drink for man or other animals, (2) chewing gum, and (3) 
articles used for components of any such article.
  (g)(1) The term ``drug'' means (A) articles recognized in the 
official United States Pharmacopeia, official Homeopathic 
Pharmacopeia of the United States, or official National 
Formulary, or any supplement to any of them; and (B) articles 
intended for use in the diagnosis, cure, mitigation, treatment, 
or prevention of disease in man or other animals; and (C) 
articles (other than food) intended to affect the structure or 
any function of the body of man or other animals; and (D) 
articles intended for use as a component of any articles 
specified in clause (A), (B), or (C). A food or dietary 
supplement for which a claim, subject to sections 403(r)(1)(B) 
and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is 
made in accordance with the requirements of section 403(r) is 
not a drug solely because the label or the labeling contains 
such a claim. A food, dietary ingredient, or dietary supplement 
for which a truthful and not misleading statement is made in 
accordance with section 403(r)(6) is not a drug under clause 
(C) solely because the label or the labeling contains such a 
statement.
  (2) The term ``counterfeit drug'' means a drug which, or the 
container or labeling of which, without authorization, bears 
the trademark, trade name, or other identifying mark, imprint, 
or device, or any likeness thereof, of a drug manufacturer, 
processor, packer, or distributor other than the person or 
persons who in fact manufactured, processed, packed, or 
distributed such drug and which thereby falsely purports or is 
represented to be the product of, or to have been packed or 
distributed by, such other drug manufacturer, processor, 
packer, or distributor.
  (h)(1) The term ``device'' (except when used in paragraph (n) 
of this section and in sections 301(i), 403(f), 502(c), and 
602(c)) means an instrument, apparatus, implement, machine, 
contrivance, implant, in vitro reagent, or other similar or 
related article, including any component, part, or accessory, 
which is--
          [(1)] (A) recognized in the official National 
        Formulary, or the United States Pharmacopeia, or any 
        supplement to them,
          [(2)] (B) intended for use in the diagnosis of 
        disease or other conditions, or in the cure, 
        mitigation, treatment, or prevention of disease, in man 
        or other animals, or
          [(3)] (C) intended to affect the structure or any 
        function of the body of man or other animals, and
which does not achieve its primary intended purposes through 
chemical action within or on the body of man or other animals 
and which is not dependent upon being metabolized for the 
achievement of its primary intended purposes. The term 
``device'' does not include software functions excluded 
pursuant to section 520(o).
          (2) The term ``counterfeit device'' means a device 
        which, or the container, packaging, or labeling of 
        which, without authorization, bears a trademark, trade 
        name, or other identifying mark, imprint, or symbol, or 
        any likeness thereof, or is manufactured using a 
        design, of a device manufacturer, packer, or 
        distributor other than the person or persons who in 
        fact manufactured, packed, or distributed such device 
        and which thereby falsely purports or is represented to 
        be the product of, or to have been packed or 
        distributed by, such other device manufacturer, packer, 
        or distributor.
          (3) For purposes of subparagraph (2)--
                  (A) the term ``manufactured'' refers to any 
                of the following activities: manufacture, 
                preparation, propagation, compounding, 
                assembly, or processing; and
                  (B) the term ``manufacturer'' means a person 
                who is engaged in any of the activities listed 
                in clause (A).
  (i) The term ``cosmetic'' means (1) articles intended to be 
rubbed, poured, sprinkled, or sprayed on, introduced into, or 
otherwise applied to the human body or any part thereof for 
cleansing, beautifying, promoting attractiveness, or altering 
the appearance, and (2) articles intended for use as a 
component of any such articles; except that such term shall not 
include soap.
  (j) The term ``official compendium'' means the official 
United States Pharmacopeia, official Homeopathic Pharmacopeia 
of the United States, official National Formulary, or any 
supplement to any of them.
  (k) The term ``label'' means a display of written, printed, 
or graphic matter upon the immediate container of any article; 
and a requirement made by or under authority of this Act that 
any word, statement, or other information appear on the label 
shall not be considered to be complied with unless such word, 
statement, or other information also appears on the outside 
container or wrapper, if any there be, of the retail package of 
such article, or is easily legible through the outside 
container or wrapper.
  (l) The term ``immediate container'' does not include package 
liners.
  (m) The term ``labeling'' means all labels and other written, 
printed, or graphic matter (1) upon any article or any of its 
containers or wrappers, or (2) accompanying such article.
  (n) If an article is alleged to be misbranded because the 
labeling or advertising is misleading, then in determining 
whether the labeling or advertising is misleading there shall 
be taken into account (among other things) not only 
representations made or suggested by statement, word, design, 
device, or any combination thereof, but also the extent to 
which the labeling or advertising fails to reveal facts 
material in the light of such representations or material with 
respect to consequences which may result from the use of the 
article to which the labeling or advertising relates under the 
conditions of use prescribed in the labeling or advertising 
thereof or under such conditions of use as are customary or 
usual.
  (o) The representation of a drug, in its labeling, as an 
antiseptic shall be considered to be a representation that it 
is a germicide, except in the case of a drug purporting to be, 
or represented as, an antiseptic for inhibitory use as a wet 
dressing, ointment, dusting powder, or such other use as 
involves prolonged contact with the body.
  (p) The term ``new drug'' means--
          (1) Any drug (except a new animal drug or an animal 
        feed bearing or containing a new animal drug) the 
        composition of which is such that such drug is not 
        generally recognized, among experts qualified by 
        scientific training and experience to evaluate the 
        safety and effectiveness of drugs, as safe and 
        effective for use under the conditions prescribed, 
        recommended, or suggested in the labeling thereof, 
        except that such a drug not so recognized shall not be 
        deemed to be a ``new drug'' if at any time prior to the 
        enactment of this Act it was subject to the Food and 
        Drugs Act of June 30, 1906, as amended, and if at such 
        time its labeling contained the same representations 
        concerning the conditions of its use; or
          (2) Any drug (except a new animal drug or an animal 
        feed bearing or containing a new animal drug) the 
        composition of which is such that such drug, as a 
        result of investigations to determine its safety and 
        effectiveness for use under such conditions, has become 
        so recognized, but which has not, otherwise than in 
        such investigations, been used to a material extent or 
        for a material time under such conditions.
  (q)(1)(A) Except as provided in clause (B), the term 
``pesticide chemical'' means any substance that is a pesticide 
within the meaning of the Federal Insecticide, Fungicide, and 
Rodenticide Act, including all active and inert ingredients of 
such pesticide. Notwithstanding any other provision of law, the 
term ``pesticide'' within such meaning includes ethylene oxide 
and propylene oxide when such substances are applied on food.
  (B) In the case of the use, with respect to food, of a 
substance described in clause (A) to prevent, destroy, repel, 
or mitigate microorganisms (including bacteria, viruses, fungi, 
protozoa, algae, and slime), the following applies for purposes 
of clause (A):
          (i) The definition in such clause for the term 
        ``pesticide chemical'' does not include the substance 
        if the substance is applied for such use on food, or 
        the substance is included for such use in water that 
        comes into contact with the food, in the preparing, 
        packing, or holding of the food for commercial 
        purposes. The substance is not excluded under this 
        subclause from such definition if the substance is 
        ethylene oxide or propylene oxide, and is applied for 
        such use on food. The substance is not so excluded if 
        the substance is applied for such use on a raw 
        agricultural commodity, or the substance is included 
        for such use in water that comes into contact with the 
        commodity, as follows:
                  (I) The substance is applied in the field.
                  (II) The substance is applied at a treatment 
                facility where raw agricultural commodities are 
                the only food treated, and the treatment is in 
                a manner that does not change the status of the 
                food as a raw agricultural commodity (including 
                treatment through washing, waxing, fumigating, 
                and packing such commodities in such manner).
                  (III) The substance is applied during the 
                transportation of such commodity between the 
                field and such a treatment facility.
          (ii) The definition in such clause for the term 
        ``pesticide chemical'' does not include the substance 
        if the substance is a food contact substance as defined 
        in section 409(h)(6), and any of the following 
        circumstances exist: The substance is included for such 
        use in an object that has a food contact surface but is 
        not intended to have an ongoing effect on any portion 
        of the object; the substance is included for such use 
        in an object that has a food contact surface and is 
        intended to have an ongoing effect on a portion of the 
        object but not on the food contact surface; or the 
        substance is included for such use in or is applied for 
        such use on food packaging (without regard to whether 
        the substance is intended to have an ongoing effect on 
        any portion of the packaging). The food contact 
        substance is not excluded under this subclause from 
        such definition if any of the following circumstances 
        exist: The substance is applied for such use on a 
        semipermanent or permanent food contact surface (other 
        than being applied on food packaging); or the substance 
        is included for such use in an object that has a 
        semipermanent or permanent food contact surface (other 
        than being included in food packaging) and the 
        substance is intended to have an ongoing effect on the 
        food contact surface.
With respect to the definition of the term ``pesticide'' that 
is applicable to the Federal Insecticide, Fungicide, and 
Rodenticide Act, this clause does not exclude any substance 
from such definition.
  (2) The term ``pesticide chemical residue'' means a residue 
in or on raw agricultural commodity or processed food of--
          (A) a pesticide chemical; or
          (B) any other added substance that is present on or 
        in the commodity or food primarily as a result of the 
        metabolism or other degradation of a pesticide 
        chemical.
  (3) Notwithstanding subparagraphs (1) and (2), the 
Administrator may by regulation except a substance from the 
definition of ``pesticide chemical'' or ``pesticide chemical 
residue'' if--
          (A) its occurrence as a residue on or in a raw 
        agricultural commodity or processed food is 
        attributable primarily to natural causes or to human 
        activities not involving the use of any substances for 
        a pesticidal purpose in the production, storage, 
        processing, or transportation of any raw agricultural 
        commodity or processed food; and
          (B) the Administrator, after consultation with the 
        Secretary, determines that the substance more 
        appropriately should be regulated under one or more 
        provisions of this Act other than sections 402(a)(2)(B) 
        and 408.
  (r) The term ``raw agricultural commodity'' means any food in 
its raw or natural state, including all fruits that are washed, 
colored, or otherwise treated in their unpeeled natural form 
prior to marketing.
  (s) The term ``food additive'' means any substance the 
intended use of which results or may reasonably be expected to 
result, directly or indirectly, in its becoming a component or 
otherwise affecting the characteristics of any food (including 
any substance intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, 
transporting, or holding food; and including any source of 
radiation intended for any such use), if such substance is not 
generally recognized, among experts qualified by scientific 
training and experience to evaluate its safety, as having been 
adequately shown through scientific procedures (or, in the case 
of a substance used in food prior to January 1, 1958, through 
either scientific procedures or experience based on common use 
in food) to be safe under the conditions of its intended use; 
except that such term does not include--
          (1) a pesticide chemical residue in or on a raw 
        agricultural commodity or processed food; or
          (2) a pesticide chemical; or
          (3) a color additive; or
          (4) any substance used in accordance with a sanction 
        or approval granted prior to the enactment of this 
        paragraph pursuant to this Act, the Poultry Products 
        Inspection Act (21 U.S.C. 451 and the following) or the 
        Meat Inspection Act of March 4, 1907 (34 Stat. 1260), 
        as amended and extended (21 U.S.C. 71 and the 
        following);
          (5) a new animal drug; or
          (6) an ingredient described in paragraph (ff) in, or 
        intended for use in, a dietary supplement.
  (t)(1) The term ``color additive'' means a material which--
          (A) is a dye, pigment, or other substance made by a 
        process of synthesis or similar artifice, or extracted, 
        isolated, or otherwise derived, with or without 
        intermediate or final change of identity, from a 
        vegetable, animal, mineral, or other source, and
          (B) when added or applied to a food, drug, or 
        cosmetic, or to the human body or any part thereof, is 
        capable (alone or through reaction with other 
        substance) of imparting color thereto;
except that such term does not include any material which the 
Secretary, by regulation, determines is used (or intended to be 
used) solely for a purpose or purposes other than coloring.
  (2) The term ``color'' includes black, white, and 
intermediate grays.
  (3) Nothing in subparagraph (1) of this paragraph shall be 
construed to apply to any pesticide chemical, soil or plant 
nutrient, or other agricultural chemical solely because of its 
effect in aiding, retarding, or otherwise affecting, directly 
or indirectly, the growth or other natural physiological 
processes of produce of the soil and thereby affecting its 
color, whether before or after harvest.
  (u) The term ``safe,'' as used in paragraph (s) of this 
section and in sections 409, 512, 571, and 721, has reference 
to the health of man or animal.
  (v) The term ``new animal drug'' means any drug intended for 
use for animals other than man, including any drug intended for 
use in animal feed but not including such animal feed--
          (1) the composition of which is such that such drug 
        is not generally recognized, among experts qualified by 
        scientific training and experience to evaluate the 
        safety and effectiveness of animal drugs, as safe and 
        effective for use under the conditions prescribed, 
        recommended, or suggested in the labeling thereof; 
        except that such a drug not so recognized shall not be 
        deemed to be a ``new animal drug'' if at any time prior 
        to June 25, 1938, it was subject to the Food and Drug 
        Act of June 30, 1906, as amended, and if at such time 
        its labeling contained the same representations 
        concerning the conditions of its use; or
          (2) the composition of which is such that such drug, 
        as a result of investigations to determine its safety 
        and effectiveness for use under such conditions, has 
        become so recognized but which has not, otherwise than 
        in such investigations, been used to a material extent 
        or for a material time under such conditions.
Provided that any drug intended for minor use or use in a minor 
species that is not the subject of a final regulation published 
by the Secretary through notice and comment rulemaking finding 
that the criteria of paragraphs (1) and (2) have not been met 
(or that the exception to the criterion in paragraph (1) has 
been met) is a new animal drug.
  (w) The term ``animal feed'', as used in paragraph (w) of 
this section, in section 512, and in provisions of this Act 
referring to such paragraph or section, means an article which 
is intended for use for food for animals other than man and 
which is intended for use as a substantial source of nutrients 
in the diet of the animal, and is not limited to a mixture 
intended to be the sole ration of the animal.
  (x) The term ``informal hearing'' means a hearing which is 
not subject to section 554, 556, or 557 of title 5 of the 
United States Code and which provides for the following:
          (1) The presiding officer in the hearing shall be 
        designated by the Secretary from officers and employees 
        of the Department who have not participated in any 
        action of the Secretary which is the subject of the 
        hearing and who are not directly responsible to an 
        officer or employee of the Department who has 
        participated in any such action.
          (2) Each party to the hearing shall have the right at 
        all times to be advised and accompanied by an attorney.
          (3) Before the hearing, each party to the hearing 
        shall be given reasonable notice of the matters to be 
        considered at the hearing, including a comprehensive 
        statement of the basis for the action taken or proposed 
        by the Secretary which is the subject of the hearing 
        and a general summary of the information which will be 
        presented by the Secretary at the hearing in support of 
        such action.
          (4) At the hearing the parties to the hearing shall 
        have the right to hear a full and complete statement of 
        the action of the Secretary which is the subject of the 
        hearing together with the information and reasons 
        supporting such action, to conduct reasonable 
        questioning, and to present any oral or written 
        information relevant to such action.
          (5) The presiding officer in such hearing shall 
        prepare a written report of the hearing to which shall 
        be attached all written material presented at the 
        hearing. The participants in the hearing shall be given 
        the opportunity to review and correct or supplement the 
        presiding officer's report of the hearing.
          (6) The Secretary may require the hearing to be 
        transcribed. A party to the hearing shall have the 
        right to have the hearing transcribed at his expense. 
        Any transcription of a hearing shall be included in the 
        presiding officer's report of the hearing.
  (y) The term ``saccharin'' includes calcium saccharin, sodium 
saccharin, and ammonium saccharin.
  (z) The term ``infant formula'' means a food which purports 
to be or is represented for special dietary use solely as a 
food for infants by reason of its simulation of human milk or 
its suitability as a complete or partial substitute for human 
milk.
  (aa) The term ``abbreviated drug application'' means an 
application submitted under section 505(j) for the approval of 
a drug that relies on the approved application of another drug 
with the same active ingredient to establish safety and 
efficacy, and--
          (1) in the case of section 306, includes a supplement 
        to such an application for a different or additional 
        use of the drug but does not include a supplement to 
        such an application for other than a different or 
        additional use of the drug, and
          (2) in the case of sections 307 and 308, includes any 
        supplement to such an application.
  (bb) The term ``knowingly'' or ``knew'' means that a person, 
with respect to information--
          (1) has actual knowledge of the information, or
          (2) acts in deliberate ignorance or reckless 
        disregard of the truth or falsity of the information.
  (cc) For purposes of section 306, the term ``high managerial 
agent''--
          (1) means--
                  (A) an officer or director of a corporation 
                or an association,
                  (B) a partner of a partnership, or
                  (C) any employee or other agent of a 
                corporation, association, or partnership,
        having duties such that the conduct of such officer, 
        director, partner, employee, or agent may fairly be 
        assumed to represent the policy of the corporation, 
        association, or partnership, and
          (2) includes persons having management responsibility 
        for--
                  (A) submissions to the Food and Drug 
                Administration regarding the development or 
                approval of any drug product,
                  (B) production, quality assurance, or quality 
                control of any drug product, or
                  (C) research and development of any drug 
                product.
  (dd) For purposes of sections 306 and 307, the term ``drug 
product'' means a drug subject to regulation under section 505, 
512, or 802 of this Act or under section 351 of the Public 
Health Service Act.
  (ee) The term ``Commissioner'' means the Commissioner of Food 
and Drugs.
  (ff) The term ``dietary supplement''--
          (1) means a product (other than tobacco) intended to 
        supplement the diet that bears or contains one or more 
        of the following dietary ingredients:
                  (A) a vitamin;
                  (B) a mineral;
                  (C) an herb or other botanical;
                  (D) an amino acid;
                  (E) a dietary substance for use by man to 
                supplement the diet by increasing the total 
                dietary intake; or
                  (F) a concentrate, metabolite, constituent, 
                extract, or combination of any ingredient 
                described in clause (A), (B), (C), (D), or (E);
          (2) means a product that--
                  (A)(i) is intended for ingestion in a form 
                described in section 411(c)(1)(B)(i); or
                  (ii) complies with section 411(c)(1)(B)(ii);
                  (B) is not represented for use as a 
                conventional food or as a sole item of a meal 
                or the diet; and
                  (C) is labeled as a dietary supplement; and
          (3) does--
                  (A) include an article that is approved as a 
                new drug under section 505 or licensed as a 
                biologic under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) and was, prior to 
                such approval, certification, or license, 
                marketed as a dietary supplement or as a food 
                unless the Secretary has issued a regulation, 
                after notice and comment, finding that the 
                article, when used as or in a dietary 
                supplement under the conditions of use and 
                dosages set forth in the labeling for such 
                dietary supplement, is unlawful under section 
                402(f); and
                  (B) not include--
                          (i) an article that is approved as a 
                        new drug under section 505, certified 
                        as an antibiotic under section 507, or 
                        licensed as a biologic under section 
                        351 of the Public Health Service Act 
                        (42 U.S.C. 262), or
                          (ii) an article authorized for 
                        investigation as a new drug, 
                        antibiotic, or biological for which 
                        substantial clinical investigations 
                        have been instituted and for which the 
                        existence of such investigations has 
                        been made public,
        which was not before such approval, certification, 
        licensing, or authorization marketed as a dietary 
        supplement or as a food unless the Secretary, in the 
        Secretary's discretion, has issued a regulation, after 
        notice and comment, finding that the article would be 
        lawful under this Act.
Except for purposes of sections 201(g) and 417, a dietary 
supplement shall be deemed to be a food within the meaning of 
this Act.
  (gg) The term ``processed food'' means any food other than a 
raw agricultural commodity and includes any raw agricultural 
commodity that has been subject to processing, such as canning, 
cooking, freezing, dehydration, or milling.
  (hh) The term ``Administrator'' means the Administrator of 
the United States Environmental Protection Agency.
  (ii) The term ``compounded positron emission tomography 
drug''--
          (1) means a drug that--
                  (A) exhibits spontaneous disintegration of 
                unstable nuclei by the emission of positrons 
                and is used for the purpose of providing dual 
                photon positron emission tomographic diagnostic 
                images; and
                  (B) has been compounded by or on the order of 
                a practitioner who is licensed by a State to 
                compound or order compounding for a drug 
                described in subparagraph (A), and is 
                compounded in accordance with that State's law, 
                for a patient or for research, teaching, or 
                quality control; and
          (2) includes any nonradioactive reagent, reagent kit, 
        ingredient, nuclide generator, accelerator, target 
        material, electronic synthesizer, or other apparatus or 
        computer program to be used in the preparation of such 
        a drug.
  (jj) The term ``antibiotic drug'' means any drug (except 
drugs for use in animals other than humans) composed wholly or 
partly of any kind of penicillin, streptomycin, 
chlortetracycline, chloramphenicol, bacitracin, or any other 
drug intended for human use containing any quantity of any 
chemical substance which is produced by a micro-organism and 
which has the capacity to inhibit or destroy micro-organisms in 
dilute solution (including a chemically synthesized equivalent 
of any such substance) or any derivative thereof.
          (kk) Priority supplement.--The term ``priority 
        supplement'' means a drug application referred to in 
        section 101(4) of the Food and Drug Administration 
        Modernization Act of 1997 (111 Stat. 2298).
  (ll)(1) The term ``single-use device'' means a device that is 
intended for one use, or on a single patient during a single 
procedure.
  (2)(A) The term ``reprocessed'', with respect to a single-use 
device, means an original device that has previously been used 
on a patient and has been subjected to additional processing 
and manufacturing for the purpose of an additional single use 
on a patient. The subsequent processing and manufacture of a 
reprocessed single-use device shall result in a device that is 
reprocessed within the meaning of this definition.
  (B) A single-use device that meets the definition under 
clause (A) shall be considered a reprocessed device without 
regard to any description of the device used by the 
manufacturer of the device or other persons, including a 
description that uses the term ``recycled'' rather than the 
term ``reprocessed''.
  (3) The term ``original device'' means a new, unused single-
use device.
  (mm)(1) The term ``critical reprocessed single-use device'' 
means a reprocessed single-use device that is intended to 
contact normally sterile tissue or body spaces during use.
  (2) The term ``semi-critical reprocessed single-use device'' 
means a reprocessed single-use device that is intended to 
contact intact mucous membranes and not penetrate normally 
sterile areas of the body.
  (nn) The term ``major species'' means cattle, horses, swine, 
chickens, turkeys, dogs, and cats, except that the Secretary 
may add species to this definition by regulation.
  (oo) The term ``minor species'' means animals other than 
humans that are not major species.
  (pp) The term ``minor use'' means the intended use of a drug 
in a major species for an indication that occurs infrequently 
and in only a small number of animals or in limited 
geographical areas and in only a small number of animals 
annually.
  (qq) The term ``major food allergen'' means any of the 
following:
          (1) Milk, egg, fish (e.g., bass, flounder, or cod), 
        Crustacean shellfish (e.g., crab, lobster, or shrimp), 
        tree nuts (e.g., almonds, pecans, or walnuts), wheat, 
        peanuts, and soybeans.
          (2) A food ingredient that contains protein derived 
        from a food specified in paragraph (1), except the 
        following:
                  (A) Any highly refined oil derived from a 
                food specified in paragraph (1) and any 
                ingredient derived from such highly refined 
                oil.
                  (B) A food ingredient that is exempt under 
                paragraph (6) or (7) of section 403(w).
  (rr)(1) The term ``tobacco product'' means any product made 
or derived from tobacco that is intended for human consumption, 
including any component, part, or accessory of a tobacco 
product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco 
product).
  (2) The term ``tobacco product'' does not mean an article 
that is a drug under subsection (g)(1), a device under 
subsection (h), or a combination product described in section 
503(g).
  (3) The products described in paragraph (2) shall be subject 
to chapter V of this Act.
  (4) A tobacco product shall not be marketed in combination 
with any other article or product regulated under this Act 
(including a drug, biologic, food, cosmetic, medical device, or 
a dietary supplement).

           *       *       *       *       *       *       *


                   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 articleor 
(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 760 or 761 and if the Secretary 
has credible evidence or information indicating that the 
responsible person (as defined in such section 760 or 761) has 
not complied with a requirement of such section 760 or 761 with 
respect to any such article, or has not allowed access to 
records described in such section 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 ninety 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 refused admission under this 
section, if such drug 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 under the sixth 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. Where the Secretary of Health and Human Services provides 
notice and an opportunity to appear and introduce testimony on 
the destruction of a drug, the Secretary of Health and Human 
Services shall store and, as applicable, dispose of the drug 
after the issuance of the notice, except that the owner and 
consignee shall remain liable for costs pursuant to subsection 
(c).] 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 or device refused admission under this section, if such 
drug or device 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 or device 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 or 
device. Where the Secretary of Health and Human Services 
provides notice and an opportunity to appear and introduce 
testimony on the destruction of a drug or device, the Secretary 
of Health and Human Services shall store and, as applicable, 
dispose of the drug or device 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 
sections 760 or 761,, the responsible person (as defined in 
section 760 or 761) can take action that would assure that the 
responsible person is in compliance with section 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.
  (iii)(I) Subject to subclause (II), this paragraph applies to 
requests for certification on behalf of any device 
establishment registered under section 510, whether the 
establishment is located inside or outside of the United 
States, and regardless of whether such devices are to be 
exported from the United States.
  (II) If an establishment described in subclause (I) is not 
located within the United States and does not demonstrate that 
the devices manufactured, prepared, propagated, compounded, or 
processed at such establishment are to be exported from the 
United States, this paragraph shall apply only if--
          (aa) the establishment has been inspected by the 
        Secretary within 3 years of the date of the request; or
          (bb) the establishment participates in an audit 
        program in which the United States participates or the 
        United States recognizes, an audit under such program 
        has been conducted, and the findings of such audit are 
        provided to the Secretary within 3 years of the date of 
        the request.
  (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).

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