[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5752 Engrossed in House (EH)]

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115th CONGRESS
  2d Session
                                H. R. 5752

_______________________________________________________________________

                                 AN ACT


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
         importation of certain drugs, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Stop Illicit Drug 
Importation Act of 2018''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Detention, refusal, and destruction of drugs offered for 
                            importation.
Sec. 3. Seizure.
Sec. 4. Debarring violative individuals or companies.

SEC. 2. DETENTION, REFUSAL, AND DESTRUCTION OF DRUGS OFFERED FOR 
              IMPORTATION.

    (a) Articles Treated as Drugs for Purposes of Importation.--Section 
801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is 
amended by adding at the end the following:
    ``(t) Articles Treated as Drugs for Purposes of This Section.--
            ``(1) Labeled articles.--An article shall not be treated as 
        a drug pursuant to this subsection if--
                    ``(A) an electronic import entry for such article 
                is submitted using an authorized electronic data 
                interchange system; and
                    ``(B) such article is designated in such system as 
                a drug, device, dietary supplement, or other product 
                that is regulated under this Act.
            ``(2) Articles covered.--Subject to paragraph (1), for 
        purposes of this section, an article described in this 
        paragraph may be treated by the Secretary as a drug if it--
                    ``(A) is or contains an ingredient that is an 
                active ingredient that is contained within--
                            ``(i) a drug that has been approved under 
                        section 505 of this Act; or
                            ``(ii) a biological product that has been 
                        approved under section 351 of the Public Health 
                        Service Act;
                    ``(B) is or contains an ingredient that is an 
                active ingredient in a drug or biological product if--
                            ``(i) an investigational use exemption has 
                        been authorized for such drug or biological 
                        product under section 505(i) of this Act or 
                        section 351(a) of the Public Health Service 
                        Act;
                            ``(ii) substantial clinical investigation 
                        has been instituted for such drug or biological 
                        product; and
                            ``(iii) the existence of such clinical 
                        investigation has been made public; or
                    ``(C) is or contains 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 subparagraph (A) or 
                (B).
            ``(3) Effect.--Except to the extent that an article may be 
        treated as a drug pursuant to paragraph (2), this subsection 
        shall not be construed as bearing on or being relevant to the 
        question of whether any article is a drug as defined in section 
        201(g).''.
    (b) Articles of Concern.--
            (1) Delivery by treasury to hhs.--The first sentence of 
        section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 381(a)) is amended by striking ``and cosmetics'' and 
        inserting ``cosmetics, and potential articles of concern (as 
        defined in subsection (u))''.
            (2) Refused admission.--The third sentence of section 
        801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        381(a)) is amended by striking ``then such article shall be 
        refused admission'' and inserting ``or (5) such article is an 
        article of concern (as defined in subsection (u)), or (6) such 
        article is a drug that is being imported or offered for import 
        in violation of section 301(cc), then such article shall be 
        refused admission''.
            (3) Definition of article of concern.--Section 801 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as 
        amended, is further amended by adding at the end the following:
    ``(u) Article of Concern Defined.--For purposes of subsection (a), 
the term `article of concern' means an article that is or contains a 
drug or other substance--
            ``(1) for which, during the 24-month period prior to the 
        article being imported or offered for import, the Secretary of 
        Health and Human Services--
                    ``(A) has requested that, based on a determination 
                that the drug or other substance appears to meet the 
                requirements for temporary or permanent scheduling 
                pursuant to section 201 of the Controlled Substances 
                Act, the Attorney General initiate the process to 
                control the drug or other substance in accordance with 
                such Act; or
                    ``(B) has, following the publication by the 
                Attorney General of a notice in the Federal Register of 
                the intention to issue an order temporarily scheduling 
                such drug or substance in schedule I of section 202 of 
                the Controlled Substances Act pursuant to section 
                201(h) of such Act, made a determination that such 
                article presents an imminent hazard to public safety; 
                and
            ``(2) with respect to which the Attorney General has not--
                    ``(A) scheduled the drug or other substance under 
                such Act; or
                    ``(B) notified the Secretary of Health and Human 
                Services that the Attorney General has made a 
                determination not to schedule the drug or other 
                substance under such Act.''.

SEC. 3. SEIZURE.

    Section 304(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 334(b)) is amended by striking the first sentence and inserting 
the following: ``The article, equipment, or other thing proceeded 
against shall be liable to seizure by process pursuant to the libel, 
and the procedure in cases under this section shall conform, as nearly 
as may be, to the procedure in admiralty rather than the procedure used 
for civil asset forfeiture proceedings set forth in section 983 of 
title 18, United States Code. On demand of either party any issue of 
fact joined in any such a case brought under this section shall be 
tried by jury. A seizure brought under this section is not governed by 
Rule G of the Supplemental Rules of Admiralty or Maritime Claims and 
Asset Forfeiture Actions. Exigent circumstances shall be deemed to 
exist for all seizures brought under this section, and in such cases, 
the summons and arrest warrant shall be issued by the clerk of the 
court without court review.''.

SEC. 4. DEBARRING VIOLATIVE INDIVIDUALS OR COMPANIES.

    (a) Prohibited Act.--Section 301(cc) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(cc)) is amended--
            (1) by inserting after ``an article of food'' the 
        following: ``or a drug''; and
            (2) by inserting after ``a person debarred'' the following: 
        ``from such activity''.
    (b) Debarment.--Section 306(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 335a(b)) is amended--
            (1) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``paragraph (2)'' and inserting ``paragraph 
                (2) or (3)'';
                    (B) in subparagraph (B), by striking ``or'' at the 
                end;
                    (C) in subparagraph (C), by striking the period at 
                the end and inserting ``, or''; and
                    (D) by adding at the end the following:
                    ``(D) a person from importing or offering to import 
                into the United States--
                            ``(i) a controlled substance as defined in 
                        section 102(6) of the Controlled Substances 
                        Act; or
                            ``(ii) any drug, if such drug is declared 
                        to be 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), 
                        or if such drug is entering the United States 
                        by mail.''; and
            (2) in paragraph (3)--
                    (A) in the paragraph heading after ``food'' by 
                inserting ``or drug'';
                    (B) by redesignating subparagraphs (A) and (B) as 
                clauses (i) and (ii), respectively, and moving the 
                indentation of each such clause two ems to the right;
                    (C) after making the amendments required by 
                subparagraph (B), by striking ``A person is subject'' 
                and inserting the following:
                    ``(A) Food.--A person is subject''; and
                    (D) by adding at the end the following:
                    ``(B) Importation of drugs.--A person is subject to 
                debarment under paragraph (1)(D) if--
                            ``(i) the person has been convicted of a 
                        felony for conduct relating to the importation 
                        into the United States of any drug or 
                        controlled substance (as defined in section 102 
                        of the Controlled Substances Act); or
                            ``(ii) the person has engaged in a pattern 
                        of importing or offering for import articles of 
                        drug that are--
                                    ``(I)(aa) adulterated, misbranded, 
                                or in violation of section 505; and
                                    ``(bb) present a threat of serious 
                                adverse health consequences or death to 
                                humans or animals; or
                                    ``(II) controlled substances whose 
                                importation is prohibited pursuant to 
                                section 401(m) of the Tariff Act of 
                                1930.
                    ``(C) Definition.--For purposes of subparagraph 
                (B), the term `pattern of importing or offering for 
                import articles of drug' means importing or offering 
                for import articles of drug described in subclause (I) 
                or (II) of subparagraph (B)(ii) in an amount, 
                frequency, or dosage that is inconsistent with personal 
                or household use by the importer.''.

            Passed the House of Representatives June 13, 2018.

            Attest:

                                                                 Clerk.
115th CONGRESS

  2d Session

                               H. R. 5752

_______________________________________________________________________

                                 AN ACT

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
         importation of certain drugs, and for other purposes.