[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 863 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 863

To amend the Federal Food, Drug, and Cosmetic Act to prevent the abuse 
              of dextromethorphan, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 30, 2019

    Ms. Matsui (for herself and Mr. Johnson of Ohio) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to prevent the abuse 
              of dextromethorphan, 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.

    This Act may be cited as the ``DXM Abuse Prevention Act of 2019''.

SEC. 2. SALES OF OVER-THE-COUNTER DRUGS CONTAINING DEXTROMETHORPHAN.

    (a) Prohibited Acts.--
            (1) Verification system.--Section 301 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at 
        the end the following:
    ``(fff) The failure of a retailer (as defined in section 506H) that 
offers for sale in interstate commerce covered drugs (as defined in 
section 506H) to have a verification system as required by section 506H 
(relating to sales of over-the-counter drugs containing 
dextromethorphan).''.
            (2) Identifier for electronic point of sale system; active 
        ingredients.--Section 301 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 331), as amended by paragraph (1), is 
        further amended by adding at the end the following:
    ``(ggg) The introduction or delivery for introduction into 
interstate commerce of any covered drug (as defined in section 506H) 
whose labeling does not include--
            ``(1) a universal product code, universal product number, 
        bar code, or similar identifier to allow an electronic point of 
        sale system to recognize that the sale of the covered drug is 
        prohibited to those under the age of 18; and
            ``(2) the established name of each active ingredient of the 
        covered drug within the first panel of the drug facts labeling 
        required by section 201.66(c) of title 21, Code of Federal 
        Regulations (or any successor regulations), in no smaller than 
        6-point type.''.
    (b) Verification System.--The Federal Food, Drug, and Cosmetic Act 
is amended by inserting after section 506G of such Act (21 U.S.C. 356g) 
the following:

``SEC. 506H. SALES OF OVER-THE-COUNTER DRUGS CONTAINING 
              DEXTROMETHORPHAN.

    ``(a) Verification System.--Any retailer selling or offering for 
sale in interstate commerce a covered drug shall have a verification 
system in accordance with this section that is intended to ensure that 
no individual who purchases a covered drug from the retailer is under 
18 years of age. Such a system shall be set up to prompt a retailer to 
examine a purchaser's identification card.
    ``(b) Means Used To Ensure Compliance.--A verification system under 
subsection (a) may ensure compliance with this section by any of, or 
any combination of, the following means:
            ``(1) An electronic point-of-sale system that is coded--
                    ``(A) to prompt for verification of the age of 
                purchasers of covered drugs; and
                    ``(B) to deny sales of covered drugs to those under 
                the age of 18.
            ``(2) Training manuals, materials, or programs that 
        instruct employees--
                    ``(A) to verify the age of purchasers of covered 
                drugs; and
                    ``(B) to deny sales of covered drugs to those under 
                the age of 18.
            ``(3) Signage in and around the sales counter outlining the 
        age restriction on sales of covered drugs.
            ``(4) Designating one on-duty employee to approve sales of 
        covered drugs.
            ``(5) Any other verification measure adopted by a retailer 
        that is designed to ensure that a purchaser of a covered drug 
        is not under 18 years of age if, based on an examination of the 
        purchaser's identification card, the retailer reasonably 
        concludes the identification card is valid and indicates the 
        purchaser is not under 18 years of age.
    ``(c) Exceptions.--
            ``(1) Individuals over 26.--A verification system under 
        subsection (a) need not require verification of the age of any 
        individual over the age of 26.
            ``(2) Valid prescription.--A verification system under 
        subsection (a) need not apply to any sale made by a retailer 
        that is a pharmacy pursuant to a validly issued prescription.
            ``(3) Valid military identification card.--A verification 
        system under subsection (a) need not apply to any sale to an 
        individual who supplies proof at the time of such sale that 
        such individual is actively enrolled in the military and 
        presents a valid military identification card.
    ``(d) Enforcement.--In carrying out this section, the Secretary 
shall coordinate with State entities that regulate retailers, as 
designated by the State, to perform activities to ensure compliance 
with this section, including providing for appropriate investigation of 
complaints related to violations of this section.
    ``(e) Compliance With State System.--If a State has a law under 
which a retailer in the State is required to have a system that ensures 
that no individual who purchases a covered drug from the retailer is 
under 18 years of age, the Secretary shall treat any such retailer in 
the State that is in compliance with such law as having a verification 
system as required by this section, including for purposes of sections 
301(fff) and 303(h).
    ``(f) Definitions.--In this section:
            ``(1) The term `covered drug'--
                    ``(A) means a drug that--
                            ``(i) contains dextromethorphan; and
                            ``(ii) is not subject to section 503(b)(1); 
                        and
                    ``(B) excludes any drug that is packaged in packets 
                or pouches and contains 2 or fewer maximum adult doses 
                of dextromethorphan as allowable under section 341.74 
                of title 21, Code of Federal Regulations (or any 
                successor regulations).
            ``(2) The term `identification card' means an 
        identification card that--
                    ``(A) includes a photograph and the date of birth 
                of the individual; and
                    ``(B) is issued by a State or the Federal 
                Government or is considered acceptable for purposes of 
                sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B)(1) 
                of title 8, Code of Federal Regulations (including any 
                successor regulations).
            ``(3) The term `retailer' means--
                    ``(A) a grocery store, general merchandise store, 
                drug store, pharmacy, convenience store, or other 
                entity whose activities as a seller of covered drugs 
                containing dextromethorphan are limited almost 
                exclusively to sales for personal use, both in number 
                and volume of sales, including any sales made by the 
                Internet or other means; and
                    ``(B) excludes any entity listed in subparagraph 
                (A) that does not sell any covered drug described in 
                paragraph (1)(A).''.
    (c) Civil Penalties.--Section 303 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the 
following:
    ``(h) A retailer that violates section 301(fff) shall not be 
subject to subsection (a) or any civil monetary penalty under this Act 
for such violation except as follows:
            ``(1) If the Secretary finds that a retailer fails to have 
        a verification system in violation of section 301(fff)--
                    ``(A) upon the first such finding, the Secretary 
                shall issue a formal notice of violation and give the 
                retailer a period of at least 30 days (beginning on the 
                receipt of such notice) to correct the violation;
                    ``(B) upon the second such finding, the retailer 
                shall be subject to a civil penalty of not more than 
                $1,000;
                    ``(C) upon the third such finding, the retailer 
                shall be subject to a civil penalty of not more than 
                $2,000; and
                    ``(D) upon the fourth and any subsequent such 
                finding, the retailer shall be subject to a civil 
                penalty of not more than $5,000.
            ``(2) In determining the amount of a civil penalty under 
        this subsection for a retailer, the Secretary shall consider 
        whether the retailer has taken appropriate steps to prevent 
        subsequent violations, such as the establishment and 
        administration of a documented employee training program to 
        ensure all employees are familiar with, and abiding by, the 
        retailer's verification system established pursuant to section 
        506H, where such program includes--
                    ``(A) educating employees regarding covered drugs;
                    ``(B) instruction on the correct method of checking 
                a purchaser's identification card; and
                    ``(C) notifying employees of the civil penalties 
                under this subsection.
            ``(3) If a retailer transacts sales of covered drugs at 
        more than one physical location, for purposes of determining 
        the number of violations by that retailer under this 
        subsection, each individual physical location operated by that 
        retailer shall be considered a separate retailer.
            ``(4) The Secretary shall notify retailers found to have 
        violated section 301(fff) as soon as practicable after the 
        Secretary discovers such violation. Such notification shall 
        include the date and time when the failure to have a 
        verification system as required by such section was observed to 
        occur.
            ``(5) In this subsection, the terms `covered drug' and 
        `retailer' have the meanings given such terms in section 
        506H.''.
    (d) Applicability.--The amendments made by subsections (a), (b), 
and (c) shall apply with respect to drugs sold or offered for sale on 
or after the date that is one year after the date of enactment of this 
Act.
    (e) Sense of Congress Regarding Communication by Organizations 
Nominated by Manufacturers.--It is the sense of Congress that 
organizations nominated by manufacturers of covered drugs (as defined 
in section 506H of the Federal Food, Drug, and Cosmetic Act, as added 
by subsection (c)) should make reasonable efforts to communicate to 
retailers (as defined in such section 506H) the requirements of such 
section 506H, including by making available upon request materials 
(which may include signage, manuals, materials, or programs) to assist 
with educating employees regarding such covered drugs.

SEC. 3. RESTRICTIONS ON DISTRIBUTION OF BULK DEXTROMETHORPHAN.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is 
amended--
            (1) in section 301 (21 U.S.C. 331) (as amended by section 
        2(a)) by adding at the end the following:
    ``(hhh) The possession, receipt, or distribution of unfinished 
dextromethorphan in violation of section 506I.'';
            (2) by inserting after section 506H (as added by section 
        2(b)) the following:

``SEC. 506I. RESTRICTIONS ON THE DISTRIBUTION OF BULK DEXTROMETHORPHAN.

    ``(a) In General.--No person shall--
            ``(1) possess or receive unfinished dextromethorphan, 
        unless the person is registered under section 510 or otherwise 
        registered, licensed, or approved pursuant to Federal or State 
        law to engage in--
                    ``(A) the practice of pharmacy; or
                    ``(B) drug or drug ingredient discovery, 
                production, manufacture, or distribution; or
            ``(2) distribute unfinished dextromethorphan to any person 
        other than a person described in paragraph (1).
    ``(b) Exception for Common Carriers.--This section does not apply 
to a common carrier that possesses, receives, or distributes unfinished 
dextromethorphan for purposes of distributing such unfinished 
dextromethorphan between persons described in subsection (a).
    ``(c) Definitions.--In this section:
            ``(1) The term `common carrier' means any person that holds 
        itself out to the general public as a provider for hire of the 
        transportation by water, land, or air of merchandise, whether 
        or not the person actually operates the vessel, vehicle, or 
        aircraft by which the transportation is provided, between a 
        port or place and a port or place in the United States.
            ``(2) The term `unfinished dextromethorphan' means 
        dextromethorphan that is not contained in a drug that is in 
        finished dosage form.''; and
            (3) by amending section 303, as amended by section 2(c), by 
        adding at the end the following:
    ``(i) A person that violates section 301(hhh) shall not be subject 
to subsection (a) or any civil monetary penalty under this Act for such 
violation except such person shall be subject to a civil penalty in an 
amount of not more than $100,000.''.
    (b) Applicability.--The amendments made by this section apply 
beginning on the date of enactment of this Act.
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