[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3250 Reported in House (RH)]

<DOC>





                                                 Union Calendar No. 520
114th CONGRESS
  2d Session
                                H. R. 3250

                          [Report No. 114-672]

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 28, 2015

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

                              July 8, 2016

Additional sponsors: Mr. Loebsack, Mr. Tonko, Mr. Burgess, Mr. Guthrie, 
 Mr. Kinzinger of Illinois, Mr. Barletta, Ms. Brownley of California, 
Ms. Clarke of New York, Ms. Norton, Mr. Huffman, Mr. Katko, Mr. Olson, 
Mr. Hastings, Mr. Kind, Mr. Paulsen, Mr. Costello of Pennsylvania, Mr. 
              Meehan, Mr. DeSaulnier, and Mr. Fitzpatrick

                              July 8, 2016

Committed to the Committee of the Whole House on the State of the Union 
                       and ordered to be printed

_______________________________________________________________________

                                 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 2015''.

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

    (a) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(ddd) The failure of a retailer to implement a verification 
system as required by section 506G (relating to sales of over-the-
counter drugs containing dextromethorphan).''.
    (b) Verification System.--The Federal Food, Drug, and Cosmetic Act 
is amended by inserting after section 506F of such Act (21 U.S.C. 356f) 
the following:

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

    ``(a) Verification System.--Any retailer selling or offering for 
sale in interstate commerce dextromethorphan shall implement a 
verification system to ensure compliance with this section. Such a 
system may ensure such compliance by means of--
            ``(1) an electronic point-of-sale system coded to prompt 
        for verification of the age of all purchasers of drugs 
        described in subsection (b) and deny sales to those under the 
        age of 18;
            ``(2) training manuals or materials instructing employees 
        to verify the age of all purchasers of such drugs and deny 
        sales to those under the age of 18;
            ``(3) signage in and around the sales counter outlining the 
        age restriction on sales of such drugs;
            ``(4) designating one on-duty employee to approve all sales 
        of such drugs; or
            ``(5) any other verification measure deemed valid by the 
        Secretary.
    ``(b) Prohibition.--Except as provided in subsection (c), each 
retailer shall verify that no individual is under 18 years of age who 
purchases any drug that--
            ``(1) contains dextromethorphan; and
            ``(2) is not subject to section 503(b)(1).
    ``(c) Exceptions.--
            ``(1) Individuals over 26.--Subsection (b) does not require 
        verification of the age of any individual over the age of 26.
            ``(2) Valid prescription.--Subsection (b) does not apply to 
        any sale made pursuant to a validly issued prescription.
            ``(3) Valid military identification card.--Subsection (b) 
        does not apply to any sale to an individual under 18 years of 
        age if such individual 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) Affirmative Defense.--It shall be an affirmative defense to 
an alleged violation of subsection (b) that the individual selling a 
drug containing dextromethorphan--
            ``(1) examined the purchaser's identification card; and
            ``(2) based on that examination, reasonably concluded that 
        the identification was valid and indicated that the purchaser 
        was not less than 18 years of age.
    ``(e) Definition.--In this paragraph, the term `identification 
card' means an identification card that--
            ``(1) includes a photograph and the date of birth of the 
        individual; and
            ``(2) 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).''.
    (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) Notwithstanding subsection (a), the following provisions 
shall apply to violations of section 301(ddd):
            ``(1) A person who violates section 301(ddd) shall--
                    ``(A) receive a violation notification from the 
                Secretary for the first such violation; and
                    ``(B) be subject to a civil penalty in an amount--
                            ``(i) not more than $1,000 for the second 
                        such violation by a person;
                            ``(ii) not more than $2,000 for the third 
                        such violation by a person; and
                            ``(iii) not more than $5,000 for the fourth 
                        such violation, or a subsequent such violation, 
                        by a person.
            ``(2) In determining the amount of a civil penalty under 
        this subsection for a person who is 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 
        provisions of section 301(ddd), where such program includes--
                    ``(A) educating employees regarding products 
                containing dextromethorphan;
                    ``(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 person who is a retailer transacts sales of 
        products containing dextromethorphan at more than one physical 
        location, for purposes of determining the number of violations 
        by that person under this subsection, each individual physical 
        location operated by that retailer shall be considered a 
        separate person.
            ``(4) The Secretary shall notify persons found to have 
        violated section 301(ddd) as soon as practicable after the 
        Secretary discovers such violation. Such notification shall 
        include the date and time when the violation was observed to 
        occur.
            ``(5) Notwithstanding any other provision of this 
        subsection or section 301(ddd), an employee shall not be 
        subject to penalties under this subsection unless such employee 
        knowingly and willfully participates in a conspiracy to violate 
        section 301(ddd). For purposes of this paragraph, a conspiracy 
        shall consist of an agreement between two or more persons with 
        the intent to violate section 301(ddd) and the commission of at 
        least one overt act in furtherance of the agreement.
            ``(6) In this subsection--
                    ``(A) the term `employee' means an individual who 
                is employed by a retailer in a clerical or other non-
                managerial position; and
                    ``(B) the term `retailer' means a grocery store, 
                general merchandise store, drug store, pharmacy, 
                convenience store, or other entity or person whose 
                activities as a distributor relating to products 
                containing dextromethorphan are limited almost 
                exclusively to sales for personal use, both in number 
                of sales and volume of sales, including any sales made 
                by the Internet or other means.''.

SEC. 3. RESTRICTIONS ON DISTRIBUTION OF BULK DEXTROMETHORPHAN.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) is 
amended--
            (1) in section 501, by inserting at the end the following:
    ``(k) If it is unfinished dextromethorphan and is possessed, 
received, or distributed in violation of section 506H.''; and
            (2) by inserting after section 506F the following:

``SEC. 506H. 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 the practice of pharmacy, pharmaceutical 
        production, or manufacture or distribution of drug ingredients; 
        or
            ``(2) distribute unfinished dextromethorphan to any person 
        other than a person registered under section 510 or otherwise 
        registered, licensed, or approved pursuant to Federal or State 
        law to engage in the practice of pharmacy, pharmaceutical 
        production, or manufacture or distribution of drug ingredients.
    ``(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) as 
registered, licensed, or approved.
    ``(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(b), by 
        adding at the end the following:
    ``(i) Notwithstanding subsection (a), a person who violates section 
506H shall be subject to a civil penalty of not more than $100,000.''.
                                                 Union Calendar No. 520

114th CONGRESS

  2d Session

                               H. R. 3250

                          [Report No. 114-672]

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                              July 8, 2016

Committed to the Committee of the Whole House on the State of the Union 
                       and ordered to be printed