[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 644 Introduced in Senate (IS)]

113th CONGRESS
  1st Session
                                 S. 644

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 21, 2013

  Mr. Casey (for himself and Ms. Murkowski) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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 ``Preventing Abuse of Cough Treatments 
Act of 2013'' or the ``PACT Act''.

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:
    ``(ccc)(1)(A) Except as provided in subparagraph (2), the sale or 
offering for sale of a drug containing dextromethorphan to an 
individual under 18 years of age, including any such sale using the 
Internet, provided the drug is not subject to section 503(b)(1).
    ``(B) If a person fails to request identification from an 
individual under 18 years of age and sells a product containing 
dextromethorphan to that individual, that person shall be deemed to 
have known that the individual was under 18 years of age, unless from 
the individual's outward appearance the person making the sale would 
reasonably presume the individual to be 25 years of age or older.
    ``(C) It shall be an affirmative defense to an alleged violation of 
clause (A) that the person selling a product containing 
dextromethorphan examined the purchaser's identification card and, 
based on that examination, that person reasonably concluded that the 
identification was valid and indicated that the purchaser was not less 
than 18 years of age.
    ``(2)(A) This paragraph shall not apply to any sale made pursuant 
to a validly issued prescription.
    ``(B) This paragraph shall not apply to the sale or offering for 
sale of a drug containing dextromethorphan 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.
    ``(3) In this paragraph, the term `identification card' mean 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 (as in effect on or after the date of 
        the enactment of the Preventing Abuse of Cough Treatments Act 
        of 2013).''.
    (b) 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(ccc):
            ``(1) A person who violates section 301(ccc) shall--
                    ``(A) receive a warning letter 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(ccc), 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(ccc) as soon as practicable after the 
        Secretary discovers such violation. Such notification shall 
        include details of the violation, such as--
                    ``(A) the date and time of the sale;
                    ``(B) a sales receipt or credit card receipt 
                documenting the sale; and
                    ``(C) the name or description of the employee 
                involved in the sale.
            ``(5) Notwithstanding any other provision of this 
        subsection or section 301(ccc), 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(ccc). For purposes of this paragraph, a conspiracy 
        shall consist of an agreement between two or more persons with 
        the intent to violate section 301(ccc) 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, either directly to walk-
                in customers or in face-to-face transactions by direct 
                sales.''.

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 506G.'';
            (2) by inserting after section 506F the following:

``SEC. 506G. 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 
506G shall be subject to a civil penalty of not more than $100,000.''.
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