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

Summary: Preventing Abuse of Cough Treatments Act of 2012 or the PACT Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale or offering for sale of a drug containing dextromethorphan, and not subject to practitioner supervision requirements, to an individual under age 18, except if the sale is: (1) made pursuant to a validly issued prescription; or (2) to an individual who provides proof of being married, the parent of a child, or actively enrolled in the military. Imposes civil monetary penalties that escalate upon repeated violation.

Deems to be adulterated any unfinished dextromethorphan that is possessed, received, or distributed in violation of this Act. Prohibits a person from: (1) possessing or receiving unfinished dextromethorphan unless the person is registered with the Secretary of Health and Human Services (HHS) as a producer of a drug or device 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) distributing unfinished dextromethorphan to any person other than a registered or otherwise authorized person. Excludes from such prohibitions common carriers that possess, receive, or distribute unfinished dextromethorphan for purposes of distributing it between registered, licensed, or approved persons. Imposes additional civil monetary penalties for such possession and distribution violations.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Preventing Abuse of Cough Treatments 
Act of 2012'' 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:
    ``(aaa)(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.
    ``(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--
            ``(i) is married;
            ``(ii) is the parent of a child; or
            ``(iii) is actively enrolled in the military.
    ``(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 2012).''.
    (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)(1) Notwithstanding subsection (a), a person who violates 
section 301(aaa) shall be subject to a civil penalty in an amount--
            ``(A) not more than $1,000 for the first such violation by 
        a person;
            ``(B) not more than $2,000 for the second such violation by 
        a person; and
            ``(C) not more than $5,000 for the third 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--
            ``(A) the establishment and administration of a documented 
        employee training program to ensure all employees are familiar 
        with and abiding by the provisions of this section; or
            ``(B) other actions taken by a retailer to ensure 
        compliance with this section.
    ``(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) In this subsection, 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:
    ``(j) If it is unfinished dextromethorphan and is possessed, 
received, or distributed in violation of section 506D.'';
            (2) by inserting after section 506C the following:

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