[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3376 Introduced in Senate (IS)]
112th CONGRESS
2d Session
S. 3376
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
July 11, 2012
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 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.''.
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