Preventing Abuse of Cough Treatments Act of 2014 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 made: (1) pursuant to a validly issued prescription; or (2) to an individual who provides proof of being actively enrolled in the military, including a valid military identification card. 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 under 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.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3969 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 3969
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 29, 2014
Mr. Johnson of Ohio (for himself and Mr. Braley of Iowa) 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 ``Preventing Abuse of Cough Treatments
Act of 2014'' 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:
``(ddd)(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' 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 (as in effect on or after the date of
the enactment of the Preventing Abuse of Cough Treatments Act
of 2014).''.
(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(ddd):
``(1) A person who violates section 301(ddd) 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(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 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(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, 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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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