(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)
DXM Abuse Prevention Act of 2015
(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of a drug containing dextromethorphan (DXM, a cough suppressant and drug of abuse) to an individual under age 18 unless the individual has a prescription or is actively enrolled in the military. Retailers selling DXM must implement a verification system to ensure compliance. Civil monetary penalties that escalate upon repeated violation are imposed.
(Sec. 3) Unfinished DXM may only be possessed by, distributed to, and received by persons registered with the Food and Drug Administration as producers of a drug or medical device or otherwise allowed to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients. Common carriers distributing unfinished DXM between authorized persons are exempted. Civil monetary penalties are imposed for possession and distribution violations.
[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3250 Introduced in House (IH)]
114th CONGRESS
1st Session
H. R. 3250
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
_______________________________________________________________________
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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee by Voice Vote .
Committee Consideration and Mark-up Session Held.
Committee Consideration and Mark-up Session Held.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported by Voice Vote.
Reported by the Committee on Energy and Commerce. H. Rept. 114-672.
Reported by the Committee on Energy and Commerce. H. Rept. 114-672.
Placed on the Union Calendar, Calendar No. 520.
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