DXM Abuse Prevention Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to: (1) require a retailer that sells certain drugs containing dextromethorphan (DXM) to have a verification system that is intended to ensure that no one under 18 years of age purchases such drugs from the retailer, (2) establish other restrictions on the sale of over-the-counter drugs containing DXM, and (3) establish restrictions on the distribution of bulk DXM.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1271 Introduced in House (IH)]
<DOC>
115th CONGRESS
1st Session
H. R. 1271
To amend the Federal Food, Drug, and Cosmetic Act to prevent the abuse
of dextromethorphan, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 1, 2017
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 2017''.
SEC. 2. SALES OF OVER-THE-COUNTER DRUGS CONTAINING DEXTROMETHORPHAN.
(a) Prohibited Acts.--
(1) Verification system.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at
the end the following:
``(eee) The failure of a retailer (as defined in section 506H) that
offers for sale in interstate commerce covered drugs (as defined in
section 506H) to have a verification system as required by section 506H
(relating to sales of over-the-counter drugs containing
dextromethorphan).''.
(2) Identifier for electronic point of sale system; active
ingredients.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended by paragraph (1), is
further amended by adding at the end the following:
``(fff) The introduction or delivery for introduction into
interstate commerce of any covered drug (as defined in section 506H)
whose labeling does not include--
``(1) a universal product code, universal product number,
bar code, or similar identifier to allow an electronic point of
sale system to recognize that the sale of the covered drug is
prohibited to those under the age of 18; and
``(2) the established name of each active ingredient of the
covered drug within the first panel of the drug facts labeling
required by section 201.66(c) of title 21, Code of Federal
Regulations (or any successor regulations), in no smaller than
6-point type.''.
(b) Verification System.--The Federal Food, Drug, and Cosmetic Act
is amended by inserting after section 506G of such Act (21 U.S.C. 356g)
the following:
``SEC. 506H. SALES OF OVER-THE-COUNTER DRUGS CONTAINING
DEXTROMETHORPHAN.
``(a) Verification System.--Any retailer selling or offering for
sale in interstate commerce a covered drug shall have a verification
system in accordance with this section that is intended to ensure that
no individual who purchases a covered drug from the retailer is under
18 years of age. Such a system shall be set up to prompt a retailer to
examine a purchaser's identification card.
``(b) Means Used To Ensure Compliance.--A verification system under
subsection (a) may ensure compliance with this section by any of, or
any combination of, the following means:
``(1) An electronic point-of-sale system that is coded--
``(A) to prompt for verification of the age of
purchasers of covered drugs; and
``(B) to deny sales of covered drugs to those under
the age of 18.
``(2) Training manuals, materials, or programs that
instruct employees--
``(A) to verify the age of purchasers of covered
drugs; and
``(B) to deny sales of covered drugs to those under
the age of 18.
``(3) Signage in and around the sales counter outlining the
age restriction on sales of covered drugs.
``(4) Designating one on-duty employee to approve sales of
covered drugs.
``(5) Any other verification measure adopted by a retailer
that is designed to ensure that a purchaser of a covered drug
is not under 18 years of age if, based on an examination of the
purchaser's identification card, the retailer reasonably
concludes the identification card is valid and indicates the
purchaser is not under 18 years of age.
``(c) Exceptions.--
``(1) Individuals over 26.--A verification system under
subsection (a) need not require verification of the age of any
individual over the age of 26.
``(2) Valid prescription.--A verification system under
subsection (a) need not apply to any sale made by a retailer
that is a pharmacy pursuant to a validly issued prescription.
``(3) Valid military identification card.--A verification
system under subsection (a) need not apply to any sale to an
individual who 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) Enforcement.--In carrying out this section, the Secretary
shall coordinate with State entities that regulate retailers, as
designated by the State, to perform activities to ensure compliance
with this section, including providing for appropriate investigation of
complaints related to violations of this section.
``(e) Compliance With State System.--If a State has a law under
which a retailer in the State is required to have a system that ensures
that no individual who purchases a covered drug from the retailer is
under 18 years of age, the Secretary shall treat any such retailer in
the State that is in compliance with such law as having a verification
system as required by this section, including for purposes of sections
301(eee) and 303(h).
``(f) Definitions.--In this section:
``(1) The term `covered drug'--
``(A) means a drug that--
``(i) contains dextromethorphan; and
``(ii) is not subject to section 503(b)(1);
and
``(B) excludes any drug that is packaged in packets
or pouches and contains 2 or fewer maximum adult doses
of dextromethorphan as allowable under section 341.74
of title 21, Code of Federal Regulations (or any
successor regulations).
``(2) 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 (including any
successor regulations).
``(3) The term `retailer' means--
``(A) a grocery store, general merchandise store,
drug store, pharmacy, convenience store, or other
entity whose activities as a seller of covered drugs
containing dextromethorphan are limited almost
exclusively to sales for personal use, both in number
and volume of sales, including any sales made by the
Internet or other means; and
``(B) excludes any entity listed in subparagraph
(A) that does not sell any covered drug described in
paragraph (1)(A).''.
(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) A retailer that violates section 301(eee) shall not be
subject to subsection (a) or any civil monetary penalty under this Act
for such violation except as follows:
``(1) If the Secretary finds that a retailer fails to have
a verification system in violation of section 301(eee)--
``(A) upon the first such finding, the Secretary
shall issue a formal notice of violation and give the
retailer a period of at least 30 days (beginning on the
receipt of such notice) to correct the violation;
``(B) upon the second such finding, the retailer
shall be subject to a civil penalty of not more than
$1,000;
``(C) upon the third such finding, the retailer
shall be subject to a civil penalty of not more than
$2,000; and
``(D) upon the fourth and any subsequent such
finding, the retailer shall be subject to a civil
penalty of not more than $5,000.
``(2) In determining the amount of a civil penalty under
this subsection for 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
retailer's verification system established pursuant to section
506H, where such program includes--
``(A) educating employees regarding covered drugs;
``(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 retailer transacts sales of covered drugs at
more than one physical location, for purposes of determining
the number of violations by that retailer under this
subsection, each individual physical location operated by that
retailer shall be considered a separate retailer.
``(4) The Secretary shall notify retailers found to have
violated section 301(eee) as soon as practicable after the
Secretary discovers such violation. Such notification shall
include the date and time when the failure to have a
verification system as required by such section was observed to
occur.
``(5) In this subsection, the terms `covered drug' and
`retailer' have the meanings given such terms in section
506H.''.
(d) Applicability.--The amendments made by subsections (a), (b),
and (c) shall apply with respect to drugs sold or offered for sale on
or after the date that is one year after the date of enactment of this
Act.
(e) Sense of Congress Regarding Communication by Organizations
Nominated by Manufacturers.--It is the sense of Congress that
organizations nominated by manufacturers of covered drugs (as defined
in section 506H of the Federal Food, Drug, and Cosmetic Act, as added
by subsection (c)) should make reasonable efforts to communicate to
retailers (as defined in such section 506H) the requirements of such
section 506H, including by making available upon request materials
(which may include signage, manuals, materials, or programs) to assist
with educating employees regarding such covered drugs.
SEC. 3. RESTRICTIONS ON DISTRIBUTION OF BULK DEXTROMETHORPHAN.
(a) In General.--The Federal Food, Drug, and Cosmetic Act is
amended--
(1) in section 301 (21 U.S.C. 331) (as amended by section
2(a)) by adding at the end the following:
``(ggg) The possession, receipt, or distribution of unfinished
dextromethorphan in violation of section 506I.'';
(2) by inserting after section 506H (as added by section
2(b)) the following:
``SEC. 506I. 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--
``(A) the practice of pharmacy; or
``(B) drug or drug ingredient discovery,
production, manufacture, or distribution; or
``(2) distribute unfinished dextromethorphan to any person
other than a person described in paragraph (1).
``(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).
``(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(c), by
adding at the end the following:
``(i) A person that violates section 301(ggg) shall not be subject
to subsection (a) or any civil monetary penalty under this Act for such
violation except such person shall be subject to a civil penalty in an
amount of not more than $100,000.''.
(b) Applicability.--The amendments made by this section apply
beginning on the date of enactment of this Act.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line