I 
116TH CONGRESS 
1ST SESSION 
H. R. 863 
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 30, 2019 
Ms. MATSUI (for herself and Mr. JOHNSON of Ohio) 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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘DXM Abuse Preven-
tion Act of 2019’’. 
SEC. 2. SALES OF OVER-THE-COUNTER DRUGS CONTAINING 
DEXTROMETHORPHAN. 
(a) PROHIBITED ACTS.— 
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(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: 
‘‘(fff) 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 fur-
ther amended by adding at the end the following: 
‘‘(ggg) 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 ingre-
dient 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 suc-
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cessor regulations), in no smaller than 6-point 
type.’’. 
(b) VERIFICATION SYSTEM.—The Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 506G of such Act (21 U.S.C. 356g) the following: 
‘‘SEC. 506H. SALES OF OVER-THE-COUNTER DRUGS CON-
TAINING 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 com-
pliance 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. 
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‘‘(2) Training manuals, materials, or programs 
that instruct employees— 
‘‘(A) to verify the age of purchasers of cov-
ered 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 ap-
prove 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 identi-
fication card, the retailer reasonably concludes the 
identification card is valid and indicates the pur-
chaser is not under 18 years of age. 
‘‘(c) EXCEPTIONS.— 
‘‘(1) INDIVIDUALS OVER 26.—A verification sys-
tem 
under 
subsection 
(a) 
need 
not 
require 
verification of the age of any individual over the age 
of 26. 
‘‘(2) VALID PRESCRIPTION.—A verification sys-
tem under subsection (a) need not apply to any sale 
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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 ac-
tively 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 reg-
ulate retailers, as designated by the State, to perform ac-
tivities to ensure compliance with this section, including 
providing for appropriate investigation of complaints re-
lated 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 pur-
chases 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(fff) and 303(h). 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) The term ‘covered drug’— 
‘‘(A) means a drug that— 
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‘‘(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 regu-
lations). 
‘‘(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 pur-
poses 
of 
sections 
274a.2(b)(1)(v)(A) 
and 
274a.2(b)(1)(v)(B)(1) of title 8, Code of Fed-
eral Regulations (including any successor regu-
lations). 
‘‘(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 
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use, both in number and volume of sales, in-
cluding any sales made by the Internet or other 
means; and 
‘‘(B) excludes any entity listed in subpara-
graph (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 amend-
ed by adding at the end the following: 
‘‘(h) A retailer that violates section 301(fff) 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(fff)— 
‘‘(A) upon the first such finding, the Sec-
retary 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 re-
tailer shall be subject to a civil penalty of not 
more than $1,000; 
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‘‘(C) upon the third such finding, the re-
tailer 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 pen-
alty under this subsection for a retailer, the Sec-
retary 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 re-
tailer’s verification system established pursuant to 
section 506H, where such program includes— 
‘‘(A) educating employees regarding cov-
ered drugs; 
‘‘(B) instruction on the correct method of 
checking a purchaser’s identification card; and 
‘‘(C) notifying employees of the civil pen-
alties under this subsection. 
‘‘(3) If a retailer transacts sales of covered 
drugs at more than one physical location, for pur-
poses of determining the number of violations by 
that retailer under this subsection, each individual 
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physical location operated by that retailer shall be 
considered a separate retailer. 
‘‘(4) The Secretary shall notify retailers found 
to have violated section 301(fff) as soon as prac-
ticable after the Secretary discovers such violation. 
Such notification shall include the date and time 
when the failure to have a verification system as re-
quired 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 sub-
sections (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 COMMUNICA-
TION BY ORGANIZATIONS NOMINATED BY MANUFACTUR-
ERS.—It is the sense of Congress that organizations nomi-
nated 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 sec-
tion 506H) the requirements of such section 506H, includ-
ing by making available upon request materials (which 
may include signage, manuals, materials, or programs) to 
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assist with educating employees regarding such covered 
drugs. 
SEC. 3. RESTRICTIONS ON DISTRIBUTION OF BULK DEX-
TROMETHORPHAN. 
(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: 
‘‘(hhh) The possession, receipt, or distribution of un-
finished 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 dextrome-
thorphan, unless the person is registered under sec-
tion 510 or otherwise registered, licensed, or ap-
proved 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 
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‘‘(2) distribute unfinished dextromethorphan to 
any person other than a person described in para-
graph (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 dextromethor-
phan between persons described in subsection (a). 
‘‘(c) DEFINITIONS.—In this section: 
‘‘(1) The term ‘common carrier’ means any per-
son 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 per-
son 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(hhh) shall not 
be subject to subsection (a) or any civil monetary penalty 
under this Act for such violation except such person shall 
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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. 
Æ 
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