IB 
Union Calendar No. 520 
114TH CONGRESS 
2D SESSION 
H. R. 3250 
[Report No. 114–672] 
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 
JULY 8, 2016 
Additional sponsors: Mr. LOEBSACK, Mr. TONKO, Mr. BURGESS, Mr. GUTH-
RIE, Mr. KINZINGER of Illinois, Mr. BARLETTA, Ms. BROWNLEY of Cali-
fornia, Ms. CLARKE of New York, Ms. NORTON, Mr. HUFFMAN, Mr. 
KATKO, Mr. OLSON, Mr. HASTINGS, Mr. KIND, Mr. PAULSEN, Mr. COS-
TELLO of Pennsylvania, Mr. MEEHAN, Mr. DESAULNIER, and Mr. 
FITZPATRICK 
JULY 8, 2016 
Committed to the Committee of the Whole House on the State of the Union 
and ordered to be printed 
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A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
prevent the abuse of dextromethorphan, and for other 
purposes. 
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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 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 amend-
ed 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 sec-
tion 506F of such Act (21 U.S.C. 356f) the following: 
‘‘SEC. 506G. SALES OF OVER-THE-COUNTER DRUGS CON-
TAINING 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 compli-
ance by means of— 
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‘‘(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 ap-
prove all sales of such drugs; or 
‘‘(5) any other verification measure deemed 
valid by the Secretary. 
‘‘(b) PROHIBITION.—Except as provided in sub-
section (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 indi-
vidual over the age of 26. 
‘‘(2) VALID
PRESCRIPTION.—Subsection (b) 
does not apply to any sale made pursuant to a val-
idly issued prescription. 
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‘‘(3) VALID MILITARY IDENTIFICATION CARD.— 
Subsection (b) does not apply to any sale to an indi-
vidual under 18 years of age if such individual sup-
plies proof at the time of such sale that such indi-
vidual is actively enrolled in the military and pre-
sents a valid military identification card. 
‘‘(d) AFFIRMATIVE DEFENSE.—It shall be an affirm-
ative 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 con-
cluded 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 Govern-
ment or is considered acceptable for purposes of sec-
tions 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).’’. 
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(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) 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 sec-
ond 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 pen-
alty under this subsection for a person who is a re-
tailer, the Secretary shall consider whether the re-
tailer has taken appropriate steps to prevent subse-
quent violations, such as the establishment and ad-
ministration of a documented employee training pro-
gram to ensure all employees are familiar with and 
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abiding by the provisions of section 301(ddd), where 
such program includes— 
‘‘(A) educating employees regarding prod-
ucts containing dextromethorphan; 
‘‘(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 person who is a retailer transacts 
sales of products containing dextromethorphan at 
more than one physical location, for purposes of de-
termining the number of violations by that person 
under this subsection, each individual physical loca-
tion 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 prac-
ticable 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 sub-
section unless such employee knowingly and willfully 
participates in a conspiracy to violate section 
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301(ddd). For purposes of this paragraph, a con-
spiracy 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 indi-
vidual who is employed by a retailer in a cler-
ical 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: 
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‘‘(k) If it is unfinished dextromethorphan and is pos-
sessed, received, or distributed in violation of section 
506H.’’; and 
(2) by inserting after section 506F the fol-
lowing: 
‘‘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 en-
gage 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 sec-
tion 510 or otherwise registered, licensed, or ap-
proved pursuant to Federal or State law to engage 
in the practice of pharmacy, pharmaceutical produc-
tion, or manufacture or distribution of drug ingredi-
ents. 
‘‘(b) EXCEPTION
FOR COMMON CARRIERS.—This 
section does not apply to a common carrier that possesses, 
receives, or distributes unfinished dextromethorphan for 
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purposes 
of 
distributing 
such 
unfinished 
dextromethorphan between persons described in sub-
section (a) as registered, licensed, or approved. 
‘‘(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(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.’’. 
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Union Calendar No. 520 
114TH CONGRESS 
2D SESSION 
H. R. 3250 
[Report No. 114–672] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act to prevent the abuse of dextromethorphan, 
and for other purposes. 
JULY 8, 2016 
Committed to the Committee of the Whole House on the 
State of the Union and ordered to be printed 
VerDate Sep 11 2014 
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