I 
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 Representa-
tives 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 amend-
ed by adding at the end the following: 
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‘‘(ddd)(1)(A) Except as provided in subparagraph 
(2), the sale or offering for sale of a drug containing dex-
tromethorphan to an individual under 18 years of age, in-
cluding 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 per-
son shall be deemed to have known that the individual was 
under 18 years of age, unless from the individual’s out-
ward appearance the person making the sale would rea-
sonably 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 
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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 Gov-
ernment 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 Treat-
ments Act of 2014).’’. 
(b) 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 warning letter from the Sec-
retary for the first such violation; and 
‘‘(B) be subject to a civil penalty in an 
amount— 
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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 details of the viola-
tion, 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 em-
ployee 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 sub-
section unless such employee knowingly and willfully 
participates in a conspiracy to violate section 
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— 
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‘‘(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, 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 pos-
sessed, received, or distributed in violation of section 
506G.’’; 
(2) by inserting after section 506F the fol-
lowing: 
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‘‘SEC. 506G. 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 the practice of pharmacy, pharmaceutical produc-
tion, or manufacture or distribution of drug ingredi-
ents; 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 
purposes of distributing such unfinished dextromethor-
phan between persons described in subsection (a) as reg-
istered, 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 
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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 506G shall be subject to a civil penalty 
of not more than $100,000.’’. 
Æ 
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