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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Preventing Abuse of 

5 Cough Treatments Act of 2014’’ or the ‘‘PACT Act’’. 

6 SEC. 2. SALES OF OVER-THE-COUNTER DRUGS CONTAINING 

7 DEXTROMETHORPHAN. 

8 (a) PROHIBITED ACT.—Section 301 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend10 ed by adding at the end the following: 


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1 ‘‘(ddd)(1)(A) Except as provided in subparagraph 

2 (2), the sale or offering for sale of a drug containing dex3 tromethorphan to an individual under 18 years of age, in4 cluding any such sale using the Internet, provided the 

5 drug is not subject to section 503(b)(1). 

6 ‘‘(B) If a person fails to request identification from 

7 an individual under 18 years of age and sells a product 

8 containing dextromethorphan to that individual, that per9 son shall be deemed to have known that the individual was 

10 under 18 years of age, unless from the individual’s out11 ward appearance the person making the sale would rea12 sonably presume the individual to be 25 years of age or 

13 older. 

14 ‘‘(C) It shall be an affirmative defense to an alleged 

15 violation of clause (A) that the person selling a product 

16 containing dextromethorphan examined the purchaser’s 

17 identification card and, based on that examination, that 

18 person reasonably concluded that the identification was 

19 valid and indicated that the purchaser was not less than 

20 18 years of age. 

21 ‘‘(2)(A) This paragraph shall not apply to any sale 

22 made pursuant to a validly issued prescription. 

23 ‘‘(B) This paragraph shall not apply to the sale or 

24 offering for sale of a drug containing dextromethorphan 

25 to an individual under 18 years of age if such individual 


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1 supplies proof at the time of such sale that such individual 

2 is actively enrolled in the military and presents a valid 

3 military identification card. 

4 ‘‘(3) In this paragraph, the term ‘identification card’ 

5 means an identification card that— 

6 ‘‘(A) includes a photograph and the date of 

7 birth of the individual; and 

8 ‘‘(B) is issued by a State or the Federal Gov9 ernment or is considered acceptable for purposes of 

10 sections 274a.2(b)(1)(v)(A) and 

11 274a.2(b)(1)(v)(B)(1) of title 8, Code of Federal 

12 Regulations (as in effect on or after the date of the 

13 enactment of the Preventing Abuse of Cough Treat14 ments Act of 2014).’’. 

15 (b) CIVIL PENALTIES.—Section 303 of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend17 ed by adding at the end the following: 

18 ‘‘(h) Notwithstanding subsection (a), the following 

19 provisions shall apply to violations of section 301(ddd): 

20 ‘‘(1) A person who violates section 301(ddd) 

21 shall— 

22 ‘‘(A) receive a warning letter from the Sec23 retary for the first such violation; and 

24 ‘‘(B) be subject to a civil penalty in an 

25 amount— 


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1 ‘‘(i) not more than $1,000 for the sec2 ond such violation by a person; 

3 ‘‘(ii) not more than $2,000 for the 

4 third such violation by a person; and 

5 ‘‘(iii) not more than $5,000 for the 

6 fourth such violation, or a subsequent such 

7 violation, by a person. 

8 ‘‘(2) In determining the amount of a civil pen9 alty under this subsection for a person who is a re10 tailer, the Secretary shall consider whether the re11 tailer has taken appropriate steps to prevent subse12 quent violations, such as the establishment and ad13 ministration of a documented employee training pro14 gram to ensure all employees are familiar with and 

15 abiding by the provisions of section 301(ddd), where 

16 such program includes— 

17 ‘‘(A) educating employees regarding prod18 ucts containing dextromethorphan; 

19 ‘‘(B) instruction on the correct method of 

20 checking a purchaser’s identification card; and 

21 ‘‘(C) notifying employees of the civil pen22 alties under this subsection. 

23 ‘‘(3) If a person who is a retailer transacts 

24 sales of products containing dextromethorphan at 

25 more than one physical location, for purposes of deVerDate Mar 15 2010 01:48 Feb 01, 2014 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3969.IH H3969

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1 termining the number of violations by that person 

2 under this subsection, each individual physical loca3 tion operated by that retailer shall be considered a 

4 separate person. 

5 ‘‘(4) The Secretary shall notify persons found 

6 to have violated section 301(ddd) as soon as prac7 ticable after the Secretary discovers such violation. 

8 Such notification shall include details of the viola9 tion, such as— 

10 ‘‘(A) the date and time of the sale; 

11 ‘‘(B) a sales receipt or credit card receipt 

12 documenting the sale; and 

13 ‘‘(C) the name or description of the em14 ployee involved in the sale. 

15 ‘‘(5) Notwithstanding any other provision of 

16 this subsection or section 301(ddd), an employee 

17 shall not be subject to penalties under this sub18 section unless such employee knowingly and willfully 

19 participates in a conspiracy to violate section 

20 301(ddd). For purposes of this paragraph, a con21 spiracy shall consist of an agreement between two or 

22 more persons with the intent to violate section 

23 301(ddd) and the commission of at least one overt 

24 act in furtherance of the agreement. 

25 ‘‘(6) In this subsection— 


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1 ‘‘(A) the term ‘employee’ means an indi2 vidual who is employed by a retailer in a cler3 ical or other non-managerial position; and 

4 ‘‘(B) the term ‘retailer’ means a grocery 

5 store, general merchandise store, drug store, 

6 pharmacy, convenience store, or other entity or 

7 person whose activities as a distributor relating 

8 to products containing dextromethorphan are 

9 limited almost exclusively to sales for personal 

10 use, both in number of sales and volume of 

11 sales, either directly to walk-in customers or in 

12 face-to-face transactions by direct sales.’’. 

13 SEC. 3. RESTRICTIONS ON DISTRIBUTION OF BULK 

14 DEXTROMETHORPHAN. 

15 The Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 321 et seq.) is amended— 

17 (1) in section 501, by inserting at the end the 

18 following: 

19 ‘‘(k) If it is unfinished dextromethorphan and is pos20 sessed, received, or distributed in violation of section 

21 506G.’’; 

22 (2) by inserting after section 506F the fol23 lowing: 


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1 ‘‘SEC. 506G. RESTRICTIONS ON THE DISTRIBUTION OF 

2 BULK DEXTROMETHORPHAN. 

3 ‘‘(a) IN GENERAL.—No person shall— 

4 ‘‘(1) possess or receive unfinished dextrome5 thorphan, unless the person is registered under sec6 tion 510 or otherwise registered, licensed, or ap7 proved pursuant to Federal or State law to engage 

8 in the practice of pharmacy, pharmaceutical produc9 tion, or manufacture or distribution of drug ingredi10 ents; or 

11 ‘‘(2) distribute unfinished dextromethorphan to 

12 any person other than a person registered under sec13 tion 510 or otherwise registered, licensed, or ap14 proved pursuant to Federal or State law to engage 

15 in the practice of pharmacy, pharmaceutical produc16 tion, or manufacture or distribution of drug ingredi17 ents. 

18 ‘‘(b) EXCEPTION FOR COMMON CARRIERS.—This 

19 section does not apply to a common carrier that possesses, 

20 receives, or distributes unfinished dextromethorphan for 

21 purposes of distributing such unfinished dextromethor22 phan between persons described in subsection (a) as reg23 istered, licensed, or approved. 

24 ‘‘(c) DEFINITIONS.—In this section: 

25 ‘‘(1) The term ‘common carrier’ means any per26 son that holds itself out to the general public as a 


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1 provider for hire of the transportation by water, 

2 land, or air of merchandise, whether or not the per3 son actually operates the vessel, vehicle, or aircraft 

4 by which the transportation is provided, between a 

5 port or place and a port or place in the United 

6 States. 

7 ‘‘(2) The term ‘unfinished dextromethorphan’ 

8 means dextromethorphan that is not contained in a 

9 drug that is in finished dosage form.’’; and 

10 (3) by amending section 303, as amended by 

11 section 2(b), by adding at the end the following: 

12 ‘‘(i) Notwithstanding subsection (a), a person who 

13 violates section 506G shall be subject to a civil penalty 

14 of not more than $100,000.’’. 

Æ 


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