II 

113TH CONGRESS 

1ST SESSION S. 644 

To amend the Federal Food, Drug, and Cosmetic Act to prevent the abuse 

of dextromethorphan, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MARCH 21, 2013 

Mr. CASEY (for himself and Ms. MURKOWSKI) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

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 2013’’ or the ‘‘PACT Act’’. 


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

2 DEXTROMETHORPHAN. 

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

4 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend5 ed by adding at the end the following: 

6 ‘‘(ccc)(1)(A) Except as provided in subparagraph (2), 

7 the sale or offering for sale of a drug containing dextrome8 thorphan to an individual under 18 years of age, including 

9 any such sale using the Internet, provided the drug is not 

10 subject to section 503(b)(1). 

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

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

13 containing dextromethorphan to that individual, that per14 son shall be deemed to have known that the individual was 

15 under 18 years of age, unless from the individual’s out16 ward appearance the person making the sale would rea17 sonably presume the individual to be 25 years of age or 

18 older. 

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

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

21 containing dextromethorphan examined the purchaser’s 

22 identification card and, based on that examination, that 

23 person reasonably concluded that the identification was 

24 valid and indicated that the purchaser was not less than 

25 18 years of age. 


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

2 made pursuant to a validly issued prescription. 

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

4 offering for sale of a drug containing dextromethorphan 

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

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

7 is actively enrolled in the military and presents a valid 

8 military identification card. 

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

10 mean an identification card that— 

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

12 birth of the individual; and 

13 ‘‘(B) is issued by a State or the Federal Gov14 ernment or is considered acceptable for purposes of 

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

16 274a.2(b)(1)(v)(B)(1) of title 8, Code of Federal 

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

18 enactment of the Preventing Abuse of Cough Treat19 ments Act of 2013).’’. 

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

21 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend22 ed by adding at the end the following: 

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

24 provisions shall apply to violations of section 301(ccc): 


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1 ‘‘(1) A person who violates section 301(ccc) 

2 shall— 

3 ‘‘(A) receive a warning letter from the Sec4 retary for the first such violation; and 

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

6 amount— 

7 ‘‘(i) not more than $1,000 for the sec8 ond such violation by a person; 

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

10 third such violation by a person; and 

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

12 fourth such violation, or a subsequent such 

13 violation, by a person. 

14 ‘‘(2) In determining the amount of a civil pen15 alty under this subsection for a person who is a re16 tailer, the Secretary shall consider whether the re17 tailer has taken appropriate steps to prevent subse18 quent violations, such as the establishment and ad19 ministration of a documented employee training pro20 gram to ensure all employees are familiar with and 

21 abiding by the provisions of section 301(ccc), where 

22 such program includes— 

23 ‘‘(A) educating employees regarding prod24 ucts containing dextromethorphan; 


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

2 checking a purchaser’s identification card; and 

3 ‘‘(C) notifying employees of the civil pen4 alties under this subsection. 

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

6 sales of products containing dextromethorphan at 

7 more than one physical location, for purposes of de8 termining the number of violations by that person 

9 under this subsection, each individual physical loca10 tion operated by that retailer shall be considered a 

11 separate person. 

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

13 to have violated section 301(ccc) as soon as prac14 ticable after the Secretary discovers such violation. 

15 Such notification shall include details of the viola16 tion, such as— 

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

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

19 documenting the sale; and 

20 ‘‘(C) the name or description of the em21 ployee involved in the sale. 

22 ‘‘(5) Notwithstanding any other provision of 

23 this subsection or section 301(ccc), an employee 

24 shall not be subject to penalties under this sub25 section unless such employee knowingly and willfully 


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1 participates in a conspiracy to violate section 

2 301(ccc). For purposes of this paragraph, a con3 spiracy shall consist of an agreement between two or 

4 more persons with the intent to violate section 

5 301(ccc) and the commission of at least one overt 

6 act in furtherance of the agreement. 

7 ‘‘(6) In this subsection— 

8 ‘‘(A) the term ‘employee’ means an indi9 vidual who is employed by a retailer in a cler10 ical or other non-managerial position; and 

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

12 store, general merchandise store, drug store, 

13 pharmacy, convenience store, or other entity or 

14 person whose activities as a distributor relating 

15 to products containing dextromethorphan are 

16 limited almost exclusively to sales for personal 

17 use, both in number of sales and volume of 

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

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

20 SEC. 3. RESTRICTIONS ON DISTRIBUTION OF BULK 

21 DEXTROMETHORPHAN. 

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

23 U.S.C. 321 et seq.) is amended— 

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

25 following: 


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1 ‘‘(k) If it is unfinished dextromethorphan and is pos2 sessed, received, or distributed in violation of section 

3 506G.’’; 

4 (2) by inserting after section 506F the fol5 lowing: 

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

7 BULK DEXTROMETHORPHAN. 

8 ‘‘(a) IN GENERAL.—No person shall— 

9 ‘‘(1) possess or receive unfinished dextrome10 thorphan, unless the person is registered under sec11 tion 510 or otherwise registered, licensed, or ap12 proved pursuant to Federal or State law to engage 

13 in the practice of pharmacy, pharmaceutical produc14 tion, or manufacture or distribution of drug ingredi15 ents; or 

16 ‘‘(2) distribute unfinished dextromethorphan to 

17 any person other than a person registered under sec18 tion 510 or otherwise registered, licensed, or ap19 proved pursuant to Federal or State law to engage 

20 in the practice of pharmacy, pharmaceutical produc21 tion, or manufacture or distribution of drug ingredi22 ents. 

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

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

25 receives, or distributes unfinished dextromethorphan for 


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1 purposes of distributing such unfinished dextromethor2 phan between persons described in subsection (a) as reg3 istered, licensed, or approved. 

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

5 ‘‘(1) The term ‘common carrier’ means any per6 son that holds itself out to the general public as a 

7 provider for hire of the transportation by water, 

8 land, or air of merchandise, whether or not the per9 son actually operates the vessel, vehicle, or aircraft 

10 by which the transportation is provided, between a 

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

12 States. 

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

14 means dextromethorphan that is not contained in a 

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

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

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

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

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

20 of not more than $100,000.’’. 

Æ 


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