II 

112TH CONGRESS 

2D SESSION S. 3376 

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 

JULY 11, 2012 

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 2012’’ 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 ‘‘(aaa)(1)(A) Except as provided in subparagraph 

7 (2), the sale or offering for sale of a drug containing 

8 dextromethorphan to an individual under 18 years of age, 

9 including any such sale using the Internet, provided the 

10 drug is not 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. 

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

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

18 containing dextromethorphan examined the purchaser’s 

19 identification card and, based on that examination, that 

20 person reasonably concluded that the identification was 

21 valid and indicated that the purchaser was not less than 

22 18 years of age. 

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

24 made pursuant to a validly issued prescription. 

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

26 offering for sale of a drug containing dextromethorphan 


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

2 supplies proof at the time of such sale that such indi3 vidual— 

4 ‘‘(i) is married; 

5 ‘‘(ii) is the parent of a child; or 

6 ‘‘(iii) is actively enrolled in the military. 

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

8 mean an identification card that— 

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

10 birth of the individual; and 

11 ‘‘(B) is issued by a State or the Federal Gov12 ernment or is considered acceptable for purposes of 

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

14 274a.2(b)(1)(v)(B)(1) of title 8, Code of Federal 

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

16 enactment of the Preventing Abuse of Cough Treat17 ments Act of 2012).’’. 

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

19 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend20 ed by adding at the end the following: 

21 ‘‘(h)(1) Notwithstanding subsection (a), a person who 

22 violates section 301(aaa) shall be subject to a civil penalty 

23 in an amount— 

24 ‘‘(A) not more than $1,000 for the first such 

25 violation by a person; 


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1 ‘‘(B) not more than $2,000 for the second such 

2 violation by a person; and 

3 ‘‘(C) not more than $5,000 for the third such 

4 violation, or a subsequent such violation, by a per5 son. 

6 ‘‘(2) In determining the amount of a civil penalty 

7 under this subsection for a person who is a retailer, the 

8 Secretary shall consider whether the retailer has taken ap9 propriate steps to prevent subsequent violations, such as— 

10 ‘‘(A) the establishment and administration of a 

11 documented employee training program to ensure all 

12 employees are familiar with and abiding by the pro13 visions of this section; or 

14 ‘‘(B) other actions taken by a retailer to ensure 

15 compliance with this section. 

16 ‘‘(3) If a person who is a retailer transacts sales of 

17 products containing dextromethorphan at more than one 

18 physical location, for purposes of determining the number 

19 of violations by that person under this subsection, each 

20 individual physical location operated by that retailer shall 

21 be considered a separate person. 

22 ‘‘(4) In this subsection, the term ‘retailer’ means a 

23 grocery store, general merchandise store, drug store, phar24 macy, convenience store, or other entity or person whose 

25 activities as a distributor relating to products containing 


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1 dextromethorphan are limited almost exclusively to sales 

2 for personal use, both in number of sales and volume of 

3 sales, either directly to walk-in customers or in face-to4 face transactions by direct sales.’’. 

5 SEC. 3. RESTRICTIONS ON DISTRIBUTION OF BULK 

6 DEXTROMETHORPHAN. 

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

8 U.S.C. 321 et seq.) is amended— 

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

10 following: 

11 ‘‘(j) If it is unfinished dextromethorphan and is pos12 sessed, received, or distributed in violation of section 

13 506D.’’; 

14 (2) by inserting after section 506C the fol15 lowing: 

16 ‘‘SEC. 506D. RESTRICTIONS ON THE DISTRIBUTION OF 

17 BULK DEXTROMETHORPHAN. 

18 ‘‘(a) IN GENERAL.—No person shall— 

19 ‘‘(1) possess or receive unfinished dextrome20 thorphan, unless the person is registered under sec21 tion 510 or otherwise registered, licensed, or ap22 proved pursuant to Federal or State law to engage 

23 in the practice of pharmacy, pharmaceutical produc24 tion, or manufacture or distribution of drug ingredi25 ents; or 


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1 ‘‘(2) distribute unfinished dextromethorphan to 

2 any person other than a person registered under sec3 tion 510 or otherwise registered, licensed, or ap4 proved pursuant to Federal or State law to engage 

5 in the practice of pharmacy, pharmaceutical produc6 tion, or manufacture or distribution of drug ingredi7 ents. 

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

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

10 receives, or distributes unfinished dextromethorphan for 

11 purposes of distributing such unfinished dextromethor12 phan between persons described in subsection (a) as reg13 istered, licensed, or approved. 

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

15 ‘‘(1) The term ‘common carrier’ means any per16 son that holds itself out to the general public as a 

17 provider for hire of the transportation by water, 

18 land, or air of merchandise, whether or not the per19 son actually operates the vessel, vehicle, or aircraft 

20 by which the transportation is provided, between a 

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

22 States. 

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

24 means dextromethorphan that is not contained in a 

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


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

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

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

4 violates section 506D shall be subject to a civil penalty 

5 of not more than $100,000.’’. 

Æ 


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