I 

114TH CONGRESS 

1ST SESSION H. R. 3250 

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 

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 ‘‘DXM Abuse Preven5 tion Act of 2015’’. 

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) The failure of a retailer to implement a 

2 verification system as required by section 506G (relating 

3 to sales of over-the-counter drugs containing 

4 dextromethorphan).’’. 

5 (b) VERIFICATION SYSTEM.—The Federal Food, 

6 Drug, and Cosmetic Act is amended by inserting after sec7 tion 506F of such Act (21 U.S.C. 356f) the following: 

8 ‘‘SEC. 506G. SALES OF OVER-THE-COUNTER DRUGS CON9 TAINING DEXTROMETHORPHAN. 

10 ‘‘(a) VERIFICATION SYSTEM.—Any retailer selling or 

11 offering for sale in interstate commerce dextromethorphan 

12 shall implement a verification system to ensure compliance 

13 with this section. Such a system may ensure such compli14 ance by means of— 

15 ‘‘(1) an electronic point-of-sale system coded to 

16 prompt for verification of the age of all purchasers 

17 of drugs described in subsection (b) and deny sales 

18 to those under the age of 18; 

19 ‘‘(2) training manuals or materials instructing 

20 employees to verify the age of all purchasers of such 

21 drugs and deny sales to those under the age of 18; 

22 ‘‘(3) signage in and around the sales counter 

23 outlining the age restriction on sales of such drugs; 

24 ‘‘(4) designating one on-duty employee to ap25 prove all sales of such drugs; or 


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1 ‘‘(5) any other verification measure deemed 

2 valid by the Secretary. 

3 ‘‘(b) PROHIBITION.—Except as provided in sub4 section (c), each retailer shall verify that no individual is 

5 under 18 years of age who purchases any drug that— 

6 ‘‘(1) contains dextromethorphan; and 

7 ‘‘(2) is not subject to section 503(b)(1). 

8 ‘‘(c) EXCEPTIONS.— 

9 ‘‘(1) INDIVIDUALS OVER 26.—Subsection (b) 

10 does not require verification of the age of any indi11 vidual over the age of 26. 

12 ‘‘(2) VALID PRESCRIPTION.—Subsection (b) 

13 does not apply to any sale made pursuant to a val14 idly issued prescription. 

15 ‘‘(3) VALID MILITARY IDENTIFICATION CARD.— 

16 Subsection (b) does not apply to any sale to an indi17 vidual under 18 years of age if such individual sup18 plies proof at the time of such sale that such indi19 vidual is actively enrolled in the military and pre20 sents a valid military identification card. 

21 ‘‘(d) AFFIRMATIVE DEFENSE.—It shall be an affirm22 ative defense to an alleged violation of subsection (b) that 

23 the individual selling a drug containing 

24 dextromethorphan— 


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1 ‘‘(1) examined the purchaser’s identification 

2 card; and 

3 ‘‘(2) based on that examination, reasonably con4 cluded that the identification was valid and indicated 

5 that the purchaser was not less than 18 years of 

6 age. 

7 ‘‘(e) DEFINITION.—In this paragraph, the term 

8 ‘identification card’ means an identification card that— 

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

10 birth of the individual; and 

11 ‘‘(2) is issued by a State or the Federal Govern12 ment or is considered acceptable for purposes of sec13 tions 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B)(1) 

14 of title 8, Code of Federal Regulations (including 

15 any successor regulations).’’. 

16 (c) CIVIL PENALTIES.—Section 303 of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend18 ed by adding at the end the following: 

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

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

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

22 shall— 

23 ‘‘(A) receive a violation notification from 

24 the Secretary for the first such violation; and 


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

2 amount— 

3 ‘‘(i) not more than $1,000 for the sec4 ond such violation by a person; 

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

6 third such violation by a person; and 

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

8 fourth such violation, or a subsequent such 

9 violation, by a person. 

10 ‘‘(2) In determining the amount of a civil pen11 alty under this subsection for a person who is a re12 tailer, the Secretary shall consider whether the re13 tailer has taken appropriate steps to prevent subse14 quent violations, such as the establishment and ad15 ministration of a documented employee training pro16 gram to ensure all employees are familiar with and 

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

18 such program includes— 

19 ‘‘(A) educating employees regarding prod20 ucts containing dextromethorphan; 

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

22 checking a purchaser’s identification card; and 

23 ‘‘(C) notifying employees of the civil pen24 alties under this subsection. 


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

2 sales of products containing dextromethorphan at 

3 more than one physical location, for purposes of de4 termining the number of violations by that person 

5 under this subsection, each individual physical loca6 tion operated by that retailer shall be considered a 

7 separate person. 

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

9 to have violated section 301(ddd) as soon as prac10 ticable after the Secretary discovers such violation. 

11 Such notification shall include the date and time 

12 when the violation was observed to occur. 

13 ‘‘(5) Notwithstanding any other provision of 

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

15 shall not be subject to penalties under this sub16 section unless such employee knowingly and willfully 

17 participates in a conspiracy to violate section 

18 301(ddd). For purposes of this paragraph, a con19 spiracy shall consist of an agreement between two or 

20 more persons with the intent to violate section 

21 301(ddd) and the commission of at least one overt 

22 act in furtherance of the agreement. 

23 ‘‘(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, including any sales made by the Internet 

12 or other means.’’. 

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 506H.’’; and 

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


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

2 BULK DEXTROMETHORPHAN. 

3 ‘‘(a) IN GENERAL.—No person shall— 

4 ‘‘(1) possess or receive unfinished 

5 dextromethorphan, unless the person is registered 

6 under section 510 or otherwise registered, licensed, 

7 or approved pursuant to Federal or State law to en8 gage in the practice of pharmacy, pharmaceutical 

9 production, or manufacture or distribution of drug 

10 ingredients; 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 

22 dextromethorphan between persons described in sub23 section (a) as registered, 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 506H shall be subject to a civil penalty 

14 of not more than $100,000.’’. 

Æ 


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