IB 

Union Calendar No. 520 

114TH CONGRESS 

2D SESSION H. R. 3250 

[Report No. 114–672] 

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 

JULY 8, 2016 

Additional sponsors: Mr. LOEBSACK, Mr. TONKO, Mr. BURGESS, Mr. GUTHRIE, Mr. KINZINGER of Illinois, Mr. BARLETTA, Ms. BROWNLEY of California, Ms. CLARKE of New York, Ms. NORTON, Mr. HUFFMAN, Mr. 

KATKO, Mr. OLSON, Mr. HASTINGS, Mr. KIND, Mr. PAULSEN, Mr. COSTELLO of Pennsylvania, Mr. MEEHAN, Mr. DESAULNIER, and Mr. 

FITZPATRICK

JULY 8, 2016 

Committed to the Committee of the Whole House on the State of the Union 

and ordered to be printed 


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A BILL 

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

prevent the abuse of dextromethorphan, and for other 

purposes. 


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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: 

11 ‘‘(ddd) The failure of a retailer to implement a 

12 verification system as required by section 506G (relating 

13 to sales of over-the-counter drugs containing 

14 dextromethorphan).’’. 

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

16 Drug, and Cosmetic Act is amended by inserting after sec17 tion 506F of such Act (21 U.S.C. 356f) the following: 

18 ‘‘SEC. 506G. SALES OF OVER-THE-COUNTER DRUGS CON19 TAINING DEXTROMETHORPHAN. 

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

21 offering for sale in interstate commerce dextromethorphan 

22 shall implement a verification system to ensure compliance 

23 with this section. Such a system may ensure such compli24 ance by means of— 


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

2 prompt for verification of the age of all purchasers 

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

4 to those under the age of 18; 

5 ‘‘(2) training manuals or materials instructing 

6 employees to verify the age of all purchasers of such 

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

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

9 outlining the age restriction on sales of such drugs; 

10 ‘‘(4) designating one on-duty employee to ap11 prove all sales of such drugs; or 

12 ‘‘(5) any other verification measure deemed 

13 valid by the Secretary. 

14 ‘‘(b) PROHIBITION.—Except as provided in sub15 section (c), each retailer shall verify that no individual is 

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

17 ‘‘(1) contains dextromethorphan; and 

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

19 ‘‘(c) EXCEPTIONS.— 

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

21 does not require verification of the age of any indi22 vidual over the age of 26. 

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

24 does not apply to any sale made pursuant to a val25 idly issued prescription. 


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

2 Subsection (b) does not apply to any sale to an indi3 vidual under 18 years of age if such individual sup4 plies proof at the time of such sale that such indi5 vidual is actively enrolled in the military and pre6 sents a valid military identification card. 

7 ‘‘(d) AFFIRMATIVE DEFENSE.—It shall be an affirm8 ative defense to an alleged violation of subsection (b) that 

9 the individual selling a drug containing 

10 dextromethorphan— 

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

12 card; and 

13 ‘‘(2) based on that examination, reasonably con14 cluded that the identification was valid and indicated 

15 that the purchaser was not less than 18 years of 

16 age. 

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

18 ‘identification card’ means an identification card that— 

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

20 birth of the individual; and 

21 ‘‘(2) is issued by a State or the Federal Govern22 ment or is considered acceptable for purposes of sec23 tions 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B)(1) 

24 of title 8, Code of Federal Regulations (including 

25 any successor regulations).’’. 


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

2 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend3 ed by adding at the end the following: 

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

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

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

7 shall— 

8 ‘‘(A) receive a violation notification from 

9 the Secretary for the first such violation; and 

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

11 amount— 

12 ‘‘(i) not more than $1,000 for the sec13 ond such violation by a person; 

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

15 third such violation by a person; and 

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

17 fourth such violation, or a subsequent such 

18 violation, by a person. 

19 ‘‘(2) In determining the amount of a civil pen20 alty under this subsection for a person who is a re21 tailer, the Secretary shall consider whether the re22 tailer has taken appropriate steps to prevent subse23 quent violations, such as the establishment and ad24 ministration of a documented employee training pro25 gram to ensure all employees are familiar with and 


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

2 such program includes— 

3 ‘‘(A) educating employees regarding prod4 ucts containing dextromethorphan; 

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

6 checking a purchaser’s identification card; and 

7 ‘‘(C) notifying employees of the civil pen8 alties under this subsection. 

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

10 sales of products containing dextromethorphan at 

11 more than one physical location, for purposes of de12 termining the number of violations by that person 

13 under this subsection, each individual physical loca14 tion operated by that retailer shall be considered a 

15 separate person. 

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

17 to have violated section 301(ddd) as soon as prac18 ticable after the Secretary discovers such violation. 

19 Such notification shall include the date and time 

20 when the violation was observed to occur. 

21 ‘‘(5) Notwithstanding any other provision of 

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

23 shall not be subject to penalties under this sub24 section unless such employee knowingly and willfully 

25 participates in a conspiracy to violate section 


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1 301(ddd). For purposes of this paragraph, a con2 spiracy shall consist of an agreement between two or 

3 more persons with the intent to violate section 

4 301(ddd) and the commission of at least one overt 

5 act in furtherance of the agreement. 

6 ‘‘(6) In this subsection— 

7 ‘‘(A) the term ‘employee’ means an indi8 vidual who is employed by a retailer in a cler9 ical or other non-managerial position; and 

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

11 store, general merchandise store, drug store, 

12 pharmacy, convenience store, or other entity or 

13 person whose activities as a distributor relating 

14 to products containing dextromethorphan are 

15 limited almost exclusively to sales for personal 

16 use, both in number of sales and volume of 

17 sales, including any sales made by the Internet 

18 or other means.’’. 

19 SEC. 3. RESTRICTIONS ON DISTRIBUTION OF BULK 

20 DEXTROMETHORPHAN. 

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

22 U.S.C. 321 et seq.) is amended— 

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

24 following: 


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

3 506H.’’; and 

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

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

7 BULK DEXTROMETHORPHAN. 

8 ‘‘(a) IN GENERAL.—No person shall— 

9 ‘‘(1) possess or receive unfinished 

10 dextromethorphan, unless the person is registered 

11 under section 510 or otherwise registered, licensed, 

12 or approved pursuant to Federal or State law to en13 gage in the practice of pharmacy, pharmaceutical 

14 production, or manufacture or distribution of drug 

15 ingredients; 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 

2 dextromethorphan between persons described in sub3 section (a) as registered, 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 506H shall be subject to a civil penalty 

20 of not more than $100,000.’’. 


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Union Calendar No. 520 

114TH CONGRESS 

2D SESSION H. R. 3250 

[Report No. 114–672] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

and for other purposes. Act to prevent the abuse of dextromethorphan, 

JULY 8, 2016 

Committed to the Committee of the Whole House on the 

State of the Union and ordered to be printed 


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