I 

116TH CONGRESS 

1ST SESSION H. R. 863 

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 30, 2019 

Ms. MATSUI (for herself and Mr. JOHNSON of Ohio) 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 2019’’. 

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

7 DEXTROMETHORPHAN. 

8 (a) PROHIBITED ACTS.— 


kjohnson on DSK79L0C42 with BILLS
2 

•HR 863 IH

1 (1) VERIFICATION SYSTEM.—Section 301 of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 331) is amended by adding at the end the following: 

4 ‘‘(fff) The failure of a retailer (as defined in section 

5 506H) that offers for sale in interstate commerce covered 

6 drugs (as defined in section 506H) to have a verification 

7 system as required by section 506H (relating to sales of 

8 over-the-counter drugs containing dextromethorphan).’’. 

9 (2) IDENTIFIER FOR ELECTRONIC POINT OF

10 SALE SYSTEM; ACTIVE INGREDIENTS.—Section 301 

11 of the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 331), as amended by paragraph (1), is fur13 ther amended by adding at the end the following: 

14 ‘‘(ggg) The introduction or delivery for introduction 

15 into interstate commerce of any covered drug (as defined 

16 in section 506H) whose labeling does not include— 

17 ‘‘(1) a universal product code, universal product 

18 number, bar code, or similar identifier to allow an 

19 electronic point of sale system to recognize that the 

20 sale of the covered drug is prohibited to those under 

21 the age of 18; and 

22 ‘‘(2) the established name of each active ingre23 dient of the covered drug within the first panel of 

24 the drug facts labeling required by section 201.66(c) 

25 of title 21, Code of Federal Regulations (or any sucVerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H863.IH H863

kjohnson on DSK79L0C42 with BILLS
3 

•HR 863 IH

1 cessor regulations), in no smaller than 6-point 

2 type.’’. 

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

4 Drug, and Cosmetic Act is amended by inserting after sec5 tion 506G of such Act (21 U.S.C. 356g) the following: 

6 ‘‘SEC. 506H. SALES OF OVER-THE-COUNTER DRUGS CON7 TAINING DEXTROMETHORPHAN. 

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

9 offering for sale in interstate commerce a covered drug 

10 shall have a verification system in accordance with this 

11 section that is intended to ensure that no individual who 

12 purchases a covered drug from the retailer is under 18 

13 years of age. Such a system shall be set up to prompt 

14 a retailer to examine a purchaser’s identification card. 

15 ‘‘(b) MEANS USED TO ENSURE COMPLIANCE.—A 

16 verification system under subsection (a) may ensure com17 pliance with this section by any of, or any combination 

18 of, the following means: 

19 ‘‘(1) An electronic point-of-sale system that is 

20 coded— 

21 ‘‘(A) to prompt for verification of the age 

22 of purchasers of covered drugs; and 

23 ‘‘(B) to deny sales of covered drugs to 

24 those under the age of 18. 


kjohnson on DSK79L0C42 with BILLS
4 

•HR 863 IH

1 ‘‘(2) Training manuals, materials, or programs 

2 that instruct employees— 

3 ‘‘(A) to verify the age of purchasers of cov4 ered drugs; and 

5 ‘‘(B) to deny sales of covered drugs to 

6 those under the age of 18. 

7 ‘‘(3) Signage in and around the sales counter 

8 outlining the age restriction on sales of covered 

9 drugs. 

10 ‘‘(4) Designating one on-duty employee to ap11 prove sales of covered drugs. 

12 ‘‘(5) Any other verification measure adopted by 

13 a retailer that is designed to ensure that a purchaser 

14 of a covered drug is not under 18 years of age if, 

15 based on an examination of the purchaser’s identi16 fication card, the retailer reasonably concludes the 

17 identification card is valid and indicates the pur18 chaser is not under 18 years of age. 

19 ‘‘(c) EXCEPTIONS.— 

20 ‘‘(1) INDIVIDUALS OVER 26.—A verification sys21 tem under subsection (a) need not require 

22 verification of the age of any individual over the age 

23 of 26. 

24 ‘‘(2) VALID PRESCRIPTION.—A verification sys25 tem under subsection (a) need not apply to any sale 


kjohnson on DSK79L0C42 with BILLS
5 

•HR 863 IH

1 made by a retailer that is a pharmacy pursuant to 

2 a validly issued prescription. 

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

4 A verification system under subsection (a) need not 

5 apply to any sale to an individual who supplies proof 

6 at the time of such sale that such individual is ac7 tively enrolled in the military and presents a valid 

8 military identification card. 

9 ‘‘(d) ENFORCEMENT.—In carrying out this section, 

10 the Secretary shall coordinate with State entities that reg11 ulate retailers, as designated by the State, to perform ac12 tivities to ensure compliance with this section, including 

13 providing for appropriate investigation of complaints re14 lated to violations of this section. 

15 ‘‘(e) COMPLIANCE WITH STATE SYSTEM.—If a State 

16 has a law under which a retailer in the State is required 

17 to have a system that ensures that no individual who pur18 chases a covered drug from the retailer is under 18 years 

19 of age, the Secretary shall treat any such retailer in the 

20 State that is in compliance with such law as having a 

21 verification system as required by this section, including 

22 for purposes of sections 301(fff) and 303(h). 

23 ‘‘(f) DEFINITIONS.—In this section: 

24 ‘‘(1) The term ‘covered drug’— 

25 ‘‘(A) means a drug that— 


kjohnson on DSK79L0C42 with BILLS
6 

•HR 863 IH

1 ‘‘(i) contains dextromethorphan; and 

2 ‘‘(ii) is not subject to section 

3 503(b)(1); and 

4 ‘‘(B) excludes any drug that is packaged in 

5 packets or pouches and contains 2 or fewer 

6 maximum adult doses of dextromethorphan as 

7 allowable under section 341.74 of title 21, Code 

8 of Federal Regulations (or any successor regu9 lations). 

10 ‘‘(2) The term ‘identification card’ means an 

11 identification card that— 

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

13 birth of the individual; and 

14 ‘‘(B) is issued by a State or the Federal 

15 Government or is considered acceptable for pur16 poses of sections 274a.2(b)(1)(v)(A) and 

17 274a.2(b)(1)(v)(B)(1) of title 8, Code of Fed18 eral Regulations (including any successor regu19 lations). 

20 ‘‘(3) The term ‘retailer’ means— 

21 ‘‘(A) a grocery store, general merchandise 

22 store, drug store, pharmacy, convenience store, 

23 or other entity whose activities as a seller of 

24 covered drugs containing dextromethorphan are 

25 limited almost exclusively to sales for personal 


kjohnson on DSK79L0C42 with BILLS
7 

•HR 863 IH

1 use, both in number and volume of sales, in2 cluding any sales made by the Internet or other 

3 means; and 

4 ‘‘(B) excludes any entity listed in subpara5 graph (A) that does not sell any covered drug 

6 described in paragraph (1)(A).’’. 

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

8 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend9 ed by adding at the end the following: 

10 ‘‘(h) A retailer that violates section 301(fff) shall not 

11 be subject to subsection (a) or any civil monetary penalty 

12 under this Act for such violation except as follows: 

13 ‘‘(1) If the Secretary finds that a retailer fails 

14 to have a verification system in violation of section 

15 301(fff)— 

16 ‘‘(A) upon the first such finding, the Sec17 retary shall issue a formal notice of violation 

18 and give the retailer a period of at least 30 

19 days (beginning on the receipt of such notice) 

20 to correct the violation; 

21 ‘‘(B) upon the second such finding, the re22 tailer shall be subject to a civil penalty of not 

23 more than $1,000; 


kjohnson on DSK79L0C42 with BILLS
8 

•HR 863 IH

1 ‘‘(C) upon the third such finding, the re2 tailer shall be subject to a civil penalty of not 

3 more than $2,000; and 

4 ‘‘(D) upon the fourth and any subsequent 

5 such finding, the retailer shall be subject to a 

6 civil penalty of not more than $5,000. 

7 ‘‘(2) In determining the amount of a civil pen8 alty under this subsection for a retailer, the Sec9 retary shall consider whether the retailer has taken 

10 appropriate steps to prevent subsequent violations, 

11 such as the establishment and administration of a 

12 documented employee training program to ensure all 

13 employees are familiar with, and abiding by, the re14 tailer’s verification system established pursuant to 

15 section 506H, where such program includes— 

16 ‘‘(A) educating employees regarding cov17 ered drugs; 

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

19 checking a purchaser’s identification card; and 

20 ‘‘(C) notifying employees of the civil pen21 alties under this subsection. 

22 ‘‘(3) If a retailer transacts sales of covered 

23 drugs at more than one physical location, for pur24 poses of determining the number of violations by 

25 that retailer under this subsection, each individual 


kjohnson on DSK79L0C42 with BILLS
9 

•HR 863 IH

1 physical location operated by that retailer shall be 

2 considered a separate retailer. 

3 ‘‘(4) The Secretary shall notify retailers found 

4 to have violated section 301(fff) as soon as prac5 ticable after the Secretary discovers such violation. 

6 Such notification shall include the date and time 

7 when the failure to have a verification system as re8 quired by such section was observed to occur. 

9 ‘‘(5) In this subsection, the terms ‘covered 

10 drug’ and ‘retailer’ have the meanings given such 

11 terms in section 506H.’’. 

12 (d) APPLICABILITY.—The amendments made by sub13 sections (a), (b), and (c) shall apply with respect to drugs 

14 sold or offered for sale on or after the date that is one 

15 year after the date of enactment of this Act. 

16 (e) SENSE OF CONGRESS REGARDING COMMUNICA17 TION BY ORGANIZATIONS NOMINATED BY MANUFACTUR18 ERS.—It is the sense of Congress that organizations nomi19 nated by manufacturers of covered drugs (as defined in 

20 section 506H of the Federal Food, Drug, and Cosmetic 

21 Act, as added by subsection (c)) should make reasonable 

22 efforts to communicate to retailers (as defined in such sec23 tion 506H) the requirements of such section 506H, includ24 ing by making available upon request materials (which 

25 may include signage, manuals, materials, or programs) to 


kjohnson on DSK79L0C42 with BILLS
10 

•HR 863 IH

1 assist with educating employees regarding such covered 

2 drugs. 

3 SEC. 3. RESTRICTIONS ON DISTRIBUTION OF BULK DEX4 TROMETHORPHAN. 

5 (a) IN GENERAL.—The Federal Food, Drug, and 

6 Cosmetic Act is amended— 

7 (1) in section 301 (21 U.S.C. 331) (as amended 

8 by section 2(a)) by adding at the end the following: 

9 ‘‘(hhh) The possession, receipt, or distribution of un10 finished dextromethorphan in violation of section 506I.’’; 

11 (2) by inserting after section 506H (as added 

12 by section 2(b)) the following: 

13 ‘‘SEC. 506I. RESTRICTIONS ON THE DISTRIBUTION OF BULK 

14 DEXTROMETHORPHAN. 

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

16 ‘‘(1) possess or receive unfinished dextrome17 thorphan, unless the person is registered under sec18 tion 510 or otherwise registered, licensed, or ap19 proved pursuant to Federal or State law to engage 

20 in— 

21 ‘‘(A) the practice of pharmacy; or 

22 ‘‘(B) drug or drug ingredient discovery, 

23 production, manufacture, or distribution; or 


kjohnson on DSK79L0C42 with BILLS
11 

•HR 863 IH

1 ‘‘(2) distribute unfinished dextromethorphan to 

2 any person other than a person described in para3 graph (1). 

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

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

6 receives, or distributes unfinished dextromethorphan for 

7 purposes of distributing such unfinished dextromethor8 phan between persons described in subsection (a). 

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

10 ‘‘(1) The term ‘common carrier’ means any per11 son that holds itself out to the general public as a 

12 provider for hire of the transportation by water, 

13 land, or air of merchandise, whether or not the per14 son actually operates the vessel, vehicle, or aircraft 

15 by which the transportation is provided, between a 

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

17 States. 

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

19 means dextromethorphan that is not contained in a 

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

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

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

23 ‘‘(i) A person that violates section 301(hhh) shall not 

24 be subject to subsection (a) or any civil monetary penalty 

25 under this Act for such violation except such person shall 


kjohnson on DSK79L0C42 with BILLS
12 

•HR 863 IH

1 be subject to a civil penalty in an amount of not more 

2 than $100,000.’’. 

3 (b) APPLICABILITY.—The amendments made by this 

4 section apply beginning on the date of enactment of this 

5 Act. 

Æ 


kjohnson on DSK79L0C42 with BILLS