DXM Abuse Prevention Act of 2019

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘DXM Abuse Preven- 4 tion Act of 2019’’. 5 SEC. 2. SALES OF OVER-THE-COUNTER DRUGS CONTAINING 6 DEXTROMETHORPHAN. 7 (a) PROHIBITED ACTS.— 8 VerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H863.IH H863 kjohnson on DSK79L0C42 with BILLS 2 •HR 863 IH (1) VERIFICATION SYSTEM.—Section 301 of the 1 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 2 331) is amended by adding at the end the following: 3 ‘‘(fff) The failure of a retailer (as defined in section 4 506H) that offers for sale in interstate commerce covered 5 drugs (as defined in section 506H) to have a verification 6 system as required by section 506H (relating to sales of 7 over-the-counter drugs containing dextromethorphan).’’. 8 (2) IDENTIFIER FOR ELECTRONIC POINT OF 9 SALE SYSTEM; ACTIVE INGREDIENTS.—Section 301 10 of the Federal Food, Drug, and Cosmetic Act (21 11 U.S.C. 331), as amended by paragraph (1), is fur- 12 ther amended by adding at the end the following: 13 ‘‘(ggg) The introduction or delivery for introduction 14 into interstate commerce of any covered drug (as defined 15 in section 506H) whose labeling does not include— 16 ‘‘(1) a universal product code, universal product 17 number, bar code, or similar identifier to allow an 18 electronic point of sale system to recognize that the 19 sale of the covered drug is prohibited to those under 20 the age of 18; and 21 ‘‘(2) the established name of each active ingre- 22 dient of the covered drug within the first panel of 23 the drug facts labeling required by section 201.66(c) 24 of title 21, Code of Federal Regulations (or any suc- 25 VerDate 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 cessor regulations), in no smaller than 6-point 1 type.’’. 2 (b) VERIFICATION SYSTEM.—The Federal Food, 3 Drug, and Cosmetic Act is amended by inserting after sec- 4 tion 506G of such Act (21 U.S.C. 356g) the following: 5 ‘‘SEC. 506H. SALES OF OVER-THE-COUNTER DRUGS CON- 6 TAINING DEXTROMETHORPHAN. 7 ‘‘(a) VERIFICATION SYSTEM.—Any retailer selling or 8 offering for sale in interstate commerce a covered drug 9 shall have a verification system in accordance with this 10 section that is intended to ensure that no individual who 11 purchases a covered drug from the retailer is under 18 12 years of age. Such a system shall be set up to prompt 13 a retailer to examine a purchaser’s identification card. 14 ‘‘(b) MEANS USED TO ENSURE COMPLIANCE.—A 15 verification system under subsection (a) may ensure com- 16 pliance with this section by any of, or any combination 17 of, the following means: 18 ‘‘(1) An electronic point-of-sale system that is 19 coded— 20 ‘‘(A) to prompt for verification of the age 21 of purchasers of covered drugs; and 22 ‘‘(B) to deny sales of covered drugs to 23 those under the age of 18. 24 VerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H863.IH H863 kjohnson on DSK79L0C42 with BILLS 4 •HR 863 IH ‘‘(2) Training manuals, materials, or programs 1 that instruct employees— 2 ‘‘(A) to verify the age of purchasers of cov- 3 ered drugs; and 4 ‘‘(B) to deny sales of covered drugs to 5 those under the age of 18. 6 ‘‘(3) Signage in and around the sales counter 7 outlining the age restriction on sales of covered 8 drugs. 9 ‘‘(4) Designating one on-duty employee to ap- 10 prove sales of covered drugs. 11 ‘‘(5) Any other verification measure adopted by 12 a retailer that is designed to ensure that a purchaser 13 of a covered drug is not under 18 years of age if, 14 based on an examination of the purchaser’s identi- 15 fication card, the retailer reasonably concludes the 16 identification card is valid and indicates the pur- 17 chaser is not under 18 years of age. 18 ‘‘(c) EXCEPTIONS.— 19 ‘‘(1) INDIVIDUALS OVER 26.—A verification sys- 20 tem under subsection (a) need not require 21 verification of the age of any individual over the age 22 of 26. 23 ‘‘(2) VALID PRESCRIPTION.—A verification sys- 24 tem under subsection (a) need not apply to any sale 25 VerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H863.IH H863 kjohnson on DSK79L0C42 with BILLS 5 •HR 863 IH made by a retailer that is a pharmacy pursuant to 1 a validly issued prescription. 2 ‘‘(3) VALID MILITARY IDENTIFICATION CARD.— 3 A verification system under subsection (a) need not 4 apply to any sale to an individual who supplies proof 5 at the time of such sale that such individual is ac- 6 tively enrolled in the military and presents a valid 7 military identification card. 8 ‘‘(d) ENFORCEMENT.—In carrying out this section, 9 the Secretary shall coordinate with State entities that reg- 10 ulate retailers, as designated by the State, to perform ac- 11 tivities to ensure compliance with this section, including 12 providing for appropriate investigation of complaints re- 13 lated to violations of this section. 14 ‘‘(e) COMPLIANCE WITH STATE SYSTEM.—If a State 15 has a law under which a retailer in the State is required 16 to have a system that ensures that no individual who pur- 17 chases a covered drug from the retailer is under 18 years 18 of age, the Secretary shall treat any such retailer in the 19 State that is in compliance with such law as having a 20 verification system as required by this section, including 21 for purposes of sections 301(fff) and 303(h). 22 ‘‘(f) DEFINITIONS.—In this section: 23 ‘‘(1) The term ‘covered drug’— 24 ‘‘(A) means a drug that— 25 VerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H863.IH H863 kjohnson on DSK79L0C42 with BILLS 6 •HR 863 IH ‘‘(i) contains dextromethorphan; and 1 ‘‘(ii) is not subject to section 2 503(b)(1); and 3 ‘‘(B) excludes any drug that is packaged in 4 packets or pouches and contains 2 or fewer 5 maximum adult doses of dextromethorphan as 6 allowable under section 341.74 of title 21, Code 7 of Federal Regulations (or any successor regu- 8 lations). 9 ‘‘(2) The term ‘identification card’ means an 10 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 14 Government or is considered acceptable for pur- 15 poses of sections 274a.2(b)(1)(v)(A) and 16 274a.2(b)(1)(v)(B)(1) of title 8, Code of Fed- 17 eral Regulations (including any successor regu- 18 lations). 19 ‘‘(3) The term ‘retailer’ means— 20 ‘‘(A) a grocery store, general merchandise 21 store, drug store, pharmacy, convenience store, 22 or other entity whose activities as a seller of 23 covered drugs containing dextromethorphan are 24 limited almost exclusively to sales for personal 25 VerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H863.IH H863 kjohnson on DSK79L0C42 with BILLS 7 •HR 863 IH use, both in number and volume of sales, in- 1 cluding any sales made by the Internet or other 2 means; and 3 ‘‘(B) excludes any entity listed in subpara- 4 graph (A) that does not sell any covered drug 5 described in paragraph (1)(A).’’. 6 (c) CIVIL PENALTIES.—Section 303 of the Federal 7 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend- 8 ed by adding at the end the following: 9 ‘‘(h) A retailer that violates section 301(fff) shall not 10 be subject to subsection (a) or any civil monetary penalty 11 under this Act for such violation except as follows: 12 ‘‘(1) If the Secretary finds that a retailer fails 13 to have a verification system in violation of section 14 301(fff)— 15 ‘‘(A) upon the first such finding, the Sec- 16 retary shall issue a formal notice of violation 17 and give the retailer a period of at least 30 18 days (beginning on the receipt of such notice) 19 to correct the violation; 20 ‘‘(B) upon the second such finding, the re- 21 tailer shall be subject to a civil penalty of not 22 more than $1,000; 23 VerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H863.IH H863 kjohnson on DSK79L0C42 with BILLS 8 •HR 863 IH ‘‘(C) upon the third such finding, the re- 1 tailer shall be subject to a civil penalty of not 2 more than $2,000; and 3 ‘‘(D) upon the fourth and any subsequent 4 such finding, the retailer shall be subject to a 5 civil penalty of not more than $5,000. 6 ‘‘(2) In determining the amount of a civil pen- 7 alty under this subsection for a retailer, the Sec- 8 retary shall consider whether the retailer has taken 9 appropriate steps to prevent subsequent violations, 10 such as the establishment and administration of a 11 documented employee training program to ensure all 12 employees are familiar with, and abiding by, the re- 13 tailer’s verification system established pursuant to 14 section 506H, where such program includes— 15 ‘‘(A) educating employees regarding cov- 16 ered drugs; 17 ‘‘(B) instruction on the correct method of 18 checking a purchaser’s identification card; and 19 ‘‘(C) notifying employees of the civil pen- 20 alties under this subsection. 21 ‘‘(3) If a retailer transacts sales of covered 22 drugs at more than one physical location, for pur- 23 poses of determining the number of violations by 24 that retailer under this subsection, each individual 25 VerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H863.IH H863 kjohnson on DSK79L0C42 with BILLS 9 •HR 863 IH physical location operated by that retailer shall be 1 considered a separate retailer. 2 ‘‘(4) The Secretary shall notify retailers found 3 to have violated section 301(fff) as soon as prac- 4 ticable after the Secretary discovers such violation. 5 Such notification shall include the date and time 6 when the failure to have a verification system as re- 7 quired by such section was observed to occur. 8 ‘‘(5) In this subsection, the terms ‘covered 9 drug’ and ‘retailer’ have the meanings given such 10 terms in section 506H.’’. 11 (d) APPLICABILITY.—The amendments made by sub- 12 sections (a), (b), and (c) shall apply with respect to drugs 13 sold or offered for sale on or after the date that is one 14 year after the date of enactment of this Act. 15 (e) SENSE OF CONGRESS REGARDING COMMUNICA- 16 TION BY ORGANIZATIONS NOMINATED BY MANUFACTUR- 17 ERS.—It is the sense of Congress that organizations nomi- 18 nated by manufacturers of covered drugs (as defined in 19 section 506H of the Federal Food, Drug, and Cosmetic 20 Act, as added by subsection (c)) should make reasonable 21 efforts to communicate to retailers (as defined in such sec- 22 tion 506H) the requirements of such section 506H, includ- 23 ing by making available upon request materials (which 24 may include signage, manuals, materials, or programs) to 25 VerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H863.IH H863 kjohnson on DSK79L0C42 with BILLS 10 •HR 863 IH assist with educating employees regarding such covered 1 drugs. 2 SEC. 3. RESTRICTIONS ON DISTRIBUTION OF BULK DEX- 3 TROMETHORPHAN. 4 (a) IN GENERAL.—The Federal Food, Drug, and 5 Cosmetic Act is amended— 6 (1) in section 301 (21 U.S.C. 331) (as amended 7 by section 2(a)) by adding at the end the following: 8 ‘‘(hhh) The possession, receipt, or distribution of un- 9 finished dextromethorphan in violation of section 506I.’’; 10 (2) by inserting after section 506H (as added 11 by section 2(b)) the following: 12 ‘‘SEC. 506I. RESTRICTIONS ON THE DISTRIBUTION OF BULK 13 DEXTROMETHORPHAN. 14 ‘‘(a) IN GENERAL.—No person shall— 15 ‘‘(1) possess or receive unfinished dextrome- 16 thorphan, unless the person is registered under sec- 17 tion 510 or otherwise registered, licensed, or ap- 18 proved pursuant to Federal or State law to engage 19 in— 20 ‘‘(A) the practice of pharmacy; or 21 ‘‘(B) drug or drug ingredient discovery, 22 production, manufacture, or distribution; or 23 VerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H863.IH H863 kjohnson on DSK79L0C42 with BILLS 11 •HR 863 IH ‘‘(2) distribute unfinished dextromethorphan to 1 any person other than a person described in para- 2 graph (1). 3 ‘‘(b) EXCEPTION FOR COMMON CARRIERS.—This 4 section does not apply to a common carrier that possesses, 5 receives, or distributes unfinished dextromethorphan for 6 purposes of distributing such unfinished dextromethor- 7 phan between persons described in subsection (a). 8 ‘‘(c) DEFINITIONS.—In this section: 9 ‘‘(1) The term ‘common carrier’ means any per- 10 son that holds itself out to the general public as a 11 provider for hire of the transportation by water, 12 land, or air of merchandise, whether or not the per- 13 son actually operates the vessel, vehicle, or aircraft 14 by which the transportation is provided, between a 15 port or place and a port or place in the United 16 States. 17 ‘‘(2) The term ‘unfinished dextromethorphan’ 18 means dextromethorphan that is not contained in a 19 drug that is in finished dosage form.’’; and 20 (3) by amending section 303, as amended by 21 section 2(c), by adding at the end the following: 22 ‘‘(i) A person that violates section 301(hhh) shall not 23 be subject to subsection (a) or any civil monetary penalty 24 under this Act for such violation except such person shall 25 VerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H863.IH H863 kjohnson on DSK79L0C42 with BILLS 12 •HR 863 IH be subject to a civil penalty in an amount of not more 1 than $100,000.’’. 2 (b) APPLICABILITY.—The amendments made by this 3 section apply beginning on the date of enactment of this 4 Act. 5 Æ VerDate Sep 11 2014 03:06 Feb 08, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6301 E:\BILLS\H863.IH H863 kjohnson on DSK79L0C42 with BILLS