DXM Abuse Prevention Act of 2015

Bill: 114-hr-3250
Sponsor: full_name: Rep. Johnson, Bill [R-OH-6]
Introduced: 2015-07-28
Policy area: Health
Subjects: Child health

Civil actions and liability

Drug safety, medical device, and laboratory regulation

Drug trafficking and controlled substances

Drug, alcohol, tobacco use

Licensing and registrations

Prescription drugs

Retail and wholesale trades
Latest action: action_date: 2016-07-08
text: Placed on the Union Calendar, Calendar No. 520.

Summaries:
action_date: 2015-07-28
action_desc: Introduced in House
text: <p><b>DXM Abuse Prevention Act of 2015</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of a drug containing dextromethorphan (DXM) to an individual under age 18 unless the individual has a prescription or is actively enrolled in the military. Civil monetary penalties that escalate upon repeated violation are imposed.</p> <p> <p>To possess or receive unfinished DXM, a person must be registered with the Department of Health and Human Services as a producer of a drug or medical device or otherwise allowed to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients. Unfinished DXM may be distributed only to these authorized persons. Common carriers distributing unfinished DXM between authorized persons are exempted. Civil monetary penalties are imposed for possession and distribution violations. <p>

action_date: 2016-07-08
action_desc: Reported to House without amendment
text: <p>(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)</p> <p><b>DXM Abuse Prevention Act of 2015</b></p> <p>(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of a drug containing dextromethorphan (DXM, a cough suppressant and drug of abuse) to an individual under age 18 unless the individual has a prescription or is actively enrolled in the military. Retailers selling DXM must implement a verification system to ensure compliance. Civil monetary penalties that escalate upon repeated violation are imposed.</p> <p>(Sec. 3) Unfinished DXM may only be possessed by, distributed to, and received by persons registered with the Food and Drug Administration as producers of a drug or medical device or otherwise allowed to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients. Common carriers distributing unfinished DXM between authorized persons are exempted. Civil monetary penalties are imposed for possession and distribution violations. <p>

tv_txt: I 114th CONGRESS 1st Session H. R. 3250 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. Short title This Act may be cited as the DXM Abuse Prevention Act of 2015 . 2. Sales of over-the-counter drugs containing dextromethorphan (a) Prohibited act Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: (ddd) The failure of a retailer to implement a verification system as required by section 506G (relating to sales of over-the-counter drugs containing dextromethorphan). . (b) Verification system The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506F of such Act ( 21 U.S.C. 356f ) the following: 506G. Sales of over-the-counter drugs containing dextromethorphan (a) Verification system Any retailer selling or offering for sale in interstate commerce dextromethorphan shall implement a verification system to ensure compliance with this section. Such a system may ensure such compliance by means of— (1) an electronic point-of-sale system coded to prompt for verification of the age of all purchasers of drugs described in subsection (b) and deny sales to those under the age of 18; (2) training manuals or materials instructing employees to verify the age of all purchasers of such drugs and deny sales to those under the age of 18; (3) signage in and around the sales counter outlining the age restriction on sales of such drugs; (4) designating one on-duty employee to approve all sales of such drugs; or (5) any other verification measure deemed valid by the Secretary. (b) Prohibition Except as provided in subsection (c), each retailer shall verify that no individual is under 18 years of age who purchases any drug that— (1) contains dextromethorphan; and (2) is not subject to section 503(b)(1). (c) Exceptions (1) Individuals over 26 Subsection (b) does not require verification of the age of any individual over the age of 26. (2) Valid prescription Subsection (b) does not apply to any sale made pursuant to a validly issued prescription. (3) Valid military identification card Subsection (b) does not apply to any sale to an individual under 18 years of age if such individual supplies proof at the time of such sale that such individual is actively enrolled in the military and presents a valid military identification card. (d) Affirmative defense It shall be an affirmative defense to an alleged violation of subsection (b) that the individual selling a drug containing dextromethorphan— (1) examined the purchaser's identification card; and (2) based on that examination, reasonably concluded that the identification was valid and indicated that the purchaser was not less than 18 years of age. (e) Definition In this paragraph, the term identification card means an identification card that— (1) includes a photograph and the date of birth of the individual; and (2) is issued by a State or the Federal Government or is considered acceptable for purposes of sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B)(1) of title 8, Code of Federal Regulations (including any successor regulations). . (c) Civil penalties Section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333 ) is amended by adding at the end the following: (h) Notwithstanding subsection (a), the following provisions shall apply to violations of section 301(ddd): (1) A person who violates section 301(ddd) shall— (A) receive a violation notification from the Secretary for the first such violation; and (B) be subject to a civil penalty in an amount— (i) not more than $1,000 for the second such violation by a person; (ii) not more than $2,000 for the third such violation by a person; and (iii) not more than $5,000 for the fourth such violation, or a subsequent such violation, by a person. (2) In determining the amount of a civil penalty under this subsection for a person who is a retailer, the Secretary shall consider whether the retailer has taken appropriate steps to prevent subsequent violations, such as the establishment and administration of a documented employee training program to ensure all employees are familiar with and abiding by the provisions of section 301(ddd), where such program includes— (A) educating employees regarding products containing dextromethorphan; (B) instruction on the correct method of checking a purchaser’s identification card; and (C) notifying employees of the civil penalties under this subsection. (3) If a person who is a retailer transacts sales of products containing dextromethorphan at more than one physical location, for purposes of determining the number of violations by that person under this subsection, each individual physical location operated by that retailer shall be considered a separate person. (4) The Secretary shall notify persons found to have violated section 301(ddd) as soon as practicable after the Secretary discovers such violation. Such notification shall include the date and time when the violation was observed to occur. (5) Notwithstanding any other provision of this subsection or section 301(ddd), an employee shall not be subject to penalties under this subsection unless such employee knowingly and willfully participates in a conspiracy to violate section 301(ddd). For purposes of this paragraph, a conspiracy shall consist of an agreement between two or more persons with the intent to violate section 301(ddd) and the commission of at least one overt act in furtherance of the agreement. (6) In this subsection— (A) the term employee means an individual who is employed by a retailer in a clerical or other non-managerial position; and (B) the term retailer means a grocery store, general merchandise store, drug store, pharmacy, convenience store, or other entity or person whose activities as a distributor relating to products containing dextromethorphan are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, including any sales made by the Internet or other means. . 3. Restrictions on distribution of bulk dextromethorphan The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 et seq. ) is amended— (1) in section 501, by inserting at the end the following: (k) If it is unfinished dextromethorphan and is possessed, received, or distributed in violation of section 506H. ; and (2) by inserting after section 506F the following: 506H. Restrictions on the distribution of bulk dextromethorphan (a) In general No person shall— (1) possess or receive unfinished dextromethorphan, unless the person is registered under section 510 or otherwise registered, licensed, or approved pursuant to Federal or State law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients; or (2) distribute unfinished dextromethorphan to any person other than a person registered under section 510 or otherwise registered, licensed, or approved pursuant to Federal or State law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients. (b) Exception for common carriers This section does not apply to a common carrier that possesses, receives, or distributes unfinished dextromethorphan for purposes of distributing such unfinished dextromethorphan between persons described in subsection (a) as registered, licensed, or approved. (c) Definitions In this section: (1) The term common carrier means any person that holds itself out to the general public as a provider for hire of the transportation by water, land, or air of merchandise, whether or not the person actually operates the vessel, vehicle, or aircraft by which the transportation is provided, between a port or place and a port or place in the United States. (2) The term unfinished dextromethorphan means dextromethorphan that is not contained in a drug that is in finished dosage form. ; and (3) by amending section 303, as amended by section 2(b), by adding at the end the following: (i) Notwithstanding subsection (a), a person who violates section 506H shall be subject to a civil penalty of not more than $100,000. .

tv_txt: IB Union Calendar No. 520 114th CONGRESS 2d Session H. R. 3250 [Report No. 114–672] 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 A BILL To amend the Federal Food, Drug, and Cosmetic Act to prevent the abuse of dextromethorphan, and for other purposes.

1. Short title This Act may be cited as the DXM Abuse Prevention Act of 2015 . 2. Sales of over-the-counter drugs containing dextromethorphan (a) Prohibited act Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: (ddd) The failure of a retailer to implement a verification system as required by section 506G (relating to sales of over-the-counter drugs containing dextromethorphan). . (b) Verification system The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506F of such Act ( 21 U.S.C. 356f ) the following: 506G. Sales of over-the-counter drugs containing dextromethorphan (a) Verification system Any retailer selling or offering for sale in interstate commerce dextromethorphan shall implement a verification system to ensure compliance with this section. Such a system may ensure such compliance by means of— (1) an electronic point-of-sale system coded to prompt for verification of the age of all purchasers of drugs described in subsection (b) and deny sales to those under the age of 18; (2) training manuals or materials instructing employees to verify the age of all purchasers of such drugs and deny sales to those under the age of 18; (3) signage in and around the sales counter outlining the age restriction on sales of such drugs; (4) designating one on-duty employee to approve all sales of such drugs; or (5) any other verification measure deemed valid by the Secretary. (b) Prohibition Except as provided in subsection (c), each retailer shall verify that no individual is under 18 years of age who purchases any drug that— (1) contains dextromethorphan; and (2) is not subject to section 503(b)(1). (c) Exceptions (1) Individuals over 26 Subsection (b) does not require verification of the age of any individual over the age of 26. (2) Valid prescription Subsection (b) does not apply to any sale made pursuant to a validly issued prescription. (3) Valid military identification card Subsection (b) does not apply to any sale to an individual under 18 years of age if such individual supplies proof at the time of such sale that such individual is actively enrolled in the military and presents a valid military identification card. (d) Affirmative defense It shall be an affirmative defense to an alleged violation of subsection (b) that the individual selling a drug containing dextromethorphan— (1) examined the purchaser's identification card; and (2) based on that examination, reasonably concluded that the identification was valid and indicated that the purchaser was not less than 18 years of age. (e) Definition In this paragraph, the term identification card means an identification card that— (1) includes a photograph and the date of birth of the individual; and (2) is issued by a State or the Federal Government or is considered acceptable for purposes of sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B)(1) of title 8, Code of Federal Regulations (including any successor regulations). . (c) Civil penalties Section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333 ) is amended by adding at the end the following: (h) Notwithstanding subsection (a), the following provisions shall apply to violations of section 301(ddd): (1) A person who violates section 301(ddd) shall— (A) receive a violation notification from the Secretary for the first such violation; and (B) be subject to a civil penalty in an amount— (i) not more than $1,000 for the second such violation by a person; (ii) not more than $2,000 for the third such violation by a person; and (iii) not more than $5,000 for the fourth such violation, or a subsequent such violation, by a person. (2) In determining the amount of a civil penalty under this subsection for a person who is a retailer, the Secretary shall consider whether the retailer has taken appropriate steps to prevent subsequent violations, such as the establishment and administration of a documented employee training program to ensure all employees are familiar with and abiding by the provisions of section 301(ddd), where such program includes— (A) educating employees regarding products containing dextromethorphan; (B) instruction on the correct method of checking a purchaser’s identification card; and (C) notifying employees of the civil penalties under this subsection. (3) If a person who is a retailer transacts sales of products containing dextromethorphan at more than one physical location, for purposes of determining the number of violations by that person under this subsection, each individual physical location operated by that retailer shall be considered a separate person. (4) The Secretary shall notify persons found to have violated section 301(ddd) as soon as practicable after the Secretary discovers such violation. Such notification shall include the date and time when the violation was observed to occur. (5) Notwithstanding any other provision of this subsection or section 301(ddd), an employee shall not be subject to penalties under this subsection unless such employee knowingly and willfully participates in a conspiracy to violate section 301(ddd). For purposes of this paragraph, a conspiracy shall consist of an agreement between two or more persons with the intent to violate section 301(ddd) and the commission of at least one overt act in furtherance of the agreement. (6) In this subsection— (A) the term employee means an individual who is employed by a retailer in a clerical or other non-managerial position; and (B) the term retailer means a grocery store, general merchandise store, drug store, pharmacy, convenience store, or other entity or person whose activities as a distributor relating to products containing dextromethorphan are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, including any sales made by the Internet or other means. . 3. Restrictions on distribution of bulk dextromethorphan The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 et seq. ) is amended— (1) in section 501, by inserting at the end the following: (k) If it is unfinished dextromethorphan and is possessed, received, or distributed in violation of section 506H. ; and (2) by inserting after section 506F the following: 506H. Restrictions on the distribution of bulk dextromethorphan (a) In general No person shall— (1) possess or receive unfinished dextromethorphan, unless the person is registered under section 510 or otherwise registered, licensed, or approved pursuant to Federal or State law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients; or (2) distribute unfinished dextromethorphan to any person other than a person registered under section 510 or otherwise registered, licensed, or approved pursuant to Federal or State law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients. (b) Exception for common carriers This section does not apply to a common carrier that possesses, receives, or distributes unfinished dextromethorphan for purposes of distributing such unfinished dextromethorphan between persons described in subsection (a) as registered, licensed, or approved. (c) Definitions In this section: (1) The term common carrier means any person that holds itself out to the general public as a provider for hire of the transportation by water, land, or air of merchandise, whether or not the person actually operates the vessel, vehicle, or aircraft by which the transportation is provided, between a port or place and a port or place in the United States. (2) The term unfinished dextromethorphan means dextromethorphan that is not contained in a drug that is in finished dosage form. ; and (3) by amending section 303, as amended by section 2(b), by adding at the end the following: (i) Notwithstanding subsection (a), a person who violates section 506H shall be subject to a civil penalty of not more than $100,000. .

July 8, 2016 Committed to the Committee of the Whole House on the State of the Union and ordered to be printed