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Code · BILL · 114th Congress · H.R. 3250 (Introduced in House) — To amend the Federal Food, Drug, and Cosmetic Act to prevent the abuse of dextromethorphan, and for other purposes. · Sec. 2

Sec. 2. Sales of over-the-counter drugs containing dextromethorphan

850 words·~4 min read·/bill/114/hr/3250/ih/section-2

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Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: 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). . The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506F of such Act ( 21 U.S.C. 356f ) the following: 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— 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; 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; signage in and around the sales counter outlining the age restriction on sales of such drugs; designating one on-duty employee to approve all sales of such drugs; or any other verification measure deemed valid by the Secretary. Except as provided in subsection (c), each retailer shall verify that no individual is under 18 years of age who purchases any drug that— contains dextromethorphan; and is not subject to section 503(b)(1). Subsection
(b)does not require verification of the age of any individual over the age of 26. Subsection
(b)does not apply to any sale made pursuant to a validly issued prescription. 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. It shall be an affirmative defense to an alleged violation of subsection
(b)that the individual selling a drug containing dextromethorphan— examined the purchaser's identification card; and based on that examination, reasonably concluded that the identification was valid and indicated that the purchaser was not less than 18 years of age. In this paragraph, the term identification card means an identification card that— includes a photograph and the date of birth of the individual; and 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). . Section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333 ) is amended by adding at the end the following: Notwithstanding subsection (a), the following provisions shall apply to violations of section 301(ddd): A person who violates section 301(ddd) shall— receive a violation notification from the Secretary for the first such violation; and be subject to a civil penalty in an amount— not more than $1,000 for the second such violation by a person; not more than $2,000 for the third such violation by a person; and not more than $5,000 for the fourth such violation, or a subsequent such violation, by a person. 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— educating employees regarding products containing dextromethorphan; instruction on the correct method of checking a purchaser’s identification card; and notifying employees of the civil penalties under this subsection. 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. 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. 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. In this subsection— the term employee means an individual who is employed by a retailer in a clerical or other non-managerial position; and 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. .
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Sec. 2
Sales of over-the-counter drugs containing dextromethorphan
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