S.644 - PACT Act
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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SECTION 1. SHORT TITLE.
SEC. 2. SALES OF OVER-THE-COUNTER DRUGS CONTAINING DEXTROMETHORPHAN.
‘(ccc)(1)(A) Except as provided in subparagraph (2), the sale or offering for sale of a drug containing dextromethorphan to an individual under 18 years of age, including any such sale using the Internet, provided the drug is not subject to section 503(b)(1).CommentsClose CommentsPermalink
‘(B) If a person fails to request identification from an individual under 18 years of age and sells a product containing dextromethorphan to that individual, that person shall be deemed to have known that the individual was under 18 years of age, unless from the individual’s outward appearance the person making the sale would reasonably presume the individual to be 25 years of age or older.CommentsClose CommentsPermalink
‘(C) It shall be an affirmative defense to an alleged violation of clause (A) that the person selling a product containing dextromethorphan examined the purchaser’s identification card and, based on that examination, that person reasonably concluded that the identification was valid and indicated that the purchaser was not less than 18 years of age.CommentsClose CommentsPermalink
‘(B) This paragraph shall not apply to the sale or offering for sale of a drug containing dextromethorphan 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.CommentsClose CommentsPermalink
‘(B) 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 (as in effect on or after the date of the enactment of the Preventing Abuse of Cough Treatments Act of 2013).’.CommentsClose CommentsPermalink
‘(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(ccc), where such program includes--CommentsClose CommentsPermalink
‘(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.CommentsClose CommentsPermalink
‘(4) The Secretary shall notify persons found to have violated section 301(ccc) as soon as practicable after the Secretary discovers such violation. Such notification shall include details of the violation, such as--CommentsClose CommentsPermalink
‘(5) Notwithstanding any other provision of this subsection or section 301(ccc), 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(ccc). For purposes of this paragraph, a conspiracy shall consist of an agreement between two or more persons with the intent to violate section 301(ccc) and the commission of at least one overt act in furtherance of the agreement.CommentsClose CommentsPermalink
‘(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, either directly to walk-in customers or in face-to-face transactions by direct sales.’.CommentsClose CommentsPermalink
SEC. 3. RESTRICTIONS ON DISTRIBUTION OF BULK DEXTROMETHORPHAN.
‘SEC. 506G. RESTRICTIONS ON THE DISTRIBUTION OF BULK DEXTROMETHORPHAN.
‘(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; orCommentsClose CommentsPermalink
‘(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.CommentsClose CommentsPermalink
‘(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.CommentsClose CommentsPermalink
‘(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.CommentsClose CommentsPermalink