text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``DXM Abuse Prevention Act of 2016''.
  
  SEC. 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:
      ``(eee) 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:
  
  ``SEC. 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(eee):
              ``(1) A person who violates section 301(eee) 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 506G, 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(eee) 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(eee), 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(eee). For purposes of this paragraph, a conspiracy 
          shall consist of an agreement between 2 or more persons with 
          the intent to violate section 301(eee) 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.''.
  
  SEC. 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 adding at the end the following:
      ``(k) If it is unfinished dextromethorphan and is possessed, 
  received, or distributed in violation of section 506H.'';
              (2) by inserting after section 506G, as added by section 
          2(b), the following:
  
  ``SEC. 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(c), 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.''.
target: DXM Abuse Prevention Act of 2016 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. 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. 
feat_title: DXM Abuse Prevention Act of 2016