text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Securing Opioids and Unused 
  Narcotics with Deliberate Disposal and Packaging Act of 2018'' or the 
  ``SOUND Disposal and Packaging Act''.
  
  SEC. 2. IMPROVED TECHNOLOGIES, CONTROLS, OR MEASURES WITH RESPECT TO 
                THE PACKAGING OR DISPOSAL OF CERTAIN DRUGS.
  
      (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
  Act is amended by inserting after section 505-1 (21 U.S.C. 355-1) the 
  following new section:
  
  ``SEC. 505-2. SAFETY-ENHANCING PACKAGING AND DISPOSAL FEATURES.
  
      ``(a) Orders.--
              ``(1) In general.--The Secretary may issue an order 
          requiring the holder of a covered application to implement or 
          modify one or more technologies, controls, or measures with 
          respect to the packaging or disposal of one or more drugs 
          identified in the covered application, if the Secretary 
          determines such technologies, controls, or measures to be 
          appropriate to help mitigate the risk of abuse or misuse of 
          such drug or drugs, which may include by reducing the 
          availability of unused drugs.
              ``(2) Prior consultation.--The Secretary may not issue an 
          order under paragraph (1) unless the Secretary has consulted 
          with relevant stakeholders, through a public meeting, workshop, 
          or otherwise, about matters that are relevant to the subject of 
          the order.
              ``(3) Assuring access and minimizing burden.--Technologies, 
          controls, or measures required under paragraph (1) shall--
                      ``(A) be commensurate with the specific risk of 
                  abuse or misuse of the drug listed in the covered 
                  application;
                      ``(B) considering such risk, not be unduly 
                  burdensome on patient access to the drug, considering 
                  in particular any available evidence regarding the 
                  expected or demonstrated public health impact of such 
                  technologies, controls, or measures; and
                      ``(C) reduce the risk of abuse or misuse of such 
                  drug.
              ``(4) Order contents.--An order issued under paragraph (1) 
          may--
                      ``(A) provide for a range of options for 
                  implementing or modifying the technologies, controls, 
                  or measures required to be implemented by such order; 
                  and
                      ``(B) incorporate by reference standards regarding 
                  packaging or disposal set forth in an official 
                  compendium, established by a nationally or 
                  internationally recognized standard development 
                  organization, or described on the public website of the 
                  Food and Drug Administration, so long as the order 
                  includes the rationale for incorporation of such 
                  standard.
              ``(5) Orders applicable to drug class.--When a concern 
          about the risk of abuse or misuse of a drug relates to a 
          pharmacological class, the Secretary may, after consultation 
          with relevant stakeholders, issue an order under paragraph (1) 
          which applies to the pharmacological class.
      ``(b) Compliance.--The holder of a covered application shall--
              ``(1) submit a supplement containing proposed changes to 
          the covered application to comply with an order issued under 
          subsection (a) not later than--
                      ``(A) 180 calendar days after the date on which the 
                  order is issued; or
                      ``(B)(i) such longer time period as specified by 
                  the Secretary in such order; or
                      ``(ii) if a request for an alternative date is 
                  submitted by the holder of such application not later 
                  than 60 calendar days after the date on which such 
                  order is issued--
                              ``(I) such requested alternative date if 
                          agreed to by the Secretary; or
                              ``(II) another date as specified by the 
                          Secretary; and
              ``(2) implement the changes approved pursuant to such 
          supplement not later than the later of--
                      ``(A) 90 calendar days after the date on which the 
                  supplement is approved; or
                      ``(B) the end of such longer period as is--
                              ``(i) determined to be appropriate by the 
                          Secretary; or
                              ``(ii) approved by the Secretary pursuant 
                          to a request by the holder of the covered 
                          application that explains why such longer 
                          period is needed, including to satisfy any 
                          other applicable Federal statutory or 
                          regulatory requirements.
      ``(c) Alternative Measures.--The holder of the covered application 
  may propose, and the Secretary shall approve, technologies, controls, 
  or measures regarding packaging, storage, or disposal other than those 
  specified in the applicable order issued under subsection (a), if such 
  technologies, controls, or measures are supported by data and 
  information demonstrating that such alternative technologies, controls, 
  or measures can be expected to mitigate the risk of abuse or misuse of 
  the drug or drugs involved, including by reducing the availability of 
  unused drugs, to at least the same extent as the technologies, 
  controls, or measures specified in such order.
      ``(d) Dispute Resolution.--If a dispute arises in connection with a 
  supplement submitted under subsection (b), the holder of the covered 
  application may appeal a determination made with respect to such 
  supplement using applicable dispute resolution procedures specified by 
  the Secretary in regulations or guidance.
      ``(e) Definitions.--In this section--
              ``(1) the term `covered application' means an application 
          submitted under subsection (b) or (j) of section 505 for 
          approval under such section or an application submitted under 
          section 351 of Public Health Service Act for approval under 
          such section, with respect to a drug that is or contains an 
          opioid for which a listing in schedule II or III (on a 
          temporary or permanent basis) is in effect under section 202 of 
          the Controlled Substances Act; and
              ``(2) the term `relevant stakeholders' may include 
          scientific experts within the drug manufacturing industry; 
          brand and generic drug manufacturers; standard development 
          organizations; wholesalers and distributors; payers; health 
          care providers; pharmacists; pharmacies; manufacturers; poison 
          centers; and representatives of the National Institute on Drug 
          Abuse, the National Institutes of Health, the Centers for 
          Disease Control and Prevention, the Centers for Medicare & 
          Medicaid Services, the Drug Enforcement Agency, the Consumer 
          Product Safety Commission, individuals who specialize in 
          treating addiction, and patient and caregiver groups.''.
      (b) Prohibited Acts.--Section 501 of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph 
  (j) the following:
      ``(k) If it is a drug approved under a covered application (as 
  defined in section 505-2(e)), the holder of which does not meet the 
  requirements of paragraphs (1) and (2) of subsection (b) of such 
  section.''.
      (c) Required Content of an Abbreviated New Drug Application.--
  Section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 
  U.S.C. 355(j)(2)(A)) is amended--
              (1) in clause (vii)(IV), by striking ``and'' at the end;
              (2) in clause (viii), by striking the period at the end and 
          inserting ``; and''; and
              (3) by adding at the end the following:
              ``(ix) if the drug is or contains an opioid for which a 
          listing in schedule II or III (on a temporary or permanent 
          basis) is in effect under section 202 of the Controlled 
          Substances Act, information to show that the applicant has 
          proposed technologies, controls, or measures related to the 
          packaging or disposal of the drug that provide protections 
          comparable to those provided by the technologies, controls, or 
          measures required for the applicable listed drug under section 
          505-2, if applicable.''.
      (d) Grounds for Refusing to Approve an Abbreviated New Drug 
  Application.--Section 505(j)(4) of the Federal Food, Drug, and Cosmetic 
  Act (21 U.S.C. 355(j)(4)), is amended--
              (1) in subparagraph (J), by striking ``or'' at the end;
              (2) in subparagraph (K), by striking the period at the end 
          and inserting ``; or''; and
              (3) by adding at the end the following:
                      ``(L) if the drug is a drug described in paragraph 
                  (2)(A)(ix) and the applicant has not proposed 
                  technologies, controls, or measures related to the 
                  packaging or disposal of such drug that the Secretary 
                  determines provide protections comparable to those 
                  provided by the technologies, controls, or measures 
                  required for the applicable listed drug under section 
                  505-2.''.
      (e) Rules of Construction.--
              (1) Any labeling describing technologies, controls, or 
          measures related to packaging or disposal intended to mitigate 
          the risk of abuse or misuse of a drug product that is subject 
          to an abbreviated new drug application, including labeling 
          describing differences from the reference listed drug resulting 
          from the application of section 505-2 of the Federal Food, 
          Drug, and Cosmetic Act, as added by subsection (a), shall not 
          be construed--
                      (A) as changes to labeling not permissible under 
                  clause (v) of section 505(j)(2)(A) of such Act (21 
                  U.S.C. 355(j)(2)(A)), or a change in the conditions of 
                  use prescribed, recommended, or suggested in the 
                  labeling proposed for the new drug under clause (i) of 
                  such section; or
                      (B) to preclude approval of an abbreviated new drug 
                  application under subparagraph (B) or (G) of section 
                  505(j)(4) of such Act (21 U.S.C. 355(j)(4)).
              (2) For a covered application that is an application 
          submitted under subsection (j) of section 505 of the Federal 
          Food, Drug, and Cosmetic Act (21 U.S.C. 355), subsection 
          (j)(2)(A) of such section 505 shall not be construed to limit 
          the type of data or information the Secretary of Health and 
          Human Services may request or consider in connection with 
          making any determination under section 505-2.
      (f) GAO Report.--Not later than 12 months after the date of 
  enactment of this Act, the Comptroller General of the United States 
  shall prepare and submit to the Congress a report containing--
              (1) a description of available evidence, if any, on the 
          effectiveness of site-of-use, in-home controlled substance 
          disposal products and packaging technologies;
              (2) identification of ways in which such disposal products 
          intended for use by patients, consumers, and other end users 
          that are not registrants under the Controlled Substances Act, 
          are made available to the public and barriers to the use of 
          such disposal products;
              (3) identification of ways in which packaging technologies 
          are made available to the public and barriers to the use of 
          such technologies;
              (4) a description of Federal oversight, if any, of site-of-
          use, in-home controlled substance disposal products, 
          including--
                      (A) identification of the Federal agencies that 
                  oversee such products;
                      (B) identification of the methods of disposal of 
                  controlled substances recommended by these agencies for 
                  site-of-use, in-home disposal; and
                      (C) a description of the effectiveness of such 
                  recommendations at preventing the diversion of legally 
                  prescribed controlled substances;
              (5) a description of Federal oversight, if any, of 
          controlled substance packaging technologies, including--
                      (A) identification of the Federal agencies that 
                  oversee such technologies;
                      (B) identification of the technologies recommended 
                  by these agencies, including unit dose packaging, 
                  packaging that provides a set duration, or other 
                  packaging systems that may mitigate abuse or misuse; 
                  and
                      (C) a description of the effectiveness of such 
                  recommendations at preventing the diversion of legally 
                  prescribed controlled substances; and
              (6) recommendations on--
                      (A) whether site-of-use, in-home controlled 
                  substance disposal products and packaging technologies 
                  require Federal oversight and, if so, which agencies 
                  should be responsible for such oversight and, as 
                  applicable, approval of such products or technologies; 
                  and
                      (B) the potential role of the Federal Government in 
                  evaluating such products to ensure product efficacy.
  
              Passed the House of Representatives June 19, 2018.
  
              Attest:
  
                                                   KAREN L. HAAS,
  
                                                                   Clerk.
target: Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018 or the SOUND Disposal and Packaging Act This bill amends the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration to require certain packaging and disposal technologies, controls, or measures to mitigate the risk of abuse or misuse of a drug or a class of drugs.
feat_title: Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018