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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5687 Engrossed in House (EH)]

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115th CONGRESS
  2d Session
                                H. R. 5687

_______________________________________________________________________

                                 AN ACT

 
 To amend the Federal Food, Drug, and Cosmetic Act to require improved 
 packaging and disposal methods with respect to certain drugs, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

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:

                                                                 Clerk.
115th CONGRESS

  2d Session

                               H. R. 5687

_______________________________________________________________________

                                 AN ACT

 To amend the Federal Food, Drug, and Cosmetic Act to require improved 
 packaging and disposal methods with respect to certain drugs, and for 
                            other purposes.
```