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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Securing Opioids and 

3 Unused Narcotics with Deliberate Disposal and Packaging 

4 Act of 2018’’ or the ‘‘SOUND Disposal and Packaging 

5 Act’’. 

6 SEC. 2. IMPROVED TECHNOLOGIES, CONTROLS, OR MEAS7 URES WITH RESPECT TO THE PACKAGING OR 

8 DISPOSAL OF CERTAIN DRUGS. 

9 (a) IN GENERAL.—Chapter V of the Federal Food, 

10 Drug, and Cosmetic Act is amended by inserting after sec11 tion 505–1 (21 U.S.C. 355–1) the following new section: 

12 ‘‘SEC. 505–2. SAFETY-ENHANCING PACKAGING AND DIS13 POSAL FEATURES. 

14 ‘‘(a) ORDERS.— 

15 ‘‘(1) IN GENERAL.—The Secretary may issue 

16 an order requiring the holder of a covered applica17 tion to implement or modify one or more tech18 nologies, controls, or measures with respect to the 

19 packaging or disposal of one or more drugs identi20 fied in the covered application, if the Secretary de21 termines such technologies, controls, or measures to 

22 be appropriate to help mitigate the risk of abuse or 

23 misuse of such drug or drugs, which may include by 

24 reducing the availability of unused drugs. 

25 ‘‘(2) PRIOR CONSULTATION.—The Secretary 

26 may not issue an order under paragraph (1) unless 
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1 the Secretary has consulted with relevant stake2 holders, through a public meeting, workshop, or oth3 erwise, about matters that are relevant to the sub4 ject of the order. 

5 ‘‘(3) ASSURING ACCESS AND MINIMIZING BUR6 DEN.—Technologies, controls, or measures required 

7 under paragraph (1) shall— 

8 ‘‘(A) be commensurate with the specific 

9 risk of abuse or misuse of the drug listed in the 

10 covered application; 

11 ‘‘(B) considering such risk, not be unduly 

12 burdensome on patient access to the drug, con13 sidering in particular any available evidence re14 garding the expected or demonstrated public 

15 health impact of such technologies, controls, or 

16 measures; and 

17 ‘‘(C) reduce the risk of abuse or misuse of 

18 such drug. 

19 ‘‘(4) ORDER CONTENTS.—An order issued 

20 under paragraph (1) may— 

21 ‘‘(A) provide for a range of options for im22 plementing or modifying the technologies, con23 trols, or measures required to be implemented 

24 by such order; and 
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1 ‘‘(B) incorporate by reference standards 

2 regarding packaging or disposal set forth in an 

3 official compendium, established by a nationally 

4 or internationally recognized standard develop5 ment organization, or described on the public 

6 website of the Food and Drug Administration, 

7 so long as the order includes the rationale for 

8 incorporation of such standard. 

9 ‘‘(5) ORDERS APPLICABLE TO DRUG CLASS.— 

10 When a concern about the risk of abuse or misuse 

11 of a drug relates to a pharmacological class, the Sec12 retary may, after consultation with relevant stake13 holders, issue an order under paragraph (1) which 

14 applies to the pharmacological class. 

15 ‘‘(b) COMPLIANCE.—The holder of a covered applica16 tion shall— 

17 ‘‘(1) submit a supplement containing proposed 

18 changes to the covered application to comply with an 

19 order issued under subsection (a) not later than— 

20 ‘‘(A) 180 calendar days after the date on 

21 which the order is issued; or 

22 ‘‘(B)(i) such longer time period as speci23 fied by the Secretary in such order; or 

24 ‘‘(ii) if a request for an alternative date is 

25 submitted by the holder of such application not 
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1 later than 60 calendar days after the date on 

2 which such order is issued— 

3 ‘‘(I) such requested alternative date if 

4 agreed to by the Secretary; or 

5 ‘‘(II) another date as specified by the 

6 Secretary; and 

7 ‘‘(2) implement the changes approved pursuant 

8 to such supplement not later than the later of— 

9 ‘‘(A) 90 calendar days after the date on 

10 which the supplement is approved; or 

11 ‘‘(B) the end of such longer period as is— 

12 ‘‘(i) determined to be appropriate by 

13 the Secretary; or 

14 ‘‘(ii) approved by the Secretary pursu15 ant to a request by the holder of the cov16 ered application that explains why such 

17 longer period is needed, including to satisfy 

18 any other applicable Federal statutory or 

19 regulatory requirements. 

20 ‘‘(c) ALTERNATIVE MEASURES.—The holder of the 

21 covered application may propose, and the Secretary shall 

22 approve, technologies, controls, or measures regarding 

23 packaging, storage, or disposal other than those specified 

24 in the applicable order issued under subsection (a), if such 

25 technologies, controls, or measures are supported by data 
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1 and information demonstrating that such alternative tech2 nologies, controls, or measures can be expected to mitigate 

3 the risk of abuse or misuse of the drug or drugs involved, 

4 including by reducing the availability of unused drugs, to 

5 at least the same extent as the technologies, controls, or 

6 measures specified in such order. 

7 ‘‘(d) DISPUTE RESOLUTION.—If a dispute arises in 

8 connection with a supplement submitted under subsection 

9 (b), the holder of the covered application may appeal a 

10 determination made with respect to such supplement using 

11 applicable dispute resolution procedures specified by the 

12 Secretary in regulations or guidance. 

13 ‘‘(e) DEFINITIONS.—In this section— 

14 ‘‘(1) the term ‘covered application’ means an 

15 application submitted under subsection (b) or (j) of 

16 section 505 for approval under such section or an 

17 application submitted under section 351 of Public 

18 Health Service Act for approval under such section, 

19 with respect to a drug that is or contains an opioid 

20 for which a listing in schedule II or III (on a tem21 porary or permanent basis) is in effect under section 

22 202 of the Controlled Substances Act; and 

23 ‘‘(2) the term ‘relevant stakeholders’ may in24 clude scientific experts within the drug manufac25 turing industry; brand and generic drug manufactur-
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1 ers; standard development organizations; wholesalers 

2 and distributors; payers; health care providers; phar3 macists; pharmacies; manufacturers; poison centers; 

4 and representatives of the National Institute on 

5 Drug Abuse, the National Institutes of Health, the 

6 Centers for Disease Control and Prevention, the 

7 Centers for Medicare & Medicaid Services, the Drug 

8 Enforcement Agency, the Consumer Product Safety 

9 Commission, individuals who specialize in treating 

10 addiction, and patient and caregiver groups.’’. 

11 (b) PROHIBITED ACTS.—Section 501 of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend13 ed by inserting after paragraph (j) the following: 

14 ‘‘(k) If it is a drug approved under a covered applica15 tion (as defined in section 505–2(e)), the holder of which 

16 does not meet the requirements of paragraphs (1) and (2) 

17 of subsection (b) of such section.’’. 

18 (c) REQUIRED CONTENT OF AN ABBREVIATED NEW

19 DRUG APPLICATION.—Section 505(j)(2)(A) of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

21 355(j)(2)(A)) is amended— 

22 (1) in clause (vii)(IV), by striking ‘‘and’’ at the 

23 end; 

24 (2) in clause (viii), by striking the period at the 

25 end and inserting ‘‘; and’’; and 
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1 (3) by adding at the end the following: 

2 ‘‘(ix) if the drug is or contains an opioid for 

3 which a listing in schedule II or III (on a temporary 

4 or permanent basis) is in effect under section 202 of 

5 the Controlled Substances Act, information to show 

6 that the applicant has proposed technologies, con7 trols, or measures related to the packaging or dis8 posal of the drug that provide protections com9 parable to those provided by the technologies, con10 trols, or measures required for the applicable listed 

11 drug under section 505–2, if applicable.’’. 

12 (d) GROUNDS FOR REFUSING TO APPROVE AN AB13 BREVIATED NEW DRUG APPLICATION.—Section 505(j)(4) 

14 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 355(j)(4)), is amended— 

16 (1) in subparagraph (J), by striking ‘‘or’’ at the 

17 end; 

18 (2) in subparagraph (K), by striking the period 

19 at the end and inserting ‘‘; or’’; and 

20 (3) by adding at the end the following: 

21 ‘‘(L) if the drug is a drug described in 

22 paragraph (2)(A)(ix) and the applicant has not 

23 proposed technologies, controls, or measures re24 lated to the packaging or disposal of such drug 

25 that the Secretary determines provide protec-
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1 tions comparable to those provided by the tech2 nologies, controls, or measures required for the 

3 applicable listed drug under section 505–2.’’. 

4 (e) RULES OF CONSTRUCTION.— 

5 (1) Any labeling describing technologies, con6 trols, or measures related to packaging or disposal 

7 intended to mitigate the risk of abuse or misuse of 

8 a drug product that is subject to an abbreviated new 

9 drug application, including labeling describing dif10 ferences from the reference listed drug resulting 

11 from the application of section 505–2 of the Federal 

12 Food, Drug, and Cosmetic Act, as added by sub13 section (a), shall not be construed— 

14 (A) as changes to labeling not permissible 

15 under clause (v) of section 505(j)(2)(A) of such 

16 Act (21 U.S.C. 355(j)(2)(A)), or a change in 

17 the conditions of use prescribed, recommended, 

18 or suggested in the labeling proposed for the 

19 new drug under clause (i) of such section; or 

20 (B) to preclude approval of an abbreviated 

21 new drug application under subparagraph (B) 

22 or (G) of section 505(j)(4) of such Act (21 

23 U.S.C. 355(j)(4)). 

24 (2) For a covered application that is an applica25 tion submitted under subsection (j) of section 505 of 
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1 the Federal Food, Drug, and Cosmetic Act (21 

2 U.S.C. 355), subsection (j)(2)(A) of such section 

3 505 shall not be construed to limit the type of data 

4 or information the Secretary of Health and Human 

5 Services may request or consider in connection with 

6 making any determination under section 505–2. 

7 (f) GAO REPORT.—Not later than 12 months after 

8 the date of enactment of this Act, the Comptroller General 

9 of the United States shall prepare and submit to the Con10 gress a report containing— 

11 (1) a description of available evidence, if any, 

12 on the effectiveness of site-of-use, in-home controlled 

13 substance disposal products and packaging tech14 nologies; 

15 (2) identification of ways in which such disposal 

16 products intended for use by patients, consumers, 

17 and other end users that are not registrants under 

18 the Controlled Substances Act, are made available to 

19 the public and barriers to the use of such disposal 

20 products; 

21 (3) identification of ways in which packaging 

22 technologies are made available to the public and 

23 barriers to the use of such technologies; 
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1 (4) a description of Federal oversight, if any, of 

2 site-of-use, in-home controlled substance disposal 

3 products, including— 

4 (A) identification of the Federal agencies 

5 that oversee such products; 

6 (B) identification of the methods of dis7 posal of controlled substances recommended by 

8 these agencies for site-of-use, in-home disposal; 

9 and 

10 (C) a description of the effectiveness of 

11 such recommendations at preventing the diver12 sion of legally prescribed controlled substances; 

13 (5) a description of Federal oversight, if any, of 

14 controlled substance packaging technologies, includ15 ing— 

16 (A) identification of the Federal agencies 

17 that oversee such technologies; 

18 (B) identification of the technologies rec19 ommended by these agencies, including unit 

20 dose packaging, packaging that provides a set 

21 duration, or other packaging systems that may 

22 mitigate abuse or misuse; and 

23 (C) a description of the effectiveness of 

24 such recommendations at preventing the diver-
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1 sion of legally prescribed controlled substances; 

2 and 

3 (6) recommendations on— 

4 (A) whether site-of-use, in-home controlled 

5 substance disposal products and packaging 

6 technologies require Federal oversight and, if 

7 so, which agencies should be responsible for 

8 such oversight and, as applicable, approval of 

9 such products or technologies; and 

10 (B) the potential role of the Federal Gov11 ernment in evaluating such products to ensure 

12 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 

other purposes. methods with respect to certain drugs, and for Act to require improved packaging and disposal