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 MEAS-
URES 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 sec-
tion 505–1 (21 U.S.C. 355–1) the following new section: 
‘‘SEC. 505–2. SAFETY-ENHANCING PACKAGING AND DIS-
POSAL FEATURES. 
‘‘(a) ORDERS.— 
‘‘(1) IN GENERAL.—The Secretary may issue 
an order requiring the holder of a covered applica-
tion to implement or modify one or more tech-
nologies, controls, or measures with respect to the 
packaging or disposal of one or more drugs identi-
fied in the covered application, if the Secretary de-
termines 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 stake-
holders, through a public meeting, workshop, or oth-
erwise, about matters that are relevant to the sub-
ject of the order. 
‘‘(3) ASSURING ACCESS AND MINIMIZING BUR-
DEN.—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, con-
sidering in particular any available evidence re-
garding 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 im-
plementing or modifying the technologies, con-
trols, 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 develop-
ment 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 Sec-
retary may, after consultation with relevant stake-
holders, issue an order under paragraph (1) which 
applies to the pharmacological class. 
‘‘(b) COMPLIANCE.—The holder of a covered applica-
tion 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 speci-
fied 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 pursu-
ant to a request by the holder of the cov-
ered 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 tech-
nologies, 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 tem-
porary or permanent basis) is in effect under section 
202 of the Controlled Substances Act; and 
‘‘(2) the term ‘relevant stakeholders’ may in-
clude scientific experts within the drug manufac-
turing industry; brand and generic drug manufactur-