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, after 
consultation with relevant stakeholders, issue an 
order requiring the holder of a covered application to 
implement or modify one or more technologies, con-
trols, or measures with respect to the packaging or 
disposal of one or more drugs identified in the cov-
ered 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, including by reducing the availability 
of unused drugs. 
‘‘(2) 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; 
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‘‘(B) considering such risk, not be unduly 
burdensome on patient access to the drug, con-
sidering in particular the 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. 
‘‘(3) 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 
Internet website of the Food and Drug Admin-
istration, so long as the order includes the ra-
tionale for incorporation of such standard. 
‘‘(4) 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-
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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— 
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‘‘(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 
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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 approved under section 351 of Public 
Health Service Act, 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 Sub-
stances Act; and 
‘‘(2) the term ‘relevant stakeholders’ may in-
clude scientific experts within the drug manufac-
turing industry; brand and generic drug manufactur-
ers; standard development organizations; wholesalers 
and distributors; payers; health care providers; phar-
macists; manufacturers; poison centers; and rep-
resentatives of the National Institute on Drug 
Abuse, the National Institutes of Health, the Cen-
ters for Disease Control and Prevention, the Centers 
for Medicare & Medicaid Services, the Drug En-
forcement Agency, the Consumer Product Safety 
Commission, individuals who specialize in treating 
addiction, and patient and caregiver groups.’’. 
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