ers; standard development organizations; wholesalers 
and distributors; payers; health care providers; phar-
macists; 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 amend-
ed by inserting after paragraph (j) the following: 
‘‘(k) If it is a drug approved under a covered applica-
tion (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 Fed-
eral 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, con-
trols, or measures related to the packaging or dis-
posal of the drug that provide protections com-
parable to those provided by the technologies, con-
trols, or measures required for the applicable listed 
drug under section 505–2, if applicable.’’. 
(d) GROUNDS FOR REFUSING TO APPROVE AN AB-
BREVIATED 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 re-
lated to the packaging or disposal of such drug 
that the Secretary determines provide protec-
tions comparable to those provided by the tech-
nologies, controls, or measures required for the 
applicable listed drug under section 505–2.’’. 
(e) RULES OF CONSTRUCTION.— 
(1) Any labeling describing technologies, con-
trols, 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 dif-
ferences from the reference listed drug resulting 
from the application of section 505–2 of the Federal 
Food, Drug, and Cosmetic Act, as added by sub-
section (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 applica-
tion 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 Con-
gress 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 tech-
nologies; 
(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 dis-
posal 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 diver-
sion of legally prescribed controlled substances; 
(5) a description of Federal oversight, if any, of 
controlled substance packaging technologies, includ-
ing— 
(A) identification of the Federal agencies 
that oversee such technologies; 
(B) identification of the technologies rec-
ommended 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 diver-
sion 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 Gov-
ernment in evaluating such products to ensure 
product efficacy. 
Passed the House of Representatives June 19, 2018. 
Attest: 
Clerk.