103 
‘‘(3) certify to the Secretary that the State has 
in place measures that enhance access to opioid 
overdose reversal drug products, such as laws that 
provide civil or disciplinary immunity for medical 
personnel who prescribe an opioid overdose reversal 
drug product, Good Samaritan Laws, Third Party 
Prescription Laws, Collaborative Practice Agree-
ments, and Standing Orders. 
‘‘(f) INDIAN TRIBE REQUIREMENTS.—The Indian 
Health Service, in consultation with Indian tribes, shall 
determine any requirements that shall apply to Indian 
tribes receiving opioid overdose reversal drug products 
made available under this section. 
‘‘(g) DEFINITIONS.—For purposes of this section: 
‘‘(1) CAREER
FIRE
DEPARTMENT.—The term 
‘career fire department’ means a fire department 
that has an all-paid force of firefighting personnel 
other than paid-on-call firefighters. 
‘‘(2) COLLABORATIVE PRACTICE AGREEMENT.— 
The term ‘Collaborative Practice Agreement’ means 
an agreement under which a pharmacist operates 
under authority delegated by another licensed practi-
tioner with prescribing authority. 
‘‘(3) COMBINATION
FIRE
DEPARTMENT.—The 
term ‘combination fire department’ means a fire de-
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partment that has paid firefighting personnel and 
volunteer firefighting personnel. 
‘‘(4) EMERGENCY
MEDICAL
SERVICE.—The 
term ‘emergency medical service’ means resources 
used by a public or private nonprofit licensed entity 
to deliver medical care outside of a medical facility 
under emergency conditions that occur as a result of 
the condition of the patient and includes services de-
livered (either on a compensated or volunteer basis) 
by an emergency medical services provider or other 
provider that is licensed or certified by the State in-
volved as an emergency medical technician, a para-
medic, or an equivalent professional (as determined 
by the State). 
‘‘(5) GOOD SAMARITAN LAW.—The term ‘Good 
Samaritan Law’ means a law that provides criminal 
immunity for a person who administers an opioid 
overdose reversal drug product, a person who, in 
good faith, seeks medical assistance for someone ex-
periencing a drug-related overdose, or a person who 
experiences a drug-related overdose and is in need of 
medical assistance and, in good faith, seeks such 
medical assistance, or is the subject of such a good 
faith request for medical assistance. 
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‘‘(6) INDIANS.—The terms ‘Indian’, ‘Indian 
tribe’, ‘tribal organization’, and ‘Urban Indian 
Health Program’ have the meanings given such 
terms in section 4 of the Indian Health Care Im-
provement Act. 
‘‘(7) MANUFACTURER.—The term ‘manufac-
turer’ means any corporation, organization, or insti-
tution, whether public or private (including Federal, 
State, and local departments, agencies, and instru-
mentalities), which manufactures, imports, proc-
esses, or distributes under its label any opioid over-
dose reversal drug product. The term ‘manufacture’ 
means to manufacture, import, process, or distribute 
an opioid overdose reversal drug. 
‘‘(8) OPIOID OVERDOSE REVERSAL DRUG PROD-
UCT.—The term ‘opioid overdose reversal drug prod-
uct’ means a finished dosage form that has been ap-
proved by the Food and Drug Administration and 
that contains an active pharmaceutical ingredient 
that acts as an opioid receptor antagonist. The term 
‘opioid overdose reversal drug product’ includes a 
combination product, as defined in section 3.2(e) of 
title 21, Code of Federal Regulations. 
‘‘(9) STANDING
ORDER.—The term ‘standing 
order’ means a non-patient-specific order covering 
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administration of medication by others to a patient 
who may be unknown to the prescriber at the time 
of the order. 
‘‘(10) THIRD PARTY PRESCRIPTION.—The term 
‘third party prescription’ means an order written for 
medication dispensed to one person with the inten-
tion that it will be administered to another person. 
‘‘(11) VOLUNTEER
FIRE
DEPARTMENT.—The 
term ‘volunteer fire department’ means a fire de-
partment that has an all-volunteer force of fire-
fighting personnel. 
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this suc-
tion— 
‘‘(1) $500,000,000 for fiscal year 2019; 
‘‘(2) $500,000,000 for fiscal year 2020; 
‘‘(3) $500,000,000 for fiscal year 2021; 
‘‘(4) $500,000,000 for fiscal year 2022; 
‘‘(5) $500,000,000 for fiscal year 2023; 
‘‘(6) $500,000,000 for fiscal year 2024; 
‘‘(7) $500,000,000 for fiscal year 2025; 
‘‘(8) $500,000,000 for fiscal year 2026; 
‘‘(9) $500,000,000 for fiscal year 2027; and 
‘‘(10) $500,000,000 for fiscal year 2028. 
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‘‘SEC. 3436. ADDITIONAL FUNDING FOR THE NATIONAL IN-
STITUTES OF HEALTH. 
‘‘There is authorized to be appropriated to the Na-
tional Institute of Health for the purpose of conducting 
research on addiction and pain related to substance mis-
use, including research to develop overdose reversal drug 
products, non-addictive drug products for treating pain, 
and drug products used to treat substance use disorder— 
‘‘(1) $1,000,000,000 for fiscal year 2019; 
‘‘(2) $1,000,000,000 for fiscal year 2020; 
‘‘(3) $1,000,000,000 for fiscal year 2021; 
‘‘(4) $1,000,000,000 for fiscal year 2022; 
‘‘(5) $1,000,000,000 for fiscal year 2023; 
‘‘(6) $1,000,000,000 for fiscal year 2024; 
‘‘(7) $1,000,000,000 for fiscal year 2025; 
‘‘(8) $1,000,000,000 for fiscal year 2026; 
‘‘(9) $1,000,000,000 for fiscal year 2027; and 
‘‘(10) $1,000,000,000 for fiscal year 2028. 
‘‘SEC. 3437. ADDITIONAL FUNDING FOR IMPROVED DATA 
COLLECTION AND PREVENTION OF INFEC-
TIOUS DISEASE TRANSMISSION. 
‘‘(a) DATA COLLECTION.—The Centers for Disease 
Control and Prevention shall use a portion of the funding 
appropriated under this section to ensure that all States 
participate in the Enhanced State Opioid Overdose Sur-
veillance program and to provide technical assistance to 
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medical examiners and coroners to facilitate improved 
data collection on fatal overdoses through such program. 
‘‘(b) CENTERS FOR DISEASE CONTROL AND PREVEN-
TION.—The Centers for Disease Control and Prevention 
shall use amounts appropriated under this section for the 
purpose of improving data on drug overdose deaths and 
non-fatal drug overdoses, surveillance related to addiction 
and substance use disorder, and the prevention of trans-
mission of infectious diseases related to substance use. 
‘‘(c) TRIBAL EPIDEMIOLOGY CENTERS.—There shall 
be made available to the Indian Health Service for the 
purpose of funding efforts by tribal epidemiology centers 
to improve data on drug overdose deaths and non-fatal 
drug overdoses and surveillance related to addiction and 
substance use disorder, not less than 1.5 percent of the 
total amount appropriated under this section for each fis-
cal year. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section— 
‘‘(1) $400,000,000 for fiscal year 2019; 
‘‘(2) $400,000,000 for fiscal year 2020; 
‘‘(3) $400,000,000 for fiscal year 2021; 
‘‘(4) $400,000,000 for fiscal year 2022; 
‘‘(5) $400,000,000 for fiscal year 2023; 
‘‘(6) $400,000,000 for fiscal year 2024; 
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‘‘(7) $400,000,000 for fiscal year 2025; 
‘‘(8) $400,000,000 for fiscal year 2026; 
‘‘(9) $400,000,000 for fiscal year 2027; and 
‘‘(10) $400,000,000 for fiscal year 2028. 
‘‘SEC. 3438. DEFINITIONS. 
‘‘In this title: 
‘‘(1) PLANNING COUNCIL.—The term ‘planning 
council’ means the substance use planning council 
established under section 3402. 
‘‘(2) RECOVERY RESIDENCE.—The term ‘recov-
ery residence’ means a residential dwelling unit, or 
other form of group housing, that is offered or ad-
vertised through any means, including oral, written, 
electronic, or printed means, by any individual or en-
tity as a residence that provides an evidence-based, 
peer-supported living environment for individuals un-
dergoing any type of substance use disorder treat-
ment or who have received any type of substance use 
disorder treatment in the past 3 years, including 
medication-assisted treatment. 
‘‘(3) STATE.— 
‘‘(A) IN
GENERAL.—The term ‘State’ 
means each of the 50 States, the District of Co-
lumbia, and each of the territories. 
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‘‘(B) TERRITORIES.—The term ‘territory’ 
means each of American Samoa, Guam, the 
Commonwealth of Puerto Rico, the Common-
wealth of the Northern Mariana Islands, the 
Virgin Islands, the Republic of the Marshall Is-
lands, the Federated States of Micronesia, and 
Palau. 
‘‘(4) 
SUBSTANCE
USE
DISORDER
TREAT-
MENT.— 
‘‘(A) IN GENERAL.—The term ‘substance 
use disorder treatment’ means an evidence- 
based, professionally directed, deliberate, and 
planned regimen including evaluation, observa-
tion, medical monitoring, and rehabilitative 
services 
and 
interventions 
such 
as 
pharmacotherapy, behavioral therapy, and indi-
vidual and group counseling, on an inpatient or 
outpatient basis, to help patients with substance 
use disorder reach recovery. 
‘‘(B) TYPES OF TREATMENT.—Substance 
use disorder treatments shall include the fol-
lowing: 
‘‘(i) Clinical stabilization services, 
which are evidence-based services provided 
in secure, acute care facilities (which may 
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be referred to as ‘addictions receiving fa-
cilities’) that, at a minimum— 
‘‘(I) provide detoxification and 
stabilization services; 
‘‘(II) are operated 24 hours per 
day, 7 days per week; and 
‘‘(III) 
that 
serve 
individuals 
found to be substance use impaired. 
These can also be referred to as ‘Ad-
dictions receiving facilities’. 
‘‘(ii) Withdrawal management and de-
toxification, which is a service that is pro-
vided on an inpatient or an outpatient 
basis to assist individuals manage the 
process of withdrawing from the physio-
logical and psychological effects of sub-
stance use disorder. 
‘‘(iii) Intensive inpatient treatment, 
which is a service that provides a planned 
regimen of evidence-based evaluation, ob-
servation, medical monitoring, and evi-
dence-based rehabilitative services and 
interventions such as pharmacotherapy, be-
havioral therapy, and counseling, 24 hours 
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112 
per day, 7 days per week, in a highly 
structured, residential environment. 
‘‘(iv) Intensive outpatient treatment, 
which is a service that provides a planned 
regimen of evidence-based evaluation, ob-
servation, medical monitoring, and evi-
dence-based rehabilitative services and 
interventions such as pharmacotherapy, be-
havioral therapy, and counseling, in a 
structured, nonresidential environment at a 
higher level of intensity and duration than 
outpatient treatment. 
‘‘(v) Medication-assisted treatment, 
which is a service that uses Federally-ap-
proved medication as authorized by Fed-
eral and State law, in combination with 
evidence-based medical, rehabilitative, and 
counseling services, in the treatment of in-
dividuals who suffer from substance use 
disorder. 
‘‘(vi) Outpatient treatment, which is a 
service that provides a planned regimen of 
evidence-based 
evaluation, 
observation, 
medical monitoring, and evidence-based re-
habilitative services and interventions such 
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113 
as pharmacotherapy, behavioral therapy, 
and counseling in a structured, nonresiden-
tial environment by appointment during 
scheduled operating hours. 
‘‘(vii) Residential recovery treatment, 
which is a service that provides a planned 
regimen of evidence-based evaluation, ob-
servation, medical monitoring, and evi-
dence-based rehabilitative services and 
interventions such as pharmacotherapy, be-
havioral therapy, and counseling provided 
in a structured, live-in environment within 
a nonhospital setting on a 24-hours-per- 
day, 7-days-per-week basis. 
‘‘(C) LIMITATION.—Substance use disorder 
treatment providers shall not include— 
‘‘(i) prevention only providers; and 
‘‘(ii) a private practitioner who is li-
censed by a State medical licensing board 
and whose practice is limited to outpatient 
care. 
‘‘(5) SUBSTANCE USE DISORDER TREATMENT 
SERVICES.—The term ‘substance use disorder treat-
ment services’ means any prevention services, core 
medical services, recovery and support services, early 
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intervention and engagement services, and harm re-
duction services authorized under this title.’’. 
SEC. 4. AMENDMENTS TO THE CONTROLLED SUBSTANCES 
ACT. 
(a) CERTIFICATIONS.—Part C of the Controlled Sub-
stances Act (21 U.S.C. 821 et seq.) is amended by adding 
at the end the following: 
‘‘CERTIFICATIONS RELATING TO DIVERSION CONTROLS 
AND MISBRANDING 
‘‘SEC. 312. (a) DEFINITIONS.—In this section— 
‘‘(1) the term ‘covered dispenser’— 
‘‘(A) means a dispenser— 
‘‘(i) that is required to register under 
section 302(a)(2); and 
‘‘(ii) dispenses a controlled substance 
in schedule II; and 
‘‘(B) does not include a dispenser that is— 
‘‘(i) registered to dispense opioid 
agonist treatment medication under section 
303(g)(1); and 
‘‘(ii) operating in that capacity; 
‘‘(2) the term ‘covered distributor’ means a dis-
tributor— 
‘‘(A) that is required to register under sec-
tion 302(a)(1); and 
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‘‘(B) distributes a controlled substance in 
schedule II; 
‘‘(3) the term ‘covered manufacturer’ means a 
manufacturer— 
‘‘(A) that is required to register under sec-
tion 302(a)(1); and 
‘‘(B) manufactures a controlled substance 
in schedule II; 
‘‘(4) the term ‘covered officer’, with respect to 
a covered person means— 
‘‘(A) in the case of a covered person that 
is not an individual— 
‘‘(i) the chief executive officer of the 
covered person; 
‘‘(ii) the president of the covered per-
son; 
‘‘(iii) the chief medical officer of the 
covered person; and 
‘‘(iv) the chief counsel of the covered 
person; and 
‘‘(B) in the case of a covered person that 
is an individual, that individual; and 
‘‘(5) the term ‘covered person’ means a covered 
dispenser, a covered distributor, or a covered manu-
facturer. 
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‘‘(b) CERTIFICATIONS
RELATING
TO
DIVERSION 
CONTROLS.—Not later than 180 days after the date of 
enactment of this section, and each year thereafter, each 
covered officer of a covered person shall submit to the At-
torney General, for each controlled substance in schedule 
II dispensed, distributed, or manufactured by the covered 
person, a certification— 
‘‘(1) signed by the covered officer; and 
‘‘(2) certifying that— 
‘‘(A) the covered person maintains effective 
controls against diversion of the controlled sub-
stance into channels other than legitimate med-
ical, scientific, research, or industrial channels; 
‘‘(B) all information contained in any 
record, inventory, or report required to be kept 
or submitted to the Attorney General by the 
covered person under section 307, or under any 
regulation issued under that section, is accu-
rate; and 
‘‘(C) the covered person is in compliance 
with all applicable requirements under Federal 
law relating to reporting suspicious orders for 
controlled substances. 
‘‘(c) 
CERTIFICATIONS
RELATING
TO
MIS-
BRANDING.—Not later than 180 days after the date of en-
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actment of this section, and each year thereafter, each cov-
ered officer of a covered manufacturer shall submit to the 
Attorney General, for each controlled substance in sched-
ule II manufactured by the covered manufacturer, a cer-
tification— 
‘‘(1) signed by the covered officer; and 
‘‘(2) certifying that the controlled substance is 
not misbranded, as described in section 502 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
352).’’. 
(b) OFFENSES.—Part D of title II of the Controlled 
Substances Act (21 U.S.C. 841 et seq.) is amended by 
adding at the end the following: 
‘‘CERTIFICATIONS BY COVERED OFFICERS 
‘‘SEC. 424. (a) DEFINITIONS.—In this section, the 
terms ‘covered dispenser’, ‘covered distributor’, ‘covered 
manufacturer’, ‘covered officer’, and ‘covered person’ have 
the meanings given those terms in section 312. 
‘‘(b) OFFENSES.— 
‘‘(1) FAILURE TO SUBMIT CERTIFICATIONS.— 
‘‘(A) CERTIFICATIONS
RELATING
TO
DI-
VERSION CONTROLS.—It shall be unlawful for a 
covered officer of a covered person to fail to 
submit a certification required under section 
312(b), without regard to the state of mind of 
the covered officer. 
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‘‘(B) CERTIFICATIONS RELATING TO MIS-
BRANDING.—It shall be unlawful for a covered 
officer of a covered manufacturer to fail to sub-
mit a certification required under section 
312(c), without regard to the state of mind of 
the covered officer. 
‘‘(2) SUBMISSION OF FALSE CERTIFICATIONS.— 
‘‘(A) FALSE CERTIFICATIONS RELATING TO 
DIVERSION CONTROLS.—It shall be unlawful for 
a covered officer of a covered person to submit 
a certification required under section 312(b), 
without regard to the state of mind of the cov-
ered officer, that contains a materially false 
statement or representation relating to the in-
formation required to be certified under that 
section for the year for which the certification 
is submitted. 
‘‘(B) FALSE
CERTIFICATIONS
RELATING 
TO MISBRANDING.—It shall be unlawful for a 
covered officer of a covered manufacturer to 
submit a certification required under section 
312(c), without regard to the state of mind of 
the covered officer, that contains a materially 
false statement or representation relating to the 
misbranding of a controlled substance with re-
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119 
spect to the year for which the certification is 
submitted. 
‘‘(c) PENALTIES.— 
‘‘(1) CIVIL PENALTIES.—Except as provided in 
paragraph (2), a covered officer who violates sub-
section (b) shall be subject to a civil penalty of not 
more than $25,000. 
‘‘(2) CRIMINAL PENALTIES.—A covered officer 
who knowingly violates subsection (b)(2) shall be 
subject to criminal penalties under section 403(d). 
‘‘(d) 
COMPREHENSIVE
ADDICTION
RESOURCES 
FUND.— 
‘‘(1) ESTABLISHMENT.—There is established in 
the Treasury a fund to be known as the ‘Com-
prehensive Addiction Resources Fund’. 
‘‘(2) TRANSFER OF AMOUNTS.—There shall be 
transferred to the Comprehensive Addiction Re-
sources Fund 100 percent of— 
‘‘(A) any civil penalty paid to the United 
States under this section; and 
‘‘(B) any fine paid to the United States 
under section 403(d) for a knowing violation of 
subsection (b)(2) of this section. 
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‘‘(3) AVAILABILITY
AND
USE
OF
FUNDS.— 
Amounts transferred to the Comprehensive Addic-
tion Fund under paragraph (2) shall— 
‘‘(A) remain available until expended; and 
‘‘(B) be made available to supplement 
amounts appropriated to carry out title XXXIV 
of the Public Health Service Act.’’. 
(c) CRIMINAL PENALTIES.—Section 403 of the Con-
trolled Substances Act (21 U.S.C. 843) is amended— 
(1) in subsection (d)(1)— 
(A) by inserting ‘‘or knowingly violates sec-
tion 424(b)(2)’’ after ‘‘any person who violates 
this section’’; and 
(B) by striking ‘‘violation of this section’’ 
and inserting ‘‘such a violation’’; and 
(2) in subsection (f)— 
(A) in paragraph (1), by striking ‘‘or 416’’ 
and inserting ‘‘or section 416, or knowing viola-
tions of section 424(b)(2)’’; and 
(B) in paragraph (3), by inserting ‘‘or 
knowing violations of section 424(b)(2)’’ before 
the period at the end. 
(d) TECHNICAL AND CONFORMING AMENDMENTS.— 
The table of contents for the Comprehensive Drug Abuse 
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Prevention and Control Act of 1970 (Public Law 91–513; 
84 Stat. 1236) is amended— 
(1) by inserting after the item relating to sec-
tion 311 the following: 
‘‘Sec. 312. Certifications relating to diversion controls and misbranding.’’; 
and 
(2) by inserting after the item relating to sec-
tion 423 the following: 
‘‘Sec. 424. Certifications by covered officers.’’. 
(e) EFFECTIVE DATE.—The amendments made by 
subsections (b) and (c) of this section shall take effect on 
the date that is 180 days after the date of enactment of 
this Act. 
Æ 
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