I 
115TH CONGRESS 
1ST SESSION H. R. 4482 
To deter opioid abuse and addiction, to establish additional registration re-
quirements for prescribers of opioids, to encourage the development of 
abuse-deterrent formulations, to require a study and report on policy 
changes that may have contributed to the opioid epidemic, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 29, 2017 
Mr. MEADOWS (for himself and Mr. RENACCI) introduced the following bill; 
which was referred to the Committee on Energy and Commerce, and in 
addition to the Committee on the Judiciary, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To deter opioid abuse and addiction, to establish additional 
registration requirements for prescribers of opioids, to 
encourage the development of abuse-deterrent formula-
tions, to require a study and report on policy changes 
that may have contributed to the opioid epidemic, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Opioid Abuse Deter-
rence, Research, and Recovery Act of 2017’’. 
SEC. 2. REGISTRATION REQUIREMENTS FOR PRESCRIBERS. 
Section 303 of the Controlled Substances Act (21 
U.S.C. 823) is amended by adding at the end the fol-
lowing: 
‘‘(k)(1) The Attorney General shall not register, or 
renew the registration of, a practitioner under subsection 
(f) who is licensed under State law to prescribe controlled 
substances in schedule II or III, unless the practitioner 
submits to the Attorney General, for each such registra-
tion or renewal request, a certification that the practi-
tioner, during the applicable registration period, except as 
provided in paragraph (2), will not prescribe any schedule 
II or III opioid for the initial treatment of acute pain in 
an amount in excess of the lesser of— 
‘‘(A) a 7-day supply (for which no refill is avail-
able); or 
‘‘(B) an opioid prescription limit established 
under the law of the State where the prescribing oc-
curs. 
‘‘(2) The certification required by paragraph (1) shall 
not prohibit a practitioner from— 
‘‘(A) prescribing, for the treatment of an opioid 
use disorder, a schedule II or III opioid that is ap-
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proved by the Food and Drug Administration for 
such treatment; 
‘‘(B) prescribing, for immediate, post-operative 
pain relief, a schedule II or III opioid; or 
‘‘(C) prescribing a schedule II or III opioid in 
an amount in excess of a 7-day supply if the practi-
tioner— 
‘‘(i) provides a specific reason for exceed-
ing the 7-day limit that is in accordance with 
a clear medical standard of care whose imple-
mentation necessarily exceeds such limit; 
‘‘(ii) documents such reason and medical 
standard of care in the patient’s medical record; 
and 
‘‘(iii) consults the applicable State’s elec-
tronic health record system or prescription drug 
monitoring program. 
‘‘(3) In this subsection, the term ‘acute pain’— 
‘‘(A) means pain with abrupt onset and caused 
by an injury or other process that is diagnostically 
determined to have minimal risk of escalating in in-
tensity; and 
‘‘(B) does not include— 
‘‘(i) chronic pain; 
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‘‘(ii) pain being treated as part of cancer 
care; 
‘‘(iii) hospice or other end-of-life care; or 
‘‘(iv) pain being treated as part of pallia-
tive care.’’. 
SEC. 3. ENCOURAGING DEVELOPMENT OF ABUSE-DETER-
RENT FORMULATIONS. 
The Commissioner of Food and Drugs shall continue 
to work with stakeholders to encourage the development 
of opioid formulations with abuse-deterrent properties. 
SEC. 4. GAO STUDY AND REPORT ON POLICY CHANGES 
THAT MAY HAVE CONTRIBUTED TO THE 
OPIOID EPIDEMIC. 
Not later than 2 years after the date of enactment 
of this Act, the Comptroller General of the United States 
shall complete a study and submit a report to Congress 
on health care policy changes that may have contributed 
to the increase in opioid overdoses and deaths during the 
10 years preceding the date of enactment of this Act. Such 
study shall include— 
(1) a review of health care-related legislative, 
administrative, and judicial decisions by officers and 
employees of the Federal Government that have af-
fected access to pain management strategies with an 
emphasis on pharmaceuticals; 
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(2) an analysis of what is known about the 
costs and benefits, whether financial or non-finan-
cial, of reversing or revising such decisions individ-
ually or in combination, including whether the rever-
sals or revisions would be expected to achieve a re-
duction in abuse of, addiction to, overdose on, and 
death from opioids; 
(3) an analysis of the differences among State- 
based prescription drug monitoring programs, in-
cluding an analysis of what is known about the ef-
fects of such differences on monitoring for abuse of, 
addiction to, overdose on, and death from opioids; 
(4) an analysis of what is known about positive 
and negative impacts that prescribing limitations, 
both State and Federal, have on patient medical out-
comes, including for chronic pain patients; and 
(5) an analysis of what is known about the 
costs to payers of using abuse-deterrent formulations 
of opioid pain medications, compared to opioid pain 
medications without abuse-deterrent features. 
SEC. 5. STUDY ON FEASIBILITY OF REPLACING STATUTORY 
LIMITS 
WITH 
CLINICAL 
GUIDELINES 
ON 
OPIOID PRESCRIBING. 
The Commissioner of Food and Drugs shall— 
(1) conduct a study on the feasibility of— 
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(A) replacing the prescribing limits in sec-
tion 303(k)(1) of the Controlled Substances 
Act, as added by section 2 of this Act, with evi-
dence-based clinical guidelines to inform opioid 
selection, dosage, duration, follow up, and dis-
continuation, including guidelines on the first 
opioid prescription for patients for an acute 
pain diagnosis to ensure that no greater quan-
tity than needed is prescribed for the expected 
duration of pain severe enough to require 
opioids; and 
(B) the incorporation into routine medical 
visits of evidence-based screening tools for the 
misuse of opioids and other controlled sub-
stances; and 
(2) not later than the date that is 2 years after 
the date of enactment of this Act, submit to the 
Congress, and post on the public website of the Food 
and Drug Administration, a report on the results of 
such study. 
Æ 
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