Health, the Administrator of the Agency for Healthcare 
Research and Quality, the Administrator of the Drug En-
forcement Administration, and relevant stakeholders, shall 
develop recommendations regarding education programs 
for prescribers of opioids required to be disseminated 
under section 505–1 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355–1), including recommendations 
for which prescribers should participate in such programs 
and how often participation in such programs is necessary. 
(c) GUIDANCE.—Not later than 1 year after the date 
of enactment of this Act, the Commissioner of Food and 
Drugs shall issue guidance on if and how the approved 
labeling of a drug that is an opioid and is the subject of 
an application under section 505(j) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)) may include 
statements that such drug deters abuse. 
SEC. 3. OPIOID INFORMATIONAL DOCUMENTS. 
(a) IN GENERAL.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by inserting after section 505–1 the 
following: 
‘‘SEC. 505–2. OPIOID INFORMATIONAL DOCUMENTS. 
‘‘(a) DEVELOPMENT OF MATERIALS.—The Commis-
sioner shall develop informational documents describing to 
consumers of opioid drugs the risk factors for opioid-re-
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lated harm, and shall submit such documents to the Direc-
tor of the Centers for Disease Control and Prevention for 
approval. 
‘‘(b) LABELING REQUIREMENT.—The manufacturer 
of any opioid drug approved under section 505 shall en-
sure that the appropriate informational documents devel-
oped under subsection (a), and approved by the Director 
of the Centers for Disease Control and Prevention, are in-
cluded in the labeling of such drug.’’. 
(b) ENFORCEMENT.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by adding at the end the following: 
‘‘(dd) If it is an opioid drug and the labeling does 
not include the informational documents required under 
section 505–2.’’. 
SEC. 4. STRENGTHENING CONSIDERATIONS FOR DEA NAR-
COTIC QUOTAS. 
Section 306 of the Controlled Substances Act (21 
U.S.C. 826) is amended by adding at the end the fol-
lowing: 
‘‘(i)(1) In fixing manufacturing quotas under this 
section the Attorney General shall take into consideration 
the impact of the manufacturing quotas on diversion and 
efforts to reduce the costs, injuries, and deaths associated 
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with the abuse of prescription opioids and heroin in the 
United States. 
‘‘(2)(A) Not later than 1 year after the date of enact-
ment of this subsection and every year thereafter, the At-
torney General shall publish the approved manufacturing 
quota for each manufacturer of fentanyl, oxycodone, 
hyrdocodone, oxymorphone, and hyrdomorphone for that 
year. 
‘‘(B) For any year in which the approved manufac-
turing quota for a manufacturer for any substance de-
scribed in subparagraph (A) is higher than the approved 
manufacturing quota for a manufacturer for the substance 
in the previous year, the Attorney General shall publish 
a report explaining why the public health benefits of in-
creasing such quota outweigh the consequences of having 
an increased volume of such substance available for sale, 
and potential diversion, in the United States. 
‘‘(C) For any substance described in subparagraph 
(A) that is approved under section 505 of the Federal 
Food, Drug, and Cosmetic Act after the date of enactment 
of this subsection, the Attorney General shall publish a 
report explaining what factors were taken into consider-
ation in setting the manufacturing quota for the sub-
stance. 
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‘‘(3) Not later than 90 days after the date of enact-
ment of this subsection, the Attorney General shall submit 
to Congress a report on— 
‘‘(A) how the Attorney General will ensure that 
the process of fixing manufacturing quotas under 
this section takes into consideration efforts to reduce 
the costs, injuries, and deaths associated with the 
abuse of prescription opioids and heroin; 
‘‘(B) formal steps that will be taken to improve 
data collection from approved drug collection recep-
tacles, mail-back programs, and take-back events on 
the volume and class of controlled substances that 
are collected; and 
‘‘(C) how the information described in subpara-
graphs (A) and (B) will influence the quota-setting 
process of the Attorney General in the following 
year.’’. 
SEC. 5. CONTINUING MEDICAL EDUCATION AND PRESCRIP-
TION DRUG MONITORING PROGRAM REG-
ISTRATION 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 
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(f) who is licensed under State law to prescribe controlled 
substances in schedule II, III, or IV, unless the practi-
tioner submits to the Attorney General, for each such reg-
istration or renewal request, a written certification that— 
‘‘(A)(i) the practitioner has, during the 1-year 
period preceding the registration or renewal request, 
completed a training program described in para-
graph (2); or 
‘‘(ii) the practitioner, during the applicable reg-
istration period, will not prescribe such controlled 
substances in amounts in excess of a 72-hour supply 
(for which no refill is available); and 
‘‘(B) the practitioner has registered with the 
prescription drug monitoring program of the State 
in which the practitioner practices, if the State has 
such program. 
‘‘(2) A training program described in this paragraph 
is a training program that— 
‘‘(A) follows the best practices for pain manage-
ment, as described in the ‘Guideline for Prescribing 
Opioids for Chronic Pain’ as published by the Cen-
ters for Disease Control and Prevention in 2016, or 
any successor thereto; 
‘‘(B) includes information on— 
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‘‘(i) recommending non-opioid and non- 
pharmacological therapy; 
‘‘(ii) establishing treatment goals and eval-
uating patient risks; 
‘‘(iii) prescribing the lowest dose and few-
est number of pills considered effective; 
‘‘(iv) addictive and overdose risks of 
opioids; 
‘‘(v) diagnosing and managing substance 
use disorders, including linking patients to evi-
dence-based treatment; 
‘‘(vi) identifying narcotics-seeking behav-
iors; and 
‘‘(vii) using prescription drug monitoring 
programs; and 
‘‘(C) is approved by the Secretary of Health 
and Human Services.’’. 
SEC. 6. REPORT ON PRESCRIBER EDUCATION COURSES 
FOR MEDICAL AND DENTAL STUDENTS. 
Each school of medicine, school of osteopathic medi-
cine, and school of dentistry participating in a program 
under title IV of the Higher Education Act of 1965 (20 
U.S.C. 1070a et seq.), as a condition for such participa-
tion, shall submit an annual report to Congress on any 
prescriber education courses focused specifically on pain 
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management and responsible opioid prescribing practices 
that such school requires students to take, and whether 
such courses are consistent with the most recently pub-
lished version of the ‘‘Guideline for Prescribing Opioids 
for Chronic Pain’’ of the Centers for Disease Control and 
Prevention. 
SEC. 7. REQUIREMENTS UNDER PRESCRIPTION DRUG MON-
ITORING PROGRAMS. 
(a) IN GENERAL.—Beginning 1 year after the date 
of enactment of this Act, each State that receives funding 
under the Harold Rogers Prescription Drug Monitoring 
Program established under the Departments of Com-
merce, Justice, and State, the Judiciary, and Related 
Agencies Appropriations Act, 2002 (Public Law 107–77; 
115 Stat. 748), the controlled substance monitoring pro-
gram under section 399O of the Public Health Service Act 
(42 U.S.C. 280g–3), or the Prescription Drug Overdose: 
Prevention for States program of the Centers for Disease 
Control and Prevention shall— 
(1) require practitioners, or their designees, in 
the State to consult the database of the prescription 
drug monitoring program before writing prescrip-
tions for controlled substances (as such term is de-
fined in section 102 of the Controlled Substances 
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Act (21 U.S.C. 802)) in schedule II, III, or IV 
under section 202 of such Act (21 U.S.C. 812); 
(2) require dispensers of controlled substances 
in schedule II, III, or IV, or their designees, to input 
data into the database of the prescription drug mon-
itoring program within 24 hours of filling a quali-
fying prescription, as required by the Attorney Gen-
eral and the Secretary of Health and Human Serv-
ices, including patient identifier information, the na-
tional drug code of the dispensed drug, date of dis-
pensing the drug, quantity and dosage of the drug 
dispensed, form of payment, Drug Enforcement Ad-
ministration registration number of the practitioner, 
Drug Enforcement Administration registration num-
ber of the dispenser; 
(3) allow practitioners and dispensers to des-
ignate other appropriate individuals to act as agents 
of such practitioners and dispensers for purposes of 
obtaining and inputing data from the database for 
purposes of complying with paragraphs (1) and (2), 
as applicable; 
(4) provide informational materials for practi-
tioners and dispensers to identify and refer patients 
with possible substance use disorders to professional 
treatment specialists; 
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(5) establish formal data sharing agreements to 
foster electronic connectivity with the prescription 
drug monitoring programs of each State (if such 
State has such a program) with which the State 
shares a border, to facilitate the exchange of infor-
mation through an established technology architec-
ture that ensures common data standards, privacy 
protection, and secure and streamlined information 
sharing; 
(6) notwithstanding section 399O(f)(1)(B) of 
the Public Health Service Act (42 U.S.C. 280g– 
3(f)(1)(B)), authorize direct access to the State’s 
database of the prescription drug monitoring pro-
gram to all State law enforcement agencies, State 
boards responsible for the licensure, regulation, or 
discipline of practitioners, pharmacists, or other per-
sons authorized to prescribe, administer, or dispense 
controlled substances; and 
(7) in order to enhance accountability in pre-
scribing and dispensing patterns, not fewer than 4 
times per year, proactively provide informational re-
ports on aggregate trends and individual outliers, 
based on information available through the State 
prescription drug monitoring program to— 
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(A) the State entities and persons de-
scribed in paragraph (6); and 
(B) the Medicaid agency, workers com-
pensation programs, and the department of 
public health of the State. 
(b) TRANSPARENCY IN PRESCRIBING PRACTICES AND 
INTERVENTION FOR HIGH PRESCRIBERS.— 
(1) STATE
REPORTING
REQUIREMENT.—Each 
State that receives funding under the Harold Rogers 
Prescription Drug Monitoring Program established 
under the Departments of Commerce, Justice, and 
State, the Judiciary, and Related Agencies Appro-
priations Act, 2002 (Public Law 107–77; 115 Stat. 
748), the controlled substance monitoring program 
under section 399O of the Public Health Service Act 
(42 U.S.C. 280g–3), or the Prescription Drug Over-
dose: Prevention for States program of the Centers 
for Disease Control and Prevention shall, twice per 
year, submit to the Secretary of Health and Human 
Services and the Administrator of the Drug Enforce-
ment Administration— 
(A) a list of all practitioners and dis-
pensers who, in the applicable reporting period, 
have prescribed or dispensed schedule II, III, or 
IV opioids in the State; 
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(B) the amount of schedule II, III, or IV 
opioids that were prescribed and dispensed by 
each individual practitioner and dispenser de-
scribed in subparagraph (A); and 
(C) any additional information that the 
Secretary and Administrator may require to 
support surveillance and evaluation of trends in 
prescribing or dispensing of schedule II, III, or 
IV opioids, or to identify possible non-medical 
use and diversion of such substances. 
(2) ANNUAL REPORT.—Not later than 1 year 
after the date of enactment of this Act, and annually 
thereafter, the Secretary of Health and Human 
Services, in consultation with the Administrator of 
the Drug Enforcement Administration, the Secretary 
of Defense, the Secretary of Veterans Affairs, and 
the Director of the Indian Health Service, shall sub-
mit to Congress, and make public, a report identi-
fying the geographic areas with the highest rates of 
opioid prescribing in the Nation, by zip code. 
(3) DEVELOPMENT OF ACTION PLAN.— 
(A) INITIAL PLAN.—Not later than 1 year 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services, in con-
sultation with the Administrator of the Drug 
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