H. R. 6—54 
Act of 1970 is amended by inserting after the item relating to 
section 309 the following: 
‘‘Sec. 309A. Delivery of a controlled substance by a pharmacy to an administering 
practitioner.’’. 
CHAPTER 2—EMPOWERING PHARMACISTS IN THE 
FIGHT AGAINST OPIOID ABUSE 
SEC. 3211. SHORT TITLE. 
This chapter may be cited as the ‘‘Empowering Pharmacists 
in the Fight Against Opioid Abuse Act’’. 
SEC. 3212. PROGRAMS AND MATERIALS FOR TRAINING ON CERTAIN 
CIRCUMSTANCES UNDER WHICH A PHARMACIST MAY 
DECLINE TO FILL A PRESCRIPTION. 
(a) IN GENERAL.—Not later than 1 year after the date of enact-
ment of this Act, the Secretary of Health and Human Services, 
in consultation with the Administrator of the Drug Enforcement 
Administration, Commissioner of Food and Drugs, Director of the 
Centers for Disease Control and Prevention, and Assistant Secretary 
for Mental Health and Substance Use, shall develop and dissemi-
nate, as appropriate, materials for pharmacists, health care pro-
viders, and patients on— 
(1) circumstances under which a pharmacist may, con-
sistent with section 309 of the Controlled Substances Act (21 
U.S.C. 829) and regulations thereunder, including section 
1306.04 of title 21, Code of Federal Regulations, decline to 
fill a prescription for a controlled substance because the phar-
macist suspects the prescription is fraudulent, forged, or of 
doubtful, questionable, or suspicious origin; and 
(2) other Federal requirements pertaining to declining to 
fill a prescription under such circumstances, including the par-
tial fill of prescriptions for certain controlled substances. 
(b) MATERIALS INCLUDED.—In developing materials under sub-
section (a), the Secretary of Health and Human Services shall 
include information for— 
(1) pharmacists on how to decline to fill a prescription 
and actions to take after declining to fill a prescription; and 
(2) other health care practitioners and the public on a 
pharmacist’s ability to decline to fill prescriptions in certain 
circumstances and a description of those circumstances (as 
described in the materials developed under subsection (a)(1)). 
(c) STAKEHOLDER INPUT.—In developing the programs and 
materials required under subsection (a), the Secretary of Health 
and Human Services shall seek input from relevant national, State, 
and local associations, boards of pharmacy, medical societies, 
licensing boards, health care practitioners, and patients, including 
individuals with chronic pain. 
CHAPTER 3—SAFE DISPOSAL OF UNUSED MEDICATION 
SEC. 3221. SHORT TITLE. 
This chapter may be cited as the ‘‘Safe Disposal of Unused 
Medication Act’’.
H. R. 6—55 
SEC. 3222. DISPOSAL OF CONTROLLED SUBSTANCES OF A HOSPICE 
PATIENT BY EMPLOYEES OF A QUALIFIED HOSPICE PRO-
GRAM. 
(a) IN GENERAL.—Subsection (g) of section 302 of the Controlled 
Substances Act (21 U.S.C. 822) is amended by adding at the end 
the following: 
‘‘(5)(A) In the case of a person receiving hospice care, an 
employee of a qualified hospice program, acting within the scope 
of employment, may handle, without being registered under this 
section, any controlled substance that was lawfully dispensed to 
the person receiving hospice care, for the purpose of disposal of 
the controlled substance so long as such disposal occurs onsite 
in accordance with all applicable Federal, State, Tribal, and local 
law and— 
‘‘(i) the disposal occurs after the death of a person receiving 
hospice care; 
‘‘(ii) the controlled substance is expired; or 
‘‘(iii)(I) the employee is— 
‘‘(aa) the physician of the person receiving hospice 
care; and 
‘‘(bb) registered under section 303(f); and 
‘‘(II) the hospice patient no longer requires the con-
trolled substance because the plan of care of the hospice 
patient has been modified. 
‘‘(B) For the purposes of this paragraph: 
‘‘(i) The terms ‘hospice care’ and ‘hospice program’ have 
the meanings given to those terms in section 1861(dd) of the 
Social Security Act. 
‘‘(ii) The term ‘employee of a qualified hospice program’ 
means a physician, physician assistant, nurse, or other person 
who— 
‘‘(I) is employed by, or pursuant to arrangements made 
by, a qualified hospice program; 
‘‘(II)(aa) is licensed to perform medical or nursing serv-
ices by the jurisdiction in which the person receiving hos-
pice care was located; and 
‘‘(bb) is acting within the scope of such employment 
in accordance with applicable State law; and 
‘‘(III) has completed training through the qualified hos-
pice program regarding the disposal of controlled sub-
stances in a secure and responsible manner so as to discour-
age abuse, misuse, or diversion. 
‘‘(iii) The term ‘qualified hospice program’ means a hospice 
program that— 
‘‘(I) has written policies and procedures for assisting 
in the disposal of the controlled substances of a person 
receiving hospice care after the person’s death; 
‘‘(II) at the time when the controlled substances are 
first ordered— 
‘‘(aa) provides a copy of the written policies and 
procedures to the patient or patient representative and 
family; 
‘‘(bb) discusses the policies and procedures with 
the patient or representative and the family in a lan-
guage and manner that they understand to ensure 
that these parties are educated regarding the safe dis-
posal of controlled substances; and
H. R. 6—56 
‘‘(cc) documents in the patient’s clinical record that 
the written policies and procedures were provided and 
discussed; and 
‘‘(III) at the time following the disposal of the controlled 
substances— 
‘‘(aa) documents in the patient’s clinical record the 
type of controlled substance, dosage, route of adminis-
tration, and quantity so disposed; and 
‘‘(bb) the time, date, and manner in which that 
disposal occurred.’’. 
(b) GUIDANCE.—The Attorney General may issue guidance to 
hospice programs (as defined in paragraph (5) of section 302(g) 
of the Controlled Substances Act (21 U.S.C. 822(g)), as added by 
subsection (a)) to assist the programs in satisfying the requirements 
under such paragraph (5). 
(c) RULE OF CONSTRUCTION RELATING TO STATE AND LOCAL 
LAW.—Nothing in this section or the amendments made by this 
section shall be construed to prevent a State or local government 
from imposing additional controls or restrictions relating to the 
regulation of the disposal of controlled substances in hospice care 
or hospice programs. 
SEC. 3223. GAO STUDY AND REPORT ON HOSPICE SAFE DRUG MANAGE-
MENT. 
(a) STUDY.— 
(1) IN GENERAL.—The Comptroller General of the United 
States (in this section referred to as the ‘‘Comptroller General’’) 
shall conduct a study on the requirements applicable to, and 
challenges of, hospice programs with regard to the management 
and disposal of controlled substances in the home of an indi-
vidual. 
(2) CONTENTS.—In conducting the study under paragraph 
(1), the Comptroller General shall include— 
(A) an overview of any challenges encountered by 
selected hospice programs regarding the disposal of con-
trolled substances, such as opioids, in a home setting, 
including any key changes in policies, procedures, or best 
practices for the disposal of controlled substances over time; 
and 
(B) a description of Federal requirements, including 
requirements under the Medicare program, for hospice pro-
grams regarding the disposal of controlled substances in 
a home setting, and oversight of compliance with those 
requirements. 
(b) REPORT.—Not later than 18 months after the date of enact-
ment of this Act, the Comptroller General shall submit to Congress 
a report containing the results of the study conducted under sub-
section (a), together with recommendations, if any, for such legisla-
tion and administrative action as the Comptroller General deter-
mines appropriate. 
CHAPTER 4—SPECIAL REGISTRATION FOR 
TELEMEDICINE CLARIFICATION 
SEC. 3231. SHORT TITLE. 
This chapter may be cited as the ‘‘Special Registration for 
Telemedicine Clarification Act of 2018’’.
H. R. 6—57 
SEC. 3232. REGULATIONS RELATING TO A SPECIAL REGISTRATION FOR 
TELEMEDICINE. 
Section 311(h)(2) of the Controlled Substances Act (21 U.S.C. 
831(h)(2)) is amended to read as follows: 
‘‘(2) REGULATIONS.—Not later than 1 year after the date 
of enactment of the SUPPORT for Patients and Communities 
Act, in consultation with the Secretary, the Attorney General 
shall promulgate final regulations specifying— 
‘‘(A) the limited circumstances in which a special reg-
istration under this subsection may be issued; and 
‘‘(B) the procedure for obtaining a special registration 
under this subsection.’’. 
CHAPTER 5—SYNTHETIC ABUSE AND LABELING OF 
TOXIC SUBSTANCES 
SEC. 3241. CONTROLLED SUBSTANCE ANALOGUES. 
Section 203 of the Controlled Substances Act (21 U.S.C. 813) 
is amended— 
(1) by striking ‘‘A controlled’’ and inserting ‘‘(a) IN GEN-
ERAL.—A controlled’’; and 
(2) by adding at the end the following: 
‘‘(b) DETERMINATION.—In determining whether a controlled sub-
stance analogue was intended for human consumption under sub-
section (a), the following factors may be considered, along with 
any other relevant factors: 
‘‘(1) The marketing, advertising, and labeling of the sub-
stance. 
‘‘(2) The known efficacy or usefulness of the substance 
for the marketed, advertised, or labeled purpose. 
‘‘(3) The difference between the price at which the sub-
stance is sold and the price at which the substance it is pur-
ported to be or advertised as is normally sold. 
‘‘(4) The diversion of the substance from legitimate channels 
and the clandestine importation, manufacture, or distribution 
of the substance. 
‘‘(5) Whether the defendant knew or should have known 
the substance was intended to be consumed by injection, inhala-
tion, ingestion, or any other immediate means. 
‘‘(6) Any controlled substance analogue that is manufac-
tured, formulated, sold, distributed, or marketed with the intent 
to avoid the provisions of existing drug laws. 
‘‘(c) LIMITATION.—For purposes of this section, evidence that 
a substance was not marketed, advertised, or labeled for human 
consumption, by itself, shall not be sufficient to establish that 
the substance was not intended for human consumption.’’. 
CHAPTER 6—ACCESS TO INCREASED DRUG DISPOSAL 
SEC. 3251. SHORT TITLE. 
This chapter may be cited as the ‘‘Access to Increased Drug 
Disposal Act of 2018’’. 
SEC. 3252. DEFINITIONS. 
In this chapter—
H. R. 6—58 
(1) the term ‘‘Attorney General’’ means the Attorney Gen-
eral, acting through the Assistant Attorney General for the 
Office of Justice Programs; 
(2) the term ‘‘authorized collector’’ means a narcotic treat-
ment program, a hospital or clinic with an on-site pharmacy, 
a retail pharmacy, or a reverse distributor, that is authorized 
as a collector under section 1317.40 of title 21, Code of Federal 
Regulations (or any successor regulation); 
(3) the term ‘‘covered grant’’ means a grant awarded under 
section 3003; and 
(4) the term ‘‘eligible collector’’ means a person who is 
eligible to be an authorized collector. 
SEC. 3253. AUTHORITY TO MAKE GRANTS. 
The Attorney General shall award grants to States to enable 
the States to increase the participation of eligible collectors as 
authorized collectors. 
SEC. 3254. APPLICATION. 
A State desiring a covered grant shall submit to the Attorney 
General an application that, at a minimum— 
(1) identifies the single State agency that oversees pharma-
ceutical care and will be responsible for complying with the 
requirements of the grant; 
(2) details a plan to increase participation rates of eligible 
collectors as authorized collectors; and 
(3) describes how the State will select eligible collectors 
to be served under the grant. 
SEC. 3255. USE OF GRANT FUNDS. 
A State that receives a covered grant, and any subrecipient 
of the grant, may use the grant amounts only for the costs of 
installation, maintenance, training, purchasing, and disposal of con-
trolled substances associated with the participation of eligible collec-
tors as authorized collectors. 
SEC. 3256. ELIGIBILITY FOR GRANT. 
The Attorney General shall award a covered grant to 5 States, 
not less than 3 of which shall be States in the lowest quartile 
of States based on the participation rate of eligible collectors as 
authorized collectors, as determined by the Attorney General. 
SEC. 3257. DURATION OF GRANTS. 
The Attorney General shall determine the period of years for 
which a covered grant is made to a State. 
SEC. 3258. ACCOUNTABILITY AND OVERSIGHT. 
A State that receives a covered grant shall submit to the 
Attorney General a report, at such time and in such manner as 
the Attorney General may reasonably require, that— 
(1) lists the ultimate recipients of the grant amounts; 
(2) describes the activities undertaken by the State using 
the grant amounts; and 
(3) contains performance measures relating to the effective-
ness of the grant, including changes in the participation rate 
of eligible collectors as authorized collectors.
H. R. 6—59 
SEC. 3259. DURATION OF PROGRAM. 
The Attorney General may award covered grants for each of 
the first 5 fiscal years beginning after the date of enactment of 
this Act. 
SEC. 3260. AUTHORIZATION OF APPROPRIATIONS. 
There is authorized to be appropriated to the Attorney General 
such sums as may be necessary to carry out this chapter. 
CHAPTER 7—USING DATA TO PREVENT OPIOID 
DIVERSION 
SEC. 3271. SHORT TITLE. 
This chapter may be cited as the ‘‘Using Data To Prevent 
Opioid Diversion Act of 2018’’. 
SEC. 3272. PURPOSE. 
(a) IN GENERAL.—The purpose of this chapter is to provide 
drug manufacturers and distributors with access to anonymized 
information through the Automated Reports and Consolidated 
Orders System to help drug manufacturers and distributors identify, 
report, and stop suspicious orders of opioids and reduce diversion 
rates. 
(b) RULE OF CONSTRUCTION.—Nothing in this chapter should 
be construed to absolve a drug manufacturer, drug distributor, 
or other Drug Enforcement Administration registrant from the 
responsibility of the manufacturer, distributor, or other registrant 
to— 
(1) identify, stop, and report suspicious orders; or 
(2) maintain effective controls against diversion in accord-
ance with section 303 of the Controlled Substances Act (21 
U.S.C. 823) or any successor law or associated regulation. 
SEC. 3273. AMENDMENTS. 
(a) RECORDS AND REPORTS OF REGISTRANTS.—Section 307 of 
the Controlled Substances Act (21 U.S.C. 827) is amended— 
(1) by redesignating subsections (f), (g), and (h) as sub-
sections (g), (h), and (i), respectively; 
(2) by inserting after subsection (e) the following: 
‘‘(f)(1) The Attorney General shall, not less frequently than 
quarterly, make the following information available to manufacturer 
and distributor registrants through the Automated Reports and 
Consolidated Orders System, or any subsequent automated system 
developed by the Drug Enforcement Administration to monitor 
selected controlled substances: 
‘‘(A) The total number of distributor registrants that dis-
tribute controlled substances to a pharmacy or practitioner 
registrant, aggregated by the name and address of each phar-
macy and practitioner registrant. 
‘‘(B) The total quantity and type of opioids distributed, 
listed by Administration Controlled Substances Code Number, 
to each pharmacy and practitioner registrant described in 
subparagraph (A). 
‘‘(2) The information required to be made available under para-
graph (1) shall be made available not later than the 30th day 
of the first month following the quarter to which the information 
relates.
H. R. 6—60 
‘‘(3)(A) All registered manufacturers and distributors shall be 
responsible for reviewing the information made available by the 
Attorney General under this subsection. 
‘‘(B) In determining whether to initiate proceedings under this 
title against a registered manufacturer or distributor based on 
the failure of the registrant to maintain effective controls against 
diversion or otherwise comply with the requirements of this title 
or the regulations issued thereunder, the Attorney General may 
take into account that the information made available under this 
subsection was available to the registrant.’’; and 
(3) by inserting after subsection (i), as so redesignated, 
the following: 
‘‘(j) All of the reports required under this section shall be 
provided in an electronic format.’’. 
(b) COOPERATIVE ARRANGEMENTS.—Section 503 of the Con-
trolled Substances Act (21 U.S.C. 873) is amended by striking 
subsection (c) and inserting the following: 
‘‘(c)(1) The Attorney General shall, once every 6 months, prepare 
and make available to regulatory, licensing, attorneys general, and 
law enforcement agencies of States a standardized report containing 
descriptive and analytic information on the actual distribution pat-
terns, as gathered through the Automated Reports and Consolidated 
Orders System, or any subsequent automated system, pursuant 
to section 307 and which includes detailed amounts, outliers, and 
trends of distributor and pharmacy registrants, in such States 
for the controlled substances contained in schedule II, which, in 
the discretion of the Attorney General, are determined to have 
the highest abuse. 
‘‘(2) If the Attorney General publishes the report described 
in paragraph (1) once every 6 months as required under paragraph 
(1), nothing in this subsection shall be construed to bring an action 
in any court to challenge the sufficiency of the information or 
to compel the Attorney General to produce any documents or reports 
referred to in this subsection.’’. 
(c) CIVIL AND CRIMINAL PENALTIES.—Section 402 of the Con-
trolled Substances Act (21 U.S.C. 842) is amended— 
(1) in subsection (a)— 
(A) in paragraph (15), by striking ‘‘or’’ at the end; 
(B) in paragraph (16), by striking the period at the 
end and inserting ‘‘; or’’; and 
(C) by inserting after paragraph (16) the following: 
‘‘(17) in the case of a registered manufacturer or distributor 
of opioids, to fail to review the most recent information, directly 
related to the customers of the manufacturer or distributor, 
made available by the Attorney General in accordance with 
section 307(f).’’; and 
(2) in subsection (c)— 
(A) in paragraph (1), by striking subparagraph (B) 
and inserting the following: 
‘‘(B)(i) Except as provided in clause (ii), in the case of a violation 
of paragraph (5), (10), or (17) of subsection (a), the civil penalty 
shall not exceed $10,000. 
‘‘(ii) In the case of a violation described in clause (i) committed 
by a registered manufacturer or distributor of opioids and related 
to the reporting of suspicious orders for opioids, failing to maintain 
effective controls against diversion of opioids, or failing to review 
the most recent information made available by the Attorney General
H. R. 6—61 
in accordance with section 307(f), the penalty shall not exceed 
$100,000.’’; and 
(B) in paragraph (2)— 
(i) in subparagraph (A), by inserting ‘‘or (D)’’ after 
‘‘subparagraph (B)’’; and 
(ii) by adding at the end the following: 
‘‘(D) In the case of a violation described in subparagraph (A) 
that was a violation of paragraph (5), (10), or (17) of subsection 
(a) committed by a registered manufacturer or distributor of opioids 
that relates to the reporting of suspicious orders for opioids, failing 
to maintain effective controls against diversion of opioids, or failing 
to review the most recent information made available by the 
Attorney General in accordance with section 307(f), the criminal 
fine under title 18, United States Code, shall not exceed $500,000.’’. 
SEC. 3274. REPORT. 
Not later than 1 year after the date of enactment of this 
Act, the Attorney General shall submit to Congress a report that 
provides information about how the Attorney General is using data 
in the Automation of Reports and Consolidated Orders System 
to identify and stop suspicious activity, including whether the 
Attorney General is looking at aggregate orders from individual 
pharmacies to multiple distributors that in total are suspicious, 
even if no individual order rises to the level of a suspicious order 
to a given distributor. 
CHAPTER 8—OPIOID QUOTA REFORM 
SEC. 3281. SHORT TITLE. 
This chapter may be cited as the ‘‘Opioid Quota Reform Act’’. 
SEC. 3282. STRENGTHENING CONSIDERATIONS FOR DEA OPIOID 
QUOTAS. 
(a) IN GENERAL.—Section 306 of the Controlled Substances 
Act (21 U.S.C. 826) is amended— 
(1) in subsection (a)— 
(A) by inserting ‘‘(1)’’ after ‘‘(a)’’; 
(B) in the second sentence, by striking ‘‘Production’’ 
and inserting ‘‘Except as provided in paragraph (2), produc-
tion’’; and 
(C) by adding at the end the following: 
‘‘(2) The Attorney General may, if the Attorney General deter-
mines it will assist in avoiding the overproduction, shortages, or 
diversion of a controlled substance, establish an aggregate or indi-
vidual production quota under this subsection, or a procurement 
quota established by the Attorney General by regulation, in terms 
of pharmaceutical dosage forms prepared from or containing the 
controlled substance.’’; 
(2) in subsection (b), in the first sentence, by striking 
‘‘production’’ and inserting ‘‘manufacturing’’; 
(3) in subsection (c), by striking ‘‘October’’ and inserting 
‘‘December’’; and 
(4) by adding at the end the following: 
‘‘(i)(1)(A) In establishing any quota under this section, or any 
procurement quota established by the Attorney General by regula-
tion, for fentanyl, oxycodone, hydrocodone, oxymorphone, or 
hydromorphone (in this subsection referred to as a ‘covered con-
trolled substance’), the Attorney General shall estimate the amount
H. R. 6—62 
of diversion of the covered controlled substance that occurs in 
the United States. 
‘‘(B) In estimating diversion under this paragraph, the Attorney 
General— 
‘‘(i) shall consider information the Attorney General, in 
consultation with the Secretary of Health and Human Services, 
determines reliable on rates of overdose deaths and abuse and 
overall public health impact related to the covered controlled 
substance in the United States; and 
‘‘(ii) may take into consideration whatever other sources 
of information the Attorney General determines reliable. 
‘‘(C) After estimating the amount of diversion of a covered 
controlled substance, the Attorney General shall make appropriate 
quota reductions, as determined by the Attorney General, from 
the quota the Attorney General would have otherwise established 
had such diversion not been considered. 
‘‘(2)(A) For any year for which the approved aggregate produc-
tion quota for a covered controlled substance is higher than the 
approved aggregate production quota for the covered controlled 
substance for the previous year, the Attorney General, in consulta-
tion with the Secretary of Health and Human Services, shall include 
in the final order an explanation of why the public health benefits 
of increasing the quota clearly outweigh the consequences of having 
an increased volume of the covered controlled substance available 
for sale, and potential diversion, in the United States. 
‘‘(B) Not later than 1 year after the date of enactment of 
this subsection, and every year thereafter, the Attorney General 
shall submit to the Committee on the Judiciary, the Committee 
on Health, Education, Labor, and Pensions, and the Committee 
on Appropriations of the Senate and the Committee on the 
Judiciary, the Committee on Energy and Commerce, and the Com-
mittee on Appropriations of the House of Representatives the fol-
lowing information with regard to each covered controlled sub-
stance: 
‘‘(i) An anonymized count of the total number of manufac-
turers issued individual manufacturing quotas that year for 
the covered controlled substance. 
‘‘(ii) An anonymized count of how many such manufacturers 
were issued an approved manufacturing quota that was higher 
than the quota issued to that manufacturer for the covered 
controlled substance in the previous year. 
‘‘(3) Not later than 1 year after the date of enactment of 
this subsection, the Attorney General shall submit to Congress 
a report on how the Attorney General, when fixing and adjusting 
production and manufacturing quotas under this section for covered 
controlled substances, will— 
‘‘(A) take into consideration changes in the accepted medical 
use of the covered controlled substances; and 
‘‘(B) work with the Secretary of Health and Human Services 
on methods to appropriately and anonymously estimate the 
type and amount of covered controlled substances that are 
submitted for collection from approved drug collection recep-
tacles, mail-back programs, and take-back events.’’. 
(b) CONFORMING
CHANGE.—The Law Revision Counsel is 
directed to amend the heading for subsection (b) of section 826 
of title 21, United States Code, by striking ‘‘PRODUCTION’’ and 
inserting ‘‘MANUFACTURING’’.