H. Rept. 114-556 - REDUCING UNUSED MEDICATIONS ACT OF 2016114th Congress (2015-2016)
Committee Report
| Report Type: | House Report |
|---|---|
| Accompanies: | H.R.4599 |
| Committees: |
H. Rept. 114-556 - 114th Congress (2015-2016)
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House Report 114-556 - REDUCING UNUSED MEDICATIONS ACT OF 2016
[House Report 114-556]
[From the U.S. Government Publishing Office]
114th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 114-556
======================================================================
REDUCING UNUSED MEDICATIONS ACT OF 2016
_______
May 10, 2016.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Upton, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 4599]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 4599) to amend the Controlled Substances Act to
permit certain partial fillings of prescriptions, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 2
Hearings......................................................... 2
Committee Consideration.......................................... 3
Committee Votes.................................................. 3
Committee Oversight Findings..................................... 3
Statement of General Performance Goals and Objectives............ 3
New Budget Authority, Entitlement Authority, and Tax Expenditures 3
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 3
Committee Cost Estimate.......................................... 3
Congressional Budget Office Estimate............................. 3
Federal Mandates Statement....................................... 4
Duplication of Federal Programs.................................. 4
Disclosure of Directed Rule Makings.............................. 4
Advisory Committee Statement..................................... 4
Applicability to Legislative Branch.............................. 4
Section-by-Section Analysis of the Legislation................... 4
Changes in Existing Law Made by the Bill, as Reported............ 5
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Reducing Unused Medications Act of
2016''.
SEC. 2. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES.
(a) In General.--Section 309 of the Controlled Substances Act (21
U.S.C. 829) is amended by adding at the end the following:
``(f) Partial Fills of Schedule II Controlled Substances.--
``(1) Partial fills.--
``(A) In general.--A prescription for a controlled
substance in schedule II may be partially filled if--
``(i) it is not prohibited by State law;
``(ii) the prescription is written and filled
in accordance with the Controlled Substances
Act (21 U.S.C. 801 et seq.), regulations
prescribed by the Attorney General, and State
law;
``(iii) the partial fill is requested by the
patient or the practitioner that wrote the
prescription; and
``(iv) the total quantity dispensed in all
partial fillings does not exceed the total
quantity prescribed.
``(B) Other circumstances.--A prescription for a
controlled substance in schedule II may be partially
filled in accordance with section 1306.13 of title 21,
Code of Federal Regulations (as in effect on the date
of enactment of the Reducing Unused Medications Act of
2016).
``(2) Remaining portions.--
``(A) In general.--Except as provided in subparagraph
(B), remaining portions of a partially filled
prescription for a controlled substance in schedule
II--
``(i) may be filled; and
``(ii) shall be filled not later than 30 days
after the date on which the prescription is
written.
``(B) Emergency situations.--In emergency situations,
as described in subsection (a), the remaining portions
of a partially filled prescription for a controlled
substance in schedule II--
``(i) may be filled; and
``(ii) shall be filled not later than 72
hours after the prescription is issued.''.
(b) Rule of Construction.--Nothing in this section shall be construed
to affect the authority of the Attorney General to allow a prescription
for a controlled substance in schedule III, IV, or V of section 202(c)
of the Controlled Substances Act (21 U.S.C. 812(c)) to be partially
filled.
Purpose and Summary
H.R. 4599 would amend the Controlled Substances Act (CSA)
to clarify the circumstances under which a controlled substance
in Schedule II may be partially filled.
Background and Need for Legislation
The number of prescriptions for opioid pain medications has
significantly increased in recent years. While opioids can
benefit patients with acute and chronic pain, when their pain
is sufficiently addressed, there may be unused pills that could
be misused and diverted. In fact, the National Institute on
Drug Abuse estimates that over 70 percent of adults who misuse
prescription opioids get them from friends or relatives.
Several states have considered enabling pharmacies to partially
fill such prescriptions to minimize the number of pills in
circulation in a manner that continues to address patient need.
However, current regulations are not entirely clear about
whether and under what circumstances this is permitted for
drugs listed in Schedule II of the CSA. H.R. 4599 amends the
CSA to clarify the extent of permissible partial fills for
Schedule II controlled substances, including prescription
opioids.
Hearings
The Committee on Energy and Commerce did not hold a hearing
on H.R. 4599.
Committee Consideration
On April 20, 2016, the Subcommittee on Health met in open
markup session and forwarded H.R. 4599, as amended, to the full
Committee by a voice vote. On April 26, 27, and 28, 2016, the
full Committee on Energy and Commerce met in open markup
session and ordered H.R. 4599, as amended, favorably reported
to the House by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 4599 reported.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee did not hold a hearing
on this legislation.
Statement of General Performance Goals and Objectives
The purpose of this act is to to increase the flexibility
in filling opioid prescriptions, to reduce the number of unused
pills in circulation, and to help prevent opioid misuse,
diversion, and medical emergencies.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
4599 would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI
of the Rules of the House of Representatives, the Committee
finds that H.R. 4599 contains no earmarks, limited tax
benefits, or limited tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974. At the
time this report was filed, the estimate was not available.
Congressional Budget Office Estimate
At the time this report was filed, the cost estimate
prepared by the Director of the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of 1974
was not available.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Duplication of Federal Programs
No provision of H.R. 4599 establishes or reauthorizes a
program of the Federal Government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that enacting H.R. 4599 does not
direct any specific rule making within the meaning of 5 U.S.C.
551.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
The section provides the short title of ``Reducing Unused
Medications Act of 2016.''
Section 2. Partial fills of Schedule II Controlled Substances
Section 309 of the Controlled Substances Act is amended to
clarify that a prescription for a controlled substance listed
in Schedule II may be partially filled if it is not prohibited
by state law, the prescription is written and filled in
accordance with the CSA regulations and state law, the partial
fill is requested by the patient or the practitioner that wrote
the prescription, and the total quantity dispensed in all
partial fillings does not exceed the total quantity prescribed.
A prescription for a controlled substance listed in Schedule II
may also be filled in accordance with current Drug Enforcement
Administration (DEA) regulations, which allow for partial fills
of prescriptions for terminally ill or Long Term Care Facility
Patients and in instances when a pharmacy is unable to supply
the full quantity, provided that the remaining portion may not
be supplied beyond 72 hours without a new prescription. In
emergency situations, the remaining portions of such a
partially filled prescription may be filled if done so not
later than 72 hours after the prescription is issued. Remaining
portions of such a partially filled prescription may only be
filled within 30 days after the date on which the prescription
is written. Further, this bill clarifies that current DEA
regulations permitting partial fills in other circumstances are
not affected.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
CONTROLLED SUBSTANCES ACT
TITLE II--CONTROL AND ENFORCEMENT
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
* * * * * * *
prescriptions
Sec. 309. (a) Except when dispensed directly by a
practitioner, other than a pharmacist, to an ultimate user, no
controlled substance in schedule II, which is a prescription
drug as determined under the Federal Food, Drug, and Cosmetic
Act, may be dispensed without the written prescription of a
practitioner, except that in emergency situations, as
prescribed by the Secretary by regulation after consultation
with the Attorney General, such drug may be dispensed upon oral
prescription in accordance with section 503(b) of that Act.
Prescriptions shall be retained in conformity with the
requirements of section 307 of this title. No prescription for
a controlled substance in schedule II may be refilled.
(b) Except when dispensed directly by a practitioner, other
than a pharmacist, to an ultimate user, no controlled substance
in schedule III or IV, which is a prescription drug as
determined under the Federal Food, Drug, and Cosmetic Act, may
be dispensed without a written or oral prescription in
conformity with section 503(b) of that Act. Such prescriptions
may not be filled or refilled more than six months after the
date thereof or be refilled more than five times after the date
of the prescription unless renewed by the practitioner.
(c) No controlled substance in schedule V which is a drug may
be distributed or dispensed other than for a medical purpose.
(d) Whenever it appears to the Attorney General that a drug
not considered to be a prescription drug under the Federal
Food, Drug, and Cosmetic Act should be so considered because of
its abuse potential, he shall so advise the Secretary and
furnish to him all available data relevant thereto.
(e) Controlled Substances Dispensed by Means of the
Internet.--
(1) No controlled substance that is a prescription
drug as determined under the Federal Food, Drug, and
Cosmetic Act may be delivered, distributed, or
dispensed by means of the Internet without a valid
prescription.
(2) As used in this subsection:
(A) The term ``valid prescription'' means a
prescription that is issued for a legitimate
medical purpose in the usual course of
professional practice by--
(i) a practitioner who has conducted
at least 1 in-person medical evaluation
of the patient; or
(ii) a covering practitioner.
(B)(i) The term ``in-person medical
evaluation'' means a medical evaluation that is
conducted with the patient in the physical
presence of the practitioner, without regard to
whether portions of the evaluation are
conducted by other health professionals.
(ii) Nothing in clause (i) shall be construed
to imply that 1 in-person medical evaluation
demonstrates that a prescription has been
issued for a legitimate medical purpose within
the usual course of professional practice.
(C) The term ``covering practitioner'' means,
with respect to a patient, a practitioner who
conducts a medical evaluation (other than an
in-person medical evaluation) at the request of
a practitioner who--
(i) has conducted at least 1 in-
person medical evaluation of the
patient or an evaluation of the patient
through the practice of telemedicine,
within the previous 24 months; and
(ii) is temporarily unavailable to
conduct the evaluation of the patient.
(3) Nothing in this subsection shall apply to--
(A) the delivery, distribution, or dispensing
of a controlled substance by a practitioner
engaged in the practice of telemedicine; or
(B) the dispensing or selling of a controlled
substance pursuant to practices as determined
by the Attorney General by regulation, which
shall be consistent with effective controls
against diversion.
(f) Partial Fills of Schedule II Controlled Substances.--
(1) Partial fills.--
(A) In general.--A prescription for a
controlled substance in schedule II may be
partially filled if--
(i) it is not prohibited by State
law;
(ii) the prescription is written and
filled in accordance with the
Controlled Substances Act (21 U.S.C.
801 et seq.), regulations prescribed by
the Attorney General, and State law;
(iii) the partial fill is requested
by the patient or the practitioner that
wrote the prescription; and
(iv) the total quantity dispensed in
all partial fillings does not exceed
the total quantity prescribed.
(B) Other circumstances.--A prescription for
a controlled substance in schedule II may be
partially filled in accordance with section
1306.13 of title 21, Code of Federal
Regulations (as in effect on the date of
enactment of the Reducing Unused Medications
Act of 2016).
(2) Remaining portions.--
(A) In general.--Except as provided in
subparagraph (B), remaining portions of a
partially filled prescription for a controlled
substance in schedule II--
(i) may be filled; and
(ii) shall be filled not later than
30 days after the date on which the
prescription is written.
(B) Emergency situations.--In emergency
situations, as described in subsection (a), the
remaining portions of a partially filled
prescription for a controlled substance in
schedule II--
(i) may be filled; and
(ii) shall be filled not later than
72 hours after the prescription is
issued.
* * * * * * *
[all]