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[House Report 114-556]
[From the U.S. Government Publishing Office]

114th Congress    }                                      {      Report
                        HOUSE OF REPRESENTATIVES
 2d Session       }                                      {     114-556

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                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]
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