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114th Congress   }                                    {    Rept. 114-85
                        HOUSE OF REPRESENTATIVES
 1st Session     }                                    {          Part 1

======================================================================



 
   ENSURING PATIENT ACCESS AND EFFECTIVE DRUG ENFORCEMENT ACT OF 2015

                                _______
                                

 April 20, 2015.--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. 471]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 471) to improve enforcement efforts related to 
prescription drug diversion and abuse, and for other purposes, 
having considered the same, report favorably thereon without 
amendment and recommend that the bill 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.............................     4
Federal Mandates Statement.......................................     4
Duplication of Federal Programs..................................     4
Disclosure of Directed Rule Makings..............................     5
Advisory Committee Statement.....................................     5
Applicability to Legislative Branch..............................     5
Section-by-Section Analysis of the Legislation...................     5
Changes in Existing Law Made by the Bill, as Reported............     7




                          Purpose and Summary

    H.R. 471 would help prevent prescription drug abuse, while 
ensuring that patients have access to needed medications by 
fostering better collaboration between drug manufacturers, 
wholesalers, pharmacies, the Drug Enforcement Administration 
(DEA), and the Food and Drug Administration (FDA).

                  Background and Need for Legislation

    In accord with their professional medical caregivers, 
millions of Americans rely on prescription drugs to treat and 
cure illnesses, alleviate pain, and prolong and improve the 
quality of their lives. Unfortunately, despite the efforts of 
Federal agencies and private parties in the prescription drug 
supply chain to halt and prevent drug abuse and diversion, 
prescription drug abuse kills tens of thousands of Americans 
each year.\1\
---------------------------------------------------------------------------
    \1\http://www.cdc.gov/homeandrecreationalsafety/rxbrief/.
---------------------------------------------------------------------------
    The supply chain involves a myriad of stakeholders, which 
includes drug manufacturers, wholesale distributors, doctors, 
nurses, pharmacists, hospitals, and retail pharmacies. In order 
to provide prescriptions to millions of Americans, the system 
must function efficiently and seamlessly, and deliver each dose 
to a pre-designated destination and patient.
    Protecting the system from criminal exploitation while also 
ensuring its efficacy requires significant investment from both 
the government's enforcement and oversight agencies and the 
system's private operators. Law enforcement must have the tools 
to act decisively and quickly. Private industry must have the 
assurance that lawful conduct will ensure due process, protect 
them from secondary liability, and shield them from disabling 
disruptions--disruptions that endanger the health and safety of 
individual patients. The integrity of the system depends on 
clear rules for enforcement agencies and for providers.
    H.R. 471 would clarify these rules by providing certainty 
with how Federal authorities will apply the law when 
undertaking enforcement actions, and by increasing the 
investment that private industry must make to ensure the 
integrity of the system.

                                Hearings

    The Committee on Energy and Commerce held a hearing on 
January 27, 2015. The Subcommittee received testimony from:
     Mr. Ben D. Chlapek, Deputy Chief, Central Jackson 
County Fire, Blue Springs, Missouri;
     Mr. John L. Eadie, Director, Prescription Drug 
Monitoring Program Center of Excellence, Brandeis University;
     Dr. Blaine Enderson, Department of Surgery, 
University of Tennessee Medical Center;
     Dr. Nathan Fountain, Professor of Neurology, 
University of Virginia; and,
     Mr. Linden Barber, Partner and Director, DEA 
Compliance Operations, Quarles & Brady.

                        Committee Consideration

    On February 4, 2015, the Subcommittee on Health met in open 
markup session to consider H.R. 471 and forwarded the bill to 
the full Committee, without amendment, by a voice vote. On 
February 11 and 12, 2015, the full Committee met in open markup 
session to consider H.R. 471 and ordered the bill favorably 
reported to the House, without amendment, 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. 471 reported. A motion by Mr. Upton to order H.R. 471 
reported to the House, without amendment, was agreed to by a 
voice vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee held a hearing and made 
findings that are reflected in this report.

         Statement of General Performance Goals and Objectives

    The purpose of this act is to address the nation's 
prescription drug abuse crisis by improving the working 
relationship between private industry, government agencies, 
providers, and patient advocates.

   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. 
471 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. 471 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.

                  Congressional Budget Office Estimate

                                     U.S. Congress,
                               Congressional Budget Office,
                                 Washington, DC, February 26, 2015.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 471, the Ensuring 
Patient Access and Effective Drug Enforcement Act of 2015.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Mark 
Grabowicz.
            Sincerely,
                                      Douglas W. Elmendorf,
                                                          Director.
    Enclosure.

H.R. 471--Ensuring Patient Access and Effective Drug Enforcement Act of 
        2015

    H.R. 471 would modify certain administrative procedures 
followed by the Department of Justice in regulating legitimate 
uses of controlled substances. In addition, within one year of 
enactment, the bill would require the Department of Health and 
Human Services to assess the effect of law enforcement 
activities on access to medications, examine potential benefits 
to patients from collaborations between governments and 
stakeholders, and report to the Congress on these matters.
    Based on the cost of similar activities, CBO estimates that 
implementing the bill would cost less than $500,000 over the 
2015-2016 period; any spending would be subject to the 
availability of appropriated funds. Enacting the legislation 
would not affect direct spending or revenues; therefore, pay-
as-you-go procedures do not apply.
    H.R. 471 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act and 
would impose no costs on state, local, or tribal governments.
    The CBO staff contacts for this estimate are Mark Grabowicz 
and Chad Chirico. The estimate was approved by Theresa Gullo, 
Deputy Assistant Director for Budget Analysis.

                       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. 471 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. 471 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

    This section provides the short title of ``Ensuring Patient 
Access and Effective Drug Enforcement Act of 2015.''

Section 2: Registration process under Controlled Substances Act

            Part (a), Definitions
    In part (a), the bill would clarify two definitions within 
the Controlled Substances Act (CSA) essential to providing a 
clear path forward for the enforcement agencies and lawful 
purveyors of controlled substances. These two clarifications 
would establish clear standards for the Drug Enforcement 
Administration that will facilitate consistent enforcement of 
the CSA and protect the due process rights of lawful providers 
of controlled substances, preventing overly broad and 
unsubstantiated enforcement orders. The technical 
clarifications will promote certainty in the regulatory and 
enforcement regime, allowing law enforcement to use resources 
more efficiently and protecting patients from unintended 
disruptions in the supply chain.
    First, the bill specifies that the phrase ``consistent with 
the public health and safety'' corresponds to a ``substantial 
relationship to . . . preventing diversion and abuse of 
controlled substances.'' The vague phrase ``consistent with the 
public health and safety'' requires explanation because it has 
created inconsistent enforcement actions and has left the 
courts of review with uncertainty about Congress' intent. This 
clarification will ensure that law enforcement can investigate 
and target dangerous offenders more effectively without wasting 
resources on unconnected parties in the supply chain.
    Current law does not define the phrase ``consistent with 
public health and safety.'' Its closest corollary, ``consistent 
with the public interest,'' has been the subject of numerous 
court decisions and regulatory proceedings within antitrust and 
administrative law, for example. Unlike the ``public 
interest,'' the Executive Branch has never promulgated 
regulations or issued legal guidance concerning the CSA's 
``consistent with public health and safety.'' Congress enacted 
the CSA to halt and prevent the diversion and abuse of 
controlled substances, and this clarification reaffirms this 
central purpose of the CSA. The term ``consistent with the 
public health and safety'' now will be defined as having a 
substantial relationship to the CSA's purpose of preventing 
diversion and abuse of controlled substances.
    Second, the bill defines ``imminent danger'' to include 
those circumstances that pose a ``significant and present risk 
of death or serious bodily harm that is more likely than not to 
occur in the absence of an immediate suspension order.'' The 
vagueness of the term ``imminent danger'' has created uneven 
enforcement applications, and this clarification will ensure 
that action will take place only in the presence of direct and 
urgent danger.
    This clarification harmonizes the CSA with other statutes 
using the ``imminent danger'' standard, namely the Federal Mine 
Safety and Health Act (``Mine Act'') and Occupational Safety 
and Health Act (``OSHA''). Both the Mine Act and OSHA authorize 
Federal authorities to take expedited action when serious, 
current, and persistent threats persist. The circumstances must 
be grave and immediate because such Federal action denies the 
subjects of the enforcement their ability to function.
            Part (b), Opportunity to submit corrective action plan 
                    prior to revocation or suspension
    To ensure transparency and due process, part (b) requires 
that when the Attorney General suspends or revokes a party's 
registration--the registration that enables the party to 
operate lawfully within the controlled substance market--that 
the Attorney General must provide notice to the party, cite 
with specificity any laws that may have been contravened, and 
give the party the opportunity to submit a corrective action 
plan in order to remedy any potential violations. The Attorney 
General must weigh the registrant's corrective action plan and 
suggest additional changes as any revocation or suspension 
actions proceed.
    Preventing diversion and drug abuse depends on consistent 
application of the CSA, and this provision ensures that law 
enforcement and private registrants will collaborate to achieve 
these aims.

Section 3: Report to Congress on effects of law enforcement activities 
        on patient access to medications

    Finally, this bill would require the Secretary of Health 
and Human Services to work with the Commissioner of the Food 
and Drug Administration, Director of the Centers for Disease 
Control and Prevention, Administrator of the DEA, and Director 
of the Director of National Drug Control Policy to submit a 
report to Congress within one year of enactment. The report 
will assess how patient access to medication could be adversely 
affected by Federal and State law enforcement activities and 
identify how collaboration between agencies and stakeholders 
can benefit patients and prevent diversion and abuse of 
controlled substances. This report will incorporate feedback 
and recommendations from stakeholders, including: patient 
groups, pharmacies, drug manufacturers, common or contract 
carriers and warehousemen, hospitals, physicians, long term 
care providers, State attorneys general, law enforcement 
officials, health benefit plans and entities that provide 
pharmacy benefit management services on behalf of a health 
benefit plan, and wholesale drug distributors.

         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 (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, 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

           *       *       *       *       *       *       *



                       registration requirements

  Sec. 303. (a) The Attorney General shall register an 
applicant to manufacture controlled substances in schedule I or 
II if he determines that such registration is consistent with 
the public interest and with United States obligations under 
international treaties, conventions, or protocols in effect on 
the effective date of this part. In determining the public 
interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances and any 
        controlled substance in schedule I or II compounded 
        therefrom into other than legitimate medical, 
        scientific, research, or industrial channels, by 
        limiting the importation and bulk manufacture of such 
        controlled substances to a number of establishments 
        which can produce an adequate and uninterrupted supply 
        of these substances under adequately competitive 
        conditions for legitimate medical, scientific, 
        research, and industrial purposes;
          (2) compliance with applicable State and local law;
          (3) promotion of technical advances in the art of 
        manufacturing these substances and the development of 
        new substances;
          (4) prior conviction record of applicant under 
        Federal and State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (5) past experience in the manufacture of controlled 
        substances, and the existence in the establishment of 
        effective control against diversion; and
          (6) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (b) The Attorney General shall register an applicant to 
distribute a controlled substance in schedule I or II unless he 
determines that the issuance of such registration is 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances into 
        other than legitimate medical, scientific, and 
        industrial channels;
          (2) compliance with applicable State and local law;
          (3) prior conviction record of applicant under 
        Federal or State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (4) past experience in the distribution of controlled 
        substances; and
          (5) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (c) Registration granted under subsections (a) and (b) of 
this section shall not entitle a registrant to (1) manufacture 
or distribute controlled substances in schedule I or II other 
than those specified in the registration, or (2) manufacture 
any quantity of those controlled substances in excess of the 
quota assigned pursuant to section 306.
  (d) The Attorney General shall register an applicant to 
manufacture controlled substances in schedule III, IV, or V, 
unless he determines that the issuance of such registration is 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances and any 
        controlled substance in schedule III, IV, or V 
        compounded therefrom into other than legitimate 
        medical, scientific, or industrial channels;
          (2) compliance with applicable State and local law;
          (3) promotion of technical advances in the art of 
        manufacturing these substances and the development of 
        new substances;
          (4) prior conviction record of applicant under 
        Federal or State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (5) past experience in the manufacture, distribution, 
        and dispensing of controlled substances, and the 
        existence in the establishment of effective controls 
        against diversion; and
          (6) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (e) The Attorney General shall register an applicant to 
distribute controlled substances in schedule III, IV, or V, 
unless he determines that the issuance of such registration is 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances into 
        other than legitimate medical, scientific, and 
        industrial channels;
          (2) compliance with applicable State and local law;
          (3) prior conviction record of applicant under 
        Federal or State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (4) past experience in the distribution of controlled 
        substances; and
          (5) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (f) The Attorney General shall register practitioners 
(including pharmacies, as distinguished from pharmacists) to 
dispense, or conduct research with, controlled substances in 
schedule II, III, IV, or V and shall modify the registrations 
of pharmacies so registered to authorize them to dispense 
controlled substances by means of the Internet, if the 
applicant is authorized to dispense, or conduct research with 
respect to, controlled substances under the laws of the State 
in which he practices. The Attorney General may deny an 
application for such registration or such modification of 
registration if the Attorney General determines that the 
issuance of such registration or modification would be 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) The recommendation of the appropriate State 
        licensing board or professional disciplinary authority.
          (2) The applicant's experience in dispensing, or 
        conducting research with respect to controlled 
        substances.
          (3) The applicant's conviction record under Federal 
        or State laws relating to the manufacture, 
        distribution, or dispensing of controlled substances.
          (4) Compliance with applicable State, Federal, or 
        local laws relating to controlled substances.
          (5) Such other conduct which may threaten the public 
        health and safety.
Separate registration under this part for practitioners 
engaging in research with controlled substances in schedule II, 
III, IV, or V, who are already registered under this part in 
another capacity, shall not be required. Registration 
applications by practitioners wishing to conduct research with 
controlled substances in schedule I shall be referred to the 
Seretary, who shall determine the qualifications and competency 
of each practitioner requesting registration, as well as the 
merits of the research protocol. The Secretary, in determining 
the merits of each research protocol, shall consult with the 
Attorney General as to effective procedures to adequately 
safeguard against diversion of such controlled substances from 
legitimate medical or scientific use. Registration for the 
purpose of bona fide research with controlled substances in 
schedule I by a practitioner deemed qualified by the Secretary 
may be denied by the Attorney General only on a ground 
specified in section 304(a). Article 7 of the Convention on 
Psychotrophic Substances shall not be construed to prohibit, or 
impose additional restrictions upon, research involving drugs 
or other substances scheduled under the convention which is 
conducted in conformity with this subsection and other 
applicable provisions of this title.
  (g)(1) Except as provided in paragraph (2), practitioners who 
dispense narcotic drugs to individuals for maintenance 
treatment or detoxification treatment shall obtain annually a 
separate registration for that purpose. The Attorney General 
shall register an applicant to dispense narcotic drugs to 
individuals for maintenance treatment or detoxification 
treatment (or both)--
          (A) if the applicant is a practitioner who is 
        determined by the Secretary to be qualified (under 
        standards established by the Secretary) to engage in 
        the treatment with respect to which registration is 
        sought;
          (B) if the Attorney General determines that the 
        applicant will comply with standards established by the 
        Attorney General respecting (i) security of stocks of 
        narcotic drugs for such treatment, and (ii) the 
        maintenance of records (in accordance with section 307) 
        on such drugs; and
          (C) if the Secretary determines that the applicant 
        will comply with standards established by the Secretary 
        (after consultation with the Attorney General) 
        respecting the quantities of narcotic drugs which may 
        be provided for unsupervised use by individuals in such 
        treatment.
  (2)(A) Subject to subparagraphs (D) and (J), the requirements 
of paragraph (1) are waived in the case of the dispensing 
(including the prescribing), by a practitioner, of narcotic 
drugs in schedule III, IV, or V or combinations of such drugs 
if the practitioner meets the conditions specified in 
subparagraph (B) and the narcotic drugs or combinations of such 
drugs meet the conditions specified in subparagraph (C).
  (B) For purposes of subparagraph (A), the conditions 
specified in this subparagraph with respect to a practitioner 
are that, before the initial dispensing of narcotic drugs in 
schedule III, IV, or V or combinations of such drugs to 
patients for maintenance or detoxification treatment, the 
practitioner submit to the Secretary a notification of the 
intent of the practitioner to begin dispensing the drugs or 
combinations for such purpose, and that the notification 
contain the following certifications by the practitioner:
          (i) The practitioner is a qualifying physician (as 
        defined in subparagraph (G)).
          (ii) With respect to patients to whom the 
        practitioner will provide such drugs or combinations of 
        drugs, the practitioner has the capacity to refer the 
        patients for appropriate counseling and other 
        appropriate ancillary services.
          (iii) The total number of such patients of the 
        practitioner at any one time will not exceed the 
        applicable number. For purposes of this clause, the 
        applicable number is 30, unless, not sooner than 1 year 
        after the date on which the practitioner submitted the 
        initial notification, the practitioner submits a second 
        notification to the Secretary of the need and intent of 
        the practitioner to treat up to 100 patients. A second 
        notification under this clause shall contain the 
        certifications required by clauses (i) and (ii) of this 
        subparagraph. The Secretary may by regulation change 
        such total number.
  (C) For purposes of subparagraph (A), the conditions 
specified in this subparagraph with respect to narcotic drugs 
in schedule III, IV, or V or combinations of such drugs are as 
follows:
          (i) The drugs or combinations of drugs have, under 
        the Federal Food, Drug, and Cosmetic Act or section 351 
        of the Public Health Service Act, been approved for use 
        in maintenance or detoxification treatment.
          (ii) The drugs or combinations of drugs have not been 
        the subject of an adverse determination. For purposes 
        of this clause, an adverse determination is a 
        determination published in the Federal Register and 
        made by the Secretary, after consultation with the 
        Attorney General, that the use of the drugs or 
        combinations of drugs for maintenance or detoxification 
        treatment requires additional standards respecting the 
        qualifications of practitioners to provide such 
        treatment, or requires standards respecting the 
        quantities of the drugs that may be provided for 
        unsupervised use.
  (D)(i) A waiver under subparagraph (A) with respect to a 
practitioner is not in effect unless (in addition to conditions 
under subparagraphs (B) and (C)) the following conditions are 
met:
          (I) The notification under subparagraph (B) is in 
        writing and states the name of the practitioner.
          (II) The notification identifies the registration 
        issued for the practitioner pursuant to subsection (f).
          (III) If the practitioner is a member of a group 
        practice, the notification states the names of the 
        other practitioners in the practice and identifies the 
        registrations issued for the other practitioners 
        pursuant to subsection (f).
  (ii) Upon receiving a notification under subparagraph (B), 
the Attorney General shall assign the practitioner involved an 
identification number under this paragraph for inclusion with 
the registration issued for the practitioner pursuant to 
subsection (f). The identification number so assigned shall be 
appropriate to preserve the confidentiality of patients for 
whom the practitioner has dispensed narcotic drugs under a 
waiver under subparagraph (A).
  (iii) Not later than 45 days after the date on which the 
Secretary receives a notification under subparagraph (B), the 
Secretary shall make a determination of whether the 
practitioner involved meets all requirements for a waiver under 
subparagraph (B). If the Secretary fails to make such 
determination by the end of the such 45-day period, the 
Attorney General shall assign the physician an identification 
number described in clause (ii) at the end of such period.
  (E)(i) If a practitioner is not registered under paragraph 
(1) and, in violation of the conditions specified in 
subparagraphs (B) through (D), dispenses narcotic drugs in 
schedule III, IV, or V or combinations of such drugs for 
maintenance treatment or detoxification treatment, the Attorney 
General may, for purposes of section 304(a)(4), consider the 
practitioner to have committed an act that renders the 
registration of the practitioner pursuant to subsection (f) to 
be inconsistent with the public interest.
  (ii)(I) Upon the expiration of 45 days from the date on which 
the Secretary receives a notification under subparagraph (B), a 
practitioner who in good faith submits a notification under 
subparagraph (B) and reasonably believes that the conditions 
specified in subparagraphs (B) through (D) have been met shall, 
in dispensing narcotic drugs in schedule III, IV, or V or 
combinations of such drugs for maintenance treatment or 
detoxification treatment, be considered to have a waiver under 
subparagraph (A) until notified otherwise by the Secretary, 
except that such a practitioner may commence to prescribe or 
dispense such narcotic drugs for such purposes prior to the 
expiration of such 45-day period if it facilitates the 
treatment of an individual patient and both the Secretary and 
the Attorney General are notified by the practitioner of the 
intent to commence prescribing or dispensing such narcotic 
drugs.
  (II) For purposes of subclause (I), the publication in the 
Federal Register of an adverse determination by the Secretary 
pursuant to subparagraph (C)(ii) shall (with respect to the 
narcotic drug or combination involved) be considered to be a 
notification provided by the Secretary to practitioners, 
effective upon the expiration of the 30-day period beginning on 
the date on which the adverse determination is so published.
  (F)(i) With respect to the dispensing of narcotic drugs in 
schedule III, IV, or V or combinations of such drugs to 
patients for maintenance or detoxification treatment, a 
practitioner may, in his or her discretion, dispense such drugs 
or combinations for such treatment under a registration under 
paragraph (1) or a waiver under subparagraph (A) (subject to 
meeting the applicable conditions).
  (ii) This paragraph may not be construed as having any legal 
effect on the conditions for obtaining a registration under 
paragraph (1), including with respect to the number of patients 
who may be served under such a registration.
  (G) For purposes of this paragraph:
          (i) The term ``group practice'' has the meaning given 
        such term in section 1877(h)(4) of the Social Security 
        Act.
          (ii) The term ``qualifying physician'' means a 
        physician who is licensed under State law and who meets 
        one or more of the following conditions:
                  (I) The physician holds a subspecialty board 
                certification in addiction psychiatry from the 
                American Board of Medical Specialties.
                  (II) The physician holds an addiction 
                certification from the American Society of 
                Addiction Medicine.
                  (III) The physician holds a subspecialty 
                board certification in addiction medicine from 
                the American Osteopathic Association.
                  (IV) The physician has, with respect to the 
                treatment and management of opiate-dependent 
                patients, completed not less than eight hours 
                of training (through classroom situations, 
                seminars at professional society meetings, 
                electronic communications, or otherwise) that 
                is provided by the American Society of 
                Addiction Medicine, the American Academy of 
                Addiction Psychiatry, the American Medical 
                Association, the American Osteopathic 
                Association, the American Psychiatric 
                Association, or any other organization that the 
                Secretary determines is appropriate for 
                purposes of this subclause.
                  (V) The physician has participated as an 
                investigator in one or more clinical trials 
                leading to the approval of a narcotic drug in 
                schedule III, IV, or V for maintenance or 
                detoxification treatment, as demonstrated by a 
                statement submitted to the Secretary by the 
                sponsor of such approved drug.
                  (VI) The physician has such other training or 
                experience as the State medical licensing board 
                (of the State in which the physician will 
                provide maintenance or detoxification 
                treatment) considers to demonstrate the ability 
                of the physician to treat and manage opiate-
                dependent patients.
                  (VII) The physician has such other training 
                or experience as the Secretary considers to 
                demonstrate the ability of the physician to 
                treat and manage opiate-dependent patients. Any 
                criteria of the Secretary under this subclause 
                shall be established by regulation. Any such 
                criteria are effective only for 3 years after 
                the date on which the criteria are promulgated, 
                but may be extended for such additional 
                discrete 3-year periods as the Secretary 
                considers appropriate for purposes of this 
                subclause. Such an extension of criteria may 
                only be effectuated through a statement 
                published in the Federal Register by the 
                Secretary during the 30-day period preceding 
                the end of the 3-year period involved.
  (H)(i) In consultation with the Administrator of the Drug 
Enforcement Administration, the Administrator of the Substance 
Abuse and Mental Health Services Administration, the Director 
of the National Institute on Drug Abuse, and the Commissioner 
of Food and Drugs, the Secretary shall issue regulations 
(through notice and comment rulemaking) or issue practice 
guidelines to address the following:
          (I) Approval of additional credentialing bodies and 
        the responsibilities of additional credentialing 
        bodies.
          (II) Additional exemptions from the requirements of 
        this paragraph and any regulations under this 
        paragraph.
Nothing in such regulations or practice guidelines may 
authorize any Federal official or employee to exercise 
supervision or control over the practice of medicine or the 
manner in which medical services are provided.
  (ii) Not later than 120 days after the date of the enactment 
of the Drug Addiction Treatment Act of 2000, the Secretary 
shall issue a treatment improvement protocol containing best 
practice guidelines for the treatment and maintenance of 
opiate-dependent patients. The Secretary shall develop the 
protocol in consultation with the Director of the National 
Institute on Drug Abuse, the Administrator of the Drug 
Enforcement Administration, the Commissioner of Food and Drugs, 
the Administrator of the Substance Abuse and Mental Health 
Services Administration and other substance abuse disorder 
professionals. The protocol shall be guided by science.
  (I) During the 3-year period beginning on the date of the 
enactment of the Drug Addiction Treatment Act of 2000, a State 
may not preclude a practitioner from dispensing or prescribing 
drugs in schedule III, IV, or V, or combinations of such drugs, 
to patients for maintenance or detoxification treatment in 
accordance with this paragraph unless, before the expiration of 
that 3-year period, the State enacts a law prohibiting a 
practitioner from dispensing such drugs or combinations of 
drug.
  (J)(i) This paragraph takes effect on the date of the 
enactment of the Drug Addiction Treatment Act of 2000, and 
remains in effect thereafter.
  (ii) For purposes relating to clause (iii), the Secretary and 
the Attorney General may, during the 3-year period beginning on 
the date of the enactment of the Office of National Drug 
Control Policy Reauthorization Act of 2006, make determinations 
in accordance with the following:
          (I) The Secretary may make a determination of whether 
        treatments provided under waivers under subparagraph 
        (A) have been effective forms of maintenance treatment 
        and detoxification treatment in clinical settings; may 
        make a determination of whether such waivers have 
        significantly increased (relative to the beginning of 
        such period) the availability of maintenance treatment 
        and detoxification treatment; and may make a 
        determination of whether such waivers have adverse 
        consequences for the public health.
          (II) The Attorney General may make a determination of 
        the extent to which there have been violations of the 
        numerical limitations established under subparagraph 
        (B) for the number of individuals to whom a 
        practitioner may provide treatment; may make a 
        determination of whether waivers under subparagraph (A) 
        have increased (relative to the beginning of such 
        period) the extent to which narcotic drugs in schedule 
        III, IV, or V or combinations of such drugs are being 
        dispensed or possessed in violation of this Act; and 
        may make a determination of whether such waivers have 
        adverse consequences for the public health.
  (iii) If, before the expiration of the period specified in 
clause (ii), the Secretary or the Attorney General publishes in 
the Federal Register a decision, made on the basis of 
determinations under such clause, that subparagraph (B)(iii) 
should be applied by limiting the total number of patients a 
practitioner may treat to 30, then the provisions in such 
subparagraph (B)(iii) permitting more than 30 patients shall 
not apply, effective 60 days after the date on which the 
decision is so published. The Secretary shall in making any 
such decision consult with the Attorney General, and shall in 
publishing the decision in the Federal Register include any 
comments received from the Attorney General for inclusion in 
the publication. The Attorney General shall in making any such 
decision consult with the Secretary, and shall in publishing 
the decision in the Federal Register include any comments 
received from the Secretary for inclusion in the publication.
  (h) The Attorney General shall register an applicant to 
distribute a list I chemical unless the Attorney General 
determines that registration of the applicant is inconsistent 
with the public interest. Registration under this subsection 
shall not be required for the distribution of a drug product 
that is exempted under clause (iv) or (v) of section 
102(39)(A). In determining the public interest for the purposes 
of this subsection, the Attorney General shall consider--
          (1) maintenance by the applicant of effective 
        controls against diversion of listed chemicals into 
        other than legitimate channels;
          (2) compliance by the applicant with applicable 
        Federal, State, and local law;
          (3) any prior conviction record of the applicant 
        under Federal or State laws relating to controlled 
        substances or to chemicals controlled under Federal or 
        State law;
          (4) any past experience of the applicant in the 
        manufacture and distribution of chemicals; and
          (5) such other factors as are relevant to and 
        consistent with the public health and safety.
  (i) In this section, the phrase ``factors as may be relevant 
to and consistent with the public health and safety'' means 
factors that are relevant to and consistent with the findings 
contained in section 101.

           denial, revocation, or suspension of registration

  Sec. 304. (a) A registration pursuant to section 303 to 
manufacture, distribute, or dispense a controlled substance or 
a list I chemical may be suspended or revoked by the Attorney 
General upon a finding that the registrant--
          (1) has materially falsified any application filed 
        pursuant to or required by this title or title III;
          (2) has been convicted of a felony under this title 
        or title III or any other law of the United States, or 
        of any State, relating to any substance defined in this 
        title as a controlled substance or a list I chemical;
          (3) has had his State license or registration 
        suspended, revoked, or denied by competent State 
        authority and is no longer authorized by State law to 
        engage in the manufacturing, distribution, or 
        dispensing of controlled substances or list I chemicals 
        or has had the suspension, revocation, or denial of his 
        registration recommended by competent State authority;
          (4) has committed such acts as would render his 
        registration under section 303 inconsistent with the 
        public interest as determined under such section; or
          (5) has been excluded (or directed to be excluded) 
        from participation in a program pursuant to section 
        1128(a) of the Social Security Act.
A registration pursuant to section 303(g)(1) to dispense a 
narcotic drug for maintenance treatment or detoxification 
treatment may be suspended or revoked by the Attorney General 
upon a finding that the registrant has failed to comply with 
any standard referred to in section 303(g)(1).
  (b) The Attorney General may limit revocation or suspension 
of a registration to the particular controlled substance or 
list I chemical with respect to which grounds for revocation or 
suspension exist.
  [(c) Before] (c)(1) Before taking action pursuant to this 
section, or pursuant to a denial of registration under section 
303, the Attorney General shall serve upon the applicant or 
registrant an order to show cause why registration should not 
be denied, revoked, or suspended. The order to show cause shall 
contain a statement of the basis thereof and shall call upon 
the applicant or registrant to appear before the Attorney 
General at a time and place stated in the order, but in no 
event less than thirty days after the date of receipt of the 
order. [Proceedings to deny, revoke, or suspend shall be 
conducted pursuant to this section in accordance with 
subchapter II of chapter 5 of title 5 of the United States 
Code. Such proceedings shall be independent of, and not in lieu 
of, criminal prosecution or other proceedings under this title 
or any other law of the United States.]
  (2) An order to show cause under paragraph (1) shall--
          (A) contain a statement of the basis for the denial, 
        revocation, or suspension, including specific citations 
        to any laws or regulations alleged to be violated by 
        the applicant or registrant;
          (B) direct the applicant or registrant to appear 
        before the Attorney General at a time and place stated 
        in the order, but no less than thirty days after the 
        date of receipt of the order; and
          (C) notify the applicant or registrant of the 
        opportunity to submit a corrective action plan on or 
        before the date of appearance.
  (3) Upon review of any corrective action plan submitted by an 
applicant or registrant pursuant to paragraph (2), the Attorney 
General shall determine whether denial, revocation or 
suspension proceedings should be discontinued, or deferred for 
the purposes of modification, amendment, or clarification to 
such plan.
  (4) Proceedings to deny, revoke, or suspend shall be 
conducted pursuant to this section in accordance with 
subchapter II of chapter 5 of title 5. Such proceedings shall 
be independent of, and not in lieu of, criminal prosecutions or 
other proceedings under this title or any other law of the 
United States.
  (5) The requirements of this subsection shall not apply to 
the issuance of an immediate suspension order under subsection 
(d).
  [(d) The Attorney General] (d)(1) The Attorney General may, 
in his discretion, suspend any registration simultaneously with 
the institution of proceedings under this section, in cases 
where he finds that there is an imminent danger to the public 
health or safety. A failure to comply with a standard referred 
to in section 303(g)(1) may be treated under this subsection as 
grounds for immediate suspension of a registration granted 
under such section. A suspension under this subsection shall 
continue in effect until the conclusion of such proceedings, 
including judicial review thereof, unless sooner withdrawn by 
the Attorney General or dissolved by a court of competent 
jurisdiction.
  (2) In this subsection, the phrase ``imminent danger to the 
public health or safety'' means that, in the absence of an 
immediate suspension order, controlled substances--
          (A) will continue to be intentionally distributed or 
        dispensed--
                  (i) outside the usual course of professional 
                practice; or
                  (ii) in a manner that poses a present or 
                foreseeable risk of serious adverse health 
                consequences or death; or
          (B) will continue to be intentionally diverted 
        outside of legitimate distribution channels.
  (e) The suspension or revocation of a registration under this 
section shall operate to suspend or revoke any quota applicable 
under section 306.
  (f) In the event the Attorney General suspends or revokes a 
registration granted under section 303, all controlled 
substances or list I chemicals owned or possessed by the 
registrant pursuant to such registration at the time of 
suspension or the effective date of the revocation order, as 
the case may be, may, in the discretion of the Attorney 
General, be placed under seal. No disposition may be made of 
any controlled substances or list I chemicals under seal until 
the time for taking an appeal has elapsed or until all appeals 
have been concluded except that a court, upon application 
therefor, may at any time order the sale of perishable 
controlled substances or list I chemicals. Any such order shall 
require the deposit of the proceeds of the sale with the court. 
Upon a revocation order becoming final, all such controlled 
substances or list I chemicals (or proceeds of sale deposited 
in court) shall be forfeited to the United States; and the 
Attorney General shall dispose of such controlled substances or 
list I chemicals in accordance with section 511(e). All right, 
title, and interest in such controlled substances or list I 
chemicals shall vest in the United States upon a revocation 
order becoming final.
  (g) The Attorney General may, in his discretion, seize or 
place under seal any controlled substances or list I chemicals 
owned or possesed by a registrant whose registration has 
expired or who has ceased to practice or do business in the 
manner contemplated by his registration. Such controlled 
substances or list I chemicals shall be held for the benefit of 
the registrant, or his successor in interest. The Attorney 
General shall notify a registrant, or his successor in 
interest, who has any controlled substances or list I chemicals 
seized or placed under seal of the procedures to be followed to 
secure the return of the controlled substance or list I 
chemical and the conditions under which it will be returned. 
The Attorney General may not dispose of any controlled 
substance or list I chemical seized or placed under seal under 
this subsection until the expiration of one hundred and eighty 
days from the date such substance or chemical was seized or 
placed under seal.

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