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115th Congress }                                         {  Rept. 115-192
                        HOUSE OF REPRESENTATIVES
 1st Session   }                                         {  Part 1

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

 
        MEDICAL CONTROLLED SUBSTANCES TRANSPORTATION ACT OF 2017

                                _______
                                

 June 23, 2017.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Walden, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 1492]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1492) to amend the Controlled Substances Act to 
direct the Attorney General to register practitioners to 
transport controlled substances to States in which the 
practitioner is not registered under the Act for the purpose of 
administering the substances (under applicable State law) at 
locations other than principal places of business or 
professional practice, 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
Committee Action.................................................     2
Committee Votes..................................................     2
Oversight Findings and Recommendations...........................     2
New Budget Authority, Entitlement Authority, and Tax Expenditures     2
Congressional Budget Office Estimate.............................     2
Federal Mandates Statement.......................................     3
Statement of General Performance Goals and Objectives............     3
Duplication of Federal Programs..................................     3
Committee Cost Estimate..........................................     3
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     3
Disclosure of Directed Rule Makings..............................     3
Advisory Committee Statement.....................................     3
Applicability to Legislative Branch..............................     3
Section-by-Section Analysis of the Legislation...................     3
Changes in Existing Law Made by the Bill, as Reported............     4

                          Purpose and Summary

    The bill would amend the Controlled Substances Act (CSA) to 
authorize a practitioner, who is registered under section 
303(f) of the CSA, to transport and administer controlled 
substances to patients outside of the State in which they are 
registered under subsection (f) at locations other than a 
principal place of business or professional practice. In order 
to do so, the practitioner would need to have a separate 
registration issued by the Drug Enforcement Administration 
(DEA) pursuant to section 303(k), as added by this bill, and 
meet a number of conditions.

                  Background and Need for Legislation

    The CSA currently prohibits the transportation and 
administration of controlled substances away from the location 
registered with DEA. Therefore, the statute does not permit 
registered practitioners with inherently mobile practices, such 
as emergency medical services personnel traveling to a disaster 
area, to transport and administer pain or anti-seizure 
medication. This legislation would establish a separate 
registration process at DEA to authorize such transportation 
and administration while providing for appropriate oversight.

                            Committee Action

    The Committee on Energy and Commerce has not held hearings 
on the legislation, though a previous version of the bill was 
the subject of a hearing during the 114th Congress and was 
favorably reported to the House by a voice vote.
    On June 7, 2017, the full Committee on Energy and Commerce 
met in open markup session and ordered H.R. 1492 favorably 
reported to the House, without amendment, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII 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. 1492 reported.

                 Oversight Findings and Recommendations

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee has not held hearings on this 
legislation.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R. 1492 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII, 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.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to 
establish a registration process at DEA to allow practitioners 
to transport and administer controlled substances at locations 
other than their principal place of business or professional 
practice under certain conditions.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 1492 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, 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.

      Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 1492 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                  Disclosure of Directed Rule Makings

    Pursuant to section 3(i) of H. Res. 5, the Committee finds 
that H.R. 1492 contains no directed rule makings.

                      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

    Section 1 provides that the Act may be cited as the 
``Medical Controlled Substances Transportation Act of 2017''.

Section 2. Registration for transport of controlled substances to 
        states in which the practitioner is not registered under the 
        Controlled Substances Act for the purpose of administering the 
        substances at locations other than principal places of business 
        or professional practice

    Section 2 would amend section 303 of the CSA by adding a 
new subsection (k) that would authorize DEA, upon application 
by a practitioner who is registered under subsection (f), to 
issue a separate registration authorizing the practitioner to 
transport controlled substances from the practitioner's 
registered location for the purpose of administrating the 
substances at locations other than a principal place of 
business or professional practice.
    In order for a practitioner to transport and administer 
controlled substances pursuant to this registration, the 
practitioner must be licensed, registered, or otherwise 
permitted by the State in which the substances are administered 
to carry out such activity at the location where it occurs. In 
addition, the practitioner must limit the time of transport to 
not more than 72 consecutive hours and return any such 
substances not administered to their registered location from 
which they were obtained. Further, the practitioner must 
maintain records of the transporting and administering. DEA 
would maintain the authority to deny or revoke a registration.

         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

           *       *       *       *       *       *       *



                       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 practitioner (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 provide 
        directly, by referral, or in such other manner as 
        determined by the Secretary--
                  (I) all drugs approved by the Food and Drug 
                Administration for the treatment of opioid use 
                disorder, including for maintenance, 
                detoxification, overdose reversal, and relapse 
                prevention; and
                  (II) appropriate counseling and other 
                appropriate ancillary services.
          (iii)(I) The total number of such patients of the 
        practitioner at any one time will not exceed the 
        applicable number. Except as provided in subclause 
        (II), the applicable number is 30.
          (II) The applicable number is 100 if, 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.
          (III) The Secretary may by regulation change such 
        applicable number.
          (IV) The Secretary may exclude from the applicable 
        number patients to whom such drugs or combinations of 
        drugs are directly administered by the qualifying 
        practitioner in the office setting.
  (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 determination from the Secretary under 
clause (iii) finding that a practitioner meets all requirements 
for a waiver 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) and shall forward such determination to the 
Attorney General. If the Secretary fails to make such 
determination by the end of the such 45-day period, the 
Attorney General shall assign the practitioner 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 board certification 
                in addiction psychiatry or addiction medicine 
                from the American Board of Medical Specialties.
                  (II) The physician holds an addiction 
                certification or board certification from the 
                American Society of Addiction Medicine or the 
                American Board of Addiction Medicine.
                  (III) The physician holds a 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 8 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. Such training shall 
                include--
                          (aa) opioid maintenance and 
                        detoxification;
                          (bb) appropriate clinical use of all 
                        drugs approved by the Food and Drug 
                        Administration for the treatment of 
                        opioid use disorder;
                          (cc) initial and periodic patient 
                        assessments (including substance use 
                        monitoring);
                          (dd) individualized treatment 
                        planning, overdose reversal, and 
                        relapse prevention;
                          (ee) counseling and recovery support 
                        services;
                          (ff) staffing roles and 
                        considerations;
                          (gg) diversion control; and
                          (hh) other best practices, as 
                        identified by the Secretary.
                  (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.
          (iii) The term ``qualifying practitioner'' means--
                  (I) a qualifying physician, as defined in 
                clause (ii); or
                  (II) during the period beginning on the date 
                of enactment of the Comprehensive Addiction and 
                Recovery Act of 2016 and ending on October 1, 
                2021, a qualifying other practitioner, as 
                defined in clause (iv).
          (iv) The term ``qualifying other practitioner'' means 
        a nurse practitioner or physician assistant who 
        satisfies each of the following:
                  (I) The nurse practitioner or physician 
                assistant is licensed under State law to 
                prescribe schedule III, IV, or V medications 
                for the treatment of pain.
                  (II) The nurse practitioner or physician 
                assistant has--
                          (aa) completed not fewer than 24 
                        hours of initial training addressing 
                        each of the topics listed in clause 
                        (ii)(IV) (through classroom situations, 
                        seminars at professional society 
                        meetings, electronic communications, or 
                        otherwise) provided by the American 
                        Society of Addiction Medicine, the 
                        American Academy of Addiction 
                        Psychiatry, the American Medical 
                        Association, the American Osteopathic 
                        Association, the American Nurses 
                        Credentialing Center, the American 
                        Psychiatric Association, the American 
                        Association of Nurse Practitioners, the 
                        American Academy of Physician 
                        Assistants, or any other organization 
                        that the Secretary determines is 
                        appropriate for purposes of this 
                        subclause; or
                          (bb) has such other training or 
                        experience as the Secretary determines 
                        will demonstrate the ability of the 
                        nurse practitioner or physician 
                        assistant to treat and manage opiate-
                        dependent patients.
                  (III) The nurse practitioner or physician 
                assistant is supervised by, or works in 
                collaboration with, a qualifying physician, if 
                the nurse practitioner or physician assistant 
                is required by State law to prescribe 
                medications for the treatment of opioid use 
                disorder in collaboration with or under the 
                supervision of a physician.
The Secretary may, by regulation, revise the requirements for 
being a qualifying other practitioner under this clause.
  (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.
          (III) Such other elements of the requirements under 
        this paragraph as the Secretary determines necessary 
        for purposes of implementing such requirements.
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 18 months after the date of enactment of 
the Opioid Use Disorder Treatment Expansion and Modernization 
Act, the Secretary shall update the treatment improvement 
protocol containing best practice guidelines for the treatment 
of opioid-dependent patients in office-based settings. The 
Secretary shall update such protocol in consultation with 
experts in opioid use disorder research and treatment.
  (I) Notwithstanding section 708, nothing in this paragraph 
shall be construed to preempt any State law that--
          (i) permits a qualifying practitioner to dispense 
        narcotic drugs in schedule III, IV, or V, or 
        combinations of such drugs, for maintenance or 
        detoxification treatment in accordance with this 
        paragraph to a total number of patients that is more 
        than 30 or less than the total number applicable to the 
        qualifying practitioner under subparagraph (B)(iii)(II) 
        if a State enacts a law modifying such total number and 
        the Attorney General is notified by the State of such 
        modification; or
          (ii) requires a qualifying practitioner to comply 
        with additional requirements relating to the dispensing 
        of narcotic drugs in schedule III, IV, or V, or 
        combinations of such drugs, including requirements 
        relating to the practice setting in which the 
        qualifying practitioner practices and education, 
        training, and reporting requirements.
  (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)(1) For purposes of registration to manufacture a 
controlled substance under subsection (d) for use only in a 
clinical trial, the Attorney General shall register the 
applicant, or serve an order to show cause upon the applicant 
in accordance with section 304(c), not later than 180 days 
after the date on which the application is accepted for filing.
  (2) For purposes of registration to manufacture a controlled 
substance under subsection (a) for use only in a clinical 
trial, the Attorney General shall, in accordance with the 
regulations issued by the Attorney General, issue a notice of 
application not later than 90 days after the application is 
accepted for filing. Not later than 90 days after the date on 
which the period for comment pursuant to such notice ends, the 
Attorney General shall register the applicant, or serve an 
order to show cause upon the applicant in accordance with 
section 304(c), unless the Attorney General has granted a 
hearing on the application under section 1008(i) of the 
Controlled Substances Import and Export Act.
  (j) 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.
  (k) Registration for Transport of Controlled Substances to 
States in Which the Practitioner Is Not Registered for the 
Purpose of Administering the Substances at Locations Other Than 
Principal Places of Business or Professional Practice.--
          (1) In general.--Upon application by a practitioner 
        (other than a pharmacy) who is registered under 
        subsection (f), the Attorney General shall issue a 
        separate registration to the practitioner authorizing 
        the practitioner--
                  (A) to transport one or more controlled 
                substances in schedule II, III, IV, or V from 
                the practitioner's registered location in a 
                State to one or more States in which the 
                practitioner is not registered under subsection 
                (f) for the purpose of the practitioner 
                administering the substances at locations other 
                than a principal place of business or 
                professional practice; and
                  (B) to so administer the substances.
          (2) Requirements.--For a practitioner to be 
        authorized to transport and administer controlled 
        substances pursuant to a registration issued under 
        paragraph (1), all of the following conditions must be 
        satisfied:
                  (A) The practitioner must be licensed, 
                registered, or otherwise permitted by the State 
                in which the controlled substances are 
                administered to carry out such activity at the 
                location where it occurs.
                  (B) The practitioner must--
                          (i) limit the time of transport and 
                        administering of any controlled 
                        substance pursuant to such registration 
                        to not more than 72 consecutive hours; 
                        and
                          (ii) by the conclusion of such 72 
                        hours, return any such controlled 
                        substance so transported but not 
                        administered to the registered location 
                        from which such substance was obtained.
                  (C)(i) The practitioner must maintain records 
                of the transporting and administering of any 
                controlled substance pursuant to this 
                subsection.
                  (ii) Such records shall be maintained, in 
                accordance with the requirements of section 
                307(b), at the practitioner's registered 
                location from which the controlled substances 
                were obtained and shall include--
                          (I) the location where the controlled 
                        substance was administered; and
                          (II) such other information as may be 
                        required by regulation of the Attorney 
                        General with respect to records for 
                        dispensers of controlled substances.
                  (iii) Notwithstanding clause (ii), the 
                exception in subsection 307(c)(1)(B) shall not 
                apply to records required by this subparagraph.
          (3) Grounds for denial or revocation.--The Attorney 
        General may deny an application for registration under 
        this subsection, or a renewal thereof, or revoke such 
        registration, based on the criteria listed in section 
        304(a), except that the applicant shall not be 
        required, as a condition of initially obtaining such 
        registration, to present proof of State authorization 
        to administer controlled substances.
          (4) Automatic termination.--A registration issued 
        under this subsection shall automatically terminate if 
        the practitioner no longer has an active registration 
        under subsection (f) due to revocation, suspension, 
        surrender, or other termination.
          (5) Definition.--In this subsection, the term 
        ``registered location'' means, with respect to each 
        registration issued to a practitioner under subsection 
        (f), the address that appears on the certificate of 
        registration.

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