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114th Congress    }                                   {  Rept. 114-804
                        HOUSE OF REPRESENTATIVES
 2d Session       }                                   {         Part 1

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



 
     PROTECTING PATIENT ACCESS TO EMERGENCY MEDICATIONS ACT OF 2016

                                _______
                                

 November 14, 2016.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

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

                              R E P O R T

                        [To accompany H.R. 4365]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 4365) to amend the Controlled Substances Act 
with regard to the provision of emergency medical services, 
having considered the same, report favorably thereon with an 
amendment and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     4
Background and Need for Legislation..............................     5
Hearings.........................................................     5
Committee Consideration..........................................     5
Committee Votes..................................................     5
Committee Oversight Findings.....................................     6
Statement of General Performance Goals and Objectives............     6
New Budget Authority, Entitlement Authority, and Tax Expenditures     6
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     6
Committee Cost Estimate..........................................     6
Congressional Budget Office Estimate.............................     6
Federal Mandates Statement.......................................     6
Duplication of Federal Programs..................................     6
Disclosure of Directed Rule Makings..............................     7
Advisory Committee Statement.....................................     7
Applicability to Legislative Branch..............................     7
Section-by-Section Analysis of the Legislation...................     7
Changes in Existing Law Made by the Bill, as Reported............     8

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Protecting Patient Access to Emergency 
Medications Act of 2016''.

SEC. 2. EMERGENCY MEDICAL SERVICES.

  Section 303 of the Controlled Substances Act (21 U.S.C. 821 et seq.) 
is amended--
          (1) by redesignating subsection (j) as subsection (k); and
          (2) by inserting after subsection (i) the following:
  ``(j) Emergency Medical Services That Administer Controlled 
Substances.--
          ``(1) Registration.--For the purpose of enabling emergency 
        medical services professionals to administer controlled 
        substances in schedule II, III, IV, or V to ultimate users 
        receiving emergency medical services in accordance with the 
        requirements of this subsection, the Attorney General--
                  ``(A) shall register an emergency medical services 
                agency if the agency submits an application 
                demonstrating it is authorized to conduct such activity 
                under the laws of each State in which the agency 
                practices; and
                  ``(B) may deny an application for such registration 
                if the Attorney General determines that the issuance of 
                such registration would be inconsistent with the 
                requirements of this subsection or the public interest 
                based on the factors listed in subsection (f).
          ``(2) Option for single registration.--In registering an 
        emergency medical services agency pursuant to paragraph (1), 
        the Attorney General shall allow such agency the option of a 
        single registration in each State where the agency administers 
        controlled substances in lieu of requiring a separate 
        registration for each location of the emergency medical 
        services agency.
          ``(3) Hospital-based agency.--If a hospital-based emergency 
        medical services agency is registered under subsection (f), the 
        agency may use the registration of the hospital to administer 
        controlled substances in accordance with this subsection 
        without being registered under this subsection.
          ``(4) Administration outside physical presence of medical 
        director or authorizing medical professional.--Emergency 
        medical services professionals of a registrant emergency 
        medical services agency may administer controlled substances in 
        schedule II, III, IV, or V outside the physical presence of a 
        medical director or authorizing medical professional in the 
        course of providing emergency medical services if the 
        administration is--
                  ``(A) authorized by the law of the State in which it 
                occurs; and
                  ``(B) pursuant to--
                          ``(i) a standing order that is--
                                  ``(I) issued and adopted by 1 or more 
                                medical directors of the agency; or
                                  ``(II) developed by a specific State 
                                authority; or
                          ``(ii) a verbal order that is--
                                  ``(I) issued in accordance with a 
                                policy of the agency;
                                  ``(II) provided by an authorizing 
                                medical professional in response to a 
                                request by the emergency medical 
                                services professional with respect to a 
                                specific patient;
                                  ``(III) in the case of a mass 
                                casualty incident; or
                                  ``(IV) to ensure the proper care and 
                                treatment of a specific patient.
          ``(5) Delivery.--A registrant emergency medical services 
        agency may deliver controlled substances from a registered 
        location of the agency to an unregistered location of the 
        agency only if--
                  ``(A) the agency designates the unregistered location 
                for such delivery; and
                  ``(B) notifies the Attorney General at least 30 days 
                prior to first delivering controlled substances to the 
                unregistered location.
          ``(6) Storage.--A registrant emergency medical services 
        agency may store controlled substances--
                  ``(A) at a registered location of the agency;
                  ``(B) at any designated location of the agency or in 
                an emergency services vehicle situated at a registered 
                or designated location of the agency; or
                  ``(C) in an emergency medical services vehicle used 
                by the agency that is--
                          ``(i) traveling from, or returning to, a 
                        registered or designated location of the agency 
                        in the course of responding to an emergency; or
                          ``(ii) otherwise actively in use by the 
                        agency.
          ``(7) No treatment as distribution.--The delivery of 
        controlled substances by a registrant emergency medical 
        services agency pursuant to this subsection shall not be 
        treated as distribution for purposes of section 308.
          ``(8) Restocking of emergency medical services vehicles at a 
        hospital.--Notwithstanding paragraph (13)(J), a registrant 
        emergency medical services agency may receive controlled 
        substances from a hospital for purposes of restocking an 
        emergency medical services vehicle following an emergency 
        response, and without being subject to the requirements of 
        section 308, provided all of the following conditions are 
        satisfied:
                  ``(A) The registered or designated location of the 
                agency where the vehicle is primarily situated 
                maintains a record of such receipt in accordance with 
                paragraph (9).
                  ``(B) The hospital maintains a record of such 
                delivery to the agency in accordance with section 307.
                  ``(C) If the vehicle is primarily situated at a 
                designated location, such location notifies the 
                registered location of the agency within 72 hours of 
                the vehicle receiving the controlled substances.
          ``(9) Maintenance of records.--
                  ``(A) In general.--A registrant emergency medical 
                services agency shall maintain records in accordance 
                with subsections (a) and (b) of section 307 of all 
                controlled substances that are received, administered, 
                or otherwise disposed of pursuant to the agency's 
                registration, without regard to subsection 
                307(c)(1)(B).
                  ``(B) Requirements.--Such records--
                          ``(i) shall include records of deliveries of 
                        controlled substances between all locations of 
                        the agency; and
                          ``(ii) shall be maintained, whether 
                        electronically or otherwise, at each registered 
                        and designated location of the agency where the 
                        controlled substances involved are received, 
                        administered, or otherwise disposed of.
          ``(10) Other requirements.--A registrant emergency medical 
        services agency, under the supervision of a medical director, 
        shall be responsible for ensuring that--
                  ``(A) all emergency medical services professionals 
                who administer controlled substances using the agency's 
                registration act in accordance with the requirements of 
                this subsection;
                  ``(B) the recordkeeping requirements of paragraph (9) 
                are met with respect to a registered location and each 
                designated location of the agency;
                  ``(C) the applicable physical security requirements 
                established by regulation of the Attorney General are 
                complied with wherever controlled substances are stored 
                by the agency in accordance with paragraph (6); and
                  ``(D) the agency maintains, at a registered location 
                of the agency, a record of the standing orders issued 
                or adopted in accordance with paragraph (9).
          ``(11) Regulations.--The Attorney General may issue 
        regulations--
                  ``(A) specifying, with regard to delivery of 
                controlled substances under paragraph (5)--
                          ``(i) the types of locations that may 
                        designated under such paragraph; and
                          ``(ii) the manner in which a notification 
                        under paragraph (5)(B) must be made;
                  ``(B) specifying, with regard to the storage of 
                controlled substances under paragraph (6), the manner 
                in which such substances must be stored at registered 
                and designated locations, including in emergency 
                medical service vehicles; and
                  ``(C) addressing the ability of hospitals, registered 
                locations, and designated locations to deliver 
                controlled substances to each other in the event of--
                          ``(i) shortages of such substances;
                          ``(ii) a public health emergency; or
                          ``(iii) a mass casualty event.
          ``(12) Rule of construction.--Nothing in this subsection 
        shall be construed--
                  ``(A) to limit the authority vested in the Attorney 
                General by other provisions of this title to take 
                measures to prevent diversion of controlled substances; 
                or
                  ``(B) to override the authority of any State to 
                regulate the provision of emergency medical services.
          ``(13) Definitions.--In this section:
                  ``(A) The term `designated location' means a location 
                designated by an emergency medical services agency 
                under paragraph (5).
                  ``(B) The term `emergency medical services' means 
                emergency medical response and emergency mobile medical 
                services provided outside of a fixed medical facility.
                  ``(C) The term `emergency medical services agency' 
                means an organization providing emergency medical 
                services, including such an organization that--
                          ``(i) is governmental (including fire-based 
                        and hospital-based agencies), nongovernmental 
                        (including hospital-based agencies), private, 
                        or volunteer-based;
                          ``(ii) provides emergency medical services by 
                        ground, air, or otherwise; and
                          ``(iii) is authorized by the State in which 
                        the organization is providing such services to 
                        provide emergency medical care, including the 
                        administering of controlled substances, to 
                        members of the general public on an emergency 
                        basis.
                  ``(D) The term `emergency medical services 
                professional' means a health care professional 
                (including a nurse, paramedic, or emergency medical 
                technician) licensed or certified by the State in which 
                the professional practices and credentialed by a 
                medical director of the respective emergency medical 
                services agency to provide emergency medical services 
                within the scope of the professional's State license or 
                certification.
                  ``(E) The term `emergency medical services vehicle' 
                means an ambulance, fire apparatus, supervisor truck, 
                or other vehicle owned or operated by an emergency 
                medical services agency for the purpose of providing or 
                facilitating emergency medical care and transport or 
                transporting controlled substances to and from the 
                registered and designated locations.
                  ``(F) The term `hospital-based' means, with respect 
                to an agency, owned or operated by a hospital.
                  ``(G) The term `medical director' means a physician 
                who is registered under subsection (f) and provides 
                medical oversight for an emergency medical services 
                agency.
                  ``(H) The term `medical oversight' means supervision 
                of the provision of medical care by an emergency 
                medical services agency.
                  ``(I) The term `medical professional' means an 
                emergency or other physician, or another medical 
                professional (including an advanced practice registered 
                nurse or physician assistant) whose scope of practice 
                under a State license or certification includes the 
                ability to provide verbal orders.
                  ``(J) The term `registered location' means a location 
                that appears on the certificate of registration issued 
                to an emergency medical services agency under this 
                subsection or subsection (f), which shall be where the 
                agency receives controlled substances from 
                distributors.
                  ``(K) The term `registrant emergency medical services 
                agency' means--
                          ``(i) an emergency medical services agency 
                        that is registered pursuant to this subsection; 
                        or
                          ``(ii) a hospital-based emergency medical 
                        services agency that is covered by the 
                        registration of the hospital under subsection 
                        (f).
                  ``(L) The term `specific State authority' means a 
                governmental agency or other such authority, including 
                a regional oversight and coordinating body, that, 
                pursuant to State law or regulation, develops clinical 
                protocols regarding the delivery of emergency medical 
                services in the geographic jurisdiction of such agency 
                or authority within the State that may be adopted by 
                medical directors.
                  ``(M) The term `standing order' means a written 
                medical protocol in which a medical director determines 
                in advance the medical criteria that must be met before 
                administering controlled substances to individuals in 
                need of emergency medical services.
                  ``(N) The term `verbal order' means an oral directive 
                that is given through any method of communication 
                including by radio or telephone, directly to an 
                emergency medical services professional, to 
                contemporaneously administer a controlled substance to 
                individuals in need of emergency medical services 
                outside the physical presence of the authorizing 
                medical director.''.

                          Purpose and Summary

    H.R. 4365 would amend section 303 of the Controlled 
Substances Act (CSA) to provide emergency medical services 
(EMS) agencies an option of a single registration with the Drug 
Enforcement Administration (DEA) in each State where the EMS 
agency administers controlled substances. Further, the bill 
would clarify that EMS professionals are permitted to 
administer controlled substances pursuant to standing or verbal 
orders if certain conditions are met.

                  Background and Need for Legislation

    EMS agencies that administer controlled substances are 
required to register with the DEA. EMS agencies may have 
multiple locations in each State in which their professionals 
provide care. This bill would provide EMS agencies with an 
option of a single registration in each State where the agency 
administers controlled substances, in lieu of separate 
registrations for each location, so long as a number of 
requirements are met related to receipt, movement, and storage.
    Further, it is critically important for EMS professionals 
to be able to administer life-saving medications in a timely 
manner to patients in emergency situations. Paramedics and 
emergency medical technicians (EMTs) currently do so pursuant 
to standing or verbal orders when authorized by State law. 
Recently, questions have been raised about whether the CSA 
permits these practices. This bill would codify what is current 
practice across the U.S. by explicitly authorizing EMS 
professionals to administer controlled substances in emergency 
situations outside the physical presence of a medical director 
or authorizing medical professional when certain requirements 
are met.

                                Hearings

    The Subcommittee on Health held a hearing on H.R. 4365 on 
July 12, 2016. The Subcommittee received testimony from:
           Craig Manifold, Committee Chair, American 
        College of Emergency Physicians, and
           Brent Myers, President-Elect, National 
        Association of EMS Physicians.

                        Committee Consideration

    On September 12 and 13, 2016, the Subcommittee on Health 
met in open markup session and favorably forwarded H.R. 4365, 
as amended, to the full Committee by a voice vote. On September 
20 and 21, 2016, the full Committee met in open markup session 
and ordered H.R. 4365, as amended, favorably reported to the 
House by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no recorded votes taken in connection with ordering 
H.R. 4365 reported.

                      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 bill is to provide EMS agencies with a 
single registration option and to clarify that EMS 
professionals can administer controlled substances pursuant to 
standing and verbal orders.

   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. 
4365 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. 4365 contains no earmarks, limited tax 
benefits, or limited tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974. At the 
time this report was filed, the estimate was not available.

                  Congressional Budget Office Estimate

    At the time this report was filed, the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 1974 
was not available.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    Duplication of Federal Programs

    No provision of H.R. 4365 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. 4365 
specifically directs to be completed zero specific rule makings 
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

    Section 1 provides that the Act may be cited as the 
``Protecting Patient Access to Emergency Medications Act of 
2016''.

Section 2. Emergency Medical Services

    Section 2 amends section 303 of the CSA by adding 
provisions governing EMS agencies that administer controlled 
substances.
    Specifically, section 2 provides EMS agencies with an 
option of a single registration in each State where such an 
agency administers controlled substances in lieu of requiring a 
separate registration for each location of the agency. The 
language clarifies that hospital-based EMS agencies may 
continue to use the DEA registration of their hospital without 
having to register under the new authority established by this 
section.
    Pursuant to such registration, a number of requirements are 
placed on EMS agencies with respect to the delivery, storage, 
and restocking of controlled substances. Specifically, a 
registrant EMS agency may deliver controlled substances from a 
registered location to an unregistered location only if the 
agency designates the unregistered location for such delivery 
and notifies DEA at least 30 days prior to the first delivery. 
Such delivery shall not be treated as distribution for purposes 
of section 308. Further, a registrant EMS agency may store 
controlled substances at a registered or designated location 
or, in certain circumstances, in an EMS vehicle. Finally, a 
registrant EMS agency may receive controlled substances from a 
hospital for purposes of restocking an EMS vehicle following an 
emergency response, provided certain requirements are met. 
Hospitals that restock EMS vehicles consistent with such 
requirements shall not be treated as distributors.
    In addition to the provisions relating to registration of 
an EMS agency and related requirements, section 2 explicitly 
authorizes EMS professionals of a registered EMS agency to 
administer controlled substances outside the physical presence 
of a medical director or authorizing medical professional in 
the course of providing emergency medical services if the 
administration is authorized by the law of the State in which 
it occurs and it is pursuant to a standing or verbal order when 
certain conditions are satisfied.
    Section 2 also authorizes DEA to issue regulations on 
certain provisions and clarifies that nothing in the bill 
limits DEA's authority under the CSA to take measures to 
prevent the diversion of controlled substances. Further, 
section 2 states that nothing in the bill shall be construed to 
override the authority of any State to regulate the provision 
of emergency medical services.

         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, 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) Emergency Medical Services That Administer Controlled 
Substances.--
          (1) Registration.--For the purpose of enabling 
        emergency medical services professionals to administer 
        controlled substances in schedule II, III, IV, or V to 
        ultimate users receiving emergency medical services in 
        accordance with the requirements of this subsection, 
        the Attorney General--
                  (A) shall register an emergency medical 
                services agency if the agency submits an 
                application demonstrating it is authorized to 
                conduct such activity under the laws of each 
                State in which the agency practices; and
                  (B) may deny an application for such 
                registration if the Attorney General determines 
                that the issuance of such registration would be 
                inconsistent with the requirements of this 
                subsection or the public interest based on the 
                factors listed in subsection (f).
          (2) Option for single registration.--In registering 
        an emergency medical services agency pursuant to 
        paragraph (1), the Attorney General shall allow such 
        agency the option of a single registration in each 
        State where the agency administers controlled 
        substances in lieu of requiring a separate registration 
        for each location of the emergency medical services 
        agency.
          (3) Hospital-based agency.--If a hospital-based 
        emergency medical services agency is registered under 
        subsection (f), the agency may use the registration of 
        the hospital to administer controlled substances in 
        accordance with this subsection without being 
        registered under this subsection.
          (4) Administration outside physical presence of 
        medical director or authorizing medical professional.--
        Emergency medical services professionals of a 
        registrant emergency medical services agency may 
        administer controlled substances in schedule II, III, 
        IV, or V outside the physical presence of a medical 
        director or authorizing medical professional in the 
        course of providing emergency medical services if the 
        administration is--
                  (A) authorized by the law of the State in 
                which it occurs; and
                  (B) pursuant to--
                          (i) a standing order that is--
                                  (I) issued and adopted by 1 
                                or more medical directors of 
                                the agency; or
                                  (II) developed by a specific 
                                State authority; or
                          (ii) a verbal order that is--
                                  (I) issued in accordance with 
                                a policy of the agency;
                                  (II) provided by an 
                                authorizing medical 
                                professional in response to a 
                                request by the emergency 
                                medical services professional 
                                with respect to a specific 
                                patient;
                                  (III) in the case of a mass 
                                casualty incident; or
                                  (IV) to ensure the proper 
                                care and treatment of a 
                                specific patient.
          (5) Delivery.--A registrant emergency medical 
        services agency may deliver controlled substances from 
        a registered location of the agency to an unregistered 
        location of the agency only if--
                  (A) the agency designates the unregistered 
                location for such delivery; and
                  (B) notifies the Attorney General at least 30 
                days prior to first delivering controlled 
                substances to the unregistered location.
          (6) Storage.--A registrant emergency medical services 
        agency may store controlled substances--
                  (A) at a registered location of the agency;
                  (B) at any designated location of the agency 
                or in an emergency services vehicle situated at 
                a registered or designated location of the 
                agency; or
                  (C) in an emergency medical services vehicle 
                used by the agency that is--
                          (i) traveling from, or returning to, 
                        a registered or designated location of 
                        the agency in the course of responding 
                        to an emergency; or
                          (ii) otherwise actively in use by the 
                        agency.
          (7) No treatment as distribution.--The delivery of 
        controlled substances by a registrant emergency medical 
        services agency pursuant to this subsection shall not 
        be treated as distribution for purposes of section 308.
          (8) Restocking of emergency medical services vehicles 
        at a hospital.--Notwithstanding paragraph (13)(J), a 
        registrant emergency medical services agency may 
        receive controlled substances from a hospital for 
        purposes of restocking an emergency medical services 
        vehicle following an emergency response, and without 
        being subject to the requirements of section 308, 
        provided all of the following conditions are satisfied:
                  (A) The registered or designated location of 
                the agency where the vehicle is primarily 
                situated maintains a record of such receipt in 
                accordance with paragraph (9).
                  (B) The hospital maintains a record of such 
                delivery to the agency in accordance with 
                section 307.
                  (C) If the vehicle is primarily situated at a 
                designated location, such location notifies the 
                registered location of the agency within 72 
                hours of the vehicle receiving the controlled 
                substances.
          (9) Maintenance of records.--
                  (A) In general.--A registrant emergency 
                medical services agency shall maintain records 
                in accordance with subsections (a) and (b) of 
                section 307 of all controlled substances that 
                are received, administered, or otherwise 
                disposed of pursuant to the agency's 
                registration, without regard to subsection 
                307(c)(1)(B).
                  (B) Requirements.--Such records--
                          (i) shall include records of 
                        deliveries of controlled substances 
                        between all locations of the agency; 
                        and
                          (ii) shall be maintained, whether 
                        electronically or otherwise, at each 
                        registered and designated location of 
                        the agency where the controlled 
                        substances involved are received, 
                        administered, or otherwise disposed of.
          (10) Other requirements.--A registrant emergency 
        medical services agency, under the supervision of a 
        medical director, shall be responsible for ensuring 
        that--
                  (A) all emergency medical services 
                professionals who administer controlled 
                substances using the agency's registration act 
                in accordance with the requirements of this 
                subsection;
                  (B) the recordkeeping requirements of 
                paragraph (9) are met with respect to a 
                registered location and each designated 
                location of the agency;
                  (C) the applicable physical security 
                requirements established by regulation of the 
                Attorney General are complied with wherever 
                controlled substances are stored by the agency 
                in accordance with paragraph (6); and
                  (D) the agency maintains, at a registered 
                location of the agency, a record of the 
                standing orders issued or adopted in accordance 
                with paragraph (9).
          (11) Regulations.--The Attorney General may issue 
        regulations--
                  (A) specifying, with regard to delivery of 
                controlled substances under paragraph (5)--
                          (i) the types of locations that may 
                        designated under such paragraph; and
                          (ii) the manner in which a 
                        notification under paragraph (5)(B) 
                        must be made;
                  (B) specifying, with regard to the storage of 
                controlled substances under paragraph (6), the 
                manner in which such substances must be stored 
                at registered and designated locations, 
                including in emergency medical service 
                vehicles; and
                  (C) addressing the ability of hospitals, 
                registered locations, and designated locations 
                to deliver controlled substances to each other 
                in the event of--
                          (i) shortages of such substances;
                          (ii) a public health emergency; or
                          (iii) a mass casualty event.
          (12) Rule of construction.--Nothing in this 
        subsection shall be construed--
                  (A) to limit the authority vested in the 
                Attorney General by other provisions of this 
                title to take measures to prevent diversion of 
                controlled substances; or
                  (B) to override the authority of any State to 
                regulate the provision of emergency medical 
                services.
          (13) Definitions.--In this section:
                  (A) The term ``designated location'' means a 
                location designated by an emergency medical 
                services agency under paragraph (5).
                  (B) The term ``emergency medical services'' 
                means emergency medical response and emergency 
                mobile medical services provided outside of a 
                fixed medical facility.
                  (C) The term ``emergency medical services 
                agency'' means an organization providing 
                emergency medical services, including such an 
                organization that--
                          (i) is governmental (including fire-
                        based and hospital-based agencies), 
                        nongovernmental (including hospital-
                        based agencies), private, or volunteer-
                        based;
                          (ii) provides emergency medical 
                        services by ground, air, or otherwise; 
                        and
                          (iii) is authorized by the State in 
                        which the organization is providing 
                        such services to provide emergency 
                        medical care, including the 
                        administering of controlled substances, 
                        to members of the general public on an 
                        emergency basis.
                  (D) The term ``emergency medical services 
                professional'' means a health care professional 
                (including a nurse, paramedic, or emergency 
                medical technician) licensed or certified by 
                the State in which the professional practices 
                and credentialed by a medical director of the 
                respective emergency medical services agency to 
                provide emergency medical services within the 
                scope of the professional's State license or 
                certification.
                  (E) The term ``emergency medical services 
                vehicle'' means an ambulance, fire apparatus, 
                supervisor truck, or other vehicle owned or 
                operated by an emergency medical services 
                agency for the purpose of providing or 
                facilitating emergency medical care and 
                transport or transporting controlled substances 
                to and from the registered and designated 
                locations.
                  (F) The term ``hospital-based'' means, with 
                respect to an agency, owned or operated by a 
                hospital.
                  (G) The term ``medical director'' means a 
                physician who is registered under subsection 
                (f) and provides medical oversight for an 
                emergency medical services agency.
                  (H) The term ``medical oversight'' means 
                supervision of the provision of medical care by 
                an emergency medical services agency.
                  (I) The term ``medical professional'' means 
                an emergency or other physician, or another 
                medical professional (including an advanced 
                practice registered nurse or physician 
                assistant) whose scope of practice under a 
                State license or certification includes the 
                ability to provide verbal orders.
                  (J) The term ``registered location'' means a 
                location that appears on the certificate of 
                registration issued to an emergency medical 
                services agency under this subsection or 
                subsection (f), which shall be where the agency 
                receives controlled substances from 
                distributors.
                  (K) The term ``registrant emergency medical 
                services agency'' means--
                          (i) an emergency medical services 
                        agency that is registered pursuant to 
                        this subsection; or
                          (ii) a hospital-based emergency 
                        medical services agency that is covered 
                        by the registration of the hospital 
                        under subsection (f).
                  (L) The term ``specific State authority'' 
                means a governmental agency or other such 
                authority, including a regional oversight and 
                coordinating body, that, pursuant to State law 
                or regulation, develops clinical protocols 
                regarding the delivery of emergency medical 
                services in the geographic jurisdiction of such 
                agency or authority within the State that may 
                be adopted by medical directors.
                  (M) The term ``standing order'' means a 
                written medical protocol in which a medical 
                director determines in advance the medical 
                criteria that must be met before administering 
                controlled substances to individuals in need of 
                emergency medical services.
                  (N) The term ``verbal order'' means an oral 
                directive that is given through any method of 
                communication including by radio or telephone, 
                directly to an emergency medical services 
                professional, to contemporaneously administer a 
                controlled substance to individuals in need of 
                emergency medical services outside the physical 
                presence of the authorizing medical director.
  [(j)] (k) 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.

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