[House Report 115-192]
[From the U.S. Government Publishing Office]
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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