21 Usc 823

§ 822a

TITLE 21—FOOD AND DRUGS

accept controlled substances unless they get specific
permission from the Drug Enforcement Administration and arrange for full-time law enforcement officers to receive the controlled substances directly
from the member of the public who seeks to dispose
of them.
‘‘(C) Individuals seeking to reduce the amount of
unwanted controlled substances in their household
consequently have few disposal options beyond discarding or flushing the substances, which may not be
appropriate means of disposing of the substances.
Drug take-back programs are also a convenient and
effective means for individuals in various communities to reduce the introduction of some potentially
harmful substances into the environment, particularly into water.
‘‘(D) Long-term care facilities face a distinct set of
obstacles to the safe disposal of controlled substances
due to the increased volume of controlled substances
they handle.
‘‘(5) This Act [see Short Title of 2010 Amendment
note set out under section 801 of this title] gives the
Attorney General authority to promulgate new regulations, within the framework of the Controlled Substances Act [21 U.S.C. 801 et seq.], that will allow patients to deliver unused pharmaceutical controlled
substances to appropriate entities for disposal in a
safe and effective manner consistent with effective
controls against diversion.
‘‘(6) The goal of this Act is to encourage the Attorney General to set controlled substance diversion prevention parameters that will allow public and private
entities to develop a variety of methods of collection
and disposal of controlled substances, including some
pharmaceuticals, in a secure, convenient, and responsible manner. This will also serve to reduce instances
of diversion and introduction of some potentially
harmful substances into the environment.’’

Page 694

§ 822a. Prescription drug take back expansion
(a) Definition of covered entity
In this section, the term ‘‘covered entity’’
means—
(1) a State, local, or tribal law enforcement
agency;
(2) a manufacturer, distributor, or reverse
distributor of prescription medications;
(3) a retail pharmacy;
(4) a registered narcotic treatment program;
(5) a hospital or clinic with an onsite pharmacy;
(6) an eligible long-term care facility; or
(7) any other entity authorized by the Drug
Enforcement Administration to dispose of prescription medications.
(b) Program authorized
The Attorney General, in coordination with
the Administrator of the Drug Enforcement Administration, the Secretary of Health and
Human Services, and the Director of the Office
of National Drug Control Policy, shall coordinate with covered entities in expanding or making available disposal sites for unwanted prescription medications.
(Pub. L. 114–198, title II, § 203, July 22, 2016, 130
Stat. 717.)
CODIFICATION
Section was enacted as part of the Comprehensive
Addiction and Recovery Act of 2016, and not as part of
the Controlled Substances Act which comprises this
subchapter.

PROVISIONAL REGISTRATION
Pub. L. 91–513, title II, § 703, Oct. 27, 1970, 84 Stat. 1283,
as amended by Pub. L. 99–514, § 2, Oct. 22, 1986, 100 Stat.
2095, provided that:
‘‘(a)(1) Any person who—
‘‘(A) is engaged in manufacturing, distributing, or
dispensing any controlled substance on the day before
the effective date of section 302 [this section], and
‘‘(B) is registered on such day under section 510 of
the Federal Food, Drug, and Cosmetic Act [section
360 of this title] or under section 4722 of the Internal
Revenue Code of 1986 [formerly I.R.C. 1954, section
4722 of Title 26],
shall, with respect to each establishment for which
such registration is in effect under any such section, be
deemed to have a provisional registration under section
303 [section 823 of this title] for the manufacture, distribution, or dispensing (as the case may be) of controlled substances.
‘‘(2) During the period his provisional registration is
in effect under this section, the registration number assigned such person under such section 510 [section 360
of this title] or under such section 4722 [section 4722 of
Title 26] (as the case may be) shall be his registration
number for purposes of section 303 of this title [section
823 of this title].
‘‘(b) The provisions of section 304 [section 824 of this
title], relating to suspension and revocation of registration, shall apply to a provisional registration
under this section.
‘‘(c) Unless sooner suspended or revoked under subsection (b), a provisional registration of a person under
subsection (a)(1) of this section shall be in effect until—
‘‘(1) the date on which such person has registered
with the Attorney General under section 303 [section
823 of this title] or has had his registration denied
under such section, or
‘‘(2) such date as may be prescribed by the Attorney
General for registration of manufacturers, distributors, or dispensers, as the case may be,
whichever occurs first.’’

§ 823. Registration requirements
(a) Manufacturers of controlled substances in
schedule I or II
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 May 1, 1971. 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

Page 695

TITLE 21—FOOD AND DRUGS

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) Distributors of controlled substances in
schedule I or II
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 control 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) Limits of authorized activities
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
826 of this title.
(d) Manufacturers of controlled substances in
schedule III, IV, or V
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.

§ 823

(e)

Distributors of controlled substances in
schedule III, IV, or V
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) Research by practitioners; pharmacies; research applications; construction of Article 7
of the Convention on Psychotropic Substances
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 Secretary, who shall determine the qualifications and competency of

§ 823

TITLE 21—FOOD AND DRUGS

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 824(a) of
this title. Article 7 of the Convention on Psychotropic 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 subchapter.
(g) Practitioners dispensing narcotic drugs for
narcotic treatment; annual registration; separate registration; qualifications; waiver
(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 827 of this title) 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:

Page 696

(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 [21 U.S.C. 301 et seq.] or section 262 of title
42, 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).

Page 697

TITLE 21—FOOD AND DRUGS

(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
824(a)(4) of this title, 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 reg-

§ 823

istration 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 1395nn(h)(4) of
title 42.
(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

§ 823

TITLE 21—FOOD AND DRUGS

Page 698

ability of the physician to treat and manage
opiate-dependent patients.
(VII) The physician has such other training or experience as the Secretary considers
to demonstrate the ability of the physician
to treat and manage opiate-dependent patients. Any criteria of the Secretary under
this subclause shall be established by regulation. Any such criteria are effective only for
3 years after the date on which the criteria
are promulgated, but may be extended for
such additional discrete 3-year periods as
the Secretary considers appropriate for purposes of this subclause. Such an extension of
criteria may only be effectuated through a
statement published in the Federal Register
by the Secretary during the 30-day period
preceding the end of the 3-year period involved.

(H)(i) In consultation with the Administrator
of the Drug Enforcement Administration, the
Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the National Institute on Drug Abuse, and
the Commissioner of Food and Drugs, the Secretary shall issue regulations (through notice
and comment rulemaking) or issue practice
guidelines to address the following:
(I) Approval of additional credentialing bodies and the responsibilities of additional credentialing bodies.
(II) Additional exemptions from the requirements of this paragraph and any regulations
under this paragraph.
(III) Such other elements of the requirements under this paragraph as the Secretary
determines necessary for purposes of implementing such requirements.

(iii) The term ‘‘qualifying practitioner’’
means—
(I) a qualifying physician, as defined in
clause (ii); or
(II) during the period beginning on July 22,
2016, and ending on October 1, 2021, a qualifying other practitioner, as defined in clause
(iv).

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,1 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 903 of this title,
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) Applicants for distribution of list I chemicals
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 802(39)(A) of this title. In determining the public interest for the purposes of
this subsection, the Attorney General shall consider—

(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.

1 See

References in Text note below.

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TITLE 21—FOOD AND DRUGS

(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) Registration to manufacture certain controlled substances for use only in a clinical
trial
(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 824(c) of this title, 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 824(c) of this title,
unless the Attorney General has granted a hearing on the application under section 958(i) of
this title.
(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.

§ 823

(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 registered 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 issued and
adopted by one or more medical directors
of the agency, including any such order
that may be developed by a specific State
authority; or
(ii) a verbal order that is—
(I) issued in accordance with a policy
of the agency; and
(II) provided by a medical director or
authorizing medical professional in response to a request by the emergency
medical services professional with respect to a specific patient—
(aa) in the case of a mass casualty
incident; or
(bb) to ensure the proper care and
treatment of a specific patient.
(5) Delivery
A registered emergency medical services
agency may deliver controlled substances
from a registered location of the agency to an
unregistered location of the agency only if the
agency—
(A) 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 registered 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 under circumstances that provide
for security of the controlled substances
consistent with the requirements established by regulations of the Attorney General.

§ 823

TITLE 21—FOOD AND DRUGS

(7) No treatment as distribution
The delivery of controlled substances by a
registered emergency medical services agency
pursuant to this subsection shall not be treated as distribution for purposes of section 828 of
this title.
(8) Restocking of emergency medical services
vehicles at a hospital
Notwithstanding paragraph (13)(J), a registered 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 828 of this title,
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 827 of this title.
(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 registered emergency medical services
agency shall maintain records in accordance
with subsections (a) and (b) of section 827 of
this title of all controlled substances that
are received, administered, or otherwise disposed of pursuant to the agency’s registration,
without
regard
to
subsection
827(c)(1)(B) of this title.
(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 registered 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

Page 700

(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 be
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,
emergency medical services agencies, 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
subchapter 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 consistent with this subsection.
(13) Definitions
In this section:
(A) The term ‘‘authorizing medical professional’’ means an emergency or other physician, or another medical professional (including an advanced practice registered
nurse or physician assistant)—
(i) who is registered under this chapter;
(ii) who is acting within the scope of the
registration; and
(iii) whose scope of practice under a
State license or certification includes the
ability to provide verbal orders.
(B) The term ‘‘designated location’’ means
a location designated by an emergency medical services agency under paragraph (5).
(C) The term ‘‘emergency medical services’’ means emergency medical response
and emergency mobile medical services provided outside of a fixed medical facility.
(D) 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

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TITLE 21—FOOD AND DRUGS

to provide emergency medical care, including the administering of controlled substances, to members of the general public
on an emergency basis.
(E) 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.
(F) The term ‘‘emergency medical services
vehicle’’ means an ambulance, fire apparatus, supervisor truck, or other vehicle used
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.
(G) The term ‘‘hospital-based’’ means,
with respect to an agency, owned or operated by a hospital.
(H) The term ‘‘medical director’’ means a
physician who is registered under subsection
(f) and provides medical oversight for an
emergency medical services agency.
(I) The term ‘‘medical oversight’’ means
supervision of the provision of medical care
by an emergency medical services agency.
(J) The term ‘‘registered 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).
(K) 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.
(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 medical
director or authorizing medical professional.
(k) ‘‘Factors as may be relevant to and consistent
with the public health and safety’’ defined
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 801 of this title.
(Pub. L. 91–513, title II, § 303, Oct. 27, 1970, 84
Stat. 1253; Pub. L. 93–281, § 3, May 14, 1974, 88
Stat. 124; Pub. L. 95–633, title I, § 109, Nov. 10,
1978, 92 Stat. 3773; Pub. L. 98–473, title II, § 511,
Oct. 12, 1984, 98 Stat. 2073; Pub. L. 103–200, § 3(c),
Dec. 17, 1993, 107 Stat. 2336; Pub. L. 106–310, div.
B, title XXXV, § 3502(a), Oct. 17, 2000, 114 Stat.
1222; Pub. L. 107–273, div. B, title II, § 2501, Nov.
2, 2002, 116 Stat. 1803; Pub. L. 109–56, § 1(a), (b),
Aug. 2, 2005, 119 Stat. 591; Pub. L. 109–177, title
VII, § 712(a)(3), Mar. 9, 2006, 120 Stat. 263; Pub. L.
109–469, title XI, § 1102, Dec. 29, 2006, 120 Stat.
3540; Pub. L. 110–425, § 3(b), Oct. 15, 2008, 122 Stat.
4824; Pub. L. 114–89, § 3, Nov. 25, 2015, 129 Stat.
701; Pub. L. 114–145, § 2(a)(1), Apr. 19, 2016, 130
Stat. 354; Pub. L. 114–198, title III, § 303(a)(1), (b),
July 22, 2016, 130 Stat. 720, 723; Pub. L. 115–83, § 2,
Nov. 17, 2017, 131 Stat. 1267.)
REFERENCES IN TEXT
Schedules I, II, III, IV, and V, referred to in subsecs.
(a) to (f), (g)(2), and (j)(1), (4), are set out in section
812(c) of this title.
This subchapter, referred to in subsecs. (f) and
(j)(12)(A), was in the original ‘‘this title’’, meaning title
II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is
popularly known as the ‘‘Controlled Substances Act’’.
For complete classification of title II to the Code, see
second paragraph of Short Title note set out under section 801 of this title and Tables.
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (g)(2)(C)(i), is act June 25, 1938, ch. 675, 52
Stat. 1040, as amended, which is classified generally to
chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this
title and Tables.
The date of enactment of the Opioid Use Disorder
Treatment Expansion and Modernization Act, referred
to in subsec. (g)(2)(H)(ii), probably means the date of
enactment of Pub. L. 114–198, known as the Comprehensive Addiction and Recovery Act of 2016, which was approved July 22, 2016. The Opioid Use Disorder Treatment Expansion and Modernization Act was H.R. 4981 of
the 114th Congress, as introduced on Apr. 18, 2016.
Amendatory provisions of H.R. 4981 were incorporated
into Pub. L. 114–198, but no such Short Title was enacted.
This chapter, referred to in subsec. (j)(13)(A)(i), was
in the original ‘‘this Act’’, meaning Pub. L. 91–513, Oct.
27, 1970, 84 Stat. 1236. For complete classification of this
Act to the Code, see Short Title note set out under section 801 of this title and Tables.
AMENDMENTS
2017—Subsecs. (j), (k). Pub. L. 115–83 added subsec. (j)
and redesignated former subsec. (j) as (k).
2016—Subsec. (g)(2)(B). Pub. L. 114–198, § 303(a)(1)(A),
added cls. (i) to (iii) and struck out former cls. (i) to
(iii) which read as follows:
‘‘(i) The practitioner is a qualifying physician (as defined in subparagraph (G)).
‘‘(ii) With respect to patients to whom the practitioner will provide such drugs or combinations of

§ 823

TITLE 21—FOOD AND DRUGS

drugs, the practitioner has the capacity to refer the patients for appropriate counseling and other appropriate
ancillary services.
‘‘(iii) The total number of such patients of the practitioner at any one time will not exceed the applicable
number. For purposes of this clause, the applicable
number is 30, unless, not sooner than 1 year after the
date on which the practitioner submitted the initial
notification, the practitioner submits a second notification to the Secretary of the need and intent of the
practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications
required by clauses (i) and (ii) of this subparagraph.
The Secretary may by regulation change such total
number.’’
Subsec. (g)(2)(D)(ii). Pub. L. 114–198, § 303(a)(1)(B)(i),
substituted ‘‘Upon receiving a determination from the
Secretary under clause (iii) finding that a practitioner
meets all requirements for a waiver under subparagraph (B)’’ for ‘‘Upon receiving a notification under
subparagraph (B)’’.
Subsec. (g)(2)(D)(iii). Pub. L. 114–198, § 303(a)(1)(B)(ii),
inserted ‘‘and shall forward such determination to the
Attorney General’’ after ‘‘a waiver under subparagraph
(B)’’ and substituted ‘‘assign the practitioner’’ for ‘‘assign the physician’’.
Subsec. (g)(2)(G)(ii)(I). Pub. L. 114–198, § 303(a)(1)(C)(i),
amended subcl. (I) generally. Prior to amendment,
subcl. (I) read as follows: ‘‘The physician holds a subspecialty board certification in addiction psychiatry
from the American Board of Medical Specialties.’’
Subsec.
(g)(2)(G)(ii)(II).
Pub.
L.
114–198,
§ 303(a)(1)(C)(ii), amended subcl. (II) generally. Prior to
amendment, subcl. (II) read as follows: ‘‘The physician
holds an addiction certification from the American Society of Addiction Medicine.’’
Subsec.
(g)(2)(G)(ii)(III).
Pub.
L.
114–198,
§ 303(a)(1)(C)(iii), struck out ‘‘subspecialty’’ before
‘‘board certification’’.
Subsec.
(g)(2)(G)(ii)(IV).
Pub.
L.
114–198,
§ 303(a)(1)(C)(iv), amended subcl. (IV) generally. Prior to
amendment, subcl. (IV) read as follows: ‘‘The physician
has, with respect to the treatment and management of
opiate-dependent patients, completed not less than
eight hours of training (through classroom situations,
seminars at professional society meetings, electronic
communications, or otherwise) that is provided by the
American Society of Addiction Medicine, the American
Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association,
the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause.’’
Subsec.
(g)(2)(G)(iii),
(iv).
Pub.
L.
114–198,
§ 303(a)(1)(C)(v), added cls. (iii) and (iv).
Subsec.
(g)(2)(H)(i)(III).
Pub.
L.
114–198,
§ 303(a)(1)(D)(i), added subcl. (III).
Subsec. (g)(2)(H)(ii). Pub. L. 114–198, § 303(a)(1)(D)(ii),
amended cl. (ii) generally. Prior to amendment, cl. (ii)
read as follows: ‘‘Not later than 120 days after October
17, 2000, the Secretary shall issue a treatment improvement protocol containing best practice guidelines for
the treatment and maintenance of opiate-dependent patients. The Secretary shall develop the protocol in consultation with the Director of the National Institute on
Drug Abuse, the Administrator of the Drug Enforcement Administration, the Commissioner of Food and
Drugs, the Administrator of the Substance Abuse and
Mental Health Services Administration and other substance abuse disorder professionals. The protocol shall
be guided by science.’’
Subsec. (g)(2)(I), (J). Pub. L. 114–198, § 303(b), added
subpar. (I) and struck out former subpars. (I) and (J)
which limited a State’s ability to preclude a practitioner from dispensing or prescribing certain approved
drugs and provided the effective date of the paragraph
and authorized the Secretary and the Attorney General
to make certain determinations.
Subsec. (j). Pub. L. 114–145 added subsec. (j).
2015—Subsec. (i). Pub. L. 114–89 added subsec. (i).

Page 702

2008—Subsec. (f). Pub. L. 110–425, in introductory provisions, inserted ‘‘and shall modify the registrations of
pharmacies so registered to authorize them to dispense
controlled substances by means of the Internet’’ after
‘‘schedule II, III, IV, or V’’ and substituted ‘‘or such
modification of registration if the Attorney General determines that the issuance of such registration or
modification’’ for ‘‘if he determines that the issuance
of such registration’’.
2006—Subsec. (g)(2)(B)(iii). Pub. L. 109–469, § 1102(1),
substituted ‘‘unless, not sooner than 1 year after the
date on which the practitioner submitted the initial
notification, the practitioner submits a second notification to the Secretary of the need and intent of the
practitioner to treat up to 100 patients. A second notification under this clause shall contain the certifications
required by clauses (i) and (ii) of this subparagraph.
The’’ for ‘‘except that the’’.
Subsec. (g)(2)(J)(i). Pub. L. 109–469, § 1102(2)(A), substituted ‘‘thereafter.’’ for ‘‘thereafter except as provided in clause (iii) (relating to a decision by the Secretary or the Attorney General that this paragraph
should not remain in effect).’’
Subsec. (g)(2)(J)(ii). Pub. L. 109–469, § 1102(2)(B), substituted ‘‘December 29, 2006’’ for ‘‘October 17, 2000’’ in
introductory provisions.
Subsec. (g)(2)(J)(iii). Pub. L. 109–469, § 1102(2)(C), substituted ‘‘subparagraph (B)(iii) should be applied by
limiting the total number of patients a practitioner
may treat to 30, then the provisions in such subparagraph (B)(iii) permitting more than 30 patients shall
not apply, effective’’ for ‘‘this paragraph should not remain in effect, this paragraph ceases to be in effect’’.
Subsec. (h). Pub. L. 109–177 substituted ‘‘clause (iv) or
(v) of section 802(39)(A) of this title’’ for ‘‘section
802(39)(A)(iv) of this title’’ in introductory provisions.
2005—Subsec. (g)(2)(B)(iii). Pub. L. 109–56, § 1(b), substituted ‘‘The total’’ for ‘‘In any case in which the
practitioner is not in a group practice, the total’’.
Subsec. (g)(2)(B)(iv). Pub. L. 109–56, § 1(a), struck out
cl. (iv) which read as follows: ‘‘In any case in which the
practitioner is in a group practice, the total number of
such patients of the group practice at any one time will
not exceed the applicable number. For purposes of this
clause, the applicable number is 30, except that the
Secretary may by regulation change such total number, and the Secretary for such purposes may by regulation establish different categories on the basis of the
number of practitioners in a group practice and establish for the various categories different numerical limitations on the number of such patients that the group
practice may have.’’
2002—Subsec. (g)(2)(I). Pub. L. 107–273, § 2501(1), which
directed the substitution of ‘‘on the date of approval by
the Food and Drug Administration of a drug in schedule III, IV, or V, a State may not preclude a practitioner from dispensing or prescribing such drug, or
combination of such drugs,’’ for ‘‘on October 17, 2000, a
State may not preclude a practitioner from dispensing
or prescribing drugs in schedule III, IV, or V, or combinations of such drugs,’’, was executed by making the
substitution for the phrase which in the original began
with ‘‘on the date of the enactment of the Drug Addiction Treatment Act of 2000,’’ rather than the editorial
translation ‘‘on October 17, 2000,’’ to reflect the probable intent of Congress.
Subsec. (g)(2)(J)(i). Pub. L. 107–273, § 2501(2), which directed the substitution of ‘‘the date referred to in subparagraph (I),’’ for ‘‘October 17, 2000,’’ was executed by
making the substitution for text which in the original
read ‘‘the date of the enactment of the Drug Addiction
Treatment Act of 2000,’’ rather than the editorial translation ‘‘October 17, 2000,’’ to reflect the probable intent
of Congress.
2000—Subsec. (g). Pub. L. 106–310 designated existing
provisions as par. (1), substituted ‘‘Except as provided
in paragraph (2), practitioners who dispense’’ for ‘‘Practitioners who dispense’’, redesignated former pars. (1)
to (3) as subpars. (A) to (C), respectively, of par. (1) and
redesignated former subpars. (A) and (B) of former par.

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TITLE 21—FOOD AND DRUGS

(2) as cls. (i) and (ii), respectively, of subpar. (B) of par.
(1), and added par. (2).
1993—Subsec. (h). Pub. L. 103–200 added subsec. (h).
1984—Subsec. (f). Pub. L. 98–473 amended subsec. (f)
generally, substituting provisions relating to registration authority of Attorney General respecting dispensation or conduct of research with controlled research, and separate authority of Secretary respecting
registration, for provisions relating to general registration requirements respecting dispensation or conduct
of research with controlled or nonnarcotic controlled
substances.
1978—Subsec. (f). Pub. L. 95–633 inserted provision relating to the construction of the Convention on Psychotropic Substances.
1974—Subsec. (g). Pub. L. 93–281 added subsec. (g).
EFFECTIVE DATE OF 2008 AMENDMENT
Amendment by Pub. L. 110–425 effective 180 days after
Oct. 15, 2008, except as otherwise provided, see section
3(j) of Pub. L. 110–425, set out as a note under section
802 of this title.
EFFECTIVE DATE OF 2005 AMENDMENT
Pub. L. 109–56, § 1(c), Aug. 2, 2005, 119 Stat. 591, provided that: ‘‘This section [amending this section] shall
take effect on the date of enactment of this Act [Aug.
2, 2005].’’
EFFECTIVE DATE OF 1993 AMENDMENT
Amendment by Pub. L. 103–200 effective on date that
is 120 days after Dec. 17, 1993, see section 11 of Pub. L.
103–200, set out as a note under section 802 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95–633 effective on date the
Convention on Psychotropic Substances enters into
force in the United States [July 15, 1980], see section 112
of Pub. L. 95–633, set out as an Effective Date note
under section 801a of this title.
EFFECTIVE DATE
Section effective on first day of seventh calendar
month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91–513, set out as a note under section 801 of
this title.
UPDATE REGULATIONS
Pub. L. 114–198, title III, § 303(c), July 22, 2016, 130
Stat. 723, provided that: ‘‘Not later than 18 months
after the date of enactment of this Act [July 22, 2016],
the Attorney General and the Secretary of Health and
Human Services, as appropriate, shall update regulations regarding practitioners described in subsection
(a)(3)(B)(vii) (as amended by this section) [probably
means subsec. (a)(3)(B)(vii) ‘‘of this section’’, set out as
a note below] to include nurse practitioners and physician assistants to ensure the quality of patient care
and prevent diversion.’’
REPORTS TO CONGRESS
Pub. L. 114–198, title III, § 303(a)(3), July 22, 2016, 130
Stat. 722, provided that:
‘‘(A) IN GENERAL.—Not later than 3 years after the
date of enactment of this Act [July 22, 2016] and not
later than 3 years thereafter, the Secretary of Health
and Human Services, in consultation with the Drug Enforcement Administration and experts in opioid use
disorder research and treatment, shall—
‘‘(i) perform a thorough review of the provision of
opioid use disorder treatment services in the United
States, including services provided in opioid treatment programs and other specialty and nonspecialty
settings; and
‘‘(ii) submit a report to the Congress on the findings and conclusions of such review.
‘‘(B) CONTENTS.—Each report under subparagraph (A)
shall include an assessment of—

§ 824

‘‘(i) compliance with the requirements of section
303(g)(2) of the Controlled Substances Act (21 U.S.C.
823(g)(2)), as amended by this section;
‘‘(ii) the measures taken by the Secretary of Health
and Human Services to ensure such compliance;
‘‘(iii) whether there is further need to increase or
decrease the number of patients a practitioner, pursuant to a waiver under section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)), is permitted to treat;
‘‘(iv) the extent to which, and proportions with
which, the full range of Food and Drug Administration-approved treatments for opioid use disorder are
used in routine health care settings and specialty
substance use disorder treatment settings;
‘‘(v) access to, and use of, counseling and recovery
support services, including the percentage of patients
receiving such services;
‘‘(vi) changes in State or local policies and legislation relating to opioid use disorder treatment;
‘‘(vii) the use of prescription drug monitoring programs by practitioners who are permitted to dispense
narcotic drugs to individuals pursuant to a waiver described in clause (iii);
‘‘(viii) the findings resulting from inspections by
the Drug Enforcement Administration of practitioners described in clause (vii); and
‘‘(ix) the effectiveness of cross-agency collaboration
between [the] Department of Health and Human Services and the Drug Enforcement Administration for
expanding effective opioid use disorder treatment.’’
PROVISIONAL REGISTRATION
For provisional registration of persons engaged in
manufacturing, distributing, or dispensing of controlled substances on the day before the effective date
of section 822 of this title who are registered on such
date under section 360 of this title or section 4722 of
Title 26, Internal Revenue Code, see section 703 of Pub.
L. 91–513, set out as a note under section 822 of this
title.

§ 824. Denial, revocation, or suspension of registration
(a) Grounds
A registration pursuant to section 823 of this
title to manufacture, distribute, or dispense a
controlled substance or a list I chemical may be
suspended or revoked by the Attorney General
upon a finding that the registrant—
(1) has materially falsified any application
filed pursuant to or required by this subchapter or subchapter II;
(2) has been convicted of a felony under this
subchapter or subchapter II or any other law
of the United States, or of any State, relating
to any substance defined in this subchapter as
a controlled substance or a list I chemical;
(3) has had his State license or registration
suspended, revoked, or denied by competent
State authority and is no longer authorized by
State law to engage in the manufacturing, distribution, or dispensing of controlled substances or list I chemicals or has had the suspension, revocation, or denial of his registration recommended by competent State authority;
(4) has committed such acts as would render
his registration under section 823 of this title
inconsistent with the public interest as determined under such section; or
(5) has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a–7(a) of title 42.
A registration pursuant to section 823(g)(1) of
this title to dispense a narcotic drug for mainte-