-CITE-
21 USC Sec. 823 01/22/02
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE
PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL
AND ENFORCEMENT
Part C - Registration
of Manufacturers, Distributors, andDispensers
of Controlled Substances
-HEAD-
Sec. 823. Registration requirements
-STATUTE-
(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 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.
(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, 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 if he determines
that the issuance of such registration 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 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:
(i) The practitioner
is a qualifying physician (as defined in subparagraph
(G)).
(ii) With respect to
patients to whom the practitioner will provide
such drugs or combinations of drugs, the practitioner has the
capacity to refer the patients for appropriate counseling and
other appropriate
ancillary services.
(iii) In any case in
which the practitioner is not in a group practice,
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, except that the
Secretary may by regulation change such total number.
(iv) 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.
(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) of this section.
(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) of this section.
(ii) Upon receiving
a notification under subparagraph (B), the Attorney
General shall assign the practitioner involved an identification
number under this paragraph for inclusion with the registration
issued for the practitioner pursuant to subsection (f) of
this section. The identification number so assigned shall be appropriate
to preserve the confidentiality of patients for whom the
practitioner has dispensed narcotic drugs under a waiver under
subparagraph (A).
(iii) Not later than
45 days after the date on which the Secretary
receives a notification under subparagraph (B), the Secretary
shall make a determination of whether the practitioner involved
meets all requirements for a waiver under subparagraph (B).
If the Secretary fails to make such determination by the end of
the such 45-day period, the Attorney General shall assign the
physician an identification
number described in clause (ii) at the end
of such period.
(E)(i) If a practitioner
is not registered under paragraph (1) and, in violation of the conditions
specified in subparagraphs (B) through (D), dispenses narcotic drugs
in schedule III, IV, or V or combinations of such drugs for maintenance
treatment or detoxification treatment, the Attorney General may,
for purposes of section 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) of this section 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 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 subspecialty board certification in addiction
psychiatry from the American Board of Medical Specialties.
(II) The physician
holds an addiction certification from the American
Society of Addiction Medicine.
(III) The physician
holds a subspecialty board certification in
addiction medicine from the American Osteopathic Association.
(IV) The physician
has, with respect to the treatment and management
of opiate-dependent patients, completed not less than
eight hours of training (through classroom situations, seminars
at professional society meetings, electronic communications,
or otherwise) that is provided by the American Society
of Addiction Medicine, the American Academy of Addiction
Psychiatry, the American Medical Association, the American
Osteopathic Association, the American Psychiatric Association,
or any other organization that the Secretary determines
is appropriate for purposes of this subclause
(V) The physician
has participated as an investigator in one or
more clinical trials leading to the approval of a narcotic drug
in schedule III, IV, or V for maintenance or detoxification
treatment, as demonstrated by a statement submitted
to the Secretary by the sponsor of such approved drug.
(VI) The physician
has such other training or experience as the
State medical licensing board (of the State in which the physician
will provide maintenance or detoxification treatment) considers
to demonstrate the ability of the physician to treat and
manage opiate-dependent patients.
(VII) The physician
has such other training or experience as the
Secretary considers to demonstrate the ability of the physician
to treat and manage opiate-dependent patients. Any criteria
of the Secretary under this subclause shall be established
by regulation. Any such criteria are effective only
for 3 years after the date on which the criteria are promulgated,
but may be extended for such additional discrete 3-year
periods as the Secretary considers appropriate for purposes
of this subclause. Such an extension of criteria may only
be effectuated through a statement published in the Federal
Register by the Secretary during the 30-day period preceding
the end of the 3-year period involved.
(H)(i) In consultation
with the Administrator of the Drug Enforcement
Administration, the Administrator of the Substance Abuse
and Mental Health Services Administration, the Director of
the National Institute
on Drug Abuse, and the Commissioner of Food and Drugs, the Secretary
shall issue regulations (through notice and
comment rulemaking) or issue practice guidelines to address the
following:
(I) Approval of additional
credentialing bodies and the responsibilities
of additional credentialing bodies.
(II) Additional exemptions
from the requirements of this paragraph
and any regulations under this paragraph. Nothing
in such regulations or practice guidelines may authorize
any Federal official
or employee to exercise supervision or control over the practice
of medicine or the manner in which medical services
are provided.
(ii) Not later than 120
days after 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.
(I) During the 3-year
period beginning 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, to patients for maintenance or detoxification treatment
in accordance with this paragraph unless, before the expiration
of that 3-year
period, the State enacts a law prohibiting a practitioner
from dispensing such drugs or combinations of drug.(FOOTNOTE
1)
(FOOTNOTE 1) So in
original. Probably should be ''plural''.
(J)(i) This paragraph
takes effect on October 17, 2000, and remains
in effect 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).
(ii) For purposes relating
to clause (iii), the Secretary and the Attorney
General may, during the 3-year period beginning on October
17, 2000, make determinations
in accordance with the following:
(I) The Secretary may
make a determination of whether treatments
provided under waivers under subparagraph (A) have been
effective forms of maintenance treatment and detoxification
treatment in clinical
settings; may make a determination of whether
such waivers have significantly increased (relative to
the beginning of such
period) the availability of maintenance treatment
and detoxification treatment; and may make a determination
of whether such waivers have adverse consequences for
the public health.
(II) The Attorney General
may make a determination of the extent
to which there have been violations of the numerical limitations
established under subparagraph (B) for the number of individuals
to whom a practitioner may provide treatment; may make
a determination of whether waivers under subparagraph (A)
have increased (relative
to the beginning of such period) the extent
to which narcotic drugs in schedule III, IV, or V or combinations
of such drugs are being dispensed or possessed in violation
of this chapter; and may make a determination of whether
such waivers have adverse consequences for the public health.
(iii) If, before the expiration
of the period specified in clause (ii),
the Secretary or the Attorney General publishes in the Federal
Register a decision, made on the basis of determinations
under such clause, that
this paragraph should not remain in effect, this
paragraph ceases to be in effect 60 days after the date on
which the decision is so
published. The Secretary shall in making any
such decision consult with the Attorney General, and shall in
publishing the decision
in the Federal Register include any comments
received from the Attorney General for inclusion in the publication.
The Attorney General shall in making any such decision
consult with the Secretary, and shall in publishing the decision
in the Federal Register include any comments received from
the Secretary for inclusion
in the publication.
(h) 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 section
802(39)(A)(iv) of this title. 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.
-SOURCE-
(Pub. L. 91-513, title II,
Sec. 303, Oct. 27, 1970, 84 Stat. 1253; Pub.
L. 93-281, Sec. 3, May 14, 1974, 88 Stat. 124; Pub. L. 95-633,
title I, Sec. 109, Nov. 10,
1978, 92 Stat. 3773; Pub. L. 98-473, title
II, Sec. 511, Oct. 12, 1984, 98 Stat. 2073; Pub. L. 103-200,
Sec. 3(c), Dec. 17, 1993, 107
Stat. 2336; Pub. L. 106-310, div. B, title
XXXV, Sec. 3502(a), Oct. 17, 2000, 114 Stat. 1222.)
-REFTEXT-
REFERENCES
IN TEXT
Schedules I, II, III, IV,
and V, referred to in subsecs. (a) to (f)
and (g)(2), are set out in section 812(c) of
this title.
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 (Sec. 301 et seq.)
of this title. For complete classification of this Act to the
Code, see section 301 of this title and Tables.
This chapter, referred to
in subsec.(g)(2)(J)(ii)(II), was in the original
''this Act'', meaning Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
1236, as amended. For complete classification of this Act to
the Code, see Short Title note
set out under section 801 of this title
and Tables.
-MISC2-
AMENDMENTS
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. (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 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.
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.
-SECREF-
SECTION REFERRED
TO IN OTHER SECTIONS
This section is referred
to in sections 824, 827,
828, 844, 880,
952,
958, 965 of this title.
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