Regulations
& Codified CSA > USC > Subchapter
I, Part C > Section 823
Section 823. Registration Requirements
Manufacturers of controlled substances in schedule I and II
(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
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.
Distributors of controlled substances in schedule I and II
(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 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.
Limits of authorized activities
(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 826 of this title.
Manufacturers of controlled substances in schedule III, IV, and V
(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.
Distributors of controlled substances in schedule III, IV, and V
(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.
Research by practitioners; pharmacies; research applications; construction of Article 7 of
the Convention on
Psychotropic Substances
(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, 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.
Practitioners dispensing narcotic drugs for narcotic treatment; annual registration; separate
registration; qualifications
(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 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). 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) 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.\1\
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\1\ So in original. Probably should be "plural''.
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(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.
Applicants for distribution of list I chemicals
(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 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.
(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.)
HISTORICAL AND STATUTORY NOTES
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.
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.
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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