
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC823]

 
                        TITLE 21--FOOD AND DRUGS
 
              CHAPTER 13--DRUG ABUSE PREVENTION AND CONTROL
 
                  SUBCHAPTER I--CONTROL AND ENFORCEMENT
 
 Part C--Registration of Manufacturers, Distributors, and Dispensers of 
                          Controlled Substances
 
Sec. 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 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.\1\
---------------------------------------------------------------------------
    \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.

(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.

(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.)

                       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.
