21 U.S.C. § 823 : US Code - Section 823: Registration requirements

Search 21 U.S.C. § 823 : US Code - Section 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) 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.
(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 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, 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)
(J)(i) This paragraph takes effect the date referred to in
subparagraph (I), 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.