* This message forwarded from private area of Rich Woods
* Original message dated 31 Dec 96 09:55:21, from " Ray Dunegan"
Apparently-to: rich.woods@245.genesplicer.org
From: " Ray Dunegan"
Date: Tue, 31 Dec 1996 12:55:21 -0500
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
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)
(1) 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;
(2) if the Attorney General determines that the applicant will
comply with standards established by the Attorney General
respecting (A) security of stocks of narcotic drugs for such
treatment, and (B) the maintenance of records (in accordance with
section 827 of this title) on such drugs; and
(3) 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.
-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.)
-REFTEXT-
REFERENCES IN TEXT
Schedules I, II, III, IV, and V, referred to in subsecs. (a) to
(f), are set out in section 812(c) of this title.
-MISC2-
AMENDMENTS
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 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
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* Origin: I Didn't Inhale - Honest! - Clinton - White House, Washington, DC
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