I
106TH CONGRESS
1ST SESSION
H.R. 2634
To amend the Controlled Substances Act with respect to registration require-
ments for practitioners who dispense narcotic drugs in schedule IV or
V for maintenance treatment or detoxification treatment.
IN THE HOUSE OF REPRESENTATIVES
JULY 29, 1999
Mr. BLILEY (for himself, Mr. GREEN of Texas, Mr. OXLEY, Mr. BOUCHER,
Mr. COX, Mr. GREENWOOD, and Mr. COBLE) introduced the following
bill; which was referred to the Committee on Commerce, and in addition
to the Committee on the Judiciary, for a period to be subsequently deter-
mined by the Speaker, in each case for consideration of such provisions
as fall within the jurisdiction of the committee concerned.
A BILL
To amend the Controlled Substances Act with respect to
registration requirements for practitioners who dispense
narcotic drugs in schedule IV or V for maintenance
treatment or detoxification treatment.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Drug Addiction Treat-
ment Act of 1999’’.
SEC. 2. AMENDMENT TO CONTROLLED SUBSTANCES ACT.
(a) IN GENERAL.—Section 303(g) of the Controlled
Substances Act (21 U.S.C. 823(g)) is amended—
(1) in paragraph (2), by striking ‘‘(A) security’’
and inserting ‘‘(i) security’’, and by striking ‘‘(B)
the maintenance’’ and inserting ‘‘(ii) the mainte-
nance’’;
(2) by redesignating paragraphs (1) through
(3) as subparagraphs (A) through (C), respectively;
(3) by inserting ‘‘(1)’’ after ‘‘(g)’’;
(4) by striking ‘‘Practitioners who dispense’’
and inserting ‘‘Except as provided in paragraph (2),
practitioners who dispense’’; and
(5) by adding at the end the following para-
graph:
‘‘(2)(A) Subject to subparagraphs (D) and (I), the
requirements of paragraph (1) are waived in the case of
the dispensing, by a practitioner, of narcotic drugs in
schedule IV or V or combinations of such drugs if the
practitioner meets the conditions specified in subpara-
graph (B) and the narcotic drugs or combinations of such
drugs meet the conditions specified in subparagraph (C).
‘‘(B) For purposes of subparagraph (A), the condi-
tions specified in this subparagraph with respect to a prac-
titioner are that, before dispensing narcotic drugs in
schedule IV or V or combinations of such drugs to patients
the applicable number is 40, except that the Sec-
retary may by regulation change such total number,
and the Secretary for such purposes may by regula-
tion establish different categories on the basis of the
number of practitioners in a group practice and es-
tablish 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 condi-
tions specified in this subparagraph with respect to nar-
cotic drugs in schedule 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 or
section 351 of the Public Health Service Act, 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 determina-
tion is a determination published in the Federal
Register and made by the Secretary, after consulta-
tion with the Attorney General, that the use of the
drugs or combinations of drugs for maintenance or
detoxification treatment requires additional stand-
ards respecting the qualifications of practitioners to
provide such treatment, or requires standards re-
specting the quantities of the drugs that may be pro-
vided for unsupervised use.
‘‘(D)(i) A waiver under subparagraph (A) with re-
spect to a practitioner is not in effect unless (in addition
to conditions under subparagraphs (B) and (C)) the fol-
lowing 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).
‘‘(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).
‘‘(ii) The Secretary shall provide to the Attorney Gen-
eral such information contained in notifications under sub-
paragraph (B) as the Attorney General may request.
‘‘(E)(i) If a practitioner is not registered under para-
graph (1) and, in violation of the conditions specified in
subparagraphs (B) through (D), dispenses narcotic drugs
in schedule IV or V or combinations of such drugs for
maintenance treatment or detoxification treatment, the
Attorney General may, for purposes of section 304(a)(4),
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) A practitioner who in good faith submits a
notification under subparagraph (B) and reasonably be-
lieves that the conditions specified in subparagraphs (B)
through (D) have been met shall, in dispensing narcotic
drugs in schedule 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.
‘‘(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 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 reg-
istration under paragraph (1) or a waiver under subpara-
graph (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 registra-
tion under paragraph (1), including with respect to the
number of patients who may be served under such a reg-
istration.
‘‘(G) For purposes of this paragraph, the term ‘group
practice’ has the meaning given such term in section
1877(h)(4) of the Social Security Act.
‘‘(H) During the 3-year period beginning on the date
of the enactment of the Drug Addiction Treatment Act
of 1999, any law or regulation of a State or political sub-
division of a State that is in conflict with this paragraph
is superseded by this paragraph. If before the expiration
of such period a State or political subdivision of a State
enacts such a law, then upon the expiration of the period
this paragraph ceases to supersede the law.
‘‘(I)(i) This paragraph takes effect on the date of the
enactment of the Drug Addiction Treatment Act of 1999,
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 Sec-
retary and the Attorney General may, during the 3-year
period beginning on the date of the enactment of the Drug
Addiction Treatment Act of 1999, 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 main-
tenance 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 avail-
ability of maintenance treatment and detoxification
treatment; and may make a determination of wheth-
er such waivers have adverse consequences for the
public health.
‘‘(II) The Attorney General may make a deter-
mination of the extent to which there have been vio-
lations of the numerical limitations established
under subparagraph (B) for the number of individ-
uals to whom a practitioner may provide treatment;
may make a determination of whether waivers under
subparagraph (A) have increased (relative to the be-
ginning of such period) the extent to which narcotic
drugs in schedule IV or V or combinations of such
drugs are being dispensed or possessed in violation
of this Act; 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 pub-
lishes in the Federal Register a decision, made on the
basis of determinations under such clause, that this para-
graph 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 inclu-
sion 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 in-
clusion in the publication.’’.
(b) CONFORMING AMENDMENTS.—Section 304 of the
Controlled Substances Act (21 U.S.C. 824) is amended—
(1) in subsection (a), in the matter after and
below paragraph (5), by striking ‘‘section 303(g)’’
each place such term appears and inserting ‘‘section
303(g)(1)’’; and
(2) in subsection (d), by striking ‘‘section
303(g)’’ and inserting ‘‘section 303(g)(1)’’.
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