Home > 106th Congressional Bills > H.R. 2988 (ih) To direct the Secretary of the Interior, through the Bureau of Reclamation, to conserve and enhance the water supplies of the Lower Rio Grande Valley. [Introduced in House] ...H.R. 2988 (ih) To direct the Secretary of the Interior, through the Bureau of Reclamation, to conserve and enhance the water supplies of the Lower Rio Grande Valley. [Introduced in House] ...
SEC. 202. MAIL ORDER REQUIREMENTS.
Section 310(b)(3) of the Controlled Substances Act (21 U.S.C.
830(b)(3)) is amended--
(1) by redesignating subparagraphs (A) and (B) as
subparagraphs (B) and (C), respectively;
(2) by inserting before subparagraph (B), as so
redesignated, the following new subparagraph (A):
``(A) As used in this paragraph:
``(i) The term `drug product' means an active
ingredient in dosage form that has been approved or
otherwise may be lawfully marketed under the Food,
Drug, and Cosmetic Act for distribution in the United
States.
``(ii) The term `valid prescription' means a
prescription which is issued for a legitimate medical
purpose by an individual practitioner licensed by law
to administer and prescribe the drugs concerned and
acting in the usual course of the practitioner's
professional practice.'';
(3) in subparagraph (B), as so redesignated, by inserting
``or who engages in an export transaction'' after
``nonregulated person''; and
(4) adding at the end the following:
``(D) Except as provided in subparagraph (E), the following
distributions to a nonregulated person, and the following
export transactions, shall not be subject to the reporting
requirement in subparagraph (B):
``(i) Distributions of sample packages of drug
products when such packages contain not more than 2
solid dosage units or the equivalent of 2 dosage units
in liquid form, not to exceed 10 milliliters of liquid
per package, and not more than one package is
distributed to an individual or residential address in
any 30-day period.
``(ii) Distributions of drug products by retail
distributors that may not include face-to-face
transactions to the extent that such distributions are
consistent with the activities authorized for a retail
distributor as specified in section 102(46).
``(iii) Distributions of drug products to a
resident of a long term care facility (as that term is
defined in regulations prescribed by the Attorney
General) or distributions of drug products to a long
term care facility for dispensing to or for use by a
resident of that facility.
``(iv) Distributions of drug products pursuant to a
valid prescription.
``(v) Exports which have been reported to the
Attorney General pursuant to section 1004 or 1018 or
which are subject to a waiver granted under section
1018(e)(2).
``(vi) Any quantity, method, or type of
distribution or any quantity, method, or type of
distribution of a specific listed chemical (including
specific formulations or drug products) or of a group
of listed chemicals (including specific formulations or
drug products) which the Attorney General has excluded
by regulation from such reporting requirement on the
basis that such reporting is not necessary for the
enforcement of this title or title III.
``(E) The Attorney General may revoke any or all of the
exemptions listed in subparagraph (D) for an individual
regulated person if he finds that drug products distributed by
the regulated person are being used in violation of this title
or title III. The regulated person shall be notified of the
revocation, which will be effective upon receipt by the person
of such notice, as provided in section 1018(c)(1), and shall
have the right to an expedited hearing as provided in section
1018(c)(2).''.
SEC. 203. THEFT AND TRANSPORTATION OF ANHYDROUS AMMONIA FOR PURPOSES OF
ILLICIT PRODUCTION OF CONTROLLED SUBSTANCES.
(a) In General.--Part D of the Controlled Substances Act (21 U.S.C.
841 et seq.) is amended by adding at the end the following:
``anhydrous ammonia
``Sec. 423. (a) It is unlawful for any person--
``(1) to steal anhydrous ammonia, or
``(2) to transport stolen anhydrous ammonia across State
lines,
knowing, intending, or having reasonable cause to believe that such
anhydrous ammonia will be used to manufacture a controlled substance in
violation of this part.
``(b) Any person who violates subsection (a) shall be imprisoned or
fined, or both, in accordance with section 403(d) as if such violation
were a violation of a provision of section 403.''.
(b) Clerical Amendment.--The table of contents for that Act is
amended by inserting after the item relating to section 421 the
following new items:
``Sec. 422. Drug paraphernalia.
``Sec. 423. Anhydrous ammonia.''.
(c) Assistance for Certain Research.--
(1) Agreement.--The Administrator of the Drug Enforcement
Administration shall seek to enter into an agreement with Iowa
State University in order to permit the University to continue
and expand its current research into the development of inert
agents that, when added to anhydrous ammonia, eliminate the
usefulness of anhydrous ammonia as an ingredient in the
production of methamphetamine.
(2) Reimbursable provision of funds.--The agreement under
paragraph (1) may provide for the provision to Iowa State
University, on a reimbursable basis, of $500,000 for purposes
the activities specified in that paragraph.
(3) Authorization of appropriations.--There is hereby
authorized to be appropriated for the Drug Enforcement
Administration for fiscal year 2001, $500,000 for purposes of
carrying out the agreement under this subsection.
Subtitle B--Other Matters
SEC. 211. WAIVER AUTHORITY FOR PHYSICIANS WHO DISPENSE OR PRESCRIBE
CERTAIN NARCOTIC DRUGS FOR MAINTENANCE TREATMENT OR
DETOXIFICATION TREATMENT.
(a) Requirements.--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 maintenance'';
(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 or prescribe''; and
(5) by adding at the end the following:
``(2)(A) Subject to subparagraph (D), the requirements of paragraph
(1) are waived in the case of the dispensing or prescribing, by a
physician, of narcotic drugs in schedule III, IV, or V, or combinations
of such drugs, if the physician meets the conditions specified in
subparagraph (B) and the narcotic drugs or combinations of such drugs
meet the conditions specified in subparagraph (C).
``(B)(i) For purposes of subparagraph (A), the conditions specified
in this subparagraph with respect to a physician are that, before
initially dispensing or prescribing narcotic drugs in schedule III, IV,
or V, or combinations of such drugs, to patients for maintenance or
detoxification treatment, the physician submit to the Secretary and the
Attorney General a notification of the intent of the physician to begin
dispensing or prescribing the drugs or combinations for such purpose,
and that the notification to the Secretary also contain the following
certifications by the physician:
``(I) The physician--
``(aa) is a physician licensed under State law; and
``(bb) has training or experience and the ability
to treat and manage opiate-dependent patients.
``(II) With respect to patients to whom the physician will
provide such drugs or combinations of drugs, the physician has
the capacity to refer the patients for appropriate counseling
and other appropriate ancillary services.
``(III) In any case in which the physician is not in a
group practice, the total number of such patients of the
physician at any one time will not exceed the applicable
number. For purposes of this subclause, the applicable number
is 30, except that the Secretary may by regulation change such
total number.
``(IV) In any case in which the physician 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 subclause, 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 physicians 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.
``(ii)(I) The Secretary may, 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 Center for Substance Abuse Treatment, the Director of the
National Institute on Drug Abuse, and the Commissioner of Food and
Drugs, issue regulations through notice and comment rulemaking or
practice guidelines to address the following:
``(aa) Approval of additional credentialing bodies and the
responsibilities of additional credentialing bodies.
``(bb) Additional exemptions from the requirements of this
paragraph and any regulations under this paragraph.
``(II) Nothing in the regulations or practice guidelines under this
clause 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.
``(III)(aa) 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 Director of the Center for Substance Abuse
Treatment, 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.
``(bb) The protocol shall be issued not later than 120 days after
the date of the enactment of the Methamphetamine and Club Drug Anti-
Proliferation Act of 2000.
``(IV) For purposes of the regulations or practice guidelines under
subclause (I), a physician shall have training or experience under
clause (i)(I)(bb) if the physician meets one or more of the following
conditions:
``(aa) The physician is certified in addiction treatment by
the American Society of Addiction Medicine, the American Board
of Medical Specialties, the American Osteopathic Academy of
Addiction Medicine, or any other certified body accredited by
the Secretary.
``(bb) The physician has been a clinical investigator in a
clinical trial conducted for purposes of securing approval
under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or section 351 of the Public Health Service Act
(42 U.S.C. 262) of a narcotic drug in schedule III, IV, or V
for the treatment of addiction, if such approval was granted.
``(cc) The physician has completed training (through
classroom situations, seminars, professional society meetings,
electronic communications, or otherwise) provided by the
American Society of Addiction Medicine, the American Academy of
Addiction Psychiatry, the American Osteopathic Academy of
Addiction Medicine, the American Medical Association, the
American Osteopathic Association, the American Psychiatric
Association, or any other organization that the Secretary
determines appropriate for purposes of this item. The curricula
may include training in patient need for counseling regarding
HIV, Hepatitis C, and other infectious diseases, substance
abuse counseling, random drug testing, medical evaluation,
annual assessment, prenatal care, diagnosis of addiction,
rehabilitation services, confidentiality, and other appropriate
topics.
``(dd) The physician has training or experience in the
treatment and management of opiate-dependent patients, which
training or experience shall meet such criteria as the
Secretary may prescribe. Any such criteria shall be effective
for a period of three years after the effective date of such
criteria, but the Secretary may extend the effective period of
such criteria by additional periods of three years for each
extension if the Secretary determines that such extension is
appropriate for purposes of this item. Any such extension shall
go into effect only if the Secretary publishes a notice of such
extension in the Federal Register during the 30-day period
ending on the date of the end of the three-year effective
period of such criteria to which such extension will apply.
``(ee) The physician is certified in addiction treatment by
a State medical licensing board, or an entity accredited by
such board, unless the Secretary determines (after an
opportunity for a hearing) that the training provided by such
board or entity was inadequate for the treatment and management
of opiate-dependent patients.
``(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 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 determination is a determination published
in the Federal Register and made by the Secretary, after
consultation with the Attorney General, that experience since
the approval of the drug or combinations of drugs has shown
that the use of the drugs or combinations of drugs for
maintenance or detoxification treatment requires additional
standards respecting the qualifications of physicians 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
physician 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 physician.
``(II) The notification identifies the registration issued
for the physician pursuant to subsection (f).
``(III) If the physician is a member of a group practice,
the notification states the names of the other physicians in
the practice and identifies the registrations issued for the
other physicians pursuant to subsection (f).
``(IV) A period of 45 days has elapsed after the date on
which the notification was submitted, and during such period
the physician does not receive from the Secretary a written
notice that one or more of the conditions specified in
subparagraph (B), subparagraph (C), or this subparagraph, have
not been met.
``(ii) The Secretary shall provide to the Attorney General such
information contained in notifications under subparagraph (B) as the
Attorney General may request.
``(E) If in violation of subparagraph (A) a physician dispenses or
prescribes 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 304(a)(4), consider the
physician to have committed an act that renders the registration of the
physician pursuant to subsection (f) to be inconsistent with the public
interest.
``(F)(i) Upon determining that a physician meets the conditions
specified in subparagraph (B), the Secretary shall notify the physician
and the Attorney General.
``(ii) Upon receiving notice with respect to a physician under
clause (i), the Attorney General shall assign the physician an
identification number under this paragraph for inclusion with the
physician's current registration to prescribe narcotics. An
identification number assigned a physician under this clause shall be
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