[House Report 106-340]
[From the U.S. Government Publishing Office]
106th Congress Rept. 106-340
HOUSE OF REPRESENTATIVES
1st Session Part 1
======================================================================
HILLORY J. FARIAS DATE-RAPE PREVENTION DRUG ACT OF 1999
_______
September 27, 1999.--Ordered to be printed
_______
Mr. Bliley, from the Committee on Commerce, submitted the following
R E P O R T
[To accompany H.R. 2130]
[Including cost estimate of the Congressional Budget Office]
The Committee on Commerce, to whom was referred the bill
(H.R. 2130) to amend the Controlled Substances Act to add gamma
hydroxybutyric acid and ketamine to the schedules of control
substances, to provide for a national awareness campaign, and
for other purposes, having considered the same, report
favorably thereon with amendments and recommend that the bill
as amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 4
Background and Need for Legislation.............................. 5
Hearings......................................................... 8
Committee Consideration.......................................... 8
Committee Votes.................................................. 8
Committee Oversight Findings..................................... 9
Committee on Government Reform Oversight Findings................ 9
New Budget Authority, Entitlement Authority, and Tax Expenditures 9
Committee Cost Estimate.......................................... 9
Congressional Budget Office Estimate............................. 9
Federal Mandates Statement....................................... 12
Advisory Committee Statement..................................... 12
Constitutional Authority Statement............................... 12
Applicability to Legislative Branch.............................. 12
Section-by-Section Analysis of the Legislation................... 12
Changes in Existing Law Made by the Bill, as Reported............ 16
Amendment
The amendments are as follows:
Strike out all after the enacting clause and insert in lieu
thereof the following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Hillory J. Farias Date-Rape Prevention
Drug Act of 1999''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Gamma hydroxybutyric acid (also called G, Liquid X,
Liquid Ecstasy, Grievous Bodily Harm, Georgia Home Boy, Scoop)
has become a significant and growing problem in law
enforcement. At least 20 States have scheduled such drug in
their drug laws and law enforcement officials have been
experiencing an increased presence of the drug in driving under
the influence, sexual assault, and overdose cases, especially
at night clubs and parties.
(2) A behavioral depressant and a hypnotic, gamma
hydroxybutyric acid (``GHB'') is being used in conjunction with
alcohol and other drugs with detrimental effects in an
increasing number of cases. It is difficult to isolate the
impact of such drug's ingestion since it is so typically taken
with an ever-changing array of other drugs and especially
alcohol, which potentiates its impact.
(3) GHB takes the same path as alcohol, processes via alcohol
dehydrogenase, and its symptoms at high levels of intake and as
impact builds are comparable to alcohol ingestion/intoxication.
Thus, aggression and violence can be expected in some
individuals who use such drug.
(4) If taken for human consumption, common industrial
chemicals such as gamma butyrolactone and 1.4-butanediol are
swiftly converted by the body into GHB. Illicit use of these
and other GHB analogues and precursor chemicals is a
significant and growing law enforcement problem.
(5) A human pharmaceutical formulation of gamma
hydroxybutyric acid is being developed as a treatment for
cataplexy, a serious and debilitating disease. Cataplexy, which
causes sudden and total loss of muscle control, affects about
65 percent of the estimated 180,000 Americans with narcolepsy,
a sleep disorder. People with cataplexy often are unable to
work, drive a car, hold their children or live a normal life.
SEC. 3. ADDITION OF GAMMA HYDROXYBUTYRIC ACID AND KETAMINE TO SCHEDULES
OF CONTROLLED SUBSTANCES; GAMMA BUTYROLACTONE AS
ADDITIONAL LIST I CHEMICAL.
(a) Addition to Schedule I.--
(1) In general.--Section 202(c) of the Controlled Substances
Act (21 U.S.C. 812(c)) is amended by adding at the end of
schedule I the following:
``(d) Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation, which
contains any quantity of the following substance having a depressant
effect on the central nervous system, or which contains any of their
salts, isomers, and salts of isomers whenever the existence of such
salts, isomers, and salts of isomers is possible within the specific
chemical designation:
``(1) Gamma hydroxybutyric acid.''.
(2) Security of facilities.--For purposes of any requirements
that relate to the physical security of registered
manufacturers and registered distributors, gamma hydroxybutyric
acid and its salts, isomers, and salts of isomers manufactured,
distributed, or possessed in accordance with an exemption
approved under section 505(i) of the Federal Food, Drug, and
Cosmetic Act shall be treated as a controlled substance in
schedule III under section 202(c) of the Controlled Substances
Act.
(b) Addition to Schedule III.--Schedule III under section 202(c) of
the Controlled Substances Act (21 U.S.C. 812(c)) is amended in (b)--
(1) by redesignating (4) through (10) as (6) through (12),
respectively;
(2) by redesignating (3) as (4);
(3) by inserting after (2) the following:
``(3) Gamma hydroxybutyric acid and its salts, isomers, and
salts of isomers contained in a drug product for which an
application has been approved under section 505 of the Federal
Food, Drug, and Cosmetic Act.''; and
(4) by inserting after (4) (as so redesignated) the
following:
``(5) Ketamine and its salts, isomers, and salts of
isomers.''.
(c) Additional List I Chemical.--Section 102(34) of the Controlled
Substances Act (21 U.S.C. 802(34)) is amended--
(1) by redesignating subparagraph (X) as subparagraph (Y);
and
(2) by inserting after subparagraph (W) the following
subparagraph:
``(X) Gamma butyrolactone.''.
(d) Rule of Construction Regarding Controlled Substance Analogues.--
Section 102(32) of the Controlled Substances Act (21 U.S.C. 802(32)) is
amended--
(1) by redesignating subparagraph (B) as subparagraph (C);
and
(2) by inserting after subparagraph (A) the following
subparagraph:
``(B) The designation of gamma butyrolactone or any other chemical as
a listed chemical pursuant to paragraph (34) or (35) does not preclude
a finding pursuant to subparagraph (A) of this paragraph that the
chemical is a controlled substance analogue.''.
(e) Penalties Regarding Schedule I.--
(1) In general.--Section 401(b)(1)(C) of the Controlled
Substances Act (21 U.S.C. 841(b)(1)(C)) is amended in the first
sentence by inserting after ``schedule I or II,'' the
following: ``gamma hydroxybutyric acid in schedule III,''.
(2) Conforming amendment.--Section 401(b)(1)(D) of the
Controlled Substances Act (21 U.S.C. 841(b)(1)(D)) is amended
by inserting ``(other than gamma hydroxybutyric acid)'' after
``schedule III''.
(f) Distribution With Intent To Commit Crime of Violence.--Section
401(b)(7)(A) of the Controlled Substances Act (21 U.S.C. 841(b)(7)(A))
is amended by inserting ``or controlled substance analogue'' after
``distributing a controlled substance''.
SEC. 4. AUTHORITY FOR ADDITIONAL REPORTING REQUIREMENTS FOR GAMMA
HYDROXYBUTYRIC PRODUCTS IN SCHEDULE III.
Section 307 of the Controlled Substances Act (21 U.S.C. 827) is
amended by adding at the end the following:
``(h) In the case of a drug product containing gamma hydroxybutyric
acid for which an application has been approved under section 505 of
the Federal Food, Drug, and Cosmetic Act, the Attorney General may, in
addition to any other requirements that apply under this section with
respect to such a drug product, establish any of the following as
reporting requirements:
``(1) That every person who is registered as a manufacturer
of bulk or dosage form, as a packager, repackager, labeler,
relabeler, or distributor shall report acquisition and
distribution transactions quarterly, not later than the 15th
day of the month succeeding the quarter for which the report is
submitted, and annually report end-of-year inventories.
``(2) That all annual inventory reports shall be filed no
later than January 15 of the year following that for which the
report is submitted and include data on the stocks of the drug
product, drug substance, bulk drug, and dosage forms on hand as
of the close of business December 31, indicating whether
materials reported are in storage or in process of
manufacturing.
``(3) That every person who is registered as a manufacturer
of bulk or dosage form shall report all manufacturing
transactions both inventory increases, including purchases,
transfers, and returns, and reductions from inventory,
including sales, transfers, theft, destruction, and seizure,
and shall provide data on material manufactured, manufactured
from other material, use in manufacturing other material, and
use in manufacturing dosage forms.
``(4) That all reports under this section must include the
registered person's registration number as well as the
registration numbers, names, and other identifying information
of vendors, suppliers, and customers, sufficient to allow the
Attorney General to track the receipt and distribution of the
drug.
``(5) That each dispensing practitioner shall maintain for
each prescription the name of the prescribing practitioner, the
prescribing practitioner's Federal and State registration
numbers, with the expiration dates of these registrations,
verification that the prescribing practitioner possesses the
appropriate registration to prescribe this controlled
substance, the patient's name and address, the name of the
patient's insurance provider and documentation by a medical
practitioner licensed and registered to prescribe the drug of
the patient's medical need for the drug. Such information shall
be available for inspection and copying by the Attorney
General.
``(6) That section 310(b)(3) (relating to mail order
reporting) applies with respect to gamma hydroxybutyric acid to
the same extent and in the same manner as such section applies
with respect to the chemicals and drug products specified in
subparagraph (A)(i) of such section.''.
SEC. 5. DEVELOPMENT OF FORENSIC FIELD TESTS FOR GAMMA HYDROXYBUTYRIC
ACID.
The Attorney General shall make a grant for the development of
forensic field tests to assist law enforcement officials in detecting
the presence of gamma hydroxybutyric acid and related substances.
SEC. 6. ANNUAL REPORT REGARDING DATE-RAPE DRUGS; NATIONAL AWARENESS
CAMPAIGN.
(a) Annual Report.--The Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall periodically
submit to the Congress reports each of which provides an estimate of
the number of incidents of the abuse of date-rape drugs (as defined in
subsection (c)) that occurred during the most recent one-year period
for which data are available. The first such report shall be submitted
not later than January 15, 2000, and subsequent reports shall be
submitted annually thereafter.
(b) National Awareness Campaign.--
(1) Development of plan; recommendations of advisory
committee.--
(A) In general.--The Secretary, in consultation with
the Attorney General, shall develop a plan for carrying
out a national campaign to educate individuals
described in subparagraph (B) on the following:
(i) The dangers of date-rape drugs.
(ii) The applicability of the Controlled
Substances Act to such drugs, including
penalties under such Act.
(iii) Recognizing the symptoms that indicate
an individual may be a victim of such drugs,
including symptoms with respect to sexual
assault.
(iv) Appropriately responding when an
individual has such symptoms.
(B) Intended population.--The individuals referred to
in subparagraph (A) are young adults, youths, law
enforcement personnel, educators, school nurses,
counselors of rape victims, and emergency room
personnel in hospitals.
(C) Advisory committee.--Not later than 180 days
after the date of the enactment of this Act, the
Secretary shall establish an advisory committee to make
recommendations to the Secretary regarding the plan
under subparagraph (A). The committee shall be composed
of individuals who collectively possess expertise on
the effects of date-rape drugs and on detecting and
controlling the drugs.
(2) Implementation of plan.--Not later than 180 days after
the date on which the advisory committee under paragraph (1) is
established, the Secretary, in consultation with the Attorney
General, shall commence carrying out the national campaign
under such paragraph in accordance with the plan developed
under such paragraph. The campaign may be carried out directly
by the Secretary and through grants and contracts.
(3) Evaluation by general accounting office.--Not later than
two years after the date on which the national campaign under
paragraph (1) is commenced, the Comptroller General of the
United States shall submit to the Congress an evaluation of the
effects with respect to date-rape drugs of the national
campaign.
(c) Definition.--For purposes of this section, the term ``date-rape
drugs'' means gamma hydroxybutyric acid and its salts, isomers, and
salts of isomers and such other drugs or substances as the Secretary,
after consultation with the Attorney General, determines to be
appropriate.
Amend the title so as to read:
A bill to amend the Controlled Substances Act to add gamma
hydroxybutyric acid and ketamine to the schedules of controlled
substances, to provide for a national awareness campaign, and for other
purposes.
Purpose and Summary
The purpose of H.R. 2130, the Hillory J. Farias Date-Rape
Prevention Drug Act of 1999, is to give the nation's law
enforcement agencies the tools needed to control the
distribution and abuse of Gamma Hydroxybutyric Acid (GHB),
Ketamine, and Gamma Butyrolactone (GBL), otherwise known as
``date-rape'' drugs.
H.R. 2130 amends the Controlled Substances Act (21 U.S.C.
Sec. 801 et seq.) to make GHB, a central nervous system
depressant that is abused to produce intense highs and to
assist in the commission of sexual assaults, a Schedule I drug,
the Drug Enforcement Administration's (DEA's) most intensively
regulated category of drugs. In addition, H.R. 2130 schedules
Ketamine, an animal tranquilizer that has been similarly
abused, in Schedule III of the Controlled Substances Act, and
lists GBL, the primary precursor used in the production of GHB,
as a List I chemical. H.R. 2130 also provides for a limited
exemption from Schedule I manufacturing and distributing
facility security requirements for facilities manufacturing and
distributing GHB for a Food and Drug Administration (FDA)-
approved clinical study (in which case Schedule III facility
security requirements will apply), and places an FDA-approved
GHB drug product into Schedule III of the Controlled Substances
Act. However, the amendment adds additional reporting and
accountability requirements for the approved GHB drug product
similar to the requirements for Schedule I substances, Schedule
II drugs, and Schedule III narcotics (notwithstanding that GHB
is not a narcotic drug), and adds Schedule I penalties for the
unlawful use of an approved drug product that contains GHB.
H.R. 2130 requires the Department of Health and Human
Services (HHS) to establish a national awareness campaign to
educate junior high, high school, and college students on the
dangers of date-rape drugs, and to assist law enforcement
personnel in battling their abuse. The legislation establishes
an expert advisory panel to assist HHS in carrying out the
national campaign. Under H.R. 2130, HHS is required to provide
periodic reports to Congress on the national status of abuse of
date-rape drugs. Additionally, two years after the commencement
of the National Awareness Campaign, the General Accounting
Office (GAO) is required to conduct an evaluation of the effect
of the national campaign on the abuse of date-rape drugs, and,
if necessary, to provide specific recommendations to improve
its effectiveness. Finally, the legislation directs the
Attorney General to make a grant for the development of
forensic field tests to assist law enforcement officials in
detecting the presence of GHB.
Background and Need for Legislation
On March 11, 1999, the Subcommittee on Oversight and
Investigations held a hearing on date-rape drugs. The hearing
focused on the abuse of date-rape drugs, the law enforcement
challenges in battling their abuse, and the administrative
procedures involved in scheduling the drugs under the
Controlled Substances Act.
At the hearing, the Subcommittee heard from a wide range of
witnesses, including representatives from the Department of
Justice, the DEA, the FDA, and a number of witnesses
representing law enforcement organizations. The Subcommittee
also heard compelling testimony from an eighteen-year-old
Virginia woman who was sexually assaulted after being given
what police believe was a date-rape drug. Finally, a witness
from the Orphan Medical Company, the sponsor of an orphan drug
under clinical trials, testified regarding the adverse impact
that Federal controls would have on one of the date-rape drugs.
All the witnesses concluded that the time had come to place
strong controls on date-rape drugs, particularly GHB.
The abuse of date-rape drugs has substantially increased in
recent years and continues to grow. The DEA has documented over
4,000 overdoses and law-enforcement encounters with GHB and 32
GHB-related deaths. At least 20 States have scheduled GHB under
State drug control statutes, and law enforcement officials
continue to experience an increased presence of the drug in
sexual assaults, driving under the influence (DUI) offenses,
and overdose cases involving teenagers. With respect to
Ketamine, the DEA has documented more than 560 incidents of the
sale and/or use of Ketamine in the nation's junior highs, high
schools, and college campuses from 1992 through 1998. H.R. 2130
is named after a young woman from Texas who died after
unknowingly ingesting GHB, and whose mother brought her death
to the attention of the legislation's sponsor. Other Members'
concerns about date-rape drugs have intensified as a result of
several GHB-related injuries, including one death, involving
Michigan teenagers. In July of this year, five teenagers in
Michigan were hospitalized and lapsed into comas after sharing
a drink laced with GHB at a party.
Controlled Substances Act
The Controlled Substances Act (CSA) restricts the use and
distribution of certain drugs (e.g., heroin, amphetamines,
cocaine) by scheduling these drugs as controlled substances.
The scheduling is based on an eight-factor analysis which
includes: potential for abuse; scientific evidence of
pharmacological effects; current scientific knowledge; history
and current pattern of abuse; scope, duration, and significance
of abuse; risk to public health; psychic or physiological
dependence liability; and immediate precursors.
The CSA authorizes the classification of particular drugs.
There are five categories of controlled substances, known as
schedules, which determine the public availability of the drug,
storage and prescription requirements, and penalties for its
misuse. This classification process requires the DEA to submit
data to HHS and request that HHS conduct a medical and
scientific evaluation of the substance in question. HHS must
then make a recommendation as to whether and in what schedule
the substance should be controlled. HHS's findings as to
scientific and medical matters are binding on DEA. If DEA finds
that these facts and all other relevant data constitute
substantial evidence of potential for abuse, the Agency may
institute a rulemaking proceeding to add a substance to a
schedule or transfer it between schedules.
Gamma hydroxybutyrate (GHB)
GHB is a central nervous system depressant that is not
approved for medical use in the United States. The FDA has
issued advisories declaring GHB unsafe and illicit, except
under FDA-approved physician-supervised protocols. Although GHB
has not been approved by FDA for marketing, it is under
investigation for use in treating a sleeping disorder known as
narcolepsy under the FDA's Orphan Drug program. GHB abuse is
prevalent primarily in the young nightclub and party
subculture, where it is a growing concern due to its increasing
popularity. As noted above, the DEA has documented over 4,000
overdoses and law enforcement encounters with GHB, and 32 GHB-
related deaths since 1990.
Characteristics of GHB abuse include disruptions of short
term memory and the speed with which the body metabolizes the
substance, so that it can no longer be detected in tests of the
blood or urine. These factors, coupled with the general lack of
knowledge about GHB within the health and law enforcement
communities, ensure that the actual number of people who have
died from GHB (either by consumption or while driving under the
influence) could be much higher. Seventeen sexual assaults
associated with GHB have been documented, while poison control
databases show that there were over 600 GHB cases in 1996 and
over 900 in 1997. According to the Drug Abuse Warning Network
(DAWN), GHB-related hospital emergency department episodes
increased from 20 in 1992 to 629 in 1996.
GHB is not a controlled substance under the Federal CSA. To
date, 20 States have controlled GHB. Closely related to GHB is
its precursor, GBL, which the body converts into GHB when it is
consumed. In States where GHB is a Schedule I or II controlled
substance, GBL may be considered a controlled substance
``analog'' under State law because it is pharmacologically
substantially similar (in terms of its pharmacological makeup
and potential for abuse) to GHB. Products containing GBL are
readily available for sale on the Internet and in gyms and
health food stores. In addition, GBL is a chemical commonly
used as a paint stripper as well as a base chemical for other
solvents used for cleaning engines or wood. On January 21,
1999, the FDA warned consumers not to purchase or consume
products that contain GBL. FDA also asked the companies that
manufacture products containing GBL which are intended for
human consumption to recall them voluntarily. The recall was
based on 55 adverse health effects, including unconsciousness,
coma, respiratory depression, seizures, vomiting, and slowed
heart rate. Four companies agreed to cease manufacturing and
distribution of GBL, but only three agreed to recall their
products. On February 25, 1999, the Centers for Disease Control
and Prevention publicized 41 adverse event reports associated
with GBL it had recently received from three States.
On May 19, 1999, HHS recommended a dual scheduling of GHB.
First, HHS recommended that GHB be scheduled in Schedule I of
the CSA. Secondly, HHS recommended that if GHB is being studied
under a FDA authorized Investigational New Drug (IND)
exemption, the GHB drug product should be placed in Schedule
III of the CSA.
Ketamine
Ketamine is predominantly used as an animal tranquilizer
(veterinary products account for about 90 percent of sales). It
is only approved for human consumption for use in minor
surgical procedures, to treat burn wounds, dental extractions,
and as anesthesia for poor-risk patients with depressed vital
functions. Ketamine (known popularly as ``Special K'') has
become a common drug at clubs and large-scale parties called
``raves.'' It produces a dose-related progression of effects
from a state of dreamy intoxication to delirium accompanied by
the inability to move, feel pain, or remember what has occurred
while under the drug's influence. The Ketamine encountered to
date by law enforcement authorities has been diverted from
legitimate sources, such as veterinary clinics, which are often
burglarized to obtain Ketamine. According to the DEA, since
1993, juveniles were involved in 10 percent of all emergency
room episodes involving Ketamine and 25 percent of police
encounters with Ketamine. Law enforcement agencies are also
encountering Ketamine abuse when stopping drivers who appear to
be intoxicated.
Eighteen states have controlled Ketamine, with 15 listing
it in Schedule III. In 1979, the DEA requested a recommendation
from HHS on scheduling Ketamine under the CSA. In 1981, HHS
recommended that Ketamine be controlled as a Schedule III
substance based on its scientific and medical evaluation. DEA
did not schedule Ketamine at that time as the Agency believed
it lacked actual abuse data that would sustain the scheduling
in the face of legal challenges. However, DEA recently issued a
final rule, effective August 12, 1999, that places Ketamine in
Schedule III of the CSA.
Hearings
The Subcommittee on Oversight and Investigations held a
hearing on March 11, 1999. The Subcommittee received testimony
from the following witnesses: The Honorable Sheila Jackson-Lee,
U.S. House of Representatives, 18th Congressional District,
State of Texas; Ms. Candace Pruett, private citizen; Detective
Sergeant Mark Faistenhammer, Grosse Ile Police Department,
Michigan State Police, S.E.C.I.D. DRANO Unit; Ms. Trinka D.
Porrata, Retired LPD police office and designer drug
consultant; Ms. Jo Ellen Dyer, Senior Toxicology Management
Specialist, California Poison Control System, San Francisco
Division, and Assistant Clinical Professor of Pharmacy,
University of California at San Francisco; Lieutenant Paul
Bane, Drug Enforcement Command, Maryland State Police; Dr.
Felix Adatsi, Toxicologist, Michigan State Police; Ms. Denise
Snyder, D.C. Rape Crisis Center, Washington, D.C.; Ms. Patricia
L. Maher, Deputy Assistant Attorney General, Civil Division,
U.S. Department of Justice; Mr. Terrance W. Woodworth, Deputy
Director, Office of Diversion Control, Drug Enforcement
Administration; Mr. Nicholas Reuter, Associate Director,
Domestic and International Drug Control, Office of Health
Affairs, Food and Drug Administration; Dr. Stephen Zukin,
Director, Division of Clinical and Services Research, National
Institute on Drug Abuse, National Institutes of Health; and Ms.
Patti Engel, Vice President, Orphan Medical, Inc.
Committee Consideration
On July 27, 1999, the Subcommittee on Health and
Environment met in open markup session and approved H.R. 2130
for Full Committee consideration, amended, by a voice vote. On
August 5, 1999, the Full Committee met in open markup session
and ordered H.R. 2130 reported to the House, amended, by voice
vote, a quorum being present.
Committee Votes
Clause 3(b) of Rule XIII of the Rules of the House requires
the Committee to list the record votes on the motion to report
legislation and amendments thereto. There were no record votes
taken in connection with ordering H.R. 2130 reported. An
amendment offered by Mr. Upton, #1, to make technical changes
to conform provisions of the bill to the provisions of the
Controlled Substances Act, was agreed to by a voice vote. A
motion by Mr. Bliley to order H.R. 2130 reported to the House,
amended, was agreed to by a voice vote, a quorum being present.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of Rule XIII of the Rules of the
House of Representatives, the Committee held an oversight
hearing and made findings that are reflected in this report.
Committee on Government Reform Oversight Findings
Pursuant to clause 3(c)(4) of Rule XIII of the Rules of the
House of Representatives, no oversight findings have been
submitted to the Committee by the Committee on Government
Reform.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of Rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
2130, the Hillory J. Farias Date-Rape Drug Prevention Act of
1999, will result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of Rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 13, 1999.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 2130, the Hillory
J. Farias Date-Rape Prevention Drug Act of 1999.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Mark
Grabowic.
Sincerely,
Barry B. Anderson
(For Dan L. Crippen, Director).
Enclosure.
congressional budget office cost estimate
H.R. 2130--Hillory J. Farias Date-Rape Prevention Drug Act of 1999
Summary: The Controlled Substances Act of 1970 established
five schedules of controlled substances, designated by Roman
numerals I (greatest potential for abuse) to V (lowest
potential). H.R. 2130 would amend the act to add gamma
hydroxybutyric acid (GHB) to schedule I and add ketamine to
schedule III; in addition, the bill would designate gamma
butyrolactone (GB) as a list I chemical (a chemical needed to
manufacture a controlled substance). The bill also would direct
the Secretary of Health and Human Services, within one year of
enactment, to develop and implement a national awareness
campaign relating to date-rape drugs. H.R. 2130 would require
the General Accounting Office (GAO) to evaluate the
effectiveness of that campaign within two years of its start.
Finally, the bill would direct the Attorney General to make a
grant for the development of forensic field tests to detect GHB
and related substances.
CBO estimates that implementing H.R. 2130 would cost less
than $500,000 in fiscal year 2000 and about $7 million over the
2001-2004 period, subject to the availability of appropriated
funds. Because the bill could affect direct spending and
receipts, pay-as-you-go procedures would apply; however, we
estimate that the amounts involved would be less than $500,000
a year.
H.R. 2130 contains both an intergovernmental and a private-
sector mandate as defined in the Unfunded Mandates Reform Act
(UMRA). CBO estimates that the bill would results in no costs
to state, local, or tribal governments, so the threshold
established in UMRA ($50 million in 1996, adjusted annually for
inflation) would not be exceeded. CBO also estimates that the
costs of the private-sector mandate would fall below the
threshold established in UMRA ($100 million in 1996, adjusted
for inflation).
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 2130 is shown in the following table.
The costs of this legislation fall within budget functions 550
(health), 750 (administration of justice), and 800 (general
government).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars
-------------------------------------------------
2000 2001 2002 2003 2004
----------------------------------------------------------------------------------------------------------------
SPENDING SUBJECT TO APPROPRIATION
Estimated authorization level................................. (\1\) 3 4 (\1\) 0
Estimated outlays............................................. (\1\) 2 3 2 (\1\)
----------------------------------------------------------------------------------------------------------------
\1\ Less than $500,000.
basis of estimate
For purposes of this estimate, CBO assumes the bill will be
enacted by or near the beginning of fiscal year 2000, that the
necessary amounts will be provided for each year, and that
outlays will follow the historical spending rates for similar
activities.
Spending subject to appropriation
Based on information from the Department of Health and
Human Services about a similar anti-drug program, CBO estimates
that the awareness campaign required by the bill would cost
less than $500,000 in fiscal year 2000, $2 million to $3
million annually over the 2001-2003 period, and less than
$500,000 in 2004, subject to appropriations of the necessary
amounts. CBO expects that the GAO would evaluate the campaign
mostly in fiscal year 2002 and that this effort, like similar
reviews conducted by the agency, would cost about $400,000.
Based on information from the Drug Enforcement Administration
(DEA), CBO estimates that the grant for development of forensic
field tests would cost less than $500,000 in fiscal year 2000
because a significant amount of related research already has
been completed.
The bill's designations for GHB and GB would increase the
penalties for unauthorized manufacturing or distribution of
these substances and would tighten federal control over their
use. As a result, the federal government would be able to
pursue cases that it otherwise would not be able to prosecute.
CBO expects that any increase in federal costs for law
enforcement, court proceedings, or prison operations would not
be significant, however, because of the relatively small number
of cases likely to be involved. Any such additional costs would
be subject to the availability of appropriated funds.
Direct spending and revenues
Because those prosecuted and convicted of offenses
established under H.R. 2130 could be subject to criminal fines,
the federal government might collect additional fines if the
bill is enacted. Such fines are recorded in the budget as
governmental receipts (i.e., revenues), which are deposited in
the Crime Victims Fund and spent in subsequent years. CBO
estimates that any additional collections as a result of this
bill would be less than $500,000 a year. Because any increase
in direct spending from the Crime Victims Fund would equal the
fines collected (with a lag of one year or more), the
additional direct spending would be less than $500,000
annually.
Pay-as-you-go considerations: The Balanced Budget and
Emergency Deficit Control Act sets up pay-as-you-go procedures
for legislation affecting direct spending or receipts. Enacting
H.R. 2130 could affect both direct spending and receipts, but
CBO estimates that any such effects would be less than $500,000
a year.
Estimated impact on state, local, and tribal governments:
H.R. 2130 contains an intergovernmental mandate as defined in
UMRA. The bill would amend the Controlled Substances Act to
include ketamine as a schedule III controlled substance.
Because ketamine is administered for medical purposes by
practitioners in state and local public hospitals, the
administrative duties that would be required by the bill would
be considered a mandate. However, because the DEA recently
placed ketamine on the list of controlled substances under its
administrative authority, this bill would impose no new costs
on practitioners or the hospitals that employ them. The other
substances addressed in this bill are not administered by
practitioners in state or local hospitals.
Estimated impact on the private sector: H.R. 2130 would
create a new private-sector mandate for manufacturers,
distributors, and dispensers of GHB. The bill would require
most such entities to observe and comply with federal
regulations for schedule I controlled substances.
Pharmaceutical companies and individuals engaged in drug
testing would be able to use GHB under the less restrictive
schedule III regulations, but could face additional monthly
reporting requirements. Manufacturers, distributors, and
dispensers would all have to follow rules governing storage,
labeling, sales, and recordkeeping. Because the only current
private user of GHB is a group conducting clinical trials of
the drug as a treatment for cataplexy, CBO estimates that the
costs of the mandate would be below the threshold established
in UMRA ($100 million in 1996, adjusted for inflation).
Estimate prepared by: Federal Costs: Mark Grabowicz; impact
on State, Local, and Tribal Governments: Lisa Cash Driskill;
impact on the Private Sector: John Harris.
Estimate approved by: Peter H. Fontaine, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
Section 6 of H.R. 2130 directs the Secretary to establish
an Advisory Committee to make recommendations to the Secretary
regarding the National Awareness Campaign. Pursuant to the
requirements of subsection 5(b) of the Federal Advisory
Committee Act, the Committee finds that the functions of the
proposed advisory committee are not and cannot be performed by
an existing Federal agency or advisory commission or by
enlarging the mandate of an existing advisory committee.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of Rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 provides the short title for the legislation,
``Hillory J. Farias Date-Rape Prevention Drug Act of 1999.''
Section 2. Findings
Section 2 lists finding made by Congress.
Section 3. Addition of gamma hydroxybutyric acid and ketamine to
schedules of controlled substances; gamma butyrolactone as
additional list I chemical
Subsection (a) adds GHB, its salts, isomers, the salts of
its isomers, and any material containing any of these to
Schedule I of the Controlled Substances Act, the schedule
reserved for those substances that are highly subject to abuse
and that have no accepted medical use.
The Controlled Substances Act and implementing regulations
tightly control the manufacture and distribution of Schedule I
controlled substances. For example, manufacturers must store
raw materials, materials being processed, and final products in
a safe, steel cabinet, or vault that meets stringent security
requirements (28 C.F.R. Sec. 1301.72(a)). Compliance is costly;
indeed so costly as to discourage research into, and
development of, GHB's potential as a treatment for cataplexy.
On the other hand, GHB's potential for abuse necessitates
protection against the risk of diversion during the course of
lawful scientific research. Thus, for security purposes,
registered manufacturers and registered distributors who come
within the exemption for the investigation of new drugs
authorized by section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)) may treat GHB, its salts,
isomers, and salts of its isomers as Schedule III controlled
substances. Unless otherwise approved by the Drug Enforcement
Administration, the minimum security requirements for storage
of Schedule III controlled substances demand that the materials
be kept in a secure building with limited and controlled access
or in a locked concrete and steel cage enclosed within a
building (28 C.F.R. Sec. 1301.72(b)).
Subsection (b) classifies as Schedule III controlled
substances any GHB products subsequently approved for medical
purposes by the Food and Drug Administration under the new drug
provisions of section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. Sec. 355). Schedule III is the
repository of substances that are less subject to abuse than
those in Schedule I or II, that have accepted medical uses, but
that may be addictive (21 U.S.C. Sec. 812(b)(3)).
Subsection (b) also confirms the classification of Ketamine
as a Schedule III controlled substance. Ketamine has recognized
medical uses, primarily for the treatment of animals. It has a
hallucinogenic effect on human beings and can produce memory
loss. As a consequence, it too may be misused as a date-rape
drug, although reported cases more often involve GHB. The
Department of Health and Human Services has previously
recommended its inclusion in Schedule III, but the Drug
Enforcement Administration has only recently concluded that
incidents of abuse warranted such classification (64 Fed. Reg.
17299 (April 9, 1999); 64 Fed. Reg. 37673 (July 13, 1999)).
More than a third of the States have determined that it should
be classified as a controlled substance for purposes of State
law.
Section 102 of the Controlled Substances Act defines List I
chemicals as chemicals used in the manufacture of a controlled
substances (21 U.S.C. Sec. 802(34)). Section 310 of the
Controlled Substances Act imposes record keeping and reporting
requirements upon manufacturers and distributors of listed
chemicals, (21 U.S.C. Sec. 830) to prevent diversion of theflow
of products from lawful commerce to illicit drug production. Subsection
3(c) of H.R. 2130 adds GBL, a chemical used to manufacture GHB, to the
inventory of List 1 chemicals.
Subsection (d) clarifies that GBL's or any other chemical's
designation as a listed chemical does not preclude the Attorney
General from designating it also as a ``controlled substance
analogue'' as well. Controlled substance analogues are the
chemical twins of Schedule I or II controlled substances,
structurally similar, often with similar effects, but slightly
different in composition (21 U.S.C. Sec. 802(32)). For purposes
of prosecuting substance misconduct, the Controlled Substances
Act treats analogues as Schedule I controlled substances (21
U.S.C. Sec. 813).
GBL has legitimate commercial uses. It is a commonly
employed industrial solvent. The Drug Enforcement
Administration testified that since analogues are not subject
to regulatory control if GHB was designated a Schedule I or II
controlled substance, distribution of GBL could be treated as a
controlled substance analogue for purposes of prosecution
without encumbering its lawful industrial manufacture, sale, or
use. Subsection (d) reiterates the continued availability of
that option.
Should any GHB product be approved for medical use under
the FDA's investigational new drug procedures it must be
classified as a Schedule III controlled substance under
subsection (b). Subsection (e) establishes the same criminal
penalties for the illicit manufacturing or distribution of
Schedule III GHB as apply to Schedule I GHB-related crimes.
GHB, by virtue of its classification as a Schedule I
controlled substance, carries with it the criminal penalties
for criminal misconduct involving Schedule I or II controlled
substances under section 401(b) of the Controlled Substances
Act (21 U.S.C. Sec. 841(b)(1)(C)). Thus, anyone who unlawfully
manufactures, distributes, dispenses, or possesses GHB with the
intent to manufacture, distribute, or dispense it is subject to
imprisonment for not more than 20 years, a subsequent period of
supervised release of at least 3 years, and a fine of not more
than $1 million for an individual defendant and of not more
than $5 million for an organization. A violation is punishable
by imprisonment for not less than 20 years or more than life,
if death or serious bodily injury results from its commission.
Offenders with a prior, final felony drug conviction, face
imprisonment for not more than 30 years, followed by a term of
supervised release of at least 6 years, and a fine of either
not more than $2 million or $10 million, depending upon whether
the offender is an individual or an organization. If death or
serious bodily injury results, the repeat offender must be
sentenced to life imprisonment.
Subsection (f) makes it clear that the prohibitions and
attendant penalties with respect to the use of controlled
substances to commit rape or any other crime of violence apply
to controlled substance analogues as well. The existing
prohibition in section 401 of the Controlled Substance Act does
not mention analogues (21 U.S.C. Sec. 841(b)(7)). The omission
may make coverage uncertain in spite of the declaration in
section 203 (21 U.S.C. Sec. 813) that analogues are to be
treated as Schedule I controlled substances. Clarification is
appropriate since thehuman body responds to consumption of the
commercial solvent GBL in much the same way that it reacts to the
ingestion of GHB.
Section 4. Authority for additional reporting requirements for gamma
hydroxybutyric products in schedule III
Section 4 gives the Attorney General authority to
promulgate additional record-keeping and reporting regulations
for the research being conducted with respect to GHB under the
investigational new drug procedures of the Federal Food, Drug,
and Cosmetic Act. Existing law creates no obligation to report
transaction or inventory information to the Attorney General in
the case of such Schedule III controlled substances. Existing
regulations call upon registrants to provide quarterly
acquisition and distribution transaction reports, but only with
respect to Schedule I controlled substances, Schedule II
controlled substances, narcotic controlled substances, and
certain psychotropic controlled substances (21 C.F.R.
Sec. 1304.33). Registrants must also maintain inventory,
transaction, and other controlled substance-related records and
must keep them available for inspection and copying (21 C.F.R.
Sec. Sec. 1304.03 to 1304.25).
The regulations authorized under section 4 may require
manufacturers, distributors, and other registrants to file
annual inventory reports and quarterly acquisition and
distribution transaction reports. The regulations may demand
that annual inventory reports be submitted no later than
January 15 and reflect material in storage and in process as of
the close of business on the previous December 31. Registered
manufacturers may be compelled to document fluctuations in
their inventories, specifying increases attributable to
purchases, transfers, and returns, as well as reductions caused
by sales, transfers, theft, destruction, and seizure. The
Attorney General may insist that reports include the names,
registration numbers, and other identification of vendors,
suppliers, and customers with sufficient particularity to
permit the Attorney General to trace receipts and distribution
of the drug.
Section 4 also authorizes the Attorney General to impose
additional record keeping requirements. Physicians,
pharmacists, and other registered dispensing practitioners may
be compelled to maintain for inspection and copying records
indicating for each prescription: (1) the name, Federal and
State registration numbers, and verification of controlled
substance prescription authority of the prescribing individual;
(2) the patient's name, address and the name of the patient's
insurance provider; and (3) documentation from a medical
practitioner of the patient's medical need for the drug.
Section 310 of the Controlled Substances Act requires the
manufacturers of listed chemicals to report mail order
transactions involving certain listed chemicals with
nonregulated persons to the Attorney General (21 U.S.C.
Sec. 310(b)(3)). Section 4 of H.R. 2130 allows the Attorney
General to issue regulations making those provisions applicable
with respect to GHB.
Section 5. Development of forensic field tests for gamma hydroxybutyric
acid
Section 5 instructs the Attorney General to make a grant
for the development of forensic tests that will enable law
enforcement officials to conduct field tests for the presence
of GHB and related substances.
Section 6. Annual report regarding date-rape drugs; national awareness
campaign
Section 6 directs the Secretary of Health and Human
Services (the Secretary) to submit annual reports on the
incidents of abuse of date-rape drugs and to launch a national
date-rape educational campaign. The annual report to Congress,
first due by January 15, 2000, will provide an estimate of the
number of incidents of the abuse of GHB, its salts, isomers,
and salts of its isomers, as well as of any other date-rape
drug the Secretary, in consultation with the Attorney General,
finds appropriate to include.
Section 6 provides for the establishment of an Advisory
Council consisting of date-rape drug abuse experts to make
recommendations to the Secretary. The Secretary, in
consultation with the Attorney General and the Advisory
Council, is to plan and execute a date-rape national awareness
campaign by contract or grant. The campaign, beginning not
later than 6 months after enactment, is to be directed at young
adults, youths, law enforcement personnel, teachers, school
nurses, rape counselors, and hospital emergency room personnel.
It will alert them to the danger of date-rape drugs, of the
applicable criminal penalties and other provisions of the
Controlled Substances Act, and of symptoms exhibited by a date-
drug victim including the symptoms of a sexual assault.
Section 6 also provides that two years after the
commencement of the National Awareness Campaign, the General
Accounting Office is to submit to Congress an evaluation of the
effect of the national campaign on the abuse of date-rape
drugs.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, existing law in which no change
is proposed is shown in roman):
CONTROLLED SUBSTANCES ACT
* * * * * * *
Part A--Short Title; Findings and Declaration; Definitions
* * * * * * *
definitions
Sec. 102. As used in this title:
(1) * * *
* * * * * * *
(32)(A) * * *
(B) The designation of gamma butyrolactone or any other
chemical as a listed chemical pursuant to paragraph (34) or
(35) does not preclude a finding pursuant to subparagraph (A)
of this paragraph that the chemical is a controlled substance
analogue.
[(B)] (C) Such term does not include--
(i) a controlled substance;
(ii) any substance for which there is an approved new
drug application;
(iii) with respect to a particular person any
substance, if an exemption is in effect for
investigational use, for that person, under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) to the extent conduct with respect to such
substance is pursuant to such exemption; or
(iv) any substance to the extent not intended for
human consumption before such an exemption takes effect
with respect to that substance.
* * * * * * *
(34) The term ``list I chemical'' means a chemical specified
by regulation to the Attorney General as a chemical that is
used in manufacturing a controlled substance in violation of
this title and is important to the manufacture of the
controlled substances, and such term includes (until otherwise
specified by regulation of the Attorney General, as considered
appropriate by the Attorney General or upon petition to the
Attorney General by any person) the following:
(A) * * *
* * * * * * *
(X) Gamma butyrolactone.
[(X)] (Y) Any salt, optical isomer, or salt of an
optical isomer of the chemicals listed in subparagraphs
(M) through (U) of this paragraph.
* * * * * * *
Part B--Authority To Control; Standards and Schedules
* * * * * * *
schedules of controlled substances
Sec. 202. (a) * * *
* * * * * * *
(c) Schedules I, II, III, IV, and V shall, unless and until
amended pursuant to section 201, consist of the following drugs
or other substances, by whatever official name, common or usual
name, chemical name, or brand name designated:
Schedule I
(a) * * *
* * * * * * *
(d) Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation,
which contains any quantity of the following substance having a
depressant effect on the central nervous system, or which
contains any of their salts, isomers, and salts of isomers
whenever the existence of such salts, isomers, and salts of
isomers is possible within the specific chemical designation:
(1) Gamma hydroxybutyric acid.
* * * * * * *
Schedule III
(a) * * *
(b) [Depressants] Unless specifically excepted or unless
listed in another schedule, any material, compound, mixture, or
preparation which contains any quantity of the following
substances having a depressant effect on the central nervous
system:
(1) Any substance which contains any quantity of a
derivative of barbituric acid, or any salt of a
derivative of barbituric acid.
(2) Chorexadol.
(3) Gamma hydroxybutyric acid and its salts, isomers,
and salts of isomers contained in a drug product for
which an application has been approved under section
505 of the Federal Food, Drug, and Cosmetic Act.
[(3)] (4) Glutethimide.
(5) Ketamine and its salts, isomers, and salts of
isomers.
[(4)] (6) Lysergic acid.
[(5)] (7) Lysergic acid amide.
[(6)] (8) Methyprylon.
[(7)] (9) Phencyclidine.
[(8)] (10) Sulfondiethylmethane.
[(9)] (11) Sulfonethylmethane.
[(10)] (12) Sulfonmethane.
* * * * * * *
Part C--Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances; Piperidine Reporting
* * * * * * *
records and reports of registrants
Sec. 307. (a) * * *
* * * * * * *
(h) In the case of a drug product containing gamma
hydroxybutyric acid for which an application has been approved
under section 505 of the Federal Food, Drug, and Cosmetic Act,
the Attorney General may, in addition to any other requirements
that apply under this section with respect to such a drug
product, establish any of the following as reporting
requirements:
(1) That every person who is registered as a
manufacturer of bulk or dosage form, as a packager,
repackager, labeler, relabeler, or distributor shall
report acquisition and distribution transactions
quarterly, not later than the 15th day of the month
succeeding the quarter for which the report is
submitted, and annually report end-of-year inventories.
(2) That all annual inventory reports shall be filed
no later than January 15 of the year following that for
which the report is submitted and include data on the
stocks of the drug product, drug substance, bulk drug,
and dosage forms on hand as of the close of business
December 31, indicating whether materials reported are
in storage or in process of manufacturing.
(3) That every person who is registered as a
manufacturer of bulk or dosage form shall report all
manufacturing transactions both inventory increases,
including purchases, transfers, and returns, and
reductions from inventory, including sales, transfers,
theft, destruction, and seizure, and shall provide data
on material manufactured, manufactured from other
material, use in manufacturing other material, and use
in manufacturing dosage forms.
(4) That all reports under this section must include
the registered person's registration number as well as
the registration numbers, names, and other identifying
information of vendors, suppliers, and customers,
sufficient to allow the Attorney General to track the
receipt and distribution of the drug.
(5) That each dispensing practitioner shall maintain
for each prescription the name of the prescribing
practitioner, the prescribing practitioner's Federal
and State registration numbers, with the expiration
dates of these registrations, verification that the
prescribing practitioner possesses the appropriate
registration to prescribe this controlled substance,
the patient's name and address, the name of the
patient's insurance provider and documentation by a
medical practitioner licensed and registered to
prescribe the drug of the patient's medical need for
the drug. Such information shall be available for
inspection and copying by the Attorney General.
(6) That section 310(b)(3) (relating to mail order
reporting) applies with respect to gamma hydroxybutyric
acid to the same extent and in the same manner as such
section applies with respect to the chemicals and drug
products specified in subparagraph (A)(i) of such
section.
* * * * * * *
Part D--Offenses and Penalties
prohibited acts a--penalties
Sec. 401. (a) * * *
(b) Except as otherwise provided in section 409, 418, 419, or
420 any person who violates subsection (a) of this section
shall be sentenced as follows:
(1)(A) * * *
* * * * * * *
(C) In the case of a controlled substance in schedule I or
II, gamma hydroxybutyric acid in schedule III, or 1 gram of
flunitrazepam, except as provided in subparagraphs (A), (B),
and (D), such person shall be sentenced to a term of
imprisonment of not more than 20 years and if death or serious
bodily injury results from the use of such substance shall be
sentenced to a term of imprisonment of not less than twenty
years or more than life, a fine not to exceed the greater of
that authorized in accordance with the provisions of title 18,
United States Code, or $1,000,000 if the defendant is an
individual or $5,000,000 if the defendant is other than an
individual, or both. If any person commits such a violation
after a prior conviction for a felony drug offense has become
final, such person shall be sentenced to a term of imprisonment
of not more than 30 years and if death or serious bodily injury
results from the use of such substance shall be sentenced to
life imprisonment, a fine not to exceed the greater of twice
that authorized in accordance with the provisions of title 18,
United States Code, or $2,000,000 if the defendant is an
individual or $10,000,000 if the defendant is other than an
individual, or both. Any sentence imposing a term of
imprisonment under this paragraph shall, in the absence of such
a prior conviction, impose a term of supervised release of at
least 3 years in addition to such term of imprisonment and
shall, if there was such a prior conviction, impose a term of
supervised release of at least 6 years in addition to such term
of imprisonment. Notwithstanding any other provision of law,
the court shall not place on probation or suspend the sentence
of any person sentenced under the provisions of this
subparagraph which provide for a mandatory term of imprisonment
if death or serious bodily injury results, nor shall a person
so sentenced be eligible for parole during the term of such a
sentence.
(D) In the case of less than 50 kilograms of marihuana,
except in the case of 50 or more marihuana plants regardless of
weight, 10 kilograms of hashish, or one kilogram of hashish oil
or in the case of any controlled substance in schedule III
(other than gamma hydroxybutyric acid), or 30 milligrams of
flunitrazepam, such person shall, except as provided in
paragraphs (4) and (5) of this subsection, be sentenced to a
term of imprisonment of not more than 5 years, a fine not to
exceed the greater of that authorized in accordance with the
provisions of title 18, United States Code, or $250,000 if the
defendant is an individual or $1,000,000 if the defendant is
other than an individual, or both. If any person commits such a
violation after a prior conviction for a felony drug offense
has become final, such person shall be sentenced to a term of
imprisonment of not more than 10 years, a fine not to exceed
the greater of twice that authorized in accordance with the
provisions of title 18, United State Code, or $500,000 if the
defendant is an individual or $2,000,000 if the defendant is
other than an individual, or both. Any sentence imposing a term
of imprisonment under this paragraph shall, in the absence of
such a prior conviction, impose a special parole term of at
least 2 years in addition to such term of imprisonment and
shall, if there was such a prior conviction, impose a term of
supervised release of at least 4 years in addition to such term
of imprisonment.
* * * * * * *
(7) Penalties for distribution.--
(A) In general.--Whoever, with intent to commit a
crime of violence, as defined in section 16 of title
18, United States Code (including rape), against an
individual, violates subsection (a) by distributing a
controlled substance or controlled substance analogue
to that individual without that individual's knowledge,
shall be imprisoned not more than 20 years and fined in
accordance with title 18, United States Code.
* * * * * * *