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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.

           *       *       *       *       *       *       *