Union Calendar No. 214

106TH CONGRESS

1ST SESSION H. R. 2130

[Report No. 106–340, Part I]

A BILL

To amend the Controlled Substances Act to add

gamma hydroxybutyric acid and ketamine to theschedules of controlled substances, to provide fora national awareness campaign, and for otherpurposes.

OCTOBER 8, 1999

The Committee on the Judiciary discharged; committed

to the Committee of the Whole House on the State ofthe Union and ordered to be printed
IB

Union Calendar No. 214

106TH CONGRESS

1ST SESSION H. R. 2130

[Report No. 106–340, Part I]

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.

IN THE HOUSE OF REPRESENTATIVES

JUNE 10, 1999

Mr. UPTON (for himself, Mr. STUPAK, Ms. JACKSON-LEE of Texas, and Mr.

BLILEY) introduced the following bill; which was referred to the Committee on Commerce, and in addition to the Committee on the Judiciary,

for a period to be subsequently determined by the Speaker, in each case

for consideration of such provisions as fall within the jurisdiction of the

committee concerned

SEPTEMBER 27, 1999

Reported from the Committee on Commerce with amendments

[Strike out all after the enacting clause and insert the part printed in italic]

SEPTEMBER 27, 1999

Referral to the Committee on the Judiciary extended for a period ending not

later than October 8, 1999

OCTOBER 8, 1999

Additional sponsors: Mr. WAXMAN, Mr. HORN, Mr. HOBSON, Mr.

NETHERCUTT, Mr. BASS, Mr. KINGSTON, Mrs. WILSON, Mrs. BONO,

Mrs. MINK of Hawaii, Mr. OXLEY, Mr. GONZALEZ, Mr. CAMP, Ms.

MCCARTHY of Missouri, Mr. UNDERWOOD, Mr. PRICE of North Carolina,

Mrs. MALONEY of New York, Mr. BARRETT of Wisconsin, and Ms.

STABENOW

OCTOBER 8, 1999

The Committee on the Judiciary discharged; committed to the Committee of

the Whole House on the State of the Union and ordered to be printed
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[For text of introduced bill, see copy of bill as introduced on June 10, 1999]

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Hillory J. Farias Date5 Rape Prevention Drug Act of 1999’’.

6 SEC. 2. FINDINGS.

7 The Congress finds as follows:

8 (1) Gamma hydroxybutyric acid (also called G,

9 Liquid X, Liquid Ecstasy, Grievous Bodily Harm,

10 Georgia Home Boy, Scoop) has become a significant

11 and growing problem in law enforcement. At least 20

12 States have scheduled such drug in their drug laws

13 and law enforcement officials have been experiencing

14 an increased presence of the drug in driving under

15 the influence, sexual assault, and overdose cases, espe16 cially at night clubs and parties.

17 (2) A behavioral depressant and a hypnotic,

18 gamma hydroxybutyric acid (‘‘GHB’’) is being used
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1 in conjunction with alcohol and other drugs with det2 rimental effects in an increasing number of cases. It

3 is difficult to isolate the impact of such drug’s inges4 tion since it is so typically taken with an ever-chang5 ing array of other drugs and especially alcohol, which

6 potentiates its impact.

7 (3) GHB takes the same path as alcohol, proc8 esses via alcohol dehydrogenase, and its symptoms at

9 high levels of intake and as impact builds are com10 parable to alcohol ingestion/intoxication. Thus, ag11 gression and violence can be expected in some individ12 uals who use such drug.

13 (4) If taken for human consumption, common

14 industrial chemicals such as gamma butyrolactone

15 and 1.4-butanediol are swiftly converted by the body

16 into GHB. Illicit use of these and other GHB ana17 logues and precursor chemicals is a significant and

18 growing law enforcement problem.

19 (5) A human pharmaceutical formulation of

20 gamma hydroxybutyric acid is being developed as a

21 treatment for cataplexy, a serious and debilitating

22 disease. Cataplexy, which causes sudden and total loss

23 of muscle control, affects about 65 percent of the esti24 mated 180,000 Americans with narcolepsy, a sleep

25 disorder. People with cataplexy often are unable to
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1 work, drive a car, hold their children or live a normal

2 life.

3 SEC. 3. ADDITION OF GAMMA HYDROXYBUTYRIC ACID AND

4 KETAMINE TO SCHEDULES OF CONTROLLED

5 SUBSTANCES; GAMMA BUTYROLACTONE AS

6 ADDITIONAL LIST I CHEMICAL.

7 (a) ADDITION TO SCHEDULE I.—

8 (1) IN GENERAL.—Section 202(c) of the Con9 trolled Substances Act (21 U.S.C. 812(c)) is amended

10 by adding at the end of schedule I the following:

11 ‘‘(d) Unless specifically excepted or unless listed in an12 other schedule, any material, compound, mixture, or prepa13 ration, which contains any quantity of the following sub14 stance having a depressant effect on the central nervous sys15 tem, or which contains any of their salts, isomers, and salts

16 of isomers whenever the existence of such salts, isomers, and

17 salts of isomers is possible within the specific chemical des18 ignation:

19 ‘‘(1) Gamma hydroxybutyric acid.’’.

20 (2) SECURITY OF FACILITIES.—For purposes of

21 any requirements that relate to the physical security

22 of registered manufacturers and registered distribu23 tors, gamma hydroxybutyric acid and its salts, iso24 mers, and salts of isomers manufactured, distributed,

25 or possessed in accordance with an exemption ap-
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1 proved under section 505(i) of the Federal Food,

2 Drug, and Cosmetic Act shall be treated as a con3 trolled substance in schedule III under section 202(c)

4 of the Controlled Substances Act.

5 (b) ADDITION TO SCHEDULE III.—Schedule III under

6 section 202(c) of the Controlled Substances Act (21 U.S.C.

7 812(c)) is amended in (b)—

8 (1) by redesignating (4) through (10) as (6)

9 through (12), respectively;

10 (2) by redesignating (3) as (4);

11 (3) by inserting after (2) the following:

12 ‘‘(3) Gamma hydroxybutyric acid and its salts,

13 isomers, and salts of isomers contained in a drug

14 product for which an application has been approved

15 under section 505 of the Federal Food, Drug, and

16 Cosmetic Act.’’; and

17 (4) by inserting after (4) (as so redesignated) the

18 following:

19 ‘‘(5) Ketamine and its salts, isomers, and salts

20 of isomers.’’.

21 (c) ADDITIONAL LIST I CHEMICAL.—Section 102(34)

22 of the Controlled Substances Act (21 U.S.C. 802(34)) is

23 amended—

24 (1) by redesignating subparagraph (X) as sub25 paragraph (Y); and
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1 (2) by inserting after subparagraph (W) the fol2 lowing subparagraph:

3 ‘‘(X) Gamma butyrolactone.’’.

4 (d) RULE OF CONSTRUCTION REGARDING CON5 TROLLED SUBSTANCE ANALOGUES.—Section 102(32) of the

6 Controlled Substances Act (21 U.S.C. 802(32)) is

7 amended—

8 (1) by redesignating subparagraph (B) as sub9 paragraph (C); and

10 (2) by inserting after subparagraph (A) the fol11 lowing subparagraph:

12 ‘‘(B) The designation of gamma butyrolactone or any

13 other chemical as a listed chemical pursuant to paragraph

14 (34) or (35) does not preclude a finding pursuant to sub15 paragraph (A) of this paragraph that the chemical is a con16 trolled substance analogue.’’.

17 (e) PENALTIES REGARDING SCHEDULE I.—

18 (1) IN GENERAL.—Section 401(b)(1)(C) of the

19 Controlled Substances Act (21 U.S.C. 841(b)(1)(C)) is

20 amended in the first sentence by inserting after

21 ‘‘schedule I or II,’’ the following: ‘‘gamma hydroxy22 butyric acid in schedule III,’’.

23 (2) CONFORMING AMENDMENT.—Section

24 401(b)(1)(D) of the Controlled Substances Act (21

25 U.S.C. 841(b)(1)(D)) is amended by inserting ‘‘(other
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1 than gamma hydroxybutyric acid)’’ after ‘‘schedule

2 III’’.

3 (f) DISTRIBUTION WITH INTENT TO COMMIT CRIME

4 OF VIOLENCE.—Section 401(b)(7)(A) of the Controlled Sub5 stances Act (21 U.S.C. 841(b)(7)(A)) is amended by insert6 ing ‘‘or controlled substance analogue’’ after ‘‘distributing

7 a controlled substance’’.

8 SEC. 4. AUTHORITY FOR ADDITIONAL REPORTING RE9 QUIREMENTS FOR GAMMA HYDROXYBUTYRIC

10 PRODUCTS IN SCHEDULE III.

11 Section 307 of the Controlled Substances Act (21

12 U.S.C. 827) is amended by adding at the end the following:

13 ‘‘(h) In the case of a drug product containing gamma

14 hydroxybutyric acid for which an application has been ap15 proved under section 505 of the Federal Food, Drug, and

16 Cosmetic Act, the Attorney General may, in addition to any

17 other requirements that apply under this section with re18 spect to such a drug product, establish any of the following

19 as reporting requirements:

20 ‘‘(1) That every person who is registered as a

21 manufacturer of bulk or dosage form, as a packager,

22 repackager, labeler, relabeler, or distributor shall re23 port acquisition and distribution transactions quar24 terly, not later than the 15th day of the month suc-
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1 ceeding the quarter for which the report is submitted,

2 and annually report end-of-year inventories.

3 ‘‘(2) That all annual inventory reports shall be

4 filed no later than January 15 of the year following

5 that for which the report is submitted and include

6 data on the stocks of the drug product, drug sub7 stance, bulk drug, and dosage forms on hand as of the

8 close of business December 31, indicating whether ma9 terials reported are in storage or in process of manu10 facturing.

11 ‘‘(3) That every person who is registered as a

12 manufacturer of bulk or dosage form shall report all

13 manufacturing transactions both inventory increases,

14 including purchases, transfers, and returns, and re15 ductions from inventory, including sales, transfers,

16 theft, destruction, and seizure, and shall provide data

17 on material manufactured, manufactured from other

18 material, use in manufacturing other material, and

19 use in manufacturing dosage forms.

20 ‘‘(4) That all reports under this section must in21 clude the registered person’s registration number as

22 well as the registration numbers, names, and other

23 identifying information of vendors, suppliers, and

24 customers, sufficient to allow the Attorney General to

25 track the receipt and distribution of the drug.
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1 ‘‘(5) That each dispensing practitioner shall

2 maintain for each prescription the name of the pre3 scribing practitioner, the prescribing practitioner’s

4 Federal and State registration numbers, with the ex5 piration dates of these registrations, verification that

6 the prescribing practitioner possesses the appropriate

7 registration to prescribe this controlled substance, the

8 patient’s name and address, the name of the patient’s

9 insurance provider and documentation by a medical

10 practitioner licensed and registered to prescribe the

11 drug of the patient’s medical need for the drug. Such

12 information shall be available for inspection and

13 copying by the Attorney General.

14 ‘‘(6) That section 310(b)(3) (relating to mail

15 order reporting) applies with respect to gamma hy16 droxybutyric acid to the same extent and in the same

17 manner as such section applies with respect to the

18 chemicals and drug products specified in subpara19 graph (A)(i) of such section.’’.

20 SEC. 5. DEVELOPMENT OF FORENSIC FIELD TESTS FOR

21 GAMMA HYDROXYBUTYRIC ACID.

22 The Attorney General shall make a grant for the devel23 opment of forensic field tests to assist law enforcement offi24 cials in detecting the presence of gamma hydroxybutyric

25 acid and related substances.
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1 SEC. 6. ANNUAL REPORT REGARDING DATE-RAPE DRUGS;

2 NATIONAL AWARENESS CAMPAIGN.

3 (a) ANNUAL REPORT.—The Secretary of Health and

4 Human Services (in this section referred to as the ‘‘Sec5 retary’’) shall periodically submit to the Congress reports

6 each of which provides an estimate of the number of inci7 dents of the abuse of date-rape drugs (as defined in sub8 section (c)) that occurred during the most recent one-year

9 period for which data are available. The first such report

10 shall be submitted not later than January 15, 2000, and

11 subsequent reports shall be submitted annually thereafter.

12 (b) NATIONAL AWARENESS CAMPAIGN.—

13 (1) DEVELOPMENT OF PLAN; RECOMMENDATIONS

14 OF ADVISORY COMMITTEE.—

15 (A) IN GENERAL.—The Secretary, in con16 sultation with the Attorney General, shall de17 velop a plan for carrying out a national cam18 paign to educate individuals described in sub19 paragraph (B) on the following:

20 (i) The dangers of date-rape drugs.

21 (ii) The applicability of the Controlled

22 Substances Act to such drugs, including

23 penalties under such Act.

24 (iii) Recognizing the symptoms that

25 indicate an individual may be a victim of
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1 such drugs, including symptoms with re2 spect to sexual assault.

3 (iv) Appropriately responding when an

4 individual has such symptoms.

5 (B) INTENDED POPULATION.—The individ6 uals referred to in subparagraph (A) are young

7 adults, youths, law enforcement personnel, edu8 cators, school nurses, counselors of rape victims,

9 and emergency room personnel in hospitals.

10 (C) ADVISORY COMMITTEE.—Not later than

11 180 days after the date of the enactment of this

12 Act, the Secretary shall establish an advisory

13 committee to make recommendations to the Sec14 retary regarding the plan under subparagraph

15 (A). The committee shall be composed of individ16 uals who collectively possess expertise on the ef17 fects of date-rape drugs and on detecting and

18 controlling the drugs.

19 (2) IMPLEMENTATION OF PLAN.—Not later than

20 180 days after the date on which the advisory com21 mittee under paragraph (1) is established, the Sec22 retary, in consultation with the Attorney General,

23 shall commence carrying out the national campaign

24 under such paragraph in accordance with the plan

25 developed under such paragraph. The campaign may
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1 be carried out directly by the Secretary and through

2 grants and contracts.

3 (3) EVALUATION BY GENERAL ACCOUNTING OF4 FICE.—Not later than two years after the date on

5 which the national campaign under paragraph (1) is

6 commenced, the Comptroller General of the United

7 States shall submit to the Congress an evaluation of

8 the effects with respect to date-rape drugs of the na9 tional campaign.

10 (c) DEFINITION.—For purposes of this section, the

11 term ‘‘date-rape drugs’’ means gamma hydroxybutyric acid

12 and its salts, isomers, and salts of isomers and such other

13 drugs or substances as the Secretary, after consultation with

14 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.’’.