II

106TH CONGRESS

1ST SESSION H. R. 2130

IN THE SENATE OF THE UNITED STATES

OCTOBER 13, 1999

Received

AN ACT

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,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Hillory J. Farias Date3 Rape Prevention Drug Act of 1999’’.

4 SEC. 2. FINDINGS.

5 The Congress finds as follows:

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

7 Liquid X, Liquid Ecstasy, Grievous Bodily Harm,

8 Georgia Home Boy, Scoop) has become a significant

9 and growing problem in law enforcement. At least

10 20 States have scheduled such drug in their drug

11 laws and law enforcement officials have been experi12 encing an increased presence of the drug in driving

13 under the influence, sexual assault, and overdose

14 cases, especially at night clubs and parties.

15 (2) A behavioral depressant and a hypnotic,

16 gamma hydroxybutyric acid (‘‘GHB’’) is being used

17 in conjunction with alcohol and other drugs with

18 detrimental effects in an increasing number of cases.

19 It is difficult to isolate the impact of such drug’s in20 gestion since it is so typically taken with an ever21 changing array of other drugs and especially alcohol,

22 which potentiates its impact.

23 (3) GHB takes the same path as alcohol, proc24 esses via alcohol dehydrogenase, and its symptoms

25 at high levels of intake and as impact builds are

26 comparable to alcohol ingestion/intoxication. Thus,
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1 aggression and violence can be expected in some in2 dividuals who use such drug.

3 (4) If taken for human consumption, common

4 industrial chemicals such as gamma butyrolactone

5 and 1.4-butanediol are swiftly converted by the body

6 into GHB. Illicit use of these and other GHB ana7 logues and precursor chemicals is a significant and

8 growing law enforcement problem.

9 (5) A human pharmaceutical formulation of

10 gamma hydroxybutyric acid is being developed as a

11 treatment for cataplexy, a serious and debilitating

12 disease. Cataplexy, which causes sudden and total

13 loss of muscle control, affects about 65 percent of

14 the estimated 180,000 Americans with narcolepsy, a

15 sleep disorder. People with cataplexy often are un16 able to work, drive a car, hold their children or live

17 a normal life.

18 SEC. 3. ADDITION OF GAMMA HYDROXYBUTYRIC ACID AND

19 KETAMINE TO SCHEDULES OF CONTROLLED

20 SUBSTANCES; GAMMA BUTYROLACTONE AS

21 ADDITIONAL LIST I CHEMICAL.

22 (a) ADDITION TO SCHEDULE I.—

23 (1) IN GENERAL.—Section 202(c) of the Con24 trolled Substances Act (21 U.S.C. 812(c)) is amend25 ed by adding at the end of schedule I the following:
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1 ‘‘(d) Unless specifically excepted or unless listed in

2 another schedule, any material, compound, mixture, or

3 preparation, which contains any quantity of the following

4 substance having a depressant effect on the central nerv5 ous system, or which contains any of their salts, isomers,

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

7 isomers, and salts of isomers is possible within the specific

8 chemical designation:

9 ‘‘(1) Gamma hydroxybutyric acid.’’.

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

11 any requirements that relate to the physical security

12 of registered manufacturers and registered distribu13 tors, gamma hydroxybutyric acid and its salts, iso14 mers, and salts of isomers manufactured, distrib15 uted, or possessed in accordance with an exemption

16 approved under section 505(i) of the Federal Food,

17 Drug, and Cosmetic Act shall be treated as a con18 trolled substance in schedule III under section

19 202(c) of the Controlled Substances Act.

20 (b) ADDITION TO SCHEDULE III.—Schedule III

21 under section 202(c) of the Controlled Substances Act (21

22 U.S.C. 812(c)) is amended in (b)—

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

24 through (12), respectively;

25 (2) by redesignating (3) as (4);
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1 (3) by inserting after (2) the following:

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

3 isomers, and salts of isomers contained in a drug

4 product for which an application has been approved

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

6 Cosmetic Act.’’; and

7 (4) by inserting after (4) (as so redesignated)

8 the following:

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

10 of isomers.’’.

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

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

13 amended—

14 (1) by redesignating subparagraph (X) as sub15 paragraph (Y); and

16 (2) by inserting after subparagraph (W) the fol17 lowing subparagraph:

18 ‘‘(X) Gamma butyrolactone.’’.

19 (d) RULE OF CONSTRUCTION REGARDING CON20 TROLLED SUBSTANCE ANALOGUES.—Section 102(32) of

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

22 amended—

23 (1) by redesignating subparagraph (B) as sub24 paragraph (C); and
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1 (2) by inserting after subparagraph (A) the fol2 lowing subparagraph:

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

4 other chemical as a listed chemical pursuant to paragraph

5 (34) or (35) does not preclude a finding pursuant to sub6 paragraph (A) of this paragraph that the chemical is a

7 controlled substance analogue.’’.

8 (e) PENALTIES REGARDING SCHEDULE I.—

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

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

11 is amended in the first sentence by inserting after

12 ‘‘schedule I or II,’’ the following: ‘‘gamma hydroxy13 butyric acid in schedule III,’’.

14 (2) CONFORMING AMENDMENT.—Section

15 401(b)(1)(D) of the Controlled Substances Act (21

16 U.S.C. 841(b)(1)(D)) is amended by inserting

17 ‘‘(other than gamma hydroxybutyric acid)’’ after

18 ‘‘schedule III’’.

19 (f) DISTRIBUTION WITH INTENT TO COMMIT CRIME

20 OF VIOLENCE.—Section 401(b)(7)(A) of the Controlled

21 Substances Act (21 U.S.C. 841(b)(7)(A)) is amended by

22 inserting ‘‘or controlled substance analogue’’ after ‘‘dis23 tributing a controlled substance’’.
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1 SEC. 4. AUTHORITY FOR ADDITIONAL REPORTING RE2 QUIREMENTS FOR GAMMA HYDROXYBUTYRIC

3 PRODUCTS IN SCHEDULE III.

4 Section 307 of the Controlled Substances Act (21

5 U.S.C. 827) is amended by adding at the end the fol6 lowing:

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

8 hydroxybutyric acid for which an application has been ap9 proved under section 505 of the Federal Food, Drug, and

10 Cosmetic Act, the Attorney General may, in addition to

11 any other requirements that apply under this section with

12 respect to such a drug product, establish any of the fol13 lowing as reporting requirements:

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

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

16 repackager, labeler, relabeler, or distributor shall re17 port acquisition and distribution transactions quar18 terly, not later than the 15th day of the month suc19 ceeding the quarter for which the report is sub20 mitted, and annually report end-of-year inventories.

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

22 filed no later than January 15 of the year following

23 that for which the report is submitted and include

24 data on the stocks of the drug product, drug sub25 stance, bulk drug, and dosage forms on hand as of

26 the close of business December 31, indicating wheth-
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1 er materials reported are in storage or in process of

2 manufacturing.

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

4 manufacturer of bulk or dosage form shall report all

5 manufacturing transactions both inventory increases,

6 including purchases, transfers, and returns, and re7 ductions from inventory, including sales, transfers,

8 theft, destruction, and seizure, and shall provide

9 data on material manufactured, manufactured from

10 other material, use in manufacturing other material,

11 and use in manufacturing dosage forms.

12 ‘‘(4) That all reports under this section must

13 include the registered person’s registration number

14 as well as the registration numbers, names, and

15 other identifying information of vendors, suppliers,

16 and customers, sufficient to allow the Attorney Gen17 eral to track the receipt and distribution of the drug.

18 ‘‘(5) That each dispensing practitioner shall

19 maintain for each prescription the name of the pre20 scribing practitioner, the prescribing practitioner’s

21 Federal and State registration numbers, with the ex22 piration dates of these registrations, verification that

23 the prescribing practitioner possesses the appro24 priate registration to prescribe this controlled sub25 stance, the patient’s name and address, the name of
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1 the patient’s insurance provider and documentation

2 by a medical practitioner licensed and registered to

3 prescribe the drug of the patient’s medical need for

4 the drug. Such information shall be available for in5 spection and copying by the Attorney General.

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

7 order reporting) applies with respect to gamma hy8 droxybutyric acid to the same extent and in the

9 same manner as such section applies with respect to

10 the chemicals and drug products specified in sub11 paragraph (A)(i) of such section.’’.

12 SEC. 5. DEVELOPMENT OF FORENSIC FIELD TESTS FOR

13 GAMMA HYDROXYBUTYRIC ACID.

14 The Attorney General shall make a grant for the de15 velopment of forensic field tests to assist law enforcement

16 officials in detecting the presence of gamma hydroxy17 butyric acid and related substances.

18 SEC. 6. ANNUAL REPORT REGARDING DATE-RAPE DRUGS;

19 NATIONAL AWARENESS CAMPAIGN.

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

21 Human Services (in this section referred to as the ‘‘Sec22 retary’’) shall periodically submit to the Congress reports

23 each of which provides an estimate of the number of inci24 dents of the abuse of date-rape drugs (as defined in sub25 section (c)) that occurred during the most recent one-year
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1 period for which data are available. The first such report

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

3 subsequent reports shall be submitted annually thereafter.

4 (b) NATIONAL AWARENESS CAMPAIGN.—

5 (1) DEVELOPMENT OF PLAN; RECOMMENDA6 TIONS OF ADVISORY COMMITTEE.—

7 (A) IN GENERAL.—The Secretary, in con8 sultation with the Attorney General, shall de9 velop a plan for carrying out a national cam10 paign to educate individuals described in sub11 paragraph (B) on the following:

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

13 (ii) The applicability of the Controlled

14 Substances Act to such drugs, including

15 penalties under such Act.

16 (iii) Recognizing the symptoms that

17 indicate an individual may be a victim of

18 such drugs, including symptoms with re19 spect to sexual assault.

20 (iv) Appropriately responding when an

21 individual has such symptoms.

22 (B) INTENDED POPULATION.—The individ23 uals referred to in subparagraph (A) are young

24 adults, youths, law enforcement personnel, edu25 cators, school nurses, counselors of rape vic-
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1 tims, and emergency room personnel in hos2 pitals.

3 (C) ADVISORY COMMITTEE.—Not later

4 than 180 days after the date of the enactment

5 of this Act, the Secretary shall establish an ad6 visory committee to make recommendations to

7 the Secretary regarding the plan under sub8 paragraph (A). The committee shall be com9 posed of individuals who collectively possess ex10 pertise on the effects of date-rape drugs and on

11 detecting and controlling the drugs.

12 (2) IMPLEMENTATION OF PLAN.—Not later

13 than 180 days after the date on which the advisory

14 committee under paragraph (1) is established, the

15 Secretary, in consultation with the Attorney General,

16 shall commence carrying out the national campaign

17 under such paragraph in accordance with the plan

18 developed under such paragraph. The campaign may

19 be carried out directly by the Secretary and through

20 grants and contracts.

21 (3) EVALUATION BY GENERAL ACCOUNTING OF22 FICE.—Not later than two years after the date on

23 which the national campaign under paragraph (1) is

24 commenced, the Comptroller General of the United

25 States shall submit to the Congress an evaluation of
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1 the effects with respect to date-rape drugs of the na2 tional campaign.

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

4 term ‘‘date-rape drugs’’ means gamma hydroxybutyric

5 acid and its salts, isomers, and salts of isomers and such

6 other drugs or substances as the Secretary, after consulta7 tion with the Attorney General, determines to be appro8 priate.

Passed the House of Representatives October 12,

1999.

Attest: JEFF TRANDAHL,

Clerk.