PUBLIC LAW 106–172—FEB. 18, 2000
`
`114 STAT. 7
`
`Feb. 18, 2000
`[H.R. 2130]
`
`Hillory J. Farias
`and Samantha
`Reid Date-Rape
`Drug Prohibition
`Act of 2000.
`Law enforcement
`and crimes.
`21 USC 801 note.
`21 USC 812 note.
`
`Public Law 106–172
`106th Congress
`
`An Act
`To amend the Controlled Substances Act to direct the emergency scheduling of
`gamma hydroxybutyric acid, to provide for a national awareness campaign, and
`for other purposes.
`
`Be it enacted by the Senate and House of Representatives of
`the United States of America in Congress assembled,
`SECTION 1. SHORT TITLE.
`This Act may be cited as the ‘‘Hillory J. Farias and Samantha
`Reid Date-Rape Drug Prohibition Act of 2000’’.
`SEC. 2. FINDINGS.
`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 experi-
`encing 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 inges-
`tion /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.
`
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`JAZZ EXHIBIT 2011
`Par Pharm., Inc. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case CBM2014-00151
`
`Page 1 of 7
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`

`

`114 STAT. 8
`
`PUBLIC LAW 106–172—FEB. 18, 2000
`
`21 USC 812 note.
`
`Deadline.
`
`Federal Register,
`publication.
`
`(6) Abuse of illicit GHB is an imminent hazard to public
`safety that requires immediate regulatory action under the
`Controlled Substances Act (21 U.S.C. 801 et seq.).
`SEC. 3. EMERGENCY SCHEDULING OF GAMMA HYDROXYBUTYRIC ACID
`AND LISTING OF GAMMA BUTYROLACTONE AS LIST I
`CHEMICAL.
`(a) EMERGENCY SCHEDULING OF GHB.—
`(1) IN GENERAL.—The Congress finds that the abuse of
`illicit gamma hydroxybutyric acid is an imminent hazard to
`the public safety. Accordingly, the Attorney General, notwith-
`standing sections 201(a), 201(b), 201(c), and 202 of the Con-
`trolled Substances Act, shall issue, not later than 60 days
`after the date of the enactment of this Act, a final order
`that schedules such drug (together with its salts, isomers, and
`salts of isomers) in the same schedule under section 202(c)
`of the Controlled Substances Act as would apply to a scheduling
`of a substance by the Attorney General under section 201(h)(1)
`of such Act (relating to imminent hazards to the public safety),
`except as follows:
`(A) For purposes of any requirements that relate to
`the physical security of registered manufacturers and reg-
`istered distributors, the final order shall treat such drug,
`when the drug is manufactured, distributed, or possessed
`in accordance with an exemption under section 505(i) of
`the Federal Food, Drug, and Cosmetic Act (whether the
`exemption involved is authorized before, on, or after the
`date of the enactment of this Act), as being in the same
`schedule as that recommended by the Secretary of Health
`and Human Services for the drug when the drug is the
`subject of an authorized investigational new drug applica-
`tion (relating to such section 505(i)). The recommendation
`referred to in the preceding sentence is contained in the
`first paragraph of the letter transmitted on May 19, 1999,
`by such Secretary (acting through the Assistant Secretary
`for Health) to the Attorney General (acting through the
`Deputy Administrator of the Drug Enforcement Adminis-
`tration), which letter was in response to the letter trans-
`mitted by the Attorney General (acting through such
`Deputy Administrator) on September 16, 1997. In pub-
`lishing the final order in the Federal Register, the Attorney
`General shall publish a copy of the letter that was trans-
`mitted by the Secretary of Health and Human Services.
`(B) In the case of gamma hydroxybutyric acid that
`is contained in a drug product for which an application
`is approved under section 505 of the Federal Food, Drug,
`and Cosmetic Act (whether the application involved is
`approved before, on, or after the date of the enactment
`of this Act), the final order shall schedule such drug in
`the same schedule as that recommended by the Secretary
`of Health and Human Services for authorized formulations
`of the drug. The recommendation referred to in the pre-
`ceding sentence is contained in the last sentence of the
`fourth paragraph of the letter referred to in subparagraph
`(A) with respect to May 19, 1999.
`(2) FAILURE TO ISSUE ORDER.—If the final order is not
`issued within the period specified in paragraph (1), gamma
`
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`

`PUBLIC LAW 106–172—FEB. 18, 2000
`
`114 STAT. 9
`
`hydroxybutyric acid (together with its salts, isomers, and salts
`of isomers) is deemed to be scheduled under section 202(c)
`of the Controlled Substances Act in accordance with the policies
`described in paragraph (1), as if the Attorney General had
`issued a final order in accordance with such paragraph.
`(b) ADDITIONAL PENALTIES RELATING TO GHB.—
`(1) CONTROLLED SUBSTANCES ACT.—
`(A) 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 (including when
`scheduled as an approved drug product for purposes of
`section 3(a)(1)(B) of the Hillory J. Farias and Samantha
`Reid Date-Rape Drug Prohibition Act of 2000),’’.
`(B) CONFORMING AMENDMENT.—Section 401(b)(1)(D) of
`the Controlled Substances Act (21 U.S.C. 841(b)(1)(D)) is
`amended by striking ‘‘, or 30’’ and inserting ‘‘(other than
`gamma hydroxybutyric acid), or 30’’.
`(2) CONTROLLED SUBSTANCES IMPORT AND EXPORT ACT.—
`(A) IN GENERAL.—Section 1010(b)(3) of the Controlled
`Substances Import and Export Act (21 U.S.C. 960(b)(3))
`is amended in the first sentence by inserting after ‘‘I or
`II,’’ the following: ‘‘gamma hydroxybutyric acid (including
`when scheduled as an approved drug product for purposes
`of section 3(a)(1)(B) of the Hillory J. Farias and Samantha
`Reid Date-Rape Drug Prohibition Act of 2000),’’.
`(B) CONFORMING AMENDMENT.—Section 1010(b)(4) of
`the Controlled Substances Import and Export Act (21
`U.S.C. 960(b)(4)) is amended by striking ‘‘flunitrazepam)’’
`and inserting the following: ‘‘flunitrazepam and except a
`violation involving gamma hydroxybutyric acid)’’.
`(c) GAMMA BUTYROLACTONE AS 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.’’.
`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 hydroxy-
`butyric 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.
`
`Records.
`
`Deadline.
`
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`114 STAT. 10
`
`PUBLIC LAW 106–172—FEB. 18, 2000
`
`Deadline.
`
`Applicability.
`
`‘‘(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 trans-
`actions 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 mate-
`rial, use in manufacturing other material, and use in manufac-
`turing dosage forms.
`‘‘(4) That all reports under this section must include the
`registered person’s registration number as well as the registra-
`tion numbers, names, and other identifying information of ven-
`dors, 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 num-
`bers, 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 subpara-
`graph (A)(i) of such section.’’.
`
`SEC. 5. CONTROLLED SUBSTANCES ANALOGUES.
`(a) RULE OF CONSTRUCTION REGARDING CONTROLLED SUB-
`STANCE ANALOGUES.—Section 102(32) of the Controlled Substances
`Act (21 U.S.C. 802(32)) is amended—
`(1) in subparagraph (A), by striking ‘‘subparagraph (B)’’
`and inserting ‘‘subparagraph (C)’’;
`(2) by redesignating subparagraph (B) as subparagraph
`(C); and
`(3) by inserting after subparagraph (A) the following new
`subparagraph (B):
`‘‘(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) 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 sub-
`stance analogue’’ after ‘‘distributing a controlled substance’’.
`
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`PUBLIC LAW 106–172—FEB. 18, 2000
`
`114 STAT. 11
`
`SEC. 6. DEVELOPMENT OF MODEL PROTOCOLS, TRAINING MATERIALS,
`FORENSIC FIELD TESTS, AND COORDINATION MECHA-
`NISM FOR
`INVESTIGATIONS AND PROSECUTIONS
`RELATING TO GAMMA HYDROXYBUTYRIC ACID, OTHER
`CONTROLLED SUBSTANCES, AND DESIGNER DRUGS.
`(a) IN GENERAL.—The Attorney General, in consultation with
`the Administrator of the Drug Enforcement Administration and
`the Director of the Federal Bureau of Investigation, shall—
`(1) develop—
`(A) model protocols for the collection of toxicology speci-
`mens and the taking of victim statements in connection
`with investigations into and prosecutions related to possible
`violations of the Controlled Substances Act or other Federal
`or State laws that result in or contribute to rape, other
`crimes of violence, or other crimes involving abuse of
`gamma hydroxybutyric acid, other controlled substances,
`or so-called ‘‘designer drugs’’; and
`(B) model training materials for law enforcement per-
`sonnel involved in such investigations; and
`(2) make such protocols and training materials available
`to Federal, State, and local personnel responsible for such inves-
`tigations.
`(b) GRANT.—
`(1) IN GENERAL.—The Attorney General shall make a grant,
`in such amount and to such public or private person or entity
`as the Attorney General considers appropriate, for the develop-
`ment of forensic field tests to assist law enforcement officials
`in detecting the presence of gamma hydroxybutyric acid and
`related substances.
`(2) AUTHORIZATION OF APPROPRIATIONS.—There are author-
`ized to be appropriated such sums as may be necessary to
`carry out this subsection.
`(c) REPORT.—Not later than 180 days after the date of the
`enactment of this Act, the Attorney General shall submit to the
`Committees on the Judiciary of the Senate and House of Represent-
`atives a report on current mechanisms for coordinating Federal,
`State, and local investigations into and prosecutions related to
`possible violations of the Controlled Substances Act or other Federal
`or State laws that result in or contribute to rape, other crimes
`of violence, or other crimes involving the abuse of gamma hydroxy-
`butyric acid, other controlled substances, or so-called ‘‘designer
`drugs’’. The report shall also include recommendations for the
`improvement of such mechanisms.
`SEC. 7. 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 periodi-
`cally submit to 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
`1-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.—
`
`21 USC 801 note.
`
`Deadline.
`
`21 USC 801 note.
`
`Deadline.
`
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`114 STAT. 12
`
`PUBLIC LAW 106–172—FEB. 18, 2000
`
`(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 rec-
`ommendations 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 para-
`graph (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 2 years after the date on which the national cam-
`paign under paragraph (1) is commenced, the Comptroller Gen-
`eral of the United States shall submit to 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, iso-
`mers, and salts of isomers and such other drugs or substances
`as the Secretary, after consultation with the Attorney General,
`determines to be appropriate.
`
`SEC. 8. SPECIAL UNIT IN DRUG ENFORCEMENT ADMINISTRATION FOR
`ASSESSMENT OF ABUSE AND TRAFFICKING OF GHB AND
`OTHER CONTROLLED SUBSTANCES AND DRUGS.
`(a) ESTABLISHMENT.—Not later than 60 days after the date
`of the enactment of this Act, the Attorney General shall establish
`within the Operations Division of the Drug Enforcement Adminis-
`tration a special unit which shall assess the abuse of and trafficking
`in gamma hydroxybutyric acid, flunitrazepam, ketamine, other con-
`trolled substances, and other so-called ‘‘designer drugs’’ whose use
`has been associated with sexual assault.
`(b) PARTICULAR DUTIES.—In carrying out the assessment under
`subsection (a), the special unit shall—
`
`Deadline.
`Establishment.
`
`Deadline.
`
`Deadline.
`
`Deadline.
`
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`PUBLIC LAW 106–172—FEB. 18, 2000
`
`114 STAT. 13
`
`Deadline.
`
`(1) examine the threat posed by the substances and drugs
`referred to in that subsection on a national basis and regional
`basis; and
`(2) make recommendations to the Attorney General
`regarding allocations and reallocations of resources in order
`to address the threat.
`(c) REPORT ON RECOMMENDATIONS.—
`(1) REQUIREMENT.—Not later than 180 days after the date
`of the enactment of this Act, the Attorney General shall submit
`to the Committees on the Judiciary of the Senate and House
`of Representatives a report which shall—
`(A) set forth the recommendations of the special unit
`under subsection (b)(2); and
`(B) specify the allocations and reallocations of resources
`that the Attorney General proposes to make in response
`to the recommendations.
`(2) TREATMENT OF REPORT.—Nothing in paragraph (1) may
`be construed to prohibit the Attorney General or the Adminis-
`trator of the Drug Enforcement Administration from making
`any reallocation of existing resources that the Attorney General
`or the Administrator, as the case may be, considers appropriate.
`SEC. 9. TECHNICAL AMENDMENT.
`Section 401 of the Controlled Substances Act (21 U.S.C. 841)
`is amended by redesignating subsections (d), (e), (f ), and (g) as
`subsections (c), (d), (e), and (f ), respectively.
`
`Approved February 18, 2000.
`
`LEGISLATIVE HISTORY—H.R. 2130 (S. 1561):
`HOUSE REPORTS: No. 106–340, Pt. 1 (Comm. on Commerce).
`CONGRESSIONAL RECORD:
`Vol. 145 (1999): Oct. 12, considered and passed House.
`Nov. 19, considered and passed Senate, amended, in lieu of
`S. 1561.
`Vol. 146 (2000): Jan. 31, House concurred in Senate amendments.
`WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 36 (2000):
`Feb. 18, Presidential statement.
`
`Æ
`
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