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Petition to Reschedule Cannabis (Marijuana) Per 21 CFR §1308.44(B)

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Petition to Reschedule Cannabis (Marijuana) Per 21 CFR §1308.44(B) Petition to Reschedule Cannabis (Marijuana) per 21 CFR §1308.44(b) Filed with the Drug Enforcment Administration by The Coalition for Rescheduling Cannabis www.drugscience.org October 9, 2002 PETITION TO RESCHEDULE CANNABIS (MARIJUANA) Exhibit A. Statement of the proposed rule .........................................................................................................3 Exhibit B. Statement of grounds..........................................................................................................................4 Part I – Introduction of argument.........................................................................................................................4 Part II -- Description of new relevant information............................................................................................10 I. Accepted medical use in the United States ...........................................................................................10 State laws.................................................................................................................................................10 Medical professionals ..............................................................................................................................10 Patients' experience and their confirmation by early studies...................................................................10 Reviews of earlier clinical studies ...........................................................................................................10 Basic research ..........................................................................................................................................10 Clinical research ......................................................................................................................................11 Route of administration. ..........................................................................................................................11 Pharmaceutical industry...........................................................................................................................11 II. Safety of use.............................................................................................................................................11 Acute side effects.....................................................................................................................................11 Documented safety of long-term cannabis use........................................................................................11 Side effects of the legal situation.............................................................................................................11 Cannabis as gateway drug .......................................................................................................................11 III. Dependence liabilty.................................................................................................................................11 Basic research on rewarding, tolerance and withdrawal..........................................................................12 Dependency compared to other drugs .....................................................................................................12 IV. Abuse potential........................................................................................................................................12 Use and Abuse .........................................................................................................................................12 Abuse of cannabis....................................................................................................................................12 Emergency room admissions...................................................................................................................12 Cannabis and dronabinol .........................................................................................................................12 Exhibit C. Summary of Evidence .......................................................................................................................13 I. Accepted medical use in the United States ..........................................................................................13 1) State laws.........................................................................................................................................13 2) Medical professionals......................................................................................................................15 3) Patients’ experiences and their confirmation. .................................................................................22 4) Reviews of earlier clinical studies...................................................................................................29 5) Basic research..................................................................................................................................38 6) Clinical research..............................................................................................................................48 7) Route of administration...................................................................................................................57 8) Pharmaceutical industry. .................................................................................................................60 II. Safety of use ......................................................................................................................................................63 9) Acute side effects. ...........................................................................................................................63 10) Documented safety of long-term cannabis use..............................................................................66 11) Side effects of the legal situation...................................................................................................72 12) Cannabis as gateway drug. ............................................................................................................74 III. Dependence liability .......................................................................................................................................76 13) Basic research on rewarding, tolerance and withdrawal. ..............................................................76 14) Dependency compared to other drugs...........................................................................................80 IV. Abuse potential...............................................................................................................................................87 15) Use and Abuse...............................................................................................................................87 16) Abuse of cannabis..........................................................................................................................92 17) Emergency room admissions.........................................................................................................99 18) Cannabis and dronabinol.............................................................................................................100 Comprehensive Bibliography............................................................................................................................103 Petition to Reschedule Cannabis (Marijuana) Exhibit A. Statement of the Proposed Rule The proposed rules for repeal, in the form proposed by the petitioners: The rule placing marihuana in schedule I [21 CFR 1308.11(d))17)] is repealed because cannabis has an accepted medical use in the United States, is safe for use under medical supervision, has an abuse potential lower than Schedule I or II drugs, and has a dependence liability that is also lower than Schedule I or II drugs. This is not a petition for the removal of marijuana from scheduling under the Controlled Substances Act (CSA), but a petition to have marijuana removed from Schedule I and rescheduled as “cannabis“ in either Schedule III, IV, or V. A consideration of the appropriate scheduling of cannabis should be made on the basis of the scientific and medical evaluation required by the CSA and in accordance with existing law. Exhibit B. Statement of Grounds Part I – Introduction of Argument This petition is based on consideration of research findings not examined in prior proceedings, the emergence of new research findings about marijuana/cannabis since prior rescheduling proceedings, and research findings that cast the record of prior proceedings in a new light. The Controlled Substances Act specifies eight factors that determine control of a drug or substance or its removal from schedules. The CSA states that these eight factors will be considered when making any finding regarding a drug’s accepted medical use, safety for use, abuse potential, or dependence liability; all eight of these factors must be considered in determining the scheduling or rescheduling of cannabis. (21 USC 811(c)) A review of the scientific and medical record for these factors supports recognition of the accepted medical use of cannabis in the United States and requires its rescheduling under the CSA. (1) Its actual or relative potential for abuse. The scientific record indicates that cannabis does not have a high potential for abuse; a majority of
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