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The Five Schedules of Controlled Substances (from 21 U.S.C § 812) I. Background a. Statutory law established the five schedules of controlled substances under The Controlled Substances Act. b. The Drug Enforcement Administration (DEA) follows The Controlled Substances Act in its prosecution for drug related offenses. II. What is a Schedule I Drug? a. It is the only category of controlled substances that may not be prescribed by a physician. b. Drugs must meet the following three criteria in order to be placed in Schedule I: i. The drug or other substance has a high potential for abuse. ii. The drug or other substance has no currently accepted medical use in treatment in the United States. iii. There is a lack of accepted safety for use of the drug or other substance under medical supervision. c. Examples of schedule I drugs: heroin, cocaine, marijuana. III. What is a Schedule II Drug? a. Drugs must meet the following three criteria in order to be placed in Schedule II: i. The drug or other substance has a high potential for abuse. ii. The drug or other substance has no currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. iii. Abuse of the drug or other substances may lead to severe psychological or physical dependence. b. Examples of schedule II drugs: methadone, oxycodone (OxyContin), methylphenidate (Ritalin). IV. What is a Schedule III Drug? a. Drugs must meet the following three criteria in order to be placed in Schedule III: i. The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II. ii. The drug or other substance has a currently accepted medical use in treatment in the United States. iii. Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence. b. Examples of schedule III drugs: Anabolic steroids, hydrocodone (Vicodin), synthetic THC (Marinol). V. What is a Schedule IV Drug? a. Drugs must meet the following three criteria in order to be placed in Schedule IV: i. The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III. ii. The drug or other substance has a currently accepted medical use in treatment in the United States. iii. Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. b. Example of Schedule IV drugs: Alprazolam (Xanax), diazepam (Valium). VI. What is a Schedule V Drug? a. Drugs must meet the following three criteria in order to be placed in Schedule V: i. The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV. ii. The drug or other substance has a currently accepted medical use in treatment in the United States. iii. Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV. b. Examples of Schedule V drugs: Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams. Arguments for removal of cannabis as a Schedule I Drug Main Source: http://en.wikipedia.org/wiki/Removal_of_cannabis_from_Schedule_I_of_the_Controlled_Substances_Act#Schedule_ I. II. III. 1 History a. In 1970, Congress placed cannabis into Schedule I on a provisional basis under the advice of Roger Egeberg (the Assistant Secretary of Health at the time). b. The reason for the provisional placement was because few studies had been conducted to determine the effects of cannabis at the time. i. In his letter to the Chairman of the House Committee on Interstate and Foreign Commerce (Harley Staggers), Egeberg states: 1. “Since there is a still a considerable void in our knowledge of the plant and effects of the active drug contained in it, our recommendation is that marijuana be retained within schedule I at least until the completion of certain studies now underway to resolve these issues.1” Fifteen states have accepted legislation allowing the medical use of cannabis by their citizens2. a. Alaska, California, Colorado, Hawaii, Maine, Maryland, Michigan, Montana, Nevada, New Jersey, New Mexico, Oregon, Rhode Island, Vermont, and Washington all have medical marijuana. i. At least 35,000 patients are currently using medical cannabis legally in these states, and over 2,500 different physicians have recommended it for use by their patients.3 b. The second criterion under The Controlled Substances Act for classification as a schedule I drug is: there is currently no accepted medical use in treatment in the United States. Obviously, the fact that 2,500 physicians recommended cannabis to patients proves that cannabis is currently accepted in the medical community as treatment. Cannabis is non-lethal a. The third criterion under The Controlled Substance Act is that there is a lack of general safety for use of the drug. i. “There are virtually no reports of fatal cannabis overdose in humans.”4 Jon Gettman (May 13, 1999). "Science And The End Of Marijuana Prohibition". MarijuanaNews.com. http://www.marijuananews.com/marijuananews/cowan/science_and_the_end_of_marijuana.htm.. 2 http://www.drugscience.org/amu/amu_medprof.html 3 Accepted Medical Use: Medical Professionals. The 2002 Petition to Reschedule Cannabis (Marijuana). DrugScience.org. 4 Herkenham M, Lynn A, Little M, Johnson M, Melvin L, de Costa B, Rice K (1990). "Cannabinoid receptor localization in brain". Proc. Natl. Acad. Sci. U.S.A. 87. ii. Therapeutic index is a way of measuring how safe a particular substance is to ingest. The way it is measured is to identify the quantity (dose) that a normal user ingests; then find out how many “doses” it would take to kill the normal user. Alcohol, for example, has a therapeutic index of 1:10. Cannabis is so non-toxic that its ratio is estimated to be between 1:20,000 and 1:40,000.5 iii. Further, vaporization has been developed as a to administer cannabis so that the patient does not need to smoke the plant. 1. Vaporization allows cannabinoids to the bloodstream almost instantaneously.6 2. This allows patients to self regulate their dosage of cannabinoids by immediately ceasing inhalation if the side effects become unpleasant.7 5 http://stash.normal.org/the-deas-top-ten-facts-on-legalization National Academy of Sciences, Institute of Medicine. 1999. Marijuana and Medicine: Assessing the Science Base. 7 Growing, L., et al. 1998. Therapeutic use of cannabis: clarifying the debate. Drug and Alcohol Review. 6 The Reschedule Process Main Source: http://en.wikipedia.org/wiki/Removal_of_cannabis_from_Schedule_I_of_the_Controlled_Substances_Act #Schedule_ I. II. Cannabis could be rescheduled in the following ways: a. Legislatively, through Congress b. Through the Executive Branch c. The Controlled Substance Act provides for a rulemaking process that allows the Attorney General to reschedule cannabis administratively. Stages in rescheduling process:8 a. Filing of Petition with The Drug Enforcement Administration (DEA) b. Acceptance of Petition by DEA c. Initial Review by DEA d. Referral to Department of Health and Administration Act (HHS) i. As set forth by the Controlled Substances Act e. Scientific and Medical Evaluation by HHS i. This comes from the HHS Secretary ii. The findings are binding on the DEA 1. If the Secretary recommends a drug to not be controlled, then the Attorney General will not be allowed the control the drug. f. HHS Report to DEA g. Evaluation of Additional Information by DEA h. Publication of DEA Decision i. (Judicial review by the U.S. Court of Appeals) j. (Public Hearing on Disputed Matters of Fact) III. The following factors are considered when controlling a substance: a. b. c. d. e. f. g. h. 8 The drug's actual or relative potential for abuse. Scientific evidence of its side effects, if known. The state of current scientific knowledge regarding the drug. Its history and current pattern of abuse. The scope, duration, and significance of abuse. What, if any, risk there is to the public health. Its psychological or physiological dependence liability. Whether the substance is an immediate precursor of a controlled substance. 21 U.S.C. §811b