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Appendix F
Rescheduling Criteria

Drug Enforcement Agency's Five-Factor Test For Rescheduling*

1. The drug's chemistry must be known and reproducible.

The substance's chemistry must be scientifically established to permit it to be reproduced in dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201(j) of the Food, Drug, and Cosmetic Act, 21 USC 321(f), is sufficient generally to meet this requirement.

2. There must be adequate safety studies.

There must be adequate pharmacological and toxicological studies done by all methods reasonably applicable on the basis of which it could be fairly and responsibly concluded, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, that the substance is safe for treating a specific, recognized disorder.

3. There must be adequate and well-controlled studies proving efficacy.

There must be adequate, well-controlled, well-designed, well-conducted, and well-documented studies, including clinical investigations, by experts qualified by scientific training and experience to evaluate

*Formulated in 1992 in response to a court challenge to scheduling.



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OCR for page 256
Page 256 Appendix F Rescheduling Criteria Drug Enforcement Agency's Five-Factor Test For Rescheduling* 1. The drug's chemistry must be known and reproducible. The substance's chemistry must be scientifically established to permit it to be reproduced in dosages which can be standardized. The listing of the substance in a current edition of one of the official compendia, as defined by section 201(j) of the Food, Drug, and Cosmetic Act, 21 USC 321(f), is sufficient generally to meet this requirement. 2. There must be adequate safety studies. There must be adequate pharmacological and toxicological studies done by all methods reasonably applicable on the basis of which it could be fairly and responsibly concluded, by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, that the substance is safe for treating a specific, recognized disorder. 3. There must be adequate and well-controlled studies proving efficacy. There must be adequate, well-controlled, well-designed, well-conducted, and well-documented studies, including clinical investigations, by experts qualified by scientific training and experience to evaluate *Formulated in 1992 in response to a court challenge to scheduling.

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Page 257 the safety and effectiveness of drugs on the basis of which it could fairly and responsibly be concluded by such experts that the substance will have its intended effect in treating a specific, recognized disorder. 4. The drug must be accepted by qualified experts. The drug must have a New Drug Application (NDA) approved by the Food and Drug Administration . . . or, a consensus of the national community of experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, accepts the safety and effectiveness of the substance for use in treating a specific, recognized disorder. A material conflict of opinion among experts precludes a finding of consensus. 5. The scientific evidence must be widely available. In the absence of NDA approval, information concerning the chemistry, pharmacology, toxicology, and effectiveness of the substance must be reported, published, or otherwise widely available in sufficient detail to permit experts, qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, to fairly and responsibly conclude the substance is safe and effective for use in treating a specific, recognized disorder. SOURCES: LeCraw (1996) and 57 Federal Register 10499 (1992).

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Appendix A 9:15 Precipitated Cannabinoid Withdrawal and Sensory Processing of Painful Stimuli I. Michael Walker, Brown University 9:45 Role of Cannabinoids in Movement Clara Sanudo, Brown University 10:15 ~ 0:45 BREAK Tolerance and Cannabinoid-Opioid Interactions Sandra P. Welch, Medical College of Virginia Medical Uses of Marijuana: Clinical Data and Basic Biology 1 1: 10 Moderator John A. Benson, Ir., lOM Study Investigator Oregon Health Sciences University 1 1:15 Profile of Medical Marijuana Users John Mendelson, University of California at San Francisco 1 1:45 Immune Modulation by Cannabinoids Norbert KaminskI, Michigan State University 12: ~ 5 Psychological Effects of Marijuana Use Charles R. Schuster, Wayne State University 12:45 LUNCH :45 Marijuana and Glaucoma Paul Kaufman, University of Wisconsin 2:15 Effects of Marijuana and Cannabinoids in Neurological Disorders Paul Consroe, University of Arizona Health Sciences Center 2:45 Neural Mechanisms of Cannabinoid Analgesia Howard Fields, University of California at San Francisco 3:15 3:45 Pain Management Michael Rowbotham, University of California at San Francisco Wasting Syndrome Pathogenesis and Clinical Markers Donald Kotler, St. Lukes'-Roosevelt Hospital 4: 15 Clinical Experience with Marijuana Stephen O'Brien, East Bay AIDS Center 4:45 ADJOURN