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The following DEA Drug Rescheduling Criteria is on pages 256-257 of the U.S. Government's 1999 Institute of Medicine (IOM) report:
DRUG ENFORCEMENT AGENCY'S
FIVE-FACTOR TEST FOR [DRUG] RESCHEDULING
[Formulated in 1992 in response to a court challenge to scheduling.}
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 reasonably 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 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.
[Cited Sources: LeCraw (1996) and 57 Federal Register 10499 (1992)]
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