What factors shape a substance’s federal schedule?
A substance’s schedule affects the controls that apply to it. Classification considers accepted medical use, abuse potential, and dependence when the substance is abused.
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What factors shape a substance’s federal schedule?
A substance’s schedule affects the controls that apply to it. Classification considers accepted medical use, abuse potential, and dependence when the substance is abused.
What are the federal criteria for Schedule I?
Schedule I requires high abuse potential, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.
What are the federal criteria for Schedule II?
Schedule II requires high abuse potential, accepted medical use (sometimes with severe restrictions), and the possibility of severe psychological or physical dependence.
What are the federal criteria for Schedule III?
Schedule III has lower abuse potential than Schedules I and II, accepted medical use, and potential for moderate or low physical dependence or high psychological dependence.
What are the federal criteria for Schedule IV?
Schedule IV has low abuse potential relative to Schedule III, accepted medical use, and potential for limited physical or psychological dependence relative to Schedule III.
What are the federal criteria for Schedule V?
Schedule V has low abuse potential relative to Schedule IV, accepted medical use, and potential for limited physical or psychological dependence relative to Schedule IV.
Are the schedules a simple ranking of medical usefulness or harm?
The schedules are based on statutory findings, not a simple ranking of medical usefulness or harmfulness. For example, Schedule II allows accepted medical use but still requires high abuse potential.
What eight factors must the Attorney General consider in a scheduling decision?
The eight factors are abuse potential; pharmacological effects; scientific knowledge; history and pattern of abuse; scope, duration, and significance of abuse; public-health risk; dependence liability; and whether it is an immediate precursor.
What product details should be identified before checking its schedule?
Record the active ingredient or ingredients, strength, dosage form, and, for a combination product, the amount of each controlled ingredient per unit or volume.
Where should you check a substance’s current federal schedule?
Check current 21 CFR Part 1308, especially §§1308.11–1308.15, for the substance and applicable schedule.
What details of a regulatory entry should be checked beyond the substance name?
Check whether the regulatory entry covers relevant salts, isomers, derivatives, or preparations, and whether a specific exception applies.
Why check later Federal Register rules as well as the DEA list?
Consider final rules published in the Federal Register after the CFR edition. DEA’s controlled-substances list can help with searching, but it is not comprehensive and may list a parent chemical rather than every controlled form.