Schedule of Controlled Substances

Origins of the CSA

Prior to 1970, federal drug control was administered through an ad hoc regulatory framework amassed over the previous half century. Weaknesses in this patchwork regime were exposed as new pharmaceuticals developed for legitimate medical and research purposes (e.g., the barbiturates, amphetamines, LSD) were diverted into illicit and grey markets where misuse became widespread. Alarmed by the rapid, and in some cases epidemic, increase in the recreational use of both new and traditional drugs of abuse, policymakers set out to rationalize and streamline federal drug control. In mid-1969, the Nixon administration formally sent to Congress legislation that would eventually be signed into law as the Comprehensive Drug Abuse and Prevention Control Act of 1970. With this legislation, the control of specific substances became more of an administrative rather than statutory process. The law also completed transfer of the constitutional justification for drug control from the federal government's taxing authority to its power to control interstate commerce.

The Schedule

The CSA established five schedules of controlled substances, each with specific placement criteria, regulatory controls, and associated penalties. The CSA specifies general criteria that determine placement of controlled substances into one of the five schedules. Schedule I substances (e.g., heroin, marijuana, LSD, MDMA, and methaqualone) have high abuse liability, no accepted medical utility, and clinically unproven safety. Schedule II substances (e.g., morphine, methadone, methamphetamine, PCP, and cocaine) have high abuse liability, accepted medical utility, and the potential to produce severe physical or psychological dependence. Schedule III substances (e.g., ketamine, anabolic steroids, and certain barbiturates) have moderate abuse liability, accepted medical utility, and the potential to produce moderate to low physical dependence or high psychological dependence. Schedule IV substances (e.g., Valium, Xanax, Darvon) have low abuse liability, accepted medical utility, and the potential to produce limited physical or psychological dependence. Schedule V substances (e.g., cough syrup with codeine) have the lowest abuse liability, accepted medical use, and the potential to produce minimal physical or psychological dependence.

Regulatory controls and dispensing requirements vary according to the schedule of controlled substances. For example, except for use in approved research, the use and distribution of Schedule I drugs is completely prohibited. Schedule II substances can be dispensed for legitimate medical purposes, but a written prescription is required and refills on the same prescription are prohibited. Both Schedule III and IV substances can be prescribed either in writing or verbally (e.g., by telephone) and may include up to five refills within six months of the initial prescription. Schedule V substances include certain over-the-counter (OTC) and prescription drug preparations that require pharmacists to collect and maintain information on retail transactions. Other controls that vary by schedule cover labeling and packaging, recordkeeping, physical security, and production quotas.

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