USLegal:DEA Schedule I

DEA Schedule I is the most restrictive of the five schedules of controlled substances created by the United States Controlled Substances Act of 1970. A substance in Schedule I may not be prescribed, dispensed, or possessed outside of federally registered research; the medicines in this reference that carry Schedule I status are therefore investigational rather than prescribable.

The five schedules were established by the Controlled Substances Act, enacted as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The Act replaced a patchwork of earlier federal narcotics laws with a single framework that places every regulated substance into one of five schedules according to three findings: its potential for abuse, whether it has a currently accepted medical use in the United States, and the degree of dependence its use may cause. Schedule I is defined by the absence of an accepted medical use; the other four schedules all presuppose one.

Statutory and regulatory basis

Schedule I is defined at section 202(b)(1) of the Controlled Substances Act, 21 U.S.C. § 812(b)(1); the substances currently in the schedule are listed at 21 C.F.R. § 1308.11. The placement, removal, or rescheduling of a substance follows the procedure of 21 U.S.C. § 811: the Drug Enforcement Administration acts on a scientific and medical evaluation and scheduling recommendation supplied by the Department of Health and Human Services, whose findings on medical and scientific questions bind the agency. The Act also allows a substance to be placed in Schedule I temporarily, on an emergency basis, to avoid an imminent hazard to public safety.

Criteria

A substance is placed in Schedule I on three findings: that it has a high potential for abuse; that it has no currently accepted medical use in treatment in the United States; and that there is a lack of accepted safety for its use under medical supervision. The middle finding is the one that separates Schedule I from Schedule II, which shares the high-abuse finding but recognizes an accepted medical use.

In practice

A Schedule I substance cannot be written on a prescription; it has no place in ordinary medical practice. Lawful handling is confined to research and limited industrial use under a registration issued by the Drug Enforcement Administration, with the security, recordkeeping, and reporting that registration requires. Several medicines of active clinical interest sit in Schedule I, among them psilocybin, MDMA, LSD, and DMT; the trials of them described elsewhere in this reference are conducted under that research framework. Schedule I placement is contested for some substances: a medicine may show clinical promise in trials while the finding of no currently accepted medical use keeps it in Schedule I until it is formally rescheduled.

Medicines in this status

The medicine pages that carry Schedule I status are indexed here.