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USLegal:DEA Schedule IV

From Pharmacopedia

DEA Schedule IV is the fourth of the five schedules established by the United States Controlled Substances Act of 1970. It holds prescribable medicines with a low potential for abuse relative to those in Schedule III, and it includes several of the most widely prescribed controlled medicines in the United States.

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, which sorts every regulated substance by its potential for abuse, its accepted medical use, and the dependence its use may cause. Each schedule from II downward describes a lower abuse potential and lighter controls than the one above it; Schedule IV sits between Schedule III and Schedule V.

Statutory and regulatory basis

Schedule IV is defined at section 202(b)(4) of the Controlled Substances Act, 21 U.S.C. § 812(b)(4); the substances currently in the schedule are listed at 21 C.F.R. § 1308.14.[1] Placement and rescheduling follow 21 U.S.C. § 811, on a scientific and medical recommendation from the Department of Health and Human Services.[2]

Criteria

A substance is placed in Schedule IV on three findings: that it has a low potential for abuse relative to the substances in Schedule III; that it has a currently accepted medical use in treatment in the United States; and that abuse of it may lead to limited physical or psychological dependence relative to the substances in Schedule III.

In practice

A prescription for a Schedule IV medicine, like one for a Schedule III medicine, may be refilled up to five times within six months of the date it was written; after that the prescriber must issue a new prescription.[3] Prescriptions may be written, transmitted electronically, or given orally to the pharmacy. Medicines in this schedule include the benzodiazepines such as alprazolam, diazepam, lorazepam, and clonazepam, together with tramadol, zolpidem, carisoprodol, modafinil, and phenobarbital.

Medicines in this status

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

References

  1. Controlled Substances Act, Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. 91-513. Schedule criteria at 21 U.S.C. § 812(b); Schedule IV contents at 21 C.F.R. § 1308.14.
  2. Controlled Substances Act § 201, 21 U.S.C. § 811.
  3. Refilling of prescriptions for Schedule III and IV controlled substances, 21 C.F.R. § 1306.22.