USLegal:DEA Schedule V
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DEA Schedule V is the least restrictive of the five schedules established by the United States Controlled Substances Act of 1970. It holds prescribable medicines with the lowest abuse potential of any controlled substance, lower than that of the medicines in Schedule IV.
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. Schedule V is the floor of that gradient: a substance with even less abuse potential is generally not controlled at all.
Statutory and regulatory basis
Schedule V is defined at section 202(b)(5) of the Controlled Substances Act, 21 U.S.C. § 812(b)(5); the substances currently in the schedule are listed at 21 C.F.R. § 1308.15.[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 V on three findings: that it has a low potential for abuse relative to the substances in Schedule IV; 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 IV.
In practice
A prescription for a Schedule V medicine is refilled as the prescriber authorizes, without the five-refill limit that applies to Schedules III and IV. Federal law further allows certain Schedule V products to be sold by a pharmacist without a prescription, where state law permits, subject to limits on quantity, a purchaser age of at least eighteen, and a recorded sale.[3] Medicines in this schedule include pregabalin, lacosamide, brivaracetam, cough preparations containing limited amounts of codeine, and the antidiarrheal diphenoxylate combined with atropine.
Medicines in this status
The medicine pages that carry Schedule V status are indexed here.
References
- ↑ 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 V contents at 21 C.F.R. § 1308.15.
- ↑ Controlled Substances Act § 201, 21 U.S.C. § 811.
- ↑ Dispensing of Schedule V controlled substances without a prescription, 21 C.F.R. § 1306.26.