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USLegal:DEA Schedule III

From Pharmacopedia
(Redirected from USLegal:DEASIII)

DEA Schedule III is the middle schedule of the five established by the United States Controlled Substances Act of 1970. It holds prescribable medicines whose potential for abuse is recognized but is lower than that of the medicines in Schedules I and II.

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. From Schedule III downward, the schedules describe a descending gradient of abuse potential and of the controls placed on prescribing.

Statutory and regulatory basis

Schedule III is defined at section 202(b)(3) of the Controlled Substances Act, 21 U.S.C. § 812(b)(3); the substances currently in the schedule are listed at 21 C.F.R. § 1308.13.[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 III on three findings: that it has a potential for abuse less than that of the substances in Schedules I and II; that it has a currently accepted medical use in treatment in the United States; and that abuse of it may lead to moderate or low physical dependence, or to high psychological dependence.

In practice

A prescription 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. The controls are lighter than those of Schedule II but heavier than those applied to a prescription medicine that is not a controlled substance. Medicines in this schedule include buprenorphine, ketamine, the anabolic-androgenic steroids such as testosterone, and combination products containing limited amounts of codeine.

Medicines in this status

The medicine pages that carry Schedule III 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 III contents at 21 C.F.R. § 1308.13.
  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.