Controlled Substance Schedules
Controlled substance schedules are the DEA's five-tier classification system (Schedule I through Schedule V) that categorizes drugs based on their accepted medical use, abuse potential, and likelihood of causing dependence.
Exam Tip
Schedule II = NO refills, written/electronic Rx only, exact count for inventory. Schedules III–IV = up to 5 refills in 6 months; Schedule V refills as the prescriber authorizes. Know DEA Forms: 222 (ordering C-II), 41 (destruction), 106 (theft/loss).
What Are Controlled Substance Schedules?
The Controlled Substances Act (CSA) of 1970 established five schedules for classifying drugs and other substances based on their potential for abuse, currently accepted medical use, and safety profile. The Drug Enforcement Administration (DEA) and FDA determine scheduling.
The Five Schedules
| Schedule | Abuse Potential | Medical Use | Dependence | Examples |
|---|---|---|---|---|
| Schedule I | Highest | No accepted medical use | Severe | Heroin, LSD, ecstasy, peyote |
| Schedule II | High | Accepted with restrictions | Severe physical/psychological | Oxycodone, fentanyl, morphine, amphetamine (Adderall), methylphenidate (Ritalin) |
| Schedule III | Moderate | Accepted | Moderate/low physical, high psychological | Testosterone, ketamine, anabolic steroids, Tylenol with codeine |
| Schedule IV | Low | Accepted | Limited | Benzodiazepines (Xanax, Valium), zolpidem (Ambien), tramadol |
| Schedule V | Lowest | Accepted | Limited | Pregabalin (Lyrica), cough syrups with small amounts of codeine, lacosamide |
Prescribing and Dispensing Rules
| Rule | Schedule II | Schedules III-V |
|---|---|---|
| Prescription type | Written/electronic only (no phone-in except emergency) | Written, oral, fax, or electronic |
| Refills | NO refills allowed | III–IV: up to 5 refills within 6 months (21 CFR 1306.22); V: as the prescriber authorizes |
| Transfer | No refill transfers; an unfilled electronic CII prescription may be transferred once for initial filling at the patient's request, where state law allows (21 CFR 1306.08(e)) | Can be transferred once for refills; pharmacies sharing a real-time online database may transfer up to the maximum refills permitted by law and the prescriber's authorization (21 CFR 1306.25) |
| Emergency dispensing | Emergency oral order limited to the amount needed for the emergency period; prescriber must furnish a written, signed Rx within 7 days (21 CFR 1306.11(d)) | Not applicable |
| Inventory | Exact count required | Estimated count allowed |
DEA Requirements for Pharmacies
- Must have a valid DEA registration number
- Must keep Schedule II records separate from III-V
- Biennial inventory required
- DEA Form 222 or CSOS for ordering Schedule II
- DEA Form 41 for destruction of controlled substances
- Report theft/loss on DEA Form 106
Exam Alert
Controlled substance schedules are a cornerstone topic in the Overview and Laws/Regulations domain (25% of ExCPT). Know the schedule classifications, refill rules (Schedule II = NO refills), and key DEA forms (222, 41, 106).
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DEA Number
A DEA number is a unique identifier assigned by the Drug Enforcement Administration to healthcare providers and pharmacies authorized to handle controlled substances, used to track prescribing and dispensing activity.
Biennial Inventory
A biennial inventory is the DEA-required physical count of all controlled substances that must be conducted by registrants required to keep controlled-substance records at least once every two years to account for Schedule II-V drugs on hand.
OBRA-90 (Omnibus Budget Reconciliation Act of 1990)
OBRA-90 is a federal law that mandated prospective drug utilization review (DUR), patient counseling by pharmacists, and maintenance of patient medication profiles for Medicaid covered outpatient prescriptions under state implementation rules and specified federal exceptions.
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