Key Takeaways
- The DEA enforces the Controlled Substances Act (CSA) of 1970, classifying drugs into five schedules (I-V) based on abuse potential and medical use.
- Schedule I drugs (heroin, LSD, marijuana) have high abuse potential and NO accepted medical use federally.
- Schedule II drugs (oxycodone, fentanyl, Adderall) have high abuse potential but accepted medical use; NO refills allowed.
- Pharmacies need a DEA registration number (renewed every 3 years) to handle controlled substances.
- All DEA Form 222s for Schedule II orders must be retained for 2 years; electronic ordering (CSOS) is increasingly common.
DEA Regulations and Controlled Substance Schedules
Quick Answer: The DEA classifies controlled substances into Schedules I-V based on abuse potential and medical use. Schedule II drugs require a new prescription each time (no refills), while Schedules III-V allow up to 5 refills within 6 months. Pharmacies must maintain a DEA registration (renewed every 3 years) and keep controlled substance records for at least 2 years.
The Drug Enforcement Administration (DEA) enforces the Controlled Substances Act (CSA) of 1970, which established the federal framework for regulating drugs with potential for abuse.
The Five Controlled Substance Schedules
| Schedule | Abuse Potential | Medical Use | Prescription Requirements | Examples |
|---|---|---|---|---|
| Schedule I | Highest | None accepted (federally) | Cannot be prescribed | Heroin, LSD, MDMA, marijuana* |
| Schedule II | High | Accepted | Written/electronic Rx, NO refills | Oxycodone, fentanyl, Adderall, Ritalin |
| Schedule III | Moderate | Accepted | Written/oral/faxed Rx, 5 refills in 6 months | Tylenol with codeine, testosterone, ketamine |
| Schedule IV | Low | Accepted | Written/oral/faxed Rx, 5 refills in 6 months | Xanax, Valium, Ambien, tramadol |
| Schedule V | Lowest | Accepted | Written/oral/faxed Rx, 5 refills in 6 months | Cough syrups with codeine, Lyrica |
*Note: While marijuana remains Schedule I federally, many states have legalized it for medical or recreational use. The PTCE tests federal law.
Key Rules by Schedule
Schedule II Requirements (Most Strictly Controlled)
- No refills allowed — new prescription required each time
- Written, electronic, or faxed prescription (fax only in emergencies or specific situations)
- Prescriber must have DEA number registered for Schedule II
- Partial fills allowed if pharmacy cannot supply full quantity (must complete within 72 hours)
- Long-term care facility patients may receive partial fills for up to 60 days
Schedules III-V Requirements
- Up to 5 refills within 6 months of the original prescription date
- Oral prescriptions permitted (pharmacist must document)
- Transfer of prescriptions allowed one time between pharmacies (some states allow more)
DEA Registration Requirements
| Requirement | Details |
|---|---|
| Who needs DEA registration | Pharmacies, prescribers, manufacturers, distributors |
| Registration renewal | Every 3 years |
| Separate registration | Required for each location (no blanket registrations) |
| DEA number format | 2 letters + 7 digits (e.g., AB1234567) |
DEA Number Verification
Pharmacy technicians should know how to verify a prescriber's DEA number:
- First letter: Registrant type (A, B, or F for practitioners; M for mid-level practitioners)
- Second letter: First letter of prescriber's last name
- Checksum calculation: Add 1st, 3rd, and 5th digits; add 2nd, 4th, and 6th digits and multiply by 2; sum both results — last digit should match 7th digit
Ordering Controlled Substances
Schedule II Ordering
- DEA Form 222 (triplicate form) OR
- CSOS (Controlled Substance Ordering System) — electronic ordering with digital certificate
Schedules III-V Ordering
- Standard invoice/purchase order acceptable
- No special DEA form required
Recordkeeping Requirements
| Record Type | Retention Period |
|---|---|
| DEA Form 222 | 2 years |
| Controlled substance invoices | 2 years |
| Biennial (every 2 years) inventory | 2 years |
| Prescription records | 2 years (many states require longer) |
Important: Controlled substance records must be kept separate from other pharmacy records OR must be readily retrievable (marked with red "C" stamp or similar identifier).
A patient presents a prescription for oxycodone 10mg. How many refills are allowed on this Schedule II controlled substance?
Which of the following drugs is classified as Schedule IV?
How often must a pharmacy renew its DEA registration?