Federal requirements for controlled substance prescriptions, New, Refill, Transfer and DEA controlled substance schedules
Table of Contents
What is DEA?
The Drug Enforcement Administration (DEA) is a U.S. federal law enforcement agency under the Department of Justice (DOJ) responsible for enforcing controlled substances laws and regulations. Its primary mission is to combat drug trafficking, diversion, and abuse while ensuring the legal availability of pharmaceuticals for legitimate medical use.
What are the responsibilities of the DEA?
- Enforcement of Controlled Substances Laws
- Investigates and prosecutes illegal drug manufacturing, distribution, and trafficking.
- Targets criminal organizations involved in the drug trade.
- Regulation of Prescription Drugs
- Oversees the Controlled Substances Act (CSA) and classifies drugs into Schedules I-V.
- Regulates the prescribing, dispensing, and distribution of controlled substances (e.g., opioids, stimulants, sedatives).
- Requires DEA registration for healthcare providers (doctors, dentists, veterinarians, etc.) to prescribe controlled substances.
- Registers pharmacies, manufacturers, and distributors handling controlled substances.
- Monitors prescription drugs to prevent misuse (e.g., “pill mills,” doctor shopping).
- Manages the Prescription Drug Monitoring Program (PDMP) in coordination with states.
- Works with other agencies (FBI, Customs, Homeland Security) to intercept drug smuggling.
- Collaborates with foreign governments to combat global drug trafficking.
- Runs awareness campaigns (e.g., National Prescription Drug Take Back Day).
- Provides resources on drug abuse prevention.
DEA Controlled Substance Schedules
The DEA categorizes drugs into five schedules based on medical use and abuse potential:| Schedule | Potential for Abuse | Medical Use |
| I | High | Not accepted (illegal) |
| II | High | Accepted (with severe restrictions) |
| III | Moderate | Accepted |
| IV | Low | Accepted |
| V | Lowest | Accepted |
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Schedule I (C-I)
- High abuse potential, no accepted medical use in the U.S.
- Examples: Heroin, LSD, Ecstasy (MDMA), Marijuana (federally).
Schedule II (C-II)
- High potential for abuse, may lead to severe dependence.
- Accepted medical use with strict regulations.
- No refills allowed.
- Examples: Oxycodone, Morphine, Adderall, Fentanyl.
Schedule III (C-III)
- Moderate potential for abuse and dependence.
- Up to 5 refills within 6 months.
- Examples: Codeine combinations (Tylenol with Codeine), Ketamine, Anabolic steroids.
Schedule IV (C-IV)
- Low potential for abuse and limited dependence.
- Up to 5 refills within 6 months.
- Examples: Alprazolam (Xanax), Diazepam (Valium), Tramadol.
Schedule V (C-V)
- Lowest abuse potential among controlled substances.
- May be available without a prescription in some states.
- Examples: Pregabalin (Lyrica), Cough preparations with <200mg codeine per 100mL (Robitussin AC).
Controlled Substance Prescription Requirements
Controlled substances are regulated by the Drug Enforcement Administration (DEA) under the Controlled Substances Act (CSA). The regulations apply to prescribing, dispensing, refilling, and transferring prescriptions.1. New Prescriptions Schedule II (C-II)
- Must be written and signed by a licensed prescriber.
- Electronic prescribing (EPCS) is allowed if both prescriber and pharmacy use DEA-certified systems.
- No verbal or faxed prescriptions allowed, except in emergencies like LTCF or Hospice patients (must be followed by a written prescription within 7 days).
Schedule III–V (C-III to C-V)
- May be written, electronic, faxed, or verbal.
- Must include:
- Patient’s full name and address.
- Prescriber’s name, address, and DEA number.
- Drug name, strength, dosage form, and quantity.
- Directions for use.
- Number of refills (if applicable).
- Prescriber’s signature (if written).
Controlled Substance Refill Rules
The DEA sets strict rules on refilling controlled substance prescriptions based on their schedule (II-V). State laws may impose additional restrictions. Below are the federal refill regulations:Schedule II (C-II) – Strictest Rules
- No refills allowed (must issue a new prescription each time).
- Partial fills (if allowed by state law):
- Pharmacist may dispense a partial quantity if unable to supply the full amount.
- Remaining portion must be filled within 72 hours (if not, the prescription becomes void).
Schedule II (C-II) Emergency oral prescriptions
- Permitted only in urgent situations (no prior written Rx).
- Limited to a 72-hour supply.
- Must be followed by a written prescription within 7 days.
Federal Partial Fill Rules for LTCFs & Hospice
Schedule II (C-II) Partial Fills are allowed for LTCF & Hospice patients under the Comprehensive Addiction and Recovery Act (CARA, 2016).Key Requirements:
- The prescription must include “LTCF patient” or “hospice patient” notation.
- The pharmacist may dispense a partial quantity (e.g., a 7-day supply instead of 30 days).
- Remaining balance must be filled within 60 days (not 72 hours like non-LTCF cases).
- After 60 days, any unused portion expires (cannot be dispensed).
- No refills (must issue a new prescription if more medication is needed).
Schedule III & IV (C-III, C-IV)
- Limited Refills
- Maximum of 5 refills within 6 months from the prescription issue date.
- After 6 months, a new prescription is required (even if refills remain).
- Partial fills are permitted (remaining quantity can be dispensed later within the 6-month limit).
Schedule V (C-V) – Most Flexible
- Refills permitted as authorized by the prescriber (no federal limit, but state laws may apply).
- Some Schedule V drugs (e.g., cough syrups with codeine) may be sold without a prescription in certain states, but with restrictions (e.g., ID requirement, quantity limits).
Controlled Substance Transfer Rules
The DEA allows limited transfers of controlled substance prescriptions between pharmacies, but the rules vary by schedule (II-V). Below are the federal transfer regulations—note that state laws may impose stricter restrictions.Schedule II (C-II) – No Transfers Allowed
- Prescriptions cannot be transferred between pharmacies.
- If a patient needs the prescription filled at a different pharmacy:
- The original prescription must be canceled (if not yet filled).
- A new prescription must be issued by the prescriber.
Schedules III & IV (C-III, C-IV) – One-Time Transfer Permitted
- Original pharmacy can transfer the prescription only once to another pharmacy.
- The receiving pharmacy must verify the prescription’s authenticity.
- The original pharmacy must record the transfer (including the receiving pharmacy’s name, address, DEA number and pharmacist’s name).
- The original pharmacy must void any remaining refills (only the receiving pharmacy can dispense them).
- The receiving pharmacy can dispense any remaining refills (up to the original 5 refills in 6 months).
- No further transfers are allowed.
Schedule V (C-V) – Transfer Rules Vary by State
- Federal law allows transfers, but state laws may differ.
- Some states permit unlimited transfers, while others impose restrictions.
- Example: A cough syrup with codeine (C-V) may be transferable in some states but not others.
