Controlled Substances

Controlled substances are subject to stricter controls through Federal and State laws and regulations due to their potential for misuse, abuse, diversion, and addiction.

The Federal law regulating controlled substances is the Controlled Substance Act.

The Law and its regulations controls over the manufacture, import, export, distribution, ordering, dispensing and prescribing of controlled substances.
Pharmacies must comply with both State and Federal controlled substance laws.

Schedules of Controlled Substances
The Federal Controlled Substance Law created five classifications for controlled substances numbering I, II, III, IV, and V.

A drug is placed into a controlled Schedule based on certain criteria, such as it’s potential for abuse or addiction and its medical use.

Schedule I is the most restrictive and Schedule V is the least restrictive of the controlled substances.

Labeling Controlled Substances
The symbol that indicates a controlled substance is the capital letter “C” with the appropriate roman numeral placed inside the “C” symbol.

Dispensing Controlled Substances
For a controlled substance prescription to be valid, it must be prescribed by a licensed prescriber for a legitimate medical purpose in the normal course of the prescriber’s professional practice.

The prescribing practice must be registered with the DEA and be licensed to prescribe controlled substances by the state. Controlled substances prescription must contain:

1. The date issued
2. The patients full name & address
3. The practitioners name, address & DEA registration number
4. The drug name
5. Strength
6. Dosage form
7. Quantity prescribed
8. Direction of use
9. Number of authorized refills
10. Signature of prescriber

Federal law allows Schedule III and IV prescriptions to be refilled up to five times within six months after the issuing date.

Schedule V prescriptions may be refilled more than five times, but have a six-month the limit on refills.

Schedule II prescriptions may not be refilled and are not transferable between pharmacies.
Federal law allows schedule III, IV, and V prescriptions to be transferred from one pharmacy to another for refill (if the state permits).

Pharmacies are required to maintain complete and accurate records for all controlled substances that they purchase , receive, distribute or dispense.

Federal law requires that pharmacy to keep controlled substance records for two years and have them readily available for DEA inspection if requested. Examples of records include:

1. Invoices
2. Receipts of purchases
3. Inventory of records
4. Records of transfer

State Prescription Monitoring Programs, require pharmacies to report information on controlled substance prescriptions dispensed for drugs in Schedules II, III, IV and V. (varies from state to state.) The programs help states identify potential diversion and abuse. Required information includes:

1. Patient info
2. Prescriber info
3. Pharmacy ID
4. Prescription info