According to federal regulations, all Drug Enforcement Administration (DEA) applicants and registrants shall meet the following record keeping requirements:
- Your records must show the flow of controlled substance into and out of the practice – including any time a controlled substance is acquired, dispensed, administered, distributed, stolen, lost, disposed of and inventoried;
- You must keep two physically separate files – one for Schedule II substances, and one for Schedule III-V substances (the files can be stored together);
- Your controlled substance records must be readily retrievable;
- You must store all copies of DEA Form 222* (the form used for ordering Schedule I and II controlled substances) in a substantially constructed, securely locked cabinet and you must immediately report to the DEA any change in a copy (or copies) of the form’s status (used/unused, lost, stolen);
- You may issue prescriptions for controlled substances in writing, verbally, or electronically (using systems meeting DEA criteria), or by fax (note that a paper prescription is needed before any pharmacy can dispense a Schedule II substance). Prescriptions must include the following:
- Signature of registrant;
- DEA registration number;
- Patient’s name/address;
- Practitioner’s name/address;
- Drug name, strength, dosage form and quantity;
- Directions for use (frequency and route of administration); and
- Number (if any) of refills authorized
- Note that Schedule II drugs cannot be refilled.
- Note that state law may restrict the ability to refill or the number of refills.
- You may transfer controlled substances to another DEA registrant but all transfers must be recorded and cannot comprise more than 5% of all the dosage units you distribute and dispense;
- You must report thefts or significant losses within one business day to the DEA, the state controlled substance authority, and local police. The occurrence must be recorded on DEA Form 106;
- Find your local DEA office
- Find Georgia’s controlled substance authority
- You must record controlled substance spills on DEA Form 41 and keep the form on file at your facility;
- Federal and Georgia regulations require that the records be kept for at least two years;
- Per DEA rules, an inventory of all controlled substances must be maintained separately and taken biennially on May 1st, or two (2) years from the day of the last inventory, of every odd-numbered year. The written inventory record must include the following:
- Time of day the inventory was performed;
- Each finished form (e.g., 100-milligram tablet);
- Number of dosage units for each finished form. An exact count of Schedule II drugs is required; an estimate is generally satisfactory for Schedule III-V (unless the container holds >1000 dosage units);
- Number of bottles;
- Disposition of the controlled substances.
For more information:
Section IV – Recordkeeping requirements; Practitioner’s Manual; DEA Office of Diversion Control. Available HERE.
*Order your DEA Form 222 HERE.