Required Records: Maintaining Clear and Up-to-Date Records
Accurate and comprehensive recordkeeping is vital for compliance with DEA regulations.
Acquisition Records
- Retention: Maintain records for a minimum of two years.
- Information:
- Date received
- Assigned container name/number
- Drug specific information (name, strength, container size)
- Seller information (distributor, manufacturer)
- Shipment information (lot number, NDC number, invoice number)
- Current balance on hand
- Staff initials who received the shipment
- Date of container opening
- Date and reason for any location changes
- Supporting Documentation: Retain invoices and packing slips to corroborate acquisition records. If any Schedule II drugs were received ensure you retain and update your 222 forms.
Dispensing Records
- Retention: Maintain records for a minimum of two years.
- Information:
- Date administered/dispensed
- Unique container name/number
- Amount dispensed
- Patient/client information including client address
- Reason for use/Diagnosis
- Prescriber name
- Staff signature/initials
- Additional Data: Consider recording pre- and post-use container weights for enhanced accuracy.
Inventory Records
- Frequency: Conduct a physical inventory at least once every two years (biennial inventory).
- Purpose: Compare documented inventory (expected) with physical inventory (actual) to identify discrepancies.
- Best Practices: Perform physical counts more often than biennially (e.g., monthly or quarterly) to identify errors promptly.
- State Regulations: Check state laws as they may require more frequent inventories than the federal biennial requirement.