Which statement about controlled drug records is true?

• A. Must be kept off-site and for 3 years
• B. Must be kept on the premises and for at least 2 years
• C. Must be kept in off-site permanent archive
• D. Must be kept only electronically

Answer: (B)

Records for controlled drugs must be readily accessible on the business premises and kept for a defined minimum period to ensure traceability and compliance during audits. Keeping the records on site allows immediate retrieval during inspections, stock checks, and any investigations, which is essential for accountability of controlled substances.

The minimum retention period is two years from the date of the last entry, providing a reliable window for regulatory review and monitoring of dispense and stock movements. This timeframe helps ensure that any discrepancies or irregularities can be traced and resolved.

Electronic records can be used if they are secure, backed up, and readily retrievable on the premises, but storing records off-site or archiving them permanently would hinder timely access and is not in line with standard requirement expectations. Saying they must be kept only electronically ignores the need for on-site accessibility and the possibility of traditional records where applicable.

So, the statement that records for controlled drugs must be kept on the premises and for at least two years best reflects the regulatory expectation.