How long must drug pedigree records be maintained by a purchaser and wholesaler?

The correct duration for maintaining drug pedigree records by a purchaser and wholesaler is three years. This requirement is based on regulatory standards set forth to ensure traceability and accountability in the pharmaceutical supply chain.

Maintaining records for three years allows for comprehensive tracking of the distribution of prescription drugs, which is crucial in preventing counterfeit drugs from entering the market and in enabling efficient responses to drug recalls. This period aligns with various best practices within the industry that emphasize the importance of record-keeping for adequate monitoring and verification of drug sources.

The other answer choices do not reflect the established requirements. For example, one-year or two-year retention policies may be suitable for certain other types of records but fall short of the necessary timeframe for drug pedigree records. A five-year retention period, while longer than what is required, exceeds the regulatory demand and may unnecessarily burden businesses with prolonged storage obligations. Therefore, three years is the optimal duration set forth by regulations to ensure compliance and safeguard public health.