How many years are wholesalers required to maintain records of drug source, distribution, and disposition?

Wholesalers are required to maintain records of drug sourcing, distribution, and disposition for a period of two years. This regulation is in place to ensure accountability and traceability within the pharmaceutical supply chain. Having a two-year record retention policy allows for effective tracking of drugs from manufacturers to distributors and ultimately to the end consumers. It aids in investigations related to drug safety and compliance, ensuring that there is a reliable record of all transactions that can be reviewed if necessary.

In this context, keeping records for one year would not provide sufficient oversight for tracking pharmaceuticals during the critical period in which issues may arise, and a longer retention time, such as three or five years, may exceed regulatory requirements, leading to unnecessary burdens on wholesalers. The two-year timeframe strikes a balance between compliance and practicality in the management of pharmaceutical inventory and distribution.