If a wholesaler keeps records off site, when must they be available for inspection?

The requirement that records maintained off-site must be available for inspection within two working days is rooted in regulations governing wholesale drug distribution. This stipulation ensures that regulatory bodies, such as the Drug Enforcement Administration (DEA) and state boards of pharmacy, can effectively conduct audits and check compliance with laws regarding the distribution of pharmaceuticals.

Having access to these records within a two-working-day timeframe strikes a balance between the operational realities of wholesalers maintaining records in a remote location and the necessity for timely oversight. It allows regulators to verify compliance with recordkeeping requirements, while also providing wholesalers a reasonable amount of time to gather the necessary documentation from their off-site storage.

In jurisdictions that adhere to federal standards, this two-day requirement helps to prevent any significant delays in inspections, thus supporting the integrity of the drug supply chain and ensuring patient safety. It is important for wholesalers to be aware of this timeframe and to have procedures in place to retrieve their records promptly to comply with regulatory expectations.