What must distributors establish and maintain records of?

Distributors are required to establish and maintain records of all incoming and outgoing drugs to ensure compliance with regulatory standards regarding controlled substances and prescription medications. This practice is crucial for several reasons. It enables thorough tracking of pharmaceuticals through the supply chain, which is essential for inventory management, accountability, and regulatory oversight. These records help prevent diversion and ensure that drugs are handled safely and accounted for throughout their distribution. By documenting all incoming and outgoing drugs, distributors can contribute to a robust system that safeguards public health while also adhering to legal requirements set forth by entities such as the Drug Enforcement Administration (DEA) and state pharmacy boards. The meticulous record-keeping serves as a critical element in audits, investigations, and ensuring that proper handling procedures are followed.