What is the appropriate action for expired investigational drugs?

The appropriate action for expired investigational drugs is to record the quantity and Lot number and return them to the manufacturer. This approach ensures that the drugs are properly accounted for and allows the manufacturer to handle the disposal or further management of these substances in accordance with regulatory requirements. Investigational drugs are often closely monitored and regulated due to their experimental nature and the ethical concerns surrounding their use in clinical trials.

Returning expired investigational drugs to the manufacturer helps maintain a responsible and safe approach to pharmacological research. This process aligns with good clinical practice and adheres to legal obligations regarding the handling of pharmaceuticals. Each investigational drug’s lot number and quantity are important for maintaining accurate records, which support both inventory management and compliance with research standards.

In contrast, disposing of expired drugs in regular trash does not comply with safety regulations and poses potential environmental and health risks. Storing such drugs until further notice could lead to accidental use or mishandling, which could have serious implications. Using expired investigational drugs for training purposes is not advisable, as their safety and efficacy can no longer be guaranteed, and this practice can undermine the integrity of training operations.