For a facility to comply with HD handling standards, what documentation must it maintain?

For a facility to comply with hazardous drug (HD) handling standards as outlined by USP Chapter 800, maintaining Standard Operating Procedures (SOPs) is essential. SOPs serve as a formal document that outlines the specific practices and procedures for handling hazardous drugs safely. These procedures include guidelines on various aspects such as personnel training, environmental controls, handling and disposal of HDs, and maintaining a sterile and safe environment.

Having detailed SOPs in place is not only crucial for compliance but also helps ensure that all staff members are aware of the best practices and legal requirements when engaging with hazardous materials. This documentation functions as both a training resource and a reference for staff, supporting consistent practices that minimize risk to health care workers, patients, and the environment.

While records of employee training, logs of hazardous drugs, and reports to local health authorities might be important for other compliance and operational purposes, it is the SOPs that form the backbone of HD management and safety protocols in a facility. Properly documented SOPs are a critical requirement to demonstrate compliance with regulatory standards and ensure the safety of all involved in handling such drugs.