Domain 4: Federal Requirements

This advanced course offers a thorough understanding of federal regulations surrounding the handling, disposal, and management of non-hazardous, hazardous, and pharmaceutical substances. Participants will gain insights into the complex landscape of federal requirements pertinent to controlled substances, focusing on prescriptions, including new orders, refills, and transfers, along with an overview of the DEA-controlled substance schedules. The course will delve into the federal mandates established by the DEA and FDA for the safe management of controlled substances. Students will learn essential protocols for receiving, storing, ordering, labeling, dispensing, and managing reverse distribution and take-back programs, as well as addressing incidents of loss or theft in compliance with regulatory expectations. Additionally, specialized topics will cover the federal regulations regarding restricted drug programs, emphasizing the significance of proper medication processing for substances like pseudoephedrine and the Risk Evaluation and Mitigation Strategies (REMS). A critical component of the course will also focus on FDA recall requirements, discussing the procedures and classifications related to the recall of medications, devices, supplies, and supplements. This course equips participants with the knowledge necessary to navigate and adhere to federal regulations, ensuring compliance and the promotion of public health and safety.