A Practical Review of 505(b)(2) Products: Operational, Safety, and Billing Considerations
Many medications entering today’s market are developed through the 505(b)(2) pathway, yet pharmacy teams may be unaware of how these products differ from brand or generic options—creating risks related to product selection, safety, and workflow. This course discusses the regulatory and clinical nuances of 505(b)(2)-approved medications, including how to identify them, how they appear within electronic medication-management systems (e.g., EHR), and why they create unique operational, safety, and reimbursement considerations. You will gain strategies to distinguish 505(b)(2) products, implement standardized processes to reduce medication-error risk, and anticipate financial and workflow challenges associated with their use.
