Interpreting and Implementing 503B & 797 Regulations

Overview 

Since 2012, Congress, the Food and Drug Administration (FDA), the Centers for Disease Control (CDC) and various professional organizations (ASA, OAS) have aimed at improving the quality of the drug supply in the United States, as well as enforceable USP standards for the preparation and safe handling of sterile compounded drugs. This educational activity will explain the history of compounding adverse events, the current status of the USP compounding chapters, USP <797> - Sterile Preparations and USP <795> - Nonsterile Preparations and key provisions in the Drug Quality and Security Act (DQSA), which allowed for 503B Outsourcing Facilities 

Learning Objectives

• Describe the current status of the USP compounding chapters, USP <797> - Sterile Preparations, and USP <795> - Nonsterile Preparations.
• Describe the key provisions in the Drug Quality and Security Act (DSQA) and differences between 503A Compounding Pharmacies and 503B Outsourcing Facilities.
• Describe the key factors to consider when evaluating a compounded medication provider (503A or 503B)
• Review the key CDC Safe Injection Practices as it relates to single-dose and multiple-dose drug vials and bags.