Interpreting & Implementing 503B & 797 Regulations
Wednesday, June 9, 2021, 8:00 pm ET
Presenter: Eric Kastango, Kastango Consulting Group
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
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the American Society of Anesthesiologists and the Ophthalmic Anesthesia Society.
The American Society of Anesthesiologists is accredited by the ACCME to provide continuing medical education for physicians.
The American Society of Anesthesiologists designates this live activity for a maximum of 1.0 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
The content of this activity is not related to products of services of and ACCME-defined ineligible entity; therefore, no one in control of content has a relevant financial relationship to disclose and there is no potential for conflicts of interest.
Healthcare practitioners who are responsible for compliance and the quality of compounded drug products.
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