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FDA Notice Regarding Semaglutide and Tirzepatide Adverse Events

The Food and Drug Administration (FDA) has shared with NABP, the Federation of State Medical Boards, the National Council for State Boards of Nursing, the Alliance for Pharmacy Compounding, and the Outsourcing Facility Association, the attached letter describing recent reports of adverse events following the administration of compounded semaglutide and tirzepatide products. In addition, FDA notes certain factors that may have contributed to these adverse events and encourages reporting of such events or quality problems to FDA’s MedWatch Adverse Event Reporting program. 

If you have any questions, please contact FDA’s Office of Compounding Quality and Compliance at compounding@fda.hhs.gov.

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Registration for FDA’s Compounding Quality Center of Excellence Annual Conference Now Open

The Food and Drug Administration (FDA) Compounding Quality Center of Excellence (CQCoE) has opened registration for its Annual Conference to be held August 21 – 23, 2024.

This fifth Annual Conference, themed Learning and Collaborating: Driving Toward the Future of Quality, will be held in person at the Bethesda North Marriott Hotel & Conference Center, as well as virtually. This conference will provide an opportunity for outsourcing facilities, compounders, state pharmacy regulators, and others to learn and build networks to help the industry improve the quality of compounded drugs.

The full agenda is available online and features a virtual pre-conference session on developing a new outsourcing facility, as well as in-depth sessions sharing various perspectives on quality and current good manufacturing practice (cGMP) requirements. Free continuing education credits will be available to attendees.

For more information, please contact the CQCoE at CompoundingQualityCoE@fda.hhs.gov.

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