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FDA Federal Partners Meeting

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Location

The Great Room, Room 1503

FDA’s White Oak Campus

10903 New Hampshire Avenue

Silver Spring, Maryland 20993

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Food and Drug Administration (FDA) continues to implement the human drug compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Quality and Security Act (DQSA) of 2013. Over the last four years, FDA has issued a number of policy documents, including guidance documents and regulations that are relevant both to federal facilities that compound drugs and to the pharmacies and outsourcing facilities from which federal facilities may purchase compounded drugs.

During the first day of the meeting, FDA will provide an overview of some of these key policy documents as well as certain other aspects of its compounding program such as oversight and stakeholder collaboration including a roundtable discussion for participants to share information about, for example, practical implications of FDA’s policies within federal facilities and recommendations for future policy considerations.

During the second day of the meeting, FDA will offer an in-depth session led by Agency subject matter experts on quality standards applicable to compounding, including common observations FDA makes during inspections.

If you are able to attend the meeting, please register by April 3, 2018, and indicate if you would like to attend Day 1 (May 10th), Day 2 (May 11th), or both by registering for Day 1 and Day 2 separately.

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Date and Time

Location

The Great Room, Room 1503

FDA’s White Oak Campus

10903 New Hampshire Avenue

Silver Spring, Maryland 20993

View Map

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