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Section 503A

FDA Revises Health System Compounding Guidance, Implementing a More Practical Approach

[10/14/21]

Posted on October 14, 2021 in Health Law News

Published by: Hall Render

On October 7, 2021, five years after issuing initial draft guidance on its enforcement approach for hospitals and health system pharmacy compounding under section 503A of the Food, Drug, and Cosmetic Act (the “Act”), the U.S. Food and Drug Administration (“FDA”) released revised draft guidance (“Draft Guidance”) that provides increased flexibility to hospitals and health... READ MORE

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