Articles and Blogs

On October 7, 2021, five years after issuing initial draft guidance on its enforcement approach for hospitals and health system pharmacy compounding under section 503A of the Food, Drug, and Cosmetic Act (the “Act”), the U.S. Food and Drug Administration (“FDA”) released revised draft guidance (“Draft Guidance”) that provides increased flexibility to hospitals and health...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

The United States Food and Drug Administration (“FDA”) issued a statement (the “Statement”) clarifying its position on cannabidiol (“CBD”) products in the wake of the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”) signed December 20, 2018.¹ The 2018 Farm Bill is a broad piece of legislation that regulates agricultural programs ranging from income support... READ MORE