Articles and Blogs

In May 2022, the U.S. Food and Drug Administration (“FDA”) issued guidance (“Guidance”) regarding the “Importation of Prescription Drugs” final rule (the “Final Rule”), which became effective November 30, 2020. The Final Rule aims to reduce the cost of covered products and address shortages without increasing risk to American consumers’ health and safety by... READ MORE

Earlier this year, the Food and Drug Administration (“FDA”) announced a Proposed Rule regarding national standards for the licensing of prescription drug wholesale distributors (“Wholesale Distributors”) and third-party logistics providers (“3PLs”). The proposed regulation is issued pursuant to requirements for national regulatory standards under the Drug Supply Chain Security Act (“DSCSA”), which is part... READ MORE

On October 7, 2021, five years after issuing initial draft guidance on its enforcement approach for hospitals and health system pharmacy compounding under section 503A of the Food, Drug, and Cosmetic Act (the “Act”), the U.S. Food and Drug Administration (“FDA”) released revised draft guidance (“Draft Guidance”) that provides increased flexibility to hospitals and health...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

In The Judge Rotenberg Educational Center, Inc. v. United States Food and Drug Administration, the U.S. Court of Appeals for the D.C. Circuit overturned a 2020 Food and Drug Administration (“FDA”) rule banning the use of electrical stimulation devices to treat patients suffering from severe self-injurious and aggressive behaviors. The court concluded the FDA... READ MORE

The USDA Hemp Producer License Rule and Framework On October 31, 2019, the United States Department of Agriculture (“USDA”) published an interim final rule[1] with request for comments in the Federal Register regarding hemp production (“USDA Hemp Rule” or the “Interim Final Rule”).[2] The USDA Hemp Rule establishes a federal hemp producer license and... READ MORE

On Monday, June 3, the United States District Court for the Southern District of Florida (the “Court”) ruled that the Food and Drug Administration (“FDA”) has the authority to regulate certain stem cell-based treatments offered by U.S. Stem Cell Clinic, LLC (the “Clinic”) and U.S. Stem Cell, Inc. After the Clinic failed to heed... 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