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Drug Compounding Regulatory Requirements Life Sciences

Foley & Lardner LLP

Compounded GLP-1 Drugs: Texas Judge Denies PI Motion and Request for Stay of FDA’s Declaration that Tirzepatide Shortage is...

Foley & Lardner LLP on

On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more

McDermott Will & Emery

Semaglutide Shortage Resolved

On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more

Axinn, Veltrop & Harkrider LLP

Pounding the Compounders: FDA’s “No Compound” Lists

Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

Skadden, Arps, Slate, Meagher & Flom LLP

Compounding and GLP-1s: What To Expect When GLP-1 Drugs Are Removed From FDA’s Drug Shortage List

What Are GLP-1s? Glucagon-like peptide-1 receptor agonists, also known as GLP-1 drugs, are a class of medications that mimic the action of the glucagon-like peptide-1 hormone, which is involved in the regulation of blood...more

Quarles & Brady LLP

Nevada Legislature Rejects Board of Pharmacy’s Licensing Requirement for Out-of-State Pharmacists

Quarles & Brady LLP on

On May 31, 2023, the Nevada Legislature enacted Assembly Bill 107, which reversed the Nevada Board of Pharmacy’s (the “Board”) interpretation that required Nevada pharmacist licensure for out-of-state pharmacists who dispense...more

Quarles & Brady LLP

Nevada to Require Out-of-State Pharmacists that Dispense or Compound for Nevada Patients to Hold a Nevada Pharmacist’s License

Quarles & Brady LLP on

If you are a Nevada licensed non-resident pharmacy, you will soon be receiving notification from the Nevada Board of Pharmacy (“Board”) stating that any pharmacist who dispenses or compounds prescriptions for a controlled...more

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