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Proposed Rules Food and Drug Administration (FDA) Pharmacies

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

Latham & Watkins LLP on

The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...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

McDermott Will & Schulte

FDA Publishes Proposed Rule on Sections 503A and 503B Compounding

On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more

Alston & Bird

FDA to Develop National Standards for Drug Distributors – Medical Products Supply Chain Week in Review

Alston & Bird on

Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more

McDermott Will & Schulte

FDA Publishes Proposed Rule on National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics...

The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets...more

Holland & Knight LLP

Proposed FDA Rules Could Be Game Changers for the Pharmaceutical Supply Chain

Holland & Knight LLP on

New federal regulations have been proposed that will affect licensure of wholesale drug distributors and third-party logistics providers (3PLs). The Drug Supply Chain Security Act became law in 2013. The U.S. Food and Drug...more

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