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Regulatory Agenda Life Sciences Pharmacies

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

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

Epstein Becker & Green on

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Quarles & Brady LLP

340B Developments in 2024 – Litigation and Legislation

Quarles & Brady LLP on

Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

Quarles & Brady LLP

Hot Off the Press: Mississippi Board of Pharmacy Files Proposed Rule on Shared Pharmacy Services

Quarles & Brady LLP on

On June 10, 2022, the Mississippi Board of Pharmacy filed their much-anticipated proposed rule on pharmacy shared services, starting the clock on the 25-day public comment period. The Board simultaneously filed its...more

Quarles & Brady LLP

Georgia Board of Pharmacy Continues to Review Licensure Requirements for Pharmacists

Quarles & Brady LLP on

At the April 13, 2022 Georgia Board of Pharmacy meeting, the Board discussed changes to Chapter 480-36 which governs retail pharmacy remote drug order processing. The discussion was aimed at new verbiage that would require...more

Quarles & Brady LLP

Texas Board of Pharmacy Sends Central Fill Amendment Back for Redraft but Signals Approval

Quarles & Brady LLP on

On February 1, 2022, the Texas Board of Pharmacy voted to send proposed amendments to its Central Fill Rule under 22 Tex. Admin. Code § 291.125 back to staff for a redraft....more

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