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Foley & Lardner LLP

GLP-1 Drugs: Ohio Board of Pharmacy Issues FAQs for Compounders

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Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more

Hogan Lovells

Pharmacy compounding under the EU pharma law package

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Pharmacy compounding is one of the topics in the EU Pharma Law Package that has perhaps received less attention compared to topics such as regulatory exclusivity rights, shortages, and sustainability. The EU Pharma Law...more

Goodwin

Celltrion, Samsung Bioepis, and Organon Receive Interchangeability Designations for Adalimumab Biosimilars

Goodwin on

In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars.  Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without...more

Quarles & Brady LLP

Arkansas Law Prohibits Pharmacy Benefit Managers from Obtaining or Holding Pharmacy Permits

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On April 16, 2025, Arkansas House Bill 1150 (the “Bill”) was signed by Governor Huckabee Sanders. The Bill will have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country....more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q1 2025

Bass, Berry & Sims PLC on

The healthcare mergers and acquisitions (M&A) market began 2025 with a slower start than expected given the easing headwinds and building momentum at the end of last year, with the number of deals reported in Q1 lower than...more

Quarles & Brady LLP

Alabama Bill Rewriting Pharmacy Practice Act Clears Senate Hurdle

Quarles & Brady LLP on

As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more

McDermott Will & Schulte

This Week in 340B: March 25 – 31, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Schulte

This Week in 340B: March 18 – 24, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Harris Beach Murtha PLLC

GLP-1 Weight-Loss Drugs Off Shortage List; Deadlines to Stop Compounding

Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more

Hendershot Cowart P.C.

FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding

Hendershot Cowart P.C. on

Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more

McDermott Will & Schulte

This Week in 340B: March 11 – 17, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Schulte

Trending in Telehealth: February 2025

Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

McDermott Will & Schulte

California Introduces Bill to Protect 340B Contract Pharmacy Arrangements

California legislators recently introduced AB 1460, which would prohibit prescription drug manufacturers from engaging in discriminatory practices aimed at providers participating in the 340B drug pricing program (covered...more

McDermott Will & Schulte

This Week in 340B: March 4 – 10, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

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

Hogan Lovells

Prescription Medical Device Manufacturers, Distributors, and the NABP: The Role in State Licensing

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The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers and distributors. Although the NABP does not directly regulate the...more

McDermott Will & Schulte

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

ArentFox Schiff

Massachusetts Enacts Drug Pricing Legislation: Introducing PBM Licensure, Mandatory Cost Reporting, and Consumer Cost-Sharing...

ArentFox Schiff on

On January 8, Massachusetts Governor Maura Healy signed into law “An Act Relative To Pharmaceutical Access, Costs And Transparency.” The Act will have a profound impact on all parties involved in setting and applying drug...more

McDermott Will & Schulte

This Week in 340B: February 18 – 24, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

ArentFox Schiff

FDA Announces End to Semaglutide Shortage, Impacting Compounders and Telehealth Providers Offering Injectable GLP-1 Drugs

ArentFox Schiff on

Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more

Quarles & Brady LLP

Alabama Bill Proposes Rewrite of Pharmacy Practice Act

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The future direction of the Alabama Board of Pharmacy (“the Board”) hangs in the balance following recent legislation that, if passed, would revise many portions of the state Pharmacy Practice Act. House Bill 123, sponsored...more

Fox Rothschild LLP

End of Semaglutide Shortage Means Big Changes for Prescribers and Compounders

Fox Rothschild LLP on

On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage List since 2022 because demand for the drug exceeded the available...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

Roetzel & Andress

Prescribing GLP-1 Medications: Be Aware of Legal Limitations

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On this episode of HealthLawHotSpot, Roetzel attorneys Ericka Adler and Christina Kuta discuss the potential pitfalls and best practices in dispensing GLP-1 medications.Christina shares her insights on the surge in demand,...more

McDermott Will & Schulte

This Week in 340B: January 28 – February 3, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

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