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FDA Clarifies Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act

On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more

Note of Caution to Compounding Pharmacies

Key Takeaways: ..FDA created a new category for voluntary firm registration after NECC compounding fungal meningitis outbreak in 2012. ..Individuals face criminal liability for misrepresentations made to FDA....more

Discounted Drugs under the 340B Program

The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B...more

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