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• FDA has put out a new draft MOU for stakeholders to review and provide comments over the next 90 days. • If a state enters into the proposed MOU, pharmacies within its borders would be allowed to distribute up to 50...more
What if a store clerk sells a product that, unbeknownst to him, is illegal? Can the clerk be convicted of a crime, despite not knowing the product was illegal and not intending to sell an illegal product? On January 14,...more
Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate...more
The U.S. Food and Drug Administration (FDA) has been busy since the passage of the Drug Quality and Security Act (DQSA) in November 2013. In just five short months, the FDA has issued six warning letters referencing the...more