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U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies

On September 12, 2013, U.S. Representative Morgan Griffith (R-Va.) introduced H.R. 3089 ("the House Bill") [ enhanced version available to lexis.com subscribers ], which proposes a structure for federal oversight of compounding pharmacies. The House Bill is the latest federal proposal for regulating...

FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and Calculating Fees

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act ("Draft Guidance"), which sets forth FDA's current thinking on the annual...