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FDA Releases Results of 483 Inspections of Compounders; Contemplating Enforcement Proceedings

The FDA has released an announcement regarding its recent inspections of 31 sterile compounding pharmacies across the United States. The purpose of these inspections was to determine whether certain pharmacies that were known to have produced high-risk sterile drug products in the past posed a significant threat to public health from poor sterile drug production practices. As a result of these inspections, the FDA has issued a list of inspectional...

How Will State and Federal Law Alter Compounding in 2013?

Every compound pharmacy should be preparing for the passage of new Federal and State laws and regulations addressed specifically to compounding. This article focuses on anticipated Federal legislation. Expect a State law update soon. The strongest predictor of Federal laws impacting compounders, can be found in a March 23, 2013 statement by FDA Commissioner, Margaret A. Hamburg, M.D. In the statement, Dr. Hamburg expressed the FDA’s condolences for the families...