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Lee Rosebush Speaking at FDA Meeting on Drugs Compounded for Office Stock by Outsourcing Facilities

News / May 8, 2019

Partner Lee Rosebush will be a speaker at a public meeting of the Food & Drug Administration on May 21, 2019, in Silver Spring, Md. The topic is “Drugs Compounded for Office Stock by Outsourcing Facilities” and will explore how proposed draft guidance, if finalized as written, would impact outsourcing facilities producing drugs requested for office stock, filling smaller orders of these products, and providing products with beyond-use-dating that meets prescribers’ requests, among other topics. Proposed policies in the revised draft guidance for discussion include those related to stability studies, beyond-use-dating and release testing.

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