FDA Again Proposes To Advance Outsourcing Sector With Center Of Excellence
The US FDA’s FY 2020 budget request calls for funding to help advance the emerging drug compounding outsourcing sector, as did the FY 2019 request. The money would bring more training, specially tailored GMP requirements and a center of excellence.
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FDA has announced a multifaceted effort to tackle the oversight of drug compounding facilities this year. On the to do list: setting the groundwork for establishing centers for excellence for outsourcing facilities; finalizing a guidance on identifying insanitary conditions at drug compounding facilities, and finalizing a memorandum of understanding targeting traditional compounders that distribute an “inordinate” amount of their compounded drugs across state lines.