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FDA Announces Wide-Ranging List of Compounding Priorities for 2019

 
• By Joanne S. Eglovitch

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.

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The US FDA plans to issue final guidance this year describing examples of insanitary conditions at drug compounding pharmacies and outsourcing centers and wants to set the groundwork for establishing centers of excellence to bolster the quality of compounded drugs produced by outsourcing facilities.

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