Health and Fitness

FDA Issues New Draft Documents Related to Compounding of Human Drugs

Silver Spring, Maryland–(ENEWSPF)–February 13, 2015.  Documents include draft guidances on outsourcing facility registration; outsourcing facility adverse event reporting; drug repackaging; mixing, diluting, and repackaging biological products; and a draft Memorandum of Understanding with the states

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Today, the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.

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