In mid-February, FDA issued five draft guidances on policies for compounding and repackaging. One draft covers whether a company should register as an outsourcing facility, while another discusses regulations around repackaging by outsourcing facilities. A draft on biologics repackaging covers when the agency will not take action against facilities lacking a BLA. The other two guidelines cover adverse event reporting for outsourcing facilities and a draft of a Memorandum of Understanding a state would sign relating to compounded drugs.
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