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FDA Issues Draft Guidance on Compounding at Outsourcing Facilities. EC Issues Draft Revision to Annex 1 Manufacture of Sterile Medicinal Products. FDA 483 Observations from 2017. USP Draft General Chapters on Plastic Components and Systems Used in the Manufacturing of Drug Products.
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities. In February 2015, the US FDA released a draft guidance on the repackaging of certain products by pharmacies and outsourcing facilities. The closing date for comment was set for 17. 2015, but when the actual guidance is expected to be implemented is still to be confirmed. No more than 14 days beyond completion of the sterility test or 28 days from the time of repackag.