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§ 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP

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Size:100 Grams

USP guidance describes a 28-day beyond-use date for multi-dose vials after first puncture, assuming aseptic technique on every draw

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