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NDC Numbers and Lot Traceability Every Hospira product batch carries a lot number linking it to a specific manufacturing record and release document

doi: 10.1016/j.steroids.2016.01.021 200 AlayevASalamonRSBergerSMSchwartzNSCuestaRSnyderRBet al

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Section 503B of the FD&C Act describes conditions that must be satisfied for drugs compounded by an outsourcing facility to qualify for exemption from the sections of the FD&C Act that address: Labeling of drugs with adequate directions for use