IN LATE 2004 the U regimen and Dru...

IN LATE 2004 the U regimen and Drug Administration issued a final order implementing the record keeping provisions of the Bioterrorism Act of 2002 This is the last of four rulemakings implementing the Bioterrorism Act. Regulations in succession Facility Registration, Administrative Detention and Prior Notice of Import were released earlier and have already been implemented.

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The regulation onward Establishment and Maintenance of Records requires manufacturers to maintain records identifying the immediate previous source of regimen ingredients and the immediate