title: Standard Preparations, Limits of Potency, and Dating Period   Limitations for Biological Products. Direct final rule.
abstract: The Food and Drug Administration (FDA or Agency or we) is amending the general biological products standards relating to dating periods and also removing certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This action is part of FDA's retrospective review of its regulations in response to an Executive order. FDA is issuing these amendments directly as a final rule because the Agency believes they are noncontroversial and FDA anticipates no significant adverse comments.
mesh_terms: D001688:Biological Products / Q000592:standards*; D001769:Blood; D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence* / Q000592:standards*; D004355:Drug Stability; D004356:Drug Storage / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D011786:Quality Control; D014481:United States
chemical_list: D001688:Biological Products