Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Companion to Direct Final Rule

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The Food and Drug Administration (FDA or Agency or we) is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA is proposing this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This proposed action is part of FDA's retrospective review of its regulations in response to an Executive order.