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FDA Issues Final Rule for the Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs

October 13, 2016

The US Food and Drug Administration (FDA) has issued Final Rule for the Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs.

This final rule aims to establish drug registration and drug listing through an electronic submission. This final rule also implies reorganization, modification and clarification of current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs.

This final rule applies to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients.

This final rule is effective starting November 29, 2016.

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