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New FDA Guidance Describing Exemptions, Exclusions, and Discretion Relating to Drug Supply Chain Security Act Requirements During the COVID-19 Public Health Emergency

May 5, 2020, Covington Alert

The United States Food and Drug Administration (FDA) recently published a Guidance for Industry, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency (Guidance), to (1) clarify the applicability of the Drug Supply Chain Security Act (DSCSA) to certain distribution activities, and (2) set forth an enforcement discretion policy with respect to certain authorized trading partner requirements. The Guidance outlines FDA’s policy on these topics for the duration of the Coronavirus Disease 2019 (COVID-19) public health emergency.

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