FDA Guidance for COVID-19 Exemptions

The FDA released a new guidance titled “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) During the COVID-19 Public Health Emergency” on April 30, 2020.

This guidance has been issued to clarify the scope of the public health emergency exemption under the DSCSA for the duration of the COVID-19 public health emergency. The emergency was declared on January 31, 2020 and is renewed until July 26, 2020. This is to ensure adequate distribution of finished drug products throughout the supply chain to treat COVID-19.

The COVID-19 public health emergency triggered two statutory provisions under the Federal Food, Drug, and Cosmetic (FD&C) Act. For the duration of this public health emergency, certain DSCSA requirements do not apply to a range of product distribution activities.

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