Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Guidance for Industry

Docket Number: FDA-2020-D-1136

Issued by:Guidance Issuing Office, Center for Drug Evaluation and Research

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

Due to the COVID-19 pandemic, FDA has been monitoring requests related to provisions of the Drug Supply Chain Security Act (DSCSA) because the provisions may affect the prescription drug supply chain during the COVID-19 outbreak. FDA is issuing this guidance to clarify the scope of the public health emergency exemption and exclusion under the DSCSA for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, and renewed for 90 days on April 21, 2020, effective April 26, 2020, to help ensure adequate distribution of finished prescription drug products throughout the supply chain to combat COVID-19. In addition, this guidance announces FDA's policy regarding the exercise of its discretion in the enforcement of authorized trading partner requirements under section 582(b)(3), (c)(3), (d)(3), and (e)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for certain distributions during the COVID-19 public health emergency involving other trading partners that may not be authorized trading partners.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1136.

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