Docket Number: FDA-2020-D-1136
Issued by: Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
The Food and Drug Administration (FDA or the Agency) 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.
FDA is issuing this guidance to communicate its temporary policy for the compounding of certain human drug products for hospitalized patients by outsourcing facilities that have registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b).
View Regulatory Information Here
This post is related to:
Admixture Compounding Services (503B Outsourcing Facilities)