Re: Request for Emergency Use Authorization For Use of Chloroquine Phosphate or Hydroxychloroquine Sulfate Supplied From the Strategic National Stockpile for Treatment of 2019 Coronavirus Disease
Dear Dr. Bright:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of 2019 coronavirus disease (COVID-19) when administered by a healthcare provider (HCP)1 pursuant to a valid prescription of a licensed practitioner as described in the Scope of Authorization (section II) of this letter. The authorized chloroquine phosphate and hydroxychloroquine sulfate are limited to product supplied from the Strategic National Stockpile (SNS) to public health authorities2, pursuant to Section 564 of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3).....
....I am authorizing use of the following hydroxychloroquine sulfate product that is distributed from the SNS to public health authorities for response to the COVID-19 pandemic: ....
