On 25 March 2020, FDA Circular No. 2020-011, or the “Guidelines on Pharmacy Compounding of Alcohol-Based Sanitizer Formulations in Light of the Declaration of State of Calamity Due to COVID-19,” was issued. Said Circular provides interim guidelines to drugstores/ pharmacies/ boticas for the compounding of alcohol-based sanitizers in response to the need for increased production of such products during the COVID-19 public health emergency.
Considering however that regular supply of alcohol-based sanitizers has been restored, compounding of alcohol products by drugstores/ pharmacies/ boticas is no longer necessary.
In view of the foregoing, FDA Circular No. 2020-011 is hereby rescinded effective immediately.
Attachment:->FDA Circular No.2020-011-A