Zdrowie i gospodarka · 23.03.2020
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency; Immediately in Effect Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency." Due to the Coronavirus Disease 2019 (COVID-19) pandemic, FDA has received a number of queries concerning compounding of alcohol-based hand sanitizers. The Agency is issuing this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this notice and the guidance as compounders) for the duration of the public health emergency declared by the Secretary of Health and Human Services on January 31, 2020. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.