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GUIDANCE DOCUMENT

Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency February 2021

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-1106
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Updated February 10, 2021

Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA or Agency) 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 guidance as compounders) for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

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Submit Comments Online

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-1106.

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