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GUIDANCE DOCUMENT

Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry April 2020

Final Level 1 Guidance
Docket Number:
FDA-2020-D-1136
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or 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.

Due to the COVID-19 pandemic, FDA has received a number of queries from compounders related to the impact of supply interruptions of face masks, gowns, gloves, and other garb, which we refer to collectively in this document as personal protective equipment (PPE).

FDA is issuing this guidance to communicate its temporary policy related to PPE use during human drug compounding , at State-licensed pharmacies or Federal facilities that are not registered with FDA as outsourcing facilities (referred to collectively in this guidance as compounders). This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the U.S. Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(A)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).


Submit Comments

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-1136.