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

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

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.). Office of Compliance issuing body.
Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, Office of Compliance, April 2020
Language(s):
English
Format:
Text
Subject(s):
Drug Compounding -- methods
Personal Protective Equipment -- supply & distribution
COVID-19
Sterilization -- methods
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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)).
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (7 pages)).
NLM Unique ID:
9918227374406676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918227374406676