Temporary policy for compounding of certain drugs for hospitalized patients by pharmacy compounders not registered as outsourcing facilities during the COVID-19 public health emergency (revised)

Temporary policy for compounding of certain drugs for hospitalized patients by pharmacy compounders not registered as outsourcing facilities during the COVID-19 public health emergency (revised)

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 May 21, 2020
Language(s):
English
Format:
Text
Subject(s):
Drug Compounding -- methods
Hospitalization
Outsourced Services
Pharmacies
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
FDA 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. FDA is issuing this guidance to communicate its temporary policy for the compounding of certain human drug products for hospitalized patients by State-licensed pharmacies and Federal facilities, including hospital and health system pharmacies, that are not registered with FDA as outsourcing facilities (referred to collectively in this guidance as “pharmacies”) for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, or for such shorter time as FDA may announce through updated guidance. This policy is intended to remain in effect for no longer than the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)). FDA is continually assessing the needs and circumstances that make issuance of this guidance appropriate. As relevant needs and circumstances evolve, FDA intends to update, modify, or withdraw policies in this guidance as appropriate.
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)).
Edition:
Revised
NLM Unique ID:
9918227271106676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918227271106676