Temporary policy for compounding of certain drugs for hospitalized patients by outsourcing facilities during the COVID-19 public health emergency (revised)

Temporary policy for compounding of certain drugs for hospitalized patients by 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, May 21, 2020
Language(s):
English
Format:
Text
Subject(s):
Drug Compounding -- methods
Hospitalization
Outsourced Services
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 outsourcing facilities that have registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b). This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the 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)). As noted below, the drugs that are the subject of this policy may change during the emergency.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (15 pages)).
Edition:
Revised
NLM Unique ID:
9918227271206676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918227271206676