ABSTRACT

Order Permitting Emergency Dispensing of Oral Formulations of Ciprofloxacin and Waiver of CGMP Requirements During an Anthrax Emergency   [open pdf - 51KB]

From the Document: "[T]he Food and Drug Administration (FDA) is hereby issuing this order to permit emergency dispensing of FDA-approved oral dosage forms of ciprofloxacin products ('eligible ciprofloxacin products') for the post-exposure prophylaxis (PEP) of inhalational anthrax during an emergency involving 'Bacillus anthracis (B. anthracis)', the biological agent that causes anthrax disease. Although there is not currently an active emergency involving 'B. anthracis' ('anthrax emergency'), this order will allow stakeholders to implement plans for emergency dispensing of eligible ciprofloxacin products without individual prescriptions in the future if they reasonably believe there is a need to do so because of their constituents' known, suspected, or likely imminent exposure to 'B. anthracis'."

Author:
Publisher:
Date:
2016-04-13
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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