ABSTRACT

Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles: Draft Guidance for Government Public Health and Emergency Response Stakeholders   [open pdf - 226KB]

From the Document: "This guidance provides background information on the doxycycline drug product, the recommended protocol to support extending the expiration dates of specific doxycycline lots, how to identify a suitable laboratory to conduct testing, and the process for requesting and receiving an authorized expiration date extension for an identified lot of doxycycline. The criteria for an authorized extension include the requirements and conditions under section 564A(b) of the FD&C [Federal Food, Drug, and Cosmetic] Act for any expiration date extensions authorized by FDA [Food and Drug Administration] based on testing conducted following this guidance. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other non-emergency purpose."

Publisher:
Date:
2017-04
Copyright:
Public Domain
Retrieved From:
Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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