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News & Press: Breaking News

FDA Releases Draft and Final Repackaging Related Guidances

Thursday, January 12, 2017   (0 Comments)
Posted by: Dagmar Anderson
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The U.S. Food & Drug Administration (FDA) officially will release tomorrow a Draft Guidance - Revised Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (pertains to drugs like bevacizumab) and a Final Guidance: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.

 

IACP currently is reviewing these guidances and plans to comment on the Draft Guidance for Mixing Diluting or Repackaging Biological Products. The Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities is finalwe advise pharmacies to download and review as soon as possible.

 

Please also be aware FDA yesterday released: FDA’S Human Drug Compounding Progress Report: Three Years After the Enactment of the Drug Quality and Security Act. IACP is reviewing and considering a potential response.

 

Please email iacpinfo@iacprx.org if you have questions.


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