[Drug Compounding Guidances]: Final repackaging guidance and revised draft biologics guidance

Today, FDA issued two guidances on human drug compounding:

• Final Guidance: Repackaging of Certain Human Drug Products by State-Licensed Pharmacies and Outsourcing Facilities

This guidance explains that FDA regards repackaging generally as the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container, without further manipulation. 

FDA is issuing guidance to describe the conditions under which the Agency does not intend to take action for certain violations of the FD&C Act when a state-licensed pharmacy, federal facility, or outsourcing facility repackages certain drug products. 

• Revised Draft Guidance: Mixing, Diluting, and Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

FDA has developed draft guidance describing the conditions under which FDA does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. This revised draft guidance takes the place of previous draft guidance on this subject. Examples of changes in the revised draft guidance include longer beyond-use-dates (BUDs) and a mechanism for outsourcing facilities to assign BUDs for repackaged biological products based on data.

Comments on the revised draft guidance should be submitted within 60 days. For information on how to submit comments to the public docket, see the notice in the Federal Register.

See FDA's Human Drug Compounding site for more information.