The U.S. Food and Drug Administration issued a Feb. 2015 Guidance for Industry titled, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities,” that is being distributed for comment purposes only.
The guidance says, “Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to
As background, the guidance notes, “FDA regards repackaging 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 of the drug. Repackaging also includes the act of placing the contents of multiple containers (e.g., vials) of the same finished drug product into one container, as long as the container does not include other ingredients. If a drug is manipulated in any other way, including if the drug is reconstituted, diluted, mixed, or combined with another ingredient, that act is not considered repackaging.”
The guidance goes into considerable detail on repackaging, as well as the regulatory framework for repackaging, hospital and health system repackaging of drugs in shortage for use in the health system, information on repackaging in an outsourcing facility, repackaging drugs on FDA’s drug shortage list, and more.