GMP: Mixing, Diluting, or Repackaging Biological Products - FDA Draft Guidance

In February, the FDA published a new draft guidance on \"Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application\". Background is the reality that sometimes certain licensed biological products may need to be mixed or diluted in a way not described in the approved labelling for the product to meet the needs of a specific patient. For example, if there is no licensed pediatric strength and/or dosage form for the product defined and licensed, it must be diluted for use in pediatric patients.