Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

PDA applauds FDAs efforts to further clarify its policy for these operations and appreciates the opportunity to comment on this draft guidance. PDA recommends this guidance include additional references to USP <797> throughout the document as well as include requirements consistent with GMPs to demonstrate the product was diluted as claimed. A dilution performed at an outsourcing facility should have a verification and a quality check not only on the operation but on the calculation for the dilution or addition as a dilution error may not be noticed before administration. The length of the scope section now leaves confusion at the end as to which types of products are in or out. It appears that the scope is biologicals and allergenic extracts and would be helpful if this was stated succinctly. PDA also recommends that the scope of the guidance be clearly defined so as to exclude mixing, diluting, repackaging done in the hospital pharmacy or bedside. Please see the attached detailed comments for additional rationale and recommendations.