This final guidance sets forth FDA’s
policy regarding the mixing, diluting, and repackaging
of certain types of biological products
that have been licensed under section 351 of the Public Health Service Act (PHS
Act) when such activities are not within the scope of the product’s approved
biologics license application (BLA) as described in the approved labeling for
the product.
See: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434176.pdf
Posted by Dr. Tim Sandle