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

Issue Date: January 18, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Compounding, Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP)
Status: Final

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

This 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.

Download the Guidance Document