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

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. This guidance describes the conditions under which FDA does not intend to take action for violations of sections 351 of the PHS Act and sections 502 (f)(1) and where specified, section 21 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when a state-licensed pharmacy, a Federal facility, or an outsourcing facility5 dilutes, mixes or repackages certain biological products without obtaining an approved BLA.