Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled "Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application." This draft guidance describes the conditions under which FDA does not intend to take action against a state-licensed pharmacy, a Federal facility, or outsourcing facility that mixes, dilutes, or repackages certain biological products without obtaining an approved biologics license application (BLA).