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

Resumo

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled "Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application." This final guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy.