The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' This draft guidance describes the conditions under which FDA does not intend to take action against a state-licensed pharmacy, a Federal facility, or outsourcing facility that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).
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Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Produ...
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80 FR 8881
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“Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Draft Guidance for Industry; Availability,” thefederalregister.org (February 19, 2015), https://thefederalregister.org/documents/2015-03418/mixing-diluting-or-repackaging-biological-products-outside-the-scope-of-an-approved-biologics-license-application-draft-.