The Current State of Compounding Standards:
What Happens Next?


Eric S. Kastango, M.B.A., B.S.Pharm., FASHP reviewed:

  • Activity of USP Chapters 797 and 800
  • Requirements associated with the Drug Quality and Security Act
  • Next steps after USP Chapter 800 and when to expect the final HD Chapter
  • Activity of the FDA, including: registration of 503B Outsourcing Facilities and FDA Form 483 activity
  • New draft guidance on the compounding of biologics and repackaging

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