Eric S. Kastango, BS Pharm, MBA, FASHP discusses how USP Chapters 797 and 800 have evolved over time, and what you can expect them to address in the future.
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- New draft guidance on the compounding of biologics and repackaging