2021 Proposed USP Chapter Updates | Becoming a Pharmacy Badass

**In this Episode of the Becoming a Badass Pharmacy Owner Podcast; Dr. Lisa Faast with Amy Summers talk about Proposed USP Chapter** **Show Notes:** 1. **Dr. Amy Summers Introduction** [2:15] 2. **Two Trees Consulting** [3:08] 3. **Proposed Revisions to USP 795 and 797** [4:25] 4. **USP 795 Proposal 2021** [4:44] 5. **Introduction and Scope ** [5:38] 6. **Personnel Qualification 795** [8:21] 7. **Personnel Hygiene and Garbing** [11:53] 8. **Building and Facilities** [13:35] 9. **Cleaning and Sanitizing** [14:35] 10. **Equipment and Components** [15:05] 11. **Master Formulation and Compounding Records** [19:33] 12. **Establishing BUDs** [22:00] 13. **Water Activity** [27:50] 14. **Shorter BUDs May Be Required** [29:40] 15. **Assigning a BUD From a USP Monograph** [31:01] 16. **Extending BUDs with Stability Information** [31:35] 17. **USP 797 Proposal 2021** [34:33] 18. **Definition of Compounding** [34:52] 19. **USP 2021 Proposal Overview** [37:45] 20. **Outside the Scope** [38:07] 21. **Immediate Use CSP Requirements** [38:32] 22. **Categories of CSPs** [40:40] 23. **Personnel Qualification 797** [42:55] 24. **Minimum PEC Placement** [46:21] 25. **Microbiological Air and Surface Monitoring** [47:48] 26. **Cleaning, Disinfecting, Applying a Sporicide** [49:34] 27. **Master Formulation and Compounding Records** [50:11] 28. **Visual Inspection** [50:28] 29. **Sterility Testing** [50:43] 30. **Bacterial Endotoxin Testing** [51:59] 31. **Establishing a BUD** [52:18] 32. **BUD Category Comparisons** [53:40] 33. **Multiple-Dose CSPs** [55:49] 34. **Submitting Comments** [56:30]
**Links mentioned in this episode:** [Two Trees Consulting](https://www.2treesconsulting.com/) Proposals are posted online at:(https://go.usp.org/proposed_2021_revisions_795_797) Submitting comments at:(https://usp.az1.qualtrics.com/jfe/form/SV_81VZpnzjwcQJlZA) ----- #### **Becoming a Badass Pharmacy Owner Podcast is a Proud to be Apart of the Pharmacy Podcast Network** Learn more about your ad choices. Visit megaphone.fm/adchoices