Tuesday Dec 07, 2021
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)
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