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1 Open Microphone Meeting: USP General Chapter <797> Pharmaceutical Compounding Sterile Preparations October 21, :00 p.m. to 4:00 p.m. EDT

2 Agenda Welcome Overview of USP s Revision Process Overview of Revised General Chapter <797> Pharmaceutical Compounding Sterile Preparations Background Overview of Revised Content Information on How to Submit Comments Timeline and Next Steps Question & Answer Session 2

3 3 Overview of the U.S. Pharmacopeial Convention

4 About USP Scientific non-profit organization that sets standards for the identify, strength, quality, and purity of medicines, food ingredients, and dietary supplements USP s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries USP Headquarters Rockville, MD 4

5 5

6 Compounding Expert Committee Chair: Gigi Davidson, B.S. Pharm, DICVP, NC State College of Veterinary Medicine Lisa Ashworth, B.S. Pharm Gus Bassani, Pharm.D. Ruth Ebiasah, Pharm.D., M.S. Edmund Elder, Ph.D., B.S. Pharm Ryan Forrey, Pharm.D., M.S. Deborah Houston, Pharm.D. Brenda Jensen, M.A. Patricia Kienle, MPA, B.S. Pharm 6

7 Compounding Expert Committee Chair: Gigi Davidson, B.S. Pharm, DICVP, NC State College of Veterinary Medicine William Mixon, B.S. Pharm John Musil, Pharm.D. David Newton, Ph.D. Alan Parr, Pharm.D., Ph.D. Abby Roth, B.Sc. Robert Shrewsbury, Ph.D. Connie Rae Sullivan, B.S. Pharm James Wagner Brenda Yuzdepski, B.S. Pharm 7

8 Overview of Development Process Revision proposed by stakeholder, USP EC, or USP Staff Proposal published in PF for 90-day public comment Based on the nature and significance of the public comments Forward Defer Cancel Ballot Approve Not approve Proposal republished for public comment 8

9 9 General Chapter <797> Pharmaceutical Compounding Sterile Preparations Gigi Davidson, BSPh, DICVP Chair, USP Compounding Expert Committee,

10 USP <797>: Revision Proposal Chapter History First Published in 2004 (USP27-NF22) First Revised in 2008 (USP 31-NF26 2S) Purpose of Revision To reflect new science and evidence based on updated guidance documents, best practices, and new learnings from investigations Respond to stakeholder input received throughout the cycle Clarify topics that are frequently queried and misconstrued 10

11 USP <797>: Background July 2010 Early 2013 April 2013 <797> subcommittee formed & began work Collaboration with Microbiology Expert Committee Formed <797> Expert Panel June 2015 <797> subcommittee completed work Sept Pre-post <797> for Public Comment 11

12 USP <797>: Overview of Major Changes Reorganized chapter Procedural information placed in Boxes Categories of CSPs Collapsed into two categories Category 1 CSPs BUD 12 hours at room temperature or 24 hours refrigerated PEC placed in a segregated compounding area Category 2 CSPs BUD > 12 hours at room temperature or > 24 hours refrigerated PEC placed in a classified area 12

13 USP <797>: Overview of Major Changes Hazardous Drugs Removed all handling information and replaced with crossreference to <800> Hazardous Drugs Handling in Healthcare Settings Scope Administration should follow CDC s Safe Injection Practices Reconstitution and dilution strictly in accordance to manufacturer s labeling not within scope of chapter Repackaging must be performed following the requirements in the chapter Urgent-Use CSPs (previously termed Immediate-Use CSPs ) Reserved for rare circumstances where a CSP is urgently needed 13

14 USP <797>: Overview of Major Changes Personnel Qualifications Reevaluation and Requalification Visual observation Gloved Fingertip Sampling Media-fill testing Proposed Frequency Initially and then quarterly 3 times initially and then quarterly Initially and then quarterly Personnel Protective Equipment Based on CSP Category and type of PEC Requirement for sterile sleeves (or sterile gown) 14

15 USP <797>: Overview of Major Changes Buildings and Facilities Primary Engineering Controls (PEC) new terminology Laminar Airflow System (LAFS) Restricted Access Barrier System (RABS) Isolator Placement of PEC Category 1 CSPs PEC may be placed in an unclassified Segregated Compounding Area Category 2 CSPs LAFS, BSC, and RABs must placed in an ISO Class 7 or better area Isolator must be placed in ISO Class 8 area 15

16 USP <797>: Overview of Major Changes Environmental controls Well-lit and comfortable conditions Temperature 20 or cooler Humidity below 60% Environmental Monitoring Proposed Frequency Nonviable Air Sampling Viable Air Monitoring Surface Sampling Every 6 months Monthly Monthly 16

17 USP <797>: Overview of Major Changes Documentation Master formulation records Compounding records Release Testing Sterility testing (refers to <71> Sterility Test) For batch sizes < 40, number of units to be tested is 10% rounded up to the next whole number Endotoxin Testing Required for Category 2 CSPs prepared from nonsterile ingredients (except inhalation and topical ophthalmic) Exception if endotoxin burden is predetermined (i.e. certificate of analysis) 17

18 USP <797>: Overview of Major Changes Establishing Beyond-Use Dates Based On Method of Achieving Sterility Starting Components Sterility Testing Preservative Storage Conditions New terminology for In-Use Times Time before which a conventionally manufactured product or CSP must be used after it is opened or punctured 18

19 USP <797>: Revision Proposal Roadmap Through Chapter 1. Introduction and Scope 2. Personnel Qualifications Training, Evaluation, and Requalification 3. Personal Hygiene and Personal Protective Equipment 4. Buildings and Facilities 5. Environmental Monitoring 6. Cleaning and Disinfecting Compounding Areas 7. Equipment and Components 8. Sterilization and Depyrogenation 9. SOPs and Master Formulation and Compounding Records 10. Release Testing 11. Labeling 19

20 USP <797>: Revision Proposal Roadmap Through Chapter 12. Establishing Beyond-Use Dates and In-Use Times 13. Quality Assurance and Quality Control 14. CSP Storage, Handling, Packaging, and Transport 15. Complaint Handling and Adverse Event Reporting 16. Documentation 17. Radiopharmaceuticals as CSPs Glossary Appendix 1. Acronyms Appendix 2. Common Disinfectants Used in Health Care for Inanimate Surfaces and Noncritical Devices, and Their Microbial Activity and Properties 20

21 USP <797>: How to Submit Comments General Chapter <797> is posted online at proposed-revision Download and complete the submission template submission template to Comments due January 31 st,

22 USP <797>: How to Submit Comments Provide all information in the event we need to contact you any follow-up Provide comments that do not have any corresponding line numbers. Provide comments with corresponding line numbers. Include specific suggestions and rationale. 22

23 USP <797>: Timeline and Next Steps Date Sept 25, 2015 Sept 25, 2015 through Jan 31, 2016 Oct 21, 2015 Jan 31, 2016 Activity Revised General Chapter <797> Posted for Public Comment Open Public Comment Period Open Microphone Web Meeting Deadline for Submitting Public Comments Next steps Subcommittee will review ALL comments submitted Comments will be addressed through commentary posted online 23

24 Open Microphone Q&A Session 24

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