Open Microphone Session on USP General Chapter <795 ...

1 Open Microphone Session on USP. General Chapter <797> Pharmaceutical Compounding Sterile Preparations September 5, 2018. 1:00 3:00 pm ET. General Chapter <797> Open Microphone NOTICE TO PARTICIPANTS: Your meeting controls will appear on the bottom of the screen. Select the chat feature To minimize background noise, all lines will be muted upon joining the Session . During the meeting, you may ask To submit a question, send a message to questions or make comments at any Jeanne Sun (the Host) in the chat feature time by using the Chat function Select the Chat icon from the task menu on the bottom of your WebEx view page Use the text box to enter your question In the Send dropdown, select Host . Questions will be collated for the Q&A. portion of the WebEx. General Chapter <797> Open Microphone NOTICE TO PARTICIPANTS: Please note this Session is currently being recorded and will be made available on USP's website at 3.

2 2017 USP. Agenda Session Overview Speakers USP Overview Tiffany Chan, Associate Scientific Liaison Overview of Revised General Chapter <797> Gigi Davidson, Chair Compounding Expert Pharmaceutical Compounding Sterile Preparations Committee Background Overview of Revised Content Submitting Comments Jeanne Sun, Manager, Compounding Timeline and Next Steps Jeanne Sun, Manager, Compounding Question & Answer Session Moderator: Jeanne Sun, Manager, Compounding Panelists (Expert Committee Members): Gigi Davidson Patti Kienle Abby Roth Connie Sullivan Jim Wagner 4. 2017 USP. USP Overview Tiffany Chan Building foundations for a healthier world Who we are Advocating for quality The experts behind our standards 12. 2017 USP. 2015 2020 Compounding Expert Committee Chair: Gigi Davidson, Pharm, DICVP, NC State College of Veterinary Medicine Vice Chair: Connie Sullivan, Pharm, National Home Infusion Association Member Affiliation Lisa Ashworth, Pharm Children's Health System of Texas Gus Bassani, PCCA.

3 Edmund Elder, , Pharm University of Wisconsin-Madison Ryan Forrey, , Becton Dickinson Deborah Houston, Novant Health - Kernersville Medical Center Brenda Jensen, Compounding Consultants, LLC. Patricia Kienle, MPA, Pharm Cardinal Health 13. 2017 USP. 2015 2020 Compounding Expert Committee Chair: Gigi Davidson, Pharm, DICVP, NC State College of Veterinary Medicine Vice Chair: Connie Sullivan, Pharm, National Home Infusion Association Member Affiliation William Mixon, Pharm The Compounding Pharmacy John Musil, Avella, Inc David Newton, Shenandoah University (retired). Alan Parr, , BioCeutics, LLC. Abby Roth, Clinical IQ. Robert Shrewsbury, UNC Eshelman School of Pharmacy James Wagner Controlled Environment Consulting Brenda Yuzdepski, Pharm Saskatoon Medical Arts Pharmacy 14. 2017 USP. 2015 2020 Compounding Expert Committee Expert Consultants Expert Consultants Affiliation Jane Axelrad Axelrad Solutions, LLC.

4 Dennis E. Doherty, MD, FCCP University of Kentucky College of Medicine Andrew Murphy, MD Asthma Allergy and Sinus Center Elizabeth Rebello, MD, FASA The University of Texas MD Anderson Cancer Center Allison T. Vidimos, , Cleveland Clinic 15. 2017 USP. How we work 16. 2017 USP. USP Timeline for General Chapter Revisions 17. 2017 USP. Overview of Revised General Chapter <797> Pharmaceutical Compounding . Sterile Preparations Background 1996 June 2008 Sept 25, 2015 July 27, 2018 Dec 2019. First Chapter First major Based on the Revised published for sterile revision to Proposed major revision public comments, <797>. compounding in <797> became <797> revised anticipated to to <797>. <1206> Sterile Drug official garnered and republished be official 6. Products for Home >8000 for public months after Use comments comment publication in the USP-NF. Roundtables 2004 July 2010 Discussion Jun 2019.

5 Revised and Newly formed Forums Revised <797>. renumbered EC began Expert anticipated to Chapter to <797> revisions to Consultants be published in <797> the USP-NF. 19. 2017 USP. Purpose of Current Revision To address public comments received in the first revision proposal in September 2015. Incorporate feedback and discussion from: Roundtables Discussion Forums Expert Consultants To clarify topics that are frequently queried and misconstrued To align revisions to: <795> Pharmaceutical Compounding Nonsterile Preparations <800> Hazardous Drugs Handling in Healthcare Settings 20. 2017 USP. <797> Overview Proposed Chapter Outline 1. Introduction and Scope 11. Labeling 2. Personnel Qualifications Training, 12. Establishing Beyond-Use Dates Evaluation, and Requalification 13. Use of Conventionally Manufactured 3. Personal Hygiene and Garbing Products 4. Facilities and Engineering Controls 14.

6 Use of CSPs As Components 5. Microbiological Air and Surface Monitoring 15. Quality Assurance and Quality Control 6. Cleaning and Disinfecting Compounding 16. CSP Storage, Handling, Packaging, Areas Shipping, And Transport 7. Equipment, Supplies, and Components 17. Documentation 8. Sterilization and Depyrogenation 18. Compounding Allergenic Extracts 9. SOPs and Master Formulation and Glossary Compounding Records Appendices 10. Release Testing 21. 2017 USP. <797> Proposal Administration is out of the Includes scope of the Chapter Direct and immediate application of a conventionally manufactured product or CSP. Withdrawal of doses Preparation of non-hazardous CSPs for a single patient using only sterile starting ingredients when administration will begin within 1 hour of beginning the preparation 22. 2017 USP. <797> Proposal Scope Eliminates provisions for handling of Eliminates provisions for hazardous drugs radiopharmaceuticals Compounding sterile hazardous drugs Compounding radiopharmaceuticals must additionally comply with <800> are subject to <825>.

7 Radiopharmaceuticals Preparation, <795>. Compounding, Dispensing, and Nonsterile Repackaging Handling of HDs <800>. Hazardous Drugs . Handling in Healthcare Settings <797>. Sterile Handling of HDs <797> Proposal Categories of CSPs CSP Microbial Contamination Risk Levels Category Category 1 CSPs 2 CSPs High-Risk May be prepared in a PEC located in a Must be prepared unclassified in a cleanroom Medium-Risk segregated suite compounding area Low Risk Assigned a BUD of Assigned a BUD of 12 hours at > 12 hours at controlled room controlled room Low-Risk with 12 temperature or 24. temperature or > 24. hours when Hour BUD hours if refrigerated refrigerated 24. 2017 USP. <797> Proposal Personnel Qualifications Currently Official 2015 Revision 2018 Revision Chapter (since Proposal Proposal 2008). Visual observation of hand Annually Every 3 months Every 6 months hygiene and garbing Gloved fingertip and thumb Annually.

8 Sampling Low/Medium-Risk CSPs Every 3 months Every 6 months Semi-annually . High-Risk CSPs Media fill testing Annually . Low/Medium-Risk CSPs Every 3 months Every 6 months Semi-annually . 25. High-Risk CSPs 2017 USP. <797> Proposal Garbing Requirements Currently Official 2015 Revision Proposal 2018 Revision Proposal Chapter (since 2008). Gown Determined based on: Gown Dedicated shoes or shoe Category Disposable covers for shoes covers Type of PEC Disposable covers for head Head and facial hair covers and facial hair Face masks Included: Face mask Sterile gloves Gown or coveralls Sterile gloves Disposable covers for shoes Disposable covers for head If using RABS disposable and facial hair gloves inside of gauntlet gloves Sterile gowns or sleeves Sterile gloves 26. 2017 USP. <797> Proposal Facility Design Category 1 CSPs Category 1 or 2 CSPs perimeter ISO Class Ante-Room ISO Class 5.

9 5 PEC (ISO Class 8). PEC. clean side . dirty side . Unclassified Buffer Room SCA (ISO Class 7). <797> Proposal Facility Requirements For Category 1 CSPs All PECs may be placed in an unclassified SCA. For Category 2 CSPs LAFS and RABS must be placed in an ISO Class 7 positive pressure buffer room with an ISO. Class 8 positive pressure ante-room Laminar airflow system Laminar Airflow Workbench (LAFW). (LAFS) Integrated Vertical Laminar Flow Zone (IVLFZ). Class II Biological Safety Cabinet (BSC). Restricted-access barrier Compounding Aseptic Isolator (CAI). system (RABS) Compounding Aseptic Containment Isolator (CACI). Isolators must be placed in an ISO Class 8 or better positive pressure room 28. 2017 USP. <797> Proposal Facility Requirements Added clarifications on Air Exchange Requirements HEPA filters must be located in the ceiling Returns must be low on the wall Compounding Area ACPH Requirement Unclassified SCA No requirement ISO Class 7 room(s) 30 APCH.

10 ISO Class 8 room(s) 20 APCH. Water Sources Sink may be placed inside or outside of ante-room Buffer room must not contain water sources 29. 2017 USP. <797> Proposal Certification During dynamic operating conditions Required every 6 months Includes: Airflow testing HEPA filter integrity testing Total particle count testing Smoke visualization studies <797> Proposal Microbiological Air and Surface Monitoring Viable Air Sampling Procedures including Surface Sampling incubation times described Flat Surface Sampling in Boxes Irregular Surface Sampling Currently Official 2015 Revision 2018 Revision Chapter (since 2008) Proposal Proposal Viable air sampling Every 6 months Monthly Every 6 months Surface sampling Periodically Monthly Monthly 31. 2017 USP. <797> Proposal Cleaning and Disinfecting Compounding Areas Frequencies specified for separate activities Cleaning Disinfecting Applying a sporicidal Cleaning supplies ( , wipers, sponges, mop heads).