Open Microphone Meeting: USP General Chapter <797> - PowerPoint PPT Presentation

Open Microphone Meeting: USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations October 21, 2015 2:00 p.m. to 4:00 p.m. EDT

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

Overview of the U.S. Pharmacopeial Convention 3

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

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2015 – 2020 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

2015 – 2020 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

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

General Chapter <797> Pharmaceutical Compounding – Sterile Preparations Gigi Davidson, BSPh, DICVP Chair, USP Compounding Expert Committee, 2010-2020 9

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

USP <797>: Background July 2010 Early 2013 April 2013 <797> subcommittee Collaboration with Formed <797> Expert formed & began work Microbiology Expert Panel Committee Sept 25 June 2015 2015 <797> Pre-post <797> for subcommittee Public Comment completed work 11

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

USP <797>: Overview of Major Changes  Hazardous Drugs – Removed all handling information and replaced with cross- reference 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

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

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 • PEC may be placed in an Category 1 CSPs 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

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 Every 6 months Viable Air Monitoring Monthly Surface Sampling Monthly 16

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

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

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

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

USP <797>: How to Submit Comments  General Chapter <797> is posted online at http://www.usp.org/usp-nf/notices/general-chapter- 797-proposed-revision – Download and complete the submission template – Email submission template to CompoundingSL@usp.org – Comments due January 31 st , 2016 21

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

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

Open Microphone Q&A Session 24