Open Microphone Meeting:
USP General Chapter <797> Pharmaceutical
Compounding – Sterile Preparations
October 21, 2015
2:00 p.m. to 4:00 p.m. EDT
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
Overview of the U.S. Pharmacopeial
Convention
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
About USP
USP Headquarters Rockville, MD
Chair: Gigi Davidson, B.S. Pharm, DICVP, NC State
College of Veterinary Medicine
2015 – 2020 Compounding Expert
Committee
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.
Chair: Gigi Davidson, B.S. Pharm, DICVP, NC State
College of Veterinary Medicine
2015 – 2020 Compounding Expert
Committee
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
Overview of Development Process
Based on the nature and significance of the public comments Forward Ballot Approve Not approve Defer Cancel Proposal re-published for public comment Revision proposed by stakeholder, USP EC, or USPStaff
Proposal
published in PF for 90-day public
General Chapter <797> Pharmaceutical
Compounding – Sterile Preparations
Gigi Davidson, BSPh, DICVP Chair, USP Compounding Expert Committee, 2010-2020
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
USP <797>: Revision Proposal
USP <797>: Background
July 2010
<797> subcommittee formed & began work
Early 2013
Collaboration with Microbiology Expert CommitteeApril 2013
Formed <797> Expert PanelJune 2015
<797> subcommittee completed workSept 25
2015
Pre-post <797> for Public Comment Reorganized chapter
– Procedural information placed in Boxes
Categories of CSPs
– Collapsed into two categories
USP <797>: Overview of Major
Changes
• BUD ≤ 12 hours at room temperature or ≤ 24 hours refrigerated
• PEC placed in a segregated compounding area
Category 1 CSPs
• BUD > 12 hours at room temperature or > 24 hours refrigerated
• PEC placed in a classified area
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
USP <797>: Overview of Major
Changes
Personnel Qualifications
Personnel Protective Equipment
– Based on CSP Category and type of PEC
– Requirement for sterile sleeves (or sterile gown)
USP <797>: Overview of Major
Changes
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
Buildings and Facilities
– Primary Engineering Controls (PEC) – new terminology
• Laminar Airflow System (LAFS)
• Restricted Access Barrier System (RABS) • Isolator
– Placement of PEC
USP <797>: Overview of Major
Changes
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
Environmental controls
– Well-lit and comfortable conditions – Temperature 20˚ or cooler
– Humidity below 60%
Environmental Monitoring
16
USP <797>: Overview of Major
Changes
Proposed Frequency Nonviable Air Sampling Every 6 months
Viable Air Monitoring Monthly Surface Sampling Monthly
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)
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
USP <797>: Overview of Major
Changes
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
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
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
[email protected]
– Comments due January 31
st, 2016
USP <797>: How to Submit Comments
Provide comments that do not have any corresponding line numbers.
Provide comments with corresponding line numbers. Include specific
suggestions and rationale.
Provide all information in the event we need to contact you any follow-up
Next steps
– Subcommittee will review ALL comments submitted
– Comments will be addressed through commentary
posted online
USP <797>: Timeline and Next Steps
Date Activity
Sept 25, 2015 Revised General Chapter <797> Posted for Public Comment
Sept 25, 2015 through Jan 31, 2016
Open Public Comment Period
Oct 21, 2015 Open Microphone Web Meeting
Jan 31, 2016 Deadline for Submitting Public Comments
