R Bays USP 797 Compliance

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R Bays USP 797 Compliance

  1. 1. USP 797 Compliance The Basics of Pharmaceutical Compounding Regulations Richard Bays JD, MBA, RN, CPHQ © R Bays 2013
  2. 2. USP 797 Compliance  What is the USP-NF? The United States Pharmacopeia and The National Formulary (USP-NF) is a compilation of drug monographs, biologics, medical devices, dietary supplements, reference tests and standards, and standards for compounding of sterile and non- sterile drug preparations.
  3. 3. USP 797 Compliance  Utilizing the USP USP–NF is recognized by law and custom in most countries. The United States, the federal Food, Drug, and Cosmetic Act (FDC Act) defines the term “official compendium” as the official USP, the official NF, or any supplement to them. The FDA may enforce compliance with official standards in USP–NF under the adulteration and misbranding provisions of the FD&C Act. A State Board of Pharmacy may be charged with enforcement of this law.
  4. 4. USP 797 Compliance  Utilizing the USP USP <797> HAS SPECIFIC GUIDELINES FOR:  Design of the Facility  Environmental and Engineering Controls  Environmental Testing  Personnel Training and Competency Testing  Standard Operating Procedures and Documentation  Quality Assurance  Patient Monitoring and Adverse Events Reporting  Storage and Dating
  5. 5. USP 797 Compliance  <797> Purpose “THE INTENT OF <797> IS TO PREVENT HARM AND FATALITY TO PATIENTS THAT COULD RESULT FROM MICROBIAL CONTAMINATION (NONSTERILITY), EXCESSIVE BACTERIAL ENDOTOXINS, LARGE CONTENT ERRORS IN THE STRENGTH OF CORRECT INGREDIENTS, AND INCORRECT INGREDIENTS IN COMPOUNDED STERILE PRODUCTS (CSPs).” The U.S. Pharmacopeial Convention (USP) www.USP.Org
  6. 6. USP 797 Compliance  <797> Purpose The purpose of USP 797 is to protect the health of patients by reducing the potential for microbial contamination caused by an unclean environment, excessive bacterial endotoxins, large errors in the strength of ingredients and the use of incorrect ingredients.
  7. 7. USP 797 Compliance  <797> Purpose The chapter was developed for use in healthcare institutions, pharmacies, and physician practice facilities. It also applies to other facilities in which compounded sterile preparations (CSPs) are prepared, stored and dispensed, such as pharmacy intravenous rooms, chemotherapy clinics, hospital nursing stations and in operating rooms by anesthesiologists.
  8. 8. USP 797 Compliance  <797> Purpose The U.S. Pharmacopeia (USP) 797 provides the practice standards to help ensure that compounded sterile preparations are of high quality, and is for the pre- administration phase of sterile preparations. It describes the CSP requirements (guidelines, USP 797 procedures and compliance) for CSPs and sets the standards that apply to all settings in which sterile preparations are compounded. Adherence to 797 will reduce the potential for contamination caused by unclean environment, pharmacist error, lack of quality control, incorrect beyond-use dating and other factors
  9. 9. USP 797 Compliance  <797> Purpose The standard applies to anyone who prepares CSPs and all places where they are prepared. CSPs include drugs, nutrients, biologics, diagnostics and radiopharmaceuticals. The guideline requires environmental controls to include a separate area for compounding that meets a definite level of cleanliness, and monitoring to guarantee that control is maintained. For all preparers and places where CSPs are prepared, the Joint Commission requires a gap analysis and action plan for USP 797 compliance and is enforcing USP Chapter 797 within their standards. The Joint Commission may impose stricter compliance to 797 than the states’ Board of Pharmacy.
  10. 10. USP 797 Compliance  <797> Impacts: Facility Operations 􀂄 Hospital Pharmacy 􀂄 Home Infusion 􀂄 Retail Pharmacy 􀂄 Clinic 􀂄 Specialty 􀂄 Nuclear pharmacy 􀂄 Compounding Health Practitioner Facilities 􀂄 Ophthalmologist 􀂄 Oncologist 􀂄 Dermatologist
  11. 11. USP 797 Compliance Complying with <797>  Complying with USP 797 requires the design and use of cleanroom facilities as well as the development of policies and procedures for cleaning, sterility testing and personnel and environmental monitoring.  Aseptic manipulations using only sterile ingredients and components entirely within ISO Class 5 or better conditions are considered low risk.
  12. 12. USP 797 Compliance  <797> Applies to: The standards in this chapter are intended to apply to all persons who prepare CSPs and all places where CSPs are prepared (e.g., hospitals and other healthcare institutions, patient treatment clinics, pharmacies, physicians' practice facilities, and other locations and facilities in which CSPs are prepared, stored, and transported). Persons who perform sterile compounding include pharmacists, nurses, pharmacy technicians, and physicians.
  13. 13. USP 797 Compliance Risk Levels  An increase in complexity or duration of the compounding process increases the risk level.  Compounding, or pooling, multiple doses of sterile products for administration to multiple patients or single patient on multiple occasions is considered medium risk.  For example - The transfer of multiple ampules or vials into a single final sterile container or product. If a sterility test is not performed, the usable shelf life is 3 days at room temperature, 7 days at refrigerated temperature, and 45 days frozen at -20°C or colder.
  14. 14. USP 797 Compliance Risk Levels  High-risk conditions include the use of non-sterile ingredients or components or the exposure of sterile ingredients or components to conditions less than ISO Class 5.  For example - Measuring and mixing sterile ingredients in non-sterile devices before terminal sterilization. If a sterility test is not performed on high-risk preparations, the usable shelf life is 24 hours at controlled room temperature, 3 days at refrigerated temperature, and 45 days frozen at -20°C or colder.  Complying with USP 797 requires the design and use of cleanroom facilities as well as the development of policies and procedures for cleaning, sterility testing and personnel and environmental monitoring.
  15. 15. USP 797 Compliance  Daily Compliance Maintaining the work space Are things organized and free of “clutter”? Does everything work? Is there enough work space? Are there hand washing supplies?
  16. 16. USP 797 Compliance  Daily Compliance Refrigerators: Are there opened, undated and non-initialed Single Dose Vials (SDV) and Multiple Dose Vials (MDV)? Is there food or other prohibited items? Check the Temperature log
  17. 17. USP 797 Compliance  Daily Compliance Check for Waste and Sharp disposal Check Gauges Check Temp recording “wheels” Check Hood certification stickers Are policies and procedures in place and guidelines up to date and documented?
  18. 18. USP 797 Compliance  Cabinets/Hoods - Working Aseptically Unidirectional Airflow First Air Zone Nothing to be placed between the HEPA filter and the critical compounding zone Zone of Confusion Turbulent area downstream of an obstruction possible source of cross contamination The advantages of unidirectional airflow should be exploited when considering placement of materials within the DCCA.
  19. 19. USP 797 Compliance  Cabinets/Hoods - Working Aseptically  Improper hand placement disrupts first air  Good aseptic technique in sterile compounding requires the understanding and proper use of “First-Air”.  “First-Air” is the air exiting the HEPA filter in a unidirectional airstream and is virtually free of particulate contaminants.  All critical manipulations must be carried out in the unobstructed “first air” zone in the direct path of the HEPA filter discharge.  Proper product and process - placement with respect to the supply and discharge will provide a contamination free compounding area.
  20. 20. USP 797 Compliance  Meeting Sterility Requirements The ante-area or room is where personnel hand hygiene and garbing procedures, staging, order entry, CSP labeling, and other high particulate generating activities are preformed. This room leads into the sterile IV and compounding room. This transition room needs to be an ISO 8 or better approved room that is pressurized to move particulate filled air through HEPA filters. The sterile IV products should be mixed in a positive pressure room and in a ISO 5 or better approved hood
  21. 21. USP 797 Compliance  Meeting Sterility Requirements CHEMOTHERAPY: A negative pressure hood that is vented to the outside is needed that is ISO 5 or better IN a negative pressure room
  22. 22. USP 797 Compliance
  23. 23. USP 797 Compliance  CSP’s stratification MICROBIAL CONTAMINATAION RISK LEVELS LOW-RISK LEVEL  Compounded entirely under ISO Class 5 (Class 100) conditions  Compounding involves only transfer, measuring, and mixing manipulations with closed or sealed packaging systems  Manipulations are limited to aseptically opening ampule, penetrating sterile stoppers on vials with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile administration devices and packages of other sterile products  In the absence of passing a sterility test, periods cannot exceed the following time periods: Before administration, the CSP’s are properly stored and are exposed for not more than 48 hours at a controlled room temperature, for not more than 14 days at a cold temperature, and for 45 days in solid frozen state at – 20 degrees or colder.
  24. 24. USP 797 Compliance  CSP’s stratification MEDIUM-RISK LEVEL  All conditions apply as listed under low-risk level  Compounding involves only transfer, measuring, and mixing manipulations with closed or sealed packaging systems that are performed promptly and attentively  Manipulations are limited to aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile administration devices and packages of other sterile products  Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP that will be administered either to multiple patients or to one patient on multiple conditions  Compounding process includes complex aseptic manipulations other than the single-volume transfer  Compounding process requires unusually long duration  The sterile CSPs do not contain broad-spectrum bacteriostatic agents, and are administered over several days In the absence of passing a sterility test, periods cannot exceed the following time periods: Before administration, the CSP’s are properly stored and are exposed for not more than 30 hours at a controlled room temperature, for not more than 7 days at a cold temperature, and for 45 days in solid frozen state at – 20 degrees or colder
  25. 25. USP 797 Compliance  CSP’s stratification HIGH-RISK LEVEL  Non-sterile ingredients are incorporated or a non-sterile device is employed before terminal sterilization  Sterile ingredients, components, devices and mixtures are exposed to air quality inferior to ISO Class 5 (Class 100)  Non-sterile preparations are exposed for not more than 6 hours before being sterilized  Non-sterile preparations are terminally sterilized but are not tested for bacterial endotoxins  It is assumed that the chemical purity and content strength of ingredients meet their original or compendia specifications in unopened or in opened packages of bulk ingredients  The sterile CSPs do not contain broad-spectrum bacteriostatic agents, and are administered over several days In the absence of passing a sterility test, periods cannot exceed the following time periods: Before administration, the CSP’s are properly stored and are exposed for not more than 24 hours at a controlled room temperature, for not more than 3 days
  26. 26. USP 797 Compliance  Ongoing Compliance USP <797> requires policies and procedures for all aspects of sterile compounding from personnel to product that: 􀂄 Communicates information 􀂄 Perform audit and peer review activities 􀂄 Follow Standard Operating procedures 􀂄 Provide data for benchmarking 􀂄 Documents regulatory compliance 􀂄 Provides data valuable in cost evaluations 􀂄 Applicable in a court of law
  27. 27. USP 797 Compliance  Ongoing Compliance Documents should be kept up-to-date 1. Correct form 2. Correct information on form 3. Form is complete 4. Information is legible and readily accessible 5. Demonstrates conformity: No gap between actual performance and established policy
  28. 28. USP 797 Compliance  Ongoing Compliance Personnel Training Facility Staff 1. Daily calibration 2. Proper use of equipment 3. Documentation 􀂄 Competency Evaluation of Garbing 􀂄 Competency Evaluation of Cleaning & Disinfecting Procedures 􀂄 Competency Evaluation of Aseptic Work Practices 􀂄 Environmental Monitoring
  29. 29. USP 797 Compliance  Ongoing Compliance Personnel Training Janitorial Staff 1. Proper cleaning procedures 2. Isolation of cleaning equipment 3. Documentation
  30. 30. USP 797 Compliance QUESTIONS????
  31. 31. Contact Information Richard Bays JD, MBA, RN, CPHQ RBaysConsulting@Gmail.com +1 832.316.2701

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