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Saturday, November 29, 2008
State-by-State Map of USP 797
US Boards of Pharmacy, Sterile Compounding Laws, Regulations and CE Requirements Map
For map view, go to: http://www.clinicaliq.com/component/option,com_google_maps/Itemid,111/
For text link view, go to: http://www.clinicaliq.com/content/category/1/48/125/
This informational reference map is being presented to assist you in understanding your state's laws and regulations relative to USP Chapter 797. You will also find specific information on your state's continuing education (CE) requirements. This research project was conducted by CriticalPoint, LLC and NABP. Please click on your state balloon to read the details of this research. By clicking on any state balloon you are indicating you have read and agreed to the clinicaliq.com Terms of Use. For additional information about this survey please read the information below the map. Note: this information is a starting point for analysis, check directly with your state board before proceeding with any project, to make sure you have the latest or pending data from that state.
To use the map move your mouse over the state you want to view and click on the colored balloon which will display a summary screen showing your boards contact information, link to the state’s website, state’s 797 Compliance status and a link to the detailed research information which includes information on license renewal requirements.
The three status levels are Direct (green), Indirect (yellow), or No Reference (red). If the state level is Direct (green) then the laws and regulation are harmonized with USP Chapter 797. If the state level is Indirect (yellow) then the laws and regulations do not specifically site USP Chapter 797 but there are laws and regulations for Sterile Compounding and/or Parenteral Nutrition. If the state level is No Reference (red) then there are currently no laws or regulations referencing USP Chapter 797 or Sterile Compounding/Parenteral Nutrition.
For Pharmacy Technician CE requirements please visit the PTCB web site.
For map view, go to: http://www.clinicaliq.com/component/option,com_google_maps/Itemid,111/
For text link view, go to: http://www.clinicaliq.com/content/category/1/48/125/
This informational reference map is being presented to assist you in understanding your state's laws and regulations relative to USP Chapter 797. You will also find specific information on your state's continuing education (CE) requirements. This research project was conducted by CriticalPoint, LLC and NABP. Please click on your state balloon to read the details of this research. By clicking on any state balloon you are indicating you have read and agreed to the clinicaliq.com Terms of Use. For additional information about this survey please read the information below the map. Note: this information is a starting point for analysis, check directly with your state board before proceeding with any project, to make sure you have the latest or pending data from that state.
To use the map move your mouse over the state you want to view and click on the colored balloon which will display a summary screen showing your boards contact information, link to the state’s website, state’s 797 Compliance status and a link to the detailed research information which includes information on license renewal requirements.
The three status levels are Direct (green), Indirect (yellow), or No Reference (red). If the state level is Direct (green) then the laws and regulation are harmonized with USP Chapter 797. If the state level is Indirect (yellow) then the laws and regulations do not specifically site USP Chapter 797 but there are laws and regulations for Sterile Compounding and/or Parenteral Nutrition. If the state level is No Reference (red) then there are currently no laws or regulations referencing USP Chapter 797 or Sterile Compounding/Parenteral Nutrition.
For Pharmacy Technician CE requirements please visit the PTCB web site.
AIHA Creates New Workgroup to Study USP 797
11/24/08: American Industrial Hygiene Association Creates New Workgroup to Study USP 797. Mission: Mission: Share information on the safe and healthful preparation and/or administration of healthcare involving hazardous or sterile pharmaceuticals; Develop model risk-based programs for the handling of hazardous drugs and/or sterile preparations; Develop models for the incorporation of risk-based programs that mesh patient safety and health, quality assurance, occupational health and safety, and environmental control into a facility continuous improvement program; Develop audit tools for simultaneously assuring patient safety and health, quality assurance, occupational health and safety, and environmental control; Expand the understanding of industrial hygiene issues in healthcare facilities.Project Team Lead:
Lawrence H. Hecker, CIH, PhD
Matthew L. Berkheiser, CSP
Richard D. Bennett, MSPH, CIH
Suzanne S. Blevins
Curtis E. Cannell, CIH
Sumati Dhawan
Brian E Hroch, CIH
J. Daniel James, CIH
Martin L. Jones, PhD, CIH, CSP
John F. Koerner, CIH
Thomas D. Murphy, CIH,CSP,CHMM
Leo T. Old, CIH,PE
John N. Rice
Shirley A. Smith, ASCP
Marissa L. Vieno
Shelley R. Wheeling-Park, MPH, CHMM, CSP, CIH
Matthew M. Winn
Sandra L. Witek-Eames For more information: http://www.aiha.org/Content/InsideAIHA/Volunteer+Groups/USP797.htm
Lawrence H. Hecker, CIH, PhD
Matthew L. Berkheiser, CSP
Richard D. Bennett, MSPH, CIH
Suzanne S. Blevins
Curtis E. Cannell, CIH
Sumati Dhawan
Brian E Hroch, CIH
J. Daniel James, CIH
Martin L. Jones, PhD, CIH, CSP
John F. Koerner, CIH
Thomas D. Murphy, CIH,CSP,CHMM
Leo T. Old, CIH,PE
John N. Rice
Shirley A. Smith, ASCP
Marissa L. Vieno
Shelley R. Wheeling-Park, MPH, CHMM, CSP, CIH
Matthew M. Winn
Sandra L. Witek-Eames For more information: http://www.aiha.org/Content/InsideAIHA/Volunteer+Groups/USP797.htm
New USP 797 Article by Bernstein & Associates, Architects
10/17/08: Bernstein & Associates, Architects (www.bernarch.com) announces that a new article on usp 797 facility design has been published in Health Facilities Management.
Entitled "Clean Spaces: A look at the revised and reissued USP 797 pharmacy design regulation", it was written by company principal William N. Bernstein, AIA. The article is a review of the new, 2008, usp 797 guideline, in terms of its impact on the design and construction of usp 797 compliant facilities. For further information on design and construction of usp 797 compliant facilities, contact:William N. Bernstein, AIAPrincipal Bernstein & Associates, Architects - PLLC 59 West 19th Street - 6A New York, NY 10011Office: 212.463.8200 Fax: 212.463.9898Email: wb@bernarch.com www.bernarch.com
Entitled "Clean Spaces: A look at the revised and reissued USP 797 pharmacy design regulation", it was written by company principal William N. Bernstein, AIA. The article is a review of the new, 2008, usp 797 guideline, in terms of its impact on the design and construction of usp 797 compliant facilities. For further information on design and construction of usp 797 compliant facilities, contact:William N. Bernstein, AIAPrincipal Bernstein & Associates, Architects - PLLC 59 West 19th Street - 6A New York, NY 10011Office: 212.463.8200 Fax: 212.463.9898Email: wb@bernarch.com www.bernarch.com
Hospital Selects Software to Help with USP 797 Chapter Compliance
"Henry Ford Macomb Hospital Selects Simplifi 797 to Help with USP Chapter 797 Compliance", "Pharmacy OneSource, 13 September, 2008
Software helps hospital pharmacy be in compliance with new compounding guidelines
Bellevue, WA -- Pharmacy OneSource, Inc., software as a service provider to more than 1,200 hospitals in the United States, announced today that Henry Ford Macomb Hospital has adopted Simplifi 797 to simplify meeting all of the requirements of USP Chapter 797 for compounding sites throughout the facility.
As a 435-bed facility providing comprehensive, acute care, Henry Ford Macomb Hospital in Clinton Township, Michigan provides an environment where pharmacy personnel must consistently maintain a safe and efficient pharmaceutical distribution system, while at the same time provide high-quality clinical services for their patients. With no room for less than optimal performance in either area, the pharmacy department continuously searches for new tools to aid in the provision of these services, and Simplifi 797 is the latest example.
"With Simplifi 797, our department has a simple and efficient way to track real-time compliance with USP Chapter 797 without the need for a labor-intensive paper trail," said Steve Fecteau, Manager Pharmacy Services for Henry Ford Macomb Hospital. "The system has also provided a well-organized approach to the many different requirements of USP Chapter 797, which has helped to make implementation of all of the changes less overwhelming."
Simplifi 797 is a web-based application that automates, integrates and streamlines the quality activities and documentation required to meet USP Chapter 797. Simplifi 797 manages task scheduling and monitoring and automates the reporting of exceptions and compliance.
"Simplifi 797 helps hospitals easily implement a robust quality control program. Henry Ford Macomb Hospital has taken a great step forward in protecting their patients with the adoption of Simplifi 797," said Keith Streckenbach, Chief Strategy Officer for Pharmacy OneSource.
More information about Simplifi 797 can be found at: www.simplifi797.com
About Pharmacy OneSource (www.pharmacyonesource.com)Pharmacy OneSource is healthcare's #1 Software-as-a-Service (SaaS) provider. Our more than 50 innovative team members provide best-in-class, SaaS solutions to current and future challenges within health-systems worldwide. Our SaaS solutions contribute to swift and safe healthcare through earlier, easier and better access to data. More than 1,200 healthcare organizations worldwide utilize our HIPAA compliant web-based services: Accupedia, Amplifi, Quantifi, ScheduleRx, Sentri7, Simplifi 797, and UnitStock.
About Henry Ford Macomb Hospital (www.henryfordmacomb.com)Henry Ford Macomb Hospital is a 435-bed hospital that provides comprehensive, acute care. Specialty services include a Heart & Vascular Institute, a cancer care center, a birthing center with 18 labor, deliver, recovery and post-partum suites. The hospital also has a 42-bed inpatient rehabilitation program, an ambulatory and minimally invasive surgery center and leading diagnostic imaging.
addthis_pub = 'p1source';
Software helps hospital pharmacy be in compliance with new compounding guidelines
Bellevue, WA -- Pharmacy OneSource, Inc., software as a service provider to more than 1,200 hospitals in the United States, announced today that Henry Ford Macomb Hospital has adopted Simplifi 797 to simplify meeting all of the requirements of USP Chapter 797 for compounding sites throughout the facility.
As a 435-bed facility providing comprehensive, acute care, Henry Ford Macomb Hospital in Clinton Township, Michigan provides an environment where pharmacy personnel must consistently maintain a safe and efficient pharmaceutical distribution system, while at the same time provide high-quality clinical services for their patients. With no room for less than optimal performance in either area, the pharmacy department continuously searches for new tools to aid in the provision of these services, and Simplifi 797 is the latest example.
"With Simplifi 797, our department has a simple and efficient way to track real-time compliance with USP Chapter 797 without the need for a labor-intensive paper trail," said Steve Fecteau, Manager Pharmacy Services for Henry Ford Macomb Hospital. "The system has also provided a well-organized approach to the many different requirements of USP Chapter 797, which has helped to make implementation of all of the changes less overwhelming."
Simplifi 797 is a web-based application that automates, integrates and streamlines the quality activities and documentation required to meet USP Chapter 797. Simplifi 797 manages task scheduling and monitoring and automates the reporting of exceptions and compliance.
"Simplifi 797 helps hospitals easily implement a robust quality control program. Henry Ford Macomb Hospital has taken a great step forward in protecting their patients with the adoption of Simplifi 797," said Keith Streckenbach, Chief Strategy Officer for Pharmacy OneSource.
More information about Simplifi 797 can be found at: www.simplifi797.com
About Pharmacy OneSource (www.pharmacyonesource.com)Pharmacy OneSource is healthcare's #1 Software-as-a-Service (SaaS) provider. Our more than 50 innovative team members provide best-in-class, SaaS solutions to current and future challenges within health-systems worldwide. Our SaaS solutions contribute to swift and safe healthcare through earlier, easier and better access to data. More than 1,200 healthcare organizations worldwide utilize our HIPAA compliant web-based services: Accupedia, Amplifi, Quantifi, ScheduleRx, Sentri7, Simplifi 797, and UnitStock.
About Henry Ford Macomb Hospital (www.henryfordmacomb.com)Henry Ford Macomb Hospital is a 435-bed hospital that provides comprehensive, acute care. Specialty services include a Heart & Vascular Institute, a cancer care center, a birthing center with 18 labor, deliver, recovery and post-partum suites. The hospital also has a 42-bed inpatient rehabilitation program, an ambulatory and minimally invasive surgery center and leading diagnostic imaging.
addthis_pub = 'p1source';
Web-Based Service to Simplify USP Chapter 797 Compliance
"Eric S. Kastango, MBA, RPh, FASHP, Teams with Healthprolink to Put Best Practices Into Web-Based Service to Simplify USP Chapter 797 Compliance", (c) Pharmacy OneSource, November 08, 2005
November 08, 2005 - Bellevue, WA -- Healthprolink Corporation and Clinical IQ, LLC signed a multi-year agreement to develop, market and service Simplifi 797, a web-based application that simplifies meeting all of the requirements of USP Chapter 797. On January 1, 2004, the first national pharmacy standard for compounding sterile preparations, USP Chapter 797, was published. The chapter establishes practice standards that are applicable to all settings (hospitals, retail, home infusion, ambulatory care, physician offices, nursing homes, etc.) where sterile preparations are compounded.Pharmacists and technicians are required to implement this standard as a means to improve the quality of compounded sterile preparations. Simplifi 797 automates all of the processes required to meet or exceed USP Chapter 797 and integrates practical tools to address all of the identified quality domains. As part of the agreement, Eric S. Kastango, President and Founder of Clinical IQ, LLC, will provide content and expert rules based upon 25 years of aseptic compounding experience in hospital, homecare and GMP environments. Healthprolink, provider of application services to over 900 hospitals, will design and develop the application in addition to providing marketing and ongoing customer support."We're absolutely thrilled to combine the experience of Eric Kastango with our expertise in application services," said Keith Streckenbach, Executive Vice President of Healthprolink. "This combination delivers comprehensive, yet easy-to-use, methods to assist pharmacists and technicians to meet or exceed USP Chapter 797."This web-based application automates, integrates and streamlines the quality activities and documentation required to meet USP Chapter 797. Simplifi 797 utilizes expert rules, manages task scheduling and monitoring and automates the reporting of exceptions and compliance. In addition, practice-based policies and procedures are integrated into the application to simplify compliance and include important aspects such as staff competencies, environmental monitoring, as well as media qualification."I am excited about partnering with Healthprolink, a leader in their industry, to create a tool for pharmacists and technicians that assists them in meeting 797 efficiently while also building a knowledgeable workforce," said Eric S. Kastango. Simplifi 797 will be officially launched on Sunday, December 4th at the meeting of the American Society of Health-System Pharmacists (ASHP) to be held at the Las Vegas Convention Center in Las Vegas, Nevada.
November 08, 2005 - Bellevue, WA -- Healthprolink Corporation and Clinical IQ, LLC signed a multi-year agreement to develop, market and service Simplifi 797, a web-based application that simplifies meeting all of the requirements of USP Chapter 797. On January 1, 2004, the first national pharmacy standard for compounding sterile preparations, USP Chapter 797, was published. The chapter establishes practice standards that are applicable to all settings (hospitals, retail, home infusion, ambulatory care, physician offices, nursing homes, etc.) where sterile preparations are compounded.Pharmacists and technicians are required to implement this standard as a means to improve the quality of compounded sterile preparations. Simplifi 797 automates all of the processes required to meet or exceed USP Chapter 797 and integrates practical tools to address all of the identified quality domains. As part of the agreement, Eric S. Kastango, President and Founder of Clinical IQ, LLC, will provide content and expert rules based upon 25 years of aseptic compounding experience in hospital, homecare and GMP environments. Healthprolink, provider of application services to over 900 hospitals, will design and develop the application in addition to providing marketing and ongoing customer support."We're absolutely thrilled to combine the experience of Eric Kastango with our expertise in application services," said Keith Streckenbach, Executive Vice President of Healthprolink. "This combination delivers comprehensive, yet easy-to-use, methods to assist pharmacists and technicians to meet or exceed USP Chapter 797."This web-based application automates, integrates and streamlines the quality activities and documentation required to meet USP Chapter 797. Simplifi 797 utilizes expert rules, manages task scheduling and monitoring and automates the reporting of exceptions and compliance. In addition, practice-based policies and procedures are integrated into the application to simplify compliance and include important aspects such as staff competencies, environmental monitoring, as well as media qualification."I am excited about partnering with Healthprolink, a leader in their industry, to create a tool for pharmacists and technicians that assists them in meeting 797 efficiently while also building a knowledgeable workforce," said Eric S. Kastango. Simplifi 797 will be officially launched on Sunday, December 4th at the meeting of the American Society of Health-System Pharmacists (ASHP) to be held at the Las Vegas Convention Center in Las Vegas, Nevada.
New Article by Bernstein & Associates, Architects on Architectural and Environmental Changes Required for USP 797 (usp 2004 version)
07/15/05: Bernstein &Associates, Architects (www.bernarch.com) announces that a new article on usp 797 facility design has been published in Health Facilities Management.
Entitled "Pharmacy Facts: Architectural and Environmental Changes Required for USP 797", it was written by company principal William N. Bernstein, AIA. The article is a review of the 2005 usp 797 guideline, in terms of its impact on the design and construction of usp 797 compliant facilities.
For further information on design and construction of usp 797 compliant facilities, contact:
William N. Bernstein, AIA
Principal Bernstein &Associates, Architects - PLLC
59 West 19th Street - 6A New York, NY 10011
Office: 212.463.8200 Fax: 212.463.9898
Email: wb@bernarch.com http://www.bernarch.com/
Entitled "Pharmacy Facts: Architectural and Environmental Changes Required for USP 797", it was written by company principal William N. Bernstein, AIA. The article is a review of the 2005 usp 797 guideline, in terms of its impact on the design and construction of usp 797 compliant facilities.
For further information on design and construction of usp 797 compliant facilities, contact:
William N. Bernstein, AIA
Principal Bernstein &Associates, Architects - PLLC
59 West 19th Street - 6A New York, NY 10011
Office: 212.463.8200 Fax: 212.463.9898
Email: wb@bernarch.com http://www.bernarch.com/
USP Chapter 797 on Enforceability
USP Chapter 797 on Enforceability, (c) USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations, 25 August 2008
In the USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations, USP “attempts to clarify the enforceability” of Chapter 797. The guidebook is a compilation of the full text of Chapter 797, public comments with responses from the committee which formulated the document, and five pages addressing enforceability.
Chapter 797 applies to practitioners. Practitioners are regulated by state agencies and in general, the FDA will defer to states with regard to Chapter 797. The FDA will act with the states in investigating allegations of poor quality compounded drugs, but is willing and able under the Federal Food Drug Cosmetic Act (FFDCA) to act on its own initiative.
Approaches by state to Chapter 797 generally fall into three categories, discussed in detail below in language drawn from the USP publication.
States that require compliance with USP standards
The following states likely fall into this category by having broad legal or regulatory language that requires compliance with the USP-NF generally. Since Chapter 797 is part of USP-NF, “these Boards appear to require compliance with the latest revision of the chapter”:
Massachusetts
South Dakota
South Carolina
Virginia
West Virginia
States that explicitly reference Chapter 797
The following states have laws or regulations that explicitly require compliance to varying degrees, with some broader assertions:
Minnesota
Utah: broad assertions that Chapter 797 shall apply
Georgia: immediate-use products exempted
Indiana
Maryland
New Mexico
States that include some provisions from Chapter 797 in their regulations
Some text incorporating portions of 797 has been adopted by the following states:
Arizona
Arkansas
Texas
Ohio
Reference:
USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations, 2008
International Oncology Network (ION)An AmerisourceBergen Specialty Group Company 3101 Gaylord Parkway Frisco, TX 75034
In the USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations, USP “attempts to clarify the enforceability” of Chapter 797. The guidebook is a compilation of the full text of Chapter 797, public comments with responses from the committee which formulated the document, and five pages addressing enforceability.
Chapter 797 applies to practitioners. Practitioners are regulated by state agencies and in general, the FDA will defer to states with regard to Chapter 797. The FDA will act with the states in investigating allegations of poor quality compounded drugs, but is willing and able under the Federal Food Drug Cosmetic Act (FFDCA) to act on its own initiative.
Approaches by state to Chapter 797 generally fall into three categories, discussed in detail below in language drawn from the USP publication.
States that require compliance with USP standards
The following states likely fall into this category by having broad legal or regulatory language that requires compliance with the USP-NF generally. Since Chapter 797 is part of USP-NF, “these Boards appear to require compliance with the latest revision of the chapter”:
Massachusetts
South Dakota
South Carolina
Virginia
West Virginia
States that explicitly reference Chapter 797
The following states have laws or regulations that explicitly require compliance to varying degrees, with some broader assertions:
Minnesota
Utah: broad assertions that Chapter 797 shall apply
Georgia: immediate-use products exempted
Indiana
Maryland
New Mexico
States that include some provisions from Chapter 797 in their regulations
Some text incorporating portions of 797 has been adopted by the following states:
Arizona
Arkansas
Texas
Ohio
Reference:
USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations, 2008
International Oncology Network (ION)An AmerisourceBergen Specialty Group Company 3101 Gaylord Parkway Frisco, TX 75034
USP Releases Chapter 797 Revision
"USP Releases Chapter 797 Revision", (c) Cheryl Thompson, Health-System Pharmacy News, 3/12/07
LAS VEGAS, NV, 03 December 2007 — The new version of United States Pharmacopeia (USP) chapter 797, "Pharmaceutical Compounding—Sterile Preparations," became publicly available today and goes into effect June 1, 2008.
For a limited time, U.S. Pharmacopeia stated, the new version of the chapter on compounded sterile preparations (CSPs) is accessible for no fee at www.usp.org/USPNF/pf/generalChapter797.html. This free offering ends January 1 when USP <797> Guidebook to Pharmaceutical Compounding—Sterile Preparations goes on sale.
The standards-setting organization said the current version of chapter 797, as it appears in The United States Pharmacopeia, 31st Revision, and The National Formulary, 26th Edition, remains the official text until publication of the edition's second supplement, scheduled for June 1, 2008.
The text of the new version is not entirely identical to the proposed revision published in May 2006. For example, the proposed section "Environmental Monitoring" was deleted and the content incorporated elsewhere. The new version has the subsection "Depyrogenation by Dry Heat," whereas the proposed revision did not.
In revising USP chapter 797 from the original text, the organization's Sterile Compounding Expert Committee added the following sections:
Definitions,
Intermediate-Use CSPs,
Single-Dose and Multiple-Dose Containers,
Hazardous Drugs as CSPs,
Radiopharmaceuticals as CSPs,
Allergen Extracts as CSPs,
Personnel Training and Competency Evaluation of Garbing, Aseptic Work Practices, and Cleaning/Disinfection Procedures,
Elements of Quality Control, and
Abbreviations and Acronyms.
The committee also created the section "Maintaining Sterility, Purity and Stability of Dispensed and Distributed CSPs" from the former "Maintaining Product Quality and Control after the CSP Leaves the Pharmacy" and added four appendixes.
"ASHP is pleased," said Cynthia Reilly, ASHP's director of clinical standards and quality, "that USP has released the much-anticipated revisions to chapter 797 to give practitioners time to prepare for when that document becomes official in June.
"The timing also provides ASHP an excellent opportunity to provide valuable information to our members—both here at MCM, at the Midyear Clinical Meeting, via educational sessions taught by experts who were involved in the revision and also on an ongoing basis through our practice standard, Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products.
"We'll be reviewing the new USP document carefully with an eye towards creating tools and resources that will help our members comply with state board of pharmacy regulations and accreditation standards that might be impacted by the USP changes," Reilly said.
LAS VEGAS, NV, 03 December 2007 — The new version of United States Pharmacopeia (USP) chapter 797, "Pharmaceutical Compounding—Sterile Preparations," became publicly available today and goes into effect June 1, 2008.
For a limited time, U.S. Pharmacopeia stated, the new version of the chapter on compounded sterile preparations (CSPs) is accessible for no fee at www.usp.org/USPNF/pf/generalChapter797.html. This free offering ends January 1 when USP <797> Guidebook to Pharmaceutical Compounding—Sterile Preparations goes on sale.
The standards-setting organization said the current version of chapter 797, as it appears in The United States Pharmacopeia, 31st Revision, and The National Formulary, 26th Edition, remains the official text until publication of the edition's second supplement, scheduled for June 1, 2008.
The text of the new version is not entirely identical to the proposed revision published in May 2006. For example, the proposed section "Environmental Monitoring" was deleted and the content incorporated elsewhere. The new version has the subsection "Depyrogenation by Dry Heat," whereas the proposed revision did not.
In revising USP chapter 797 from the original text, the organization's Sterile Compounding Expert Committee added the following sections:
Definitions,
Intermediate-Use CSPs,
Single-Dose and Multiple-Dose Containers,
Hazardous Drugs as CSPs,
Radiopharmaceuticals as CSPs,
Allergen Extracts as CSPs,
Personnel Training and Competency Evaluation of Garbing, Aseptic Work Practices, and Cleaning/Disinfection Procedures,
Elements of Quality Control, and
Abbreviations and Acronyms.
The committee also created the section "Maintaining Sterility, Purity and Stability of Dispensed and Distributed CSPs" from the former "Maintaining Product Quality and Control after the CSP Leaves the Pharmacy" and added four appendixes.
"ASHP is pleased," said Cynthia Reilly, ASHP's director of clinical standards and quality, "that USP has released the much-anticipated revisions to chapter 797 to give practitioners time to prepare for when that document becomes official in June.
"The timing also provides ASHP an excellent opportunity to provide valuable information to our members—both here at MCM, at the Midyear Clinical Meeting, via educational sessions taught by experts who were involved in the revision and also on an ongoing basis through our practice standard, Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products.
"We'll be reviewing the new USP document carefully with an eye towards creating tools and resources that will help our members comply with state board of pharmacy regulations and accreditation standards that might be impacted by the USP changes," Reilly said.
Particle Monitoring to Meet USP 797
Particle Monitoring to Meet USP <797>
1. Introduction
The United States Pharmacopoeia (USP) recently released procedures and requirements for compounding sterile preparations. General chapter <797>, titled “Pharmaceutical Compounding – Sterile Preparations,” states that sterile compounding procedures require clean facilities, specific training for operators, air quality evaluations, and a sound knowledge of sterilization and stability principles. The nature of defining how these preparations shall be manufactured is related to the potential risk to patients should errors occur.
This paper reviews the requirements for non-viable particle limits and the monitoring of those areas where product is exposed.
2. Environmental Requirements
Products are manufactured according to one of three risk factors: low, medium, and high. Those products which are manufactured as an aseptic parenteral have the greatest risk of contamination, and therefore they must be manufactured in an area tolerating only the lowest level of risk. “Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are errors of non-sterility and large errors in ingredients,” 1 and therefore the greatest level of control over manufacturing must be proven. They must be manufactured under a “laminar flow clean-air hood, barrier isolator, or other contamination control device appropriate for the risk level, that provide an adequate critical site environment”. 1
Critical site environments, defined below, must prove that they meet the international standard for cleanliness to ISO14644-1 Class 5, where no more than 3520 particles at 0.5 mm are present per cubic meter of sampled air. The ISO classes will be briefly discussed in this paper.
The supporting area, or clean room areas where the laminar flow stations are located, should meet at least ISO 8 air quality. The supporting area will be discussed in greater detail below.
For a better understanding of the requirements, a document to read in conjunction with the USP <797> is the Food and Drug Administration’s (FDA) Guidance for Industry Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, September 2004. This document identifies how the manufacturing of sterile products should be undertaken and defines certain elements of critical environments.
Defining Critical and Supporting Areas
Critical areas
The USP defines a critical area as the central location for performing sterile manipulations which should be a laminar flow, ISO 5 environment. The FDA Guidance defines it as the following:
A critical area is one in which the sterilized drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility (§ 211.42(c)(10)). Activities conducted in such areas include manipulations (e.g., aseptic connections, sterile ingredient additions) of sterile materials prior to and during filling and closing operations. 2
The USP and the FDA share a harmonized view of both the definition of critical areas and the activities which are critical in nature. In addition, the FDA defines the limit of particles in air:
Air in the immediate proximity of exposed sterilized containers/closures and filling/closing operations would be of appropriate particle quality when it has a per-cubic-meter particle count of no more than 3520 in a size range of 0.5 μm and larger when counted at representative locations normally not more than 1 foot away from the work site, within the airflow, and during filling/closing operations. This level of air cleanliness is also known as Class 100 (ISO 5). 2
Therefore, those activities that pose the greatest risk to final product quality must be done in an environment that meets ISO 5, again showing harmonization of the two references.
Supporting Areas
The USP defines this area as a controlled environment that minimizes the contamination of the area immediately surrounding the critical area. The FDA defines this area as the following:
Supporting clean areas can have various classifications and functions. Many support areas function as zones in which non-sterile components, formulated products, in-process materials, equipment, and container/closures are prepared, held, or transferred. These environments are soundly designed when they minimize the level of particle contaminants in the final product and control the microbiological content (bio-burden) of articles and components that are subsequently sterilized. 2
The USP states that supporting areas must meet an air quality of at least ISO 8; the FDA recommends the following:
The nature of the activities conducted in a supporting clean area determines its classification. FDA recommends that the area immediately adjacent to the aseptic processing line meet, at a minimum, Class 10,000 (ISO 7) standards (see Table 1) under dynamic conditions. Manufacturers can also classify this area as Class 1,000 (ISO 6) or maintain the entire aseptic filling room at Class 100 (ISO 5). An area classified at a Class 100,000 (ISO 8) air cleanliness level is appropriate for less critical activities (e.g., equipment cleaning). 2
Again, there is harmonization between the FDA and the USP on the expectations of supporting clean areas, though the FDA is more precise in defining that the risk of each area should be assessed and a classification assigned according to that risk. The table below is an extract from the FDA guidance and can be directly compared with that shown in USP <797>. The table also identifies the maximum permissible microbiological limits for the associated manufacturing areas.
Clean Area Classification
(0.5 µm particles/ft3)
ISO Designation
> 0.5 µm particles/m3
Microbiological Active Air Action Levels (cfu/m3 )
Microbiological Settling Plates Action Levels (diam. 90mm; cfu/4 hours)
100
5
3,520
1
1
1000
6
35,200
7
3
10,000
7
352,000
10
5
100,000
8
3,520,000
100
50
3. Monitoring Frequency
In accordance with the USP <797>, a critical area must prove to meet ISO 5 classification at least once per six-month period. The same interval is also found in the ISO14644-2 guide. The frequency of determining the cleanliness class of the supporting areas is also at least once per six months as recommended by the USP. This interval is defined in the ISO14644-2 as being at least every twelve months, so the expectations of the USP are higher than that of a typical ISO 8 clean room.
Because the FDA has a more risk-based approach to monitoring, a sample every “n” months is insufficient to determine if a specific batch of product was manufactured to specification and quality-defined attributes.
We recommend that measurements to confirm air cleanliness in critical areas be taken at sites where there is most potential risk to the exposed sterilized product, containers, and closures. The particle counting probe should be placed in an orientation demonstrated to obtain a meaningful sample. Regular monitoring should be performed during each production shift. We recommend conducting nonviable particle monitoring with a remote counting system. These systems are capable of collecting more comprehensive data and are generally less invasive than portable particle counters.2
Therefore, environmental monitoring should be performed during those periods when product is being exposed to the ambient environment, and records should show that a level of control was present during these periods. The FDA sets no recommendations for the supporting areas; however, the Parenteral Drug Association (PDA) recommends that they be sampled at least once per week for ISO 7 and at least once per month for ISO 8 (PDA Journal of Pharmaceutical Science and Technology, Volume 57 No.2 March/April 2003).
For more information on particle monitoring in pharmaceutical environments, read Particle Measuring Systems Application Note, “Particle Monitoring Requirements in Pharmaceutical Cleanrooms.”
Mark Hallworth
Pharmaceutical Business Manager
Particle Measuring Systems
Ackowledgements
1 USP. United States Pharmacopoeia General Chapter <797> Pharmaceutical Compounding – Sterile Preparations.
2 FDA. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. September 2004.
Particle Measuring Systems © 2005
1. Introduction
The United States Pharmacopoeia (USP) recently released procedures and requirements for compounding sterile preparations. General chapter <797>, titled “Pharmaceutical Compounding – Sterile Preparations,” states that sterile compounding procedures require clean facilities, specific training for operators, air quality evaluations, and a sound knowledge of sterilization and stability principles. The nature of defining how these preparations shall be manufactured is related to the potential risk to patients should errors occur.
This paper reviews the requirements for non-viable particle limits and the monitoring of those areas where product is exposed.
2. Environmental Requirements
Products are manufactured according to one of three risk factors: low, medium, and high. Those products which are manufactured as an aseptic parenteral have the greatest risk of contamination, and therefore they must be manufactured in an area tolerating only the lowest level of risk. “Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are errors of non-sterility and large errors in ingredients,” 1 and therefore the greatest level of control over manufacturing must be proven. They must be manufactured under a “laminar flow clean-air hood, barrier isolator, or other contamination control device appropriate for the risk level, that provide an adequate critical site environment”. 1
Critical site environments, defined below, must prove that they meet the international standard for cleanliness to ISO14644-1 Class 5, where no more than 3520 particles at 0.5 mm are present per cubic meter of sampled air. The ISO classes will be briefly discussed in this paper.
The supporting area, or clean room areas where the laminar flow stations are located, should meet at least ISO 8 air quality. The supporting area will be discussed in greater detail below.
For a better understanding of the requirements, a document to read in conjunction with the USP <797> is the Food and Drug Administration’s (FDA) Guidance for Industry Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, September 2004. This document identifies how the manufacturing of sterile products should be undertaken and defines certain elements of critical environments.
Defining Critical and Supporting Areas
Critical areas
The USP defines a critical area as the central location for performing sterile manipulations which should be a laminar flow, ISO 5 environment. The FDA Guidance defines it as the following:
A critical area is one in which the sterilized drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility (§ 211.42(c)(10)). Activities conducted in such areas include manipulations (e.g., aseptic connections, sterile ingredient additions) of sterile materials prior to and during filling and closing operations. 2
The USP and the FDA share a harmonized view of both the definition of critical areas and the activities which are critical in nature. In addition, the FDA defines the limit of particles in air:
Air in the immediate proximity of exposed sterilized containers/closures and filling/closing operations would be of appropriate particle quality when it has a per-cubic-meter particle count of no more than 3520 in a size range of 0.5 μm and larger when counted at representative locations normally not more than 1 foot away from the work site, within the airflow, and during filling/closing operations. This level of air cleanliness is also known as Class 100 (ISO 5). 2
Therefore, those activities that pose the greatest risk to final product quality must be done in an environment that meets ISO 5, again showing harmonization of the two references.
Supporting Areas
The USP defines this area as a controlled environment that minimizes the contamination of the area immediately surrounding the critical area. The FDA defines this area as the following:
Supporting clean areas can have various classifications and functions. Many support areas function as zones in which non-sterile components, formulated products, in-process materials, equipment, and container/closures are prepared, held, or transferred. These environments are soundly designed when they minimize the level of particle contaminants in the final product and control the microbiological content (bio-burden) of articles and components that are subsequently sterilized. 2
The USP states that supporting areas must meet an air quality of at least ISO 8; the FDA recommends the following:
The nature of the activities conducted in a supporting clean area determines its classification. FDA recommends that the area immediately adjacent to the aseptic processing line meet, at a minimum, Class 10,000 (ISO 7) standards (see Table 1) under dynamic conditions. Manufacturers can also classify this area as Class 1,000 (ISO 6) or maintain the entire aseptic filling room at Class 100 (ISO 5). An area classified at a Class 100,000 (ISO 8) air cleanliness level is appropriate for less critical activities (e.g., equipment cleaning). 2
Again, there is harmonization between the FDA and the USP on the expectations of supporting clean areas, though the FDA is more precise in defining that the risk of each area should be assessed and a classification assigned according to that risk. The table below is an extract from the FDA guidance and can be directly compared with that shown in USP <797>. The table also identifies the maximum permissible microbiological limits for the associated manufacturing areas.
Clean Area Classification
(0.5 µm particles/ft3)
ISO Designation
> 0.5 µm particles/m3
Microbiological Active Air Action Levels (cfu/m3 )
Microbiological Settling Plates Action Levels (diam. 90mm; cfu/4 hours)
100
5
3,520
1
1
1000
6
35,200
7
3
10,000
7
352,000
10
5
100,000
8
3,520,000
100
50
3. Monitoring Frequency
In accordance with the USP <797>, a critical area must prove to meet ISO 5 classification at least once per six-month period. The same interval is also found in the ISO14644-2 guide. The frequency of determining the cleanliness class of the supporting areas is also at least once per six months as recommended by the USP. This interval is defined in the ISO14644-2 as being at least every twelve months, so the expectations of the USP are higher than that of a typical ISO 8 clean room.
Because the FDA has a more risk-based approach to monitoring, a sample every “n” months is insufficient to determine if a specific batch of product was manufactured to specification and quality-defined attributes.
We recommend that measurements to confirm air cleanliness in critical areas be taken at sites where there is most potential risk to the exposed sterilized product, containers, and closures. The particle counting probe should be placed in an orientation demonstrated to obtain a meaningful sample. Regular monitoring should be performed during each production shift. We recommend conducting nonviable particle monitoring with a remote counting system. These systems are capable of collecting more comprehensive data and are generally less invasive than portable particle counters.2
Therefore, environmental monitoring should be performed during those periods when product is being exposed to the ambient environment, and records should show that a level of control was present during these periods. The FDA sets no recommendations for the supporting areas; however, the Parenteral Drug Association (PDA) recommends that they be sampled at least once per week for ISO 7 and at least once per month for ISO 8 (PDA Journal of Pharmaceutical Science and Technology, Volume 57 No.2 March/April 2003).
For more information on particle monitoring in pharmaceutical environments, read Particle Measuring Systems Application Note, “Particle Monitoring Requirements in Pharmaceutical Cleanrooms.”
Mark Hallworth
Pharmaceutical Business Manager
Particle Measuring Systems
Ackowledgements
1 USP. United States Pharmacopoeia General Chapter <797> Pharmaceutical Compounding – Sterile Preparations.
2 FDA. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. September 2004.
Particle Measuring Systems © 2005
Steps to Build a USP 797 Compliant Facility
Steps to Build a USP 797 Compliant Facility
A suggested step-by-step methodology for USP 797 compliance is as follows:
JCAHO began surveying for compliance with USP 797 on July 1, 2004, so efforts to comply with USP 797 should have begun and/or must begin immediately
To begin with, assemble a team within your healthcare institution consisting of : Chief Pharmacist, Director of Facilities, Director of Engineering, and Appropriate Administrator
Identify, with the guidance of the Chief Pharmacist, those pharmacies within the health care institution where sterile compounding is done
Create a Gap Analysis document, either in-house, or by hiring a consultant that specializes in Gap Analysis documents, such as Clinical IQ (http://www.clinicaliq.com/)
Create a Compliance Action Plan, either in-house, or by hiring an architect that specializes in Compliance Action Plans, such as Bernstein & Assoc. (http://www.bernarch.com/)
Have the architect create construction documents and specifications, indicating the detailed scope required for the project
Send out the drawings and specifications to 3-5 qualified general contractors who specialize in health care and laboratory space
Award the project to the selected contractor Work with architect and contractor to complete work in a thorough manner, meeting all project specifications.
For more information about usp 797, go to: http://www.usp797.org/
For more information about usp 797-compliant architecture, engineering and construction, go to: http://www.bernarch.com/.
A suggested step-by-step methodology for USP 797 compliance is as follows:
JCAHO began surveying for compliance with USP 797 on July 1, 2004, so efforts to comply with USP 797 should have begun and/or must begin immediately
To begin with, assemble a team within your healthcare institution consisting of : Chief Pharmacist, Director of Facilities, Director of Engineering, and Appropriate Administrator
Identify, with the guidance of the Chief Pharmacist, those pharmacies within the health care institution where sterile compounding is done
Create a Gap Analysis document, either in-house, or by hiring a consultant that specializes in Gap Analysis documents, such as Clinical IQ (http://www.clinicaliq.com/)
Create a Compliance Action Plan, either in-house, or by hiring an architect that specializes in Compliance Action Plans, such as Bernstein & Assoc. (http://www.bernarch.com/)
Have the architect create construction documents and specifications, indicating the detailed scope required for the project
Send out the drawings and specifications to 3-5 qualified general contractors who specialize in health care and laboratory space
Award the project to the selected contractor Work with architect and contractor to complete work in a thorough manner, meeting all project specifications.
For more information about usp 797, go to: http://www.usp797.org/
For more information about usp 797-compliant architecture, engineering and construction, go to: http://www.bernarch.com/.
Monday, November 24, 2008
Q & A on usp 797: Sink in Anteroom
Questions and Answers on USP 797
RJLG Question 6: I have received some conflicting information regarding USP 797 standards related to the presence of a sink in an anteroom meeting ISO Class 7. In reviewing the Revision Bulletin (copyright 2008), an ISO Class 7 buffer area shall not contain sinks or floor drains, but would the presence of a sink in a physically separate, positive pressure ISO Class 7 anteroom adjacent to a negative pressure ISO Class 7 buffer area somehow detract from the anteroom's ISO classification?
Specifically, I have a new hospital pharmacy which has provided certification documentation that the small anteroom leading into the hazardous drug preparation area (negative pressure ISO Class 7 buffer area containing ISO Class 5 PEC) meets the established guidelines for ISO Class 7 with the presence of a sink with a drain (located next to the doorway separating the anteroom from the buffer area). This was in a pre-operational, non-dynamic state. There are now some conflicting opinions about the sink and its impact on the ISO classification of the anteroom. Any guidance on this situation would be much appreciated.
RJLG Answer 6: USP<797> states “The buffer area shall not contain sources of water (sinks) or floor drains.” This is intended to reduce airborne microbial and other particulate contamination adjacent to critical sites such as ISO Class 5 primary engineering controls (PECs). The ante area sink is a critical component to personnel cleansing and garbing prior to entrance into the buffer area. Your environmental sampling programs (non-viable and viable particle testing), conducted before commissioning of the pharmacy and periodically thereafter during dynamic operating conditions, will determine the impact of a sink or other objects on the ISO classifications of your ante and buffer areas.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mailto:613-2709mzock@rjlg.com
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : mailto:info@usp797.org
RJLG Question 6: I have received some conflicting information regarding USP 797 standards related to the presence of a sink in an anteroom meeting ISO Class 7. In reviewing the Revision Bulletin (copyright 2008), an ISO Class 7 buffer area shall not contain sinks or floor drains, but would the presence of a sink in a physically separate, positive pressure ISO Class 7 anteroom adjacent to a negative pressure ISO Class 7 buffer area somehow detract from the anteroom's ISO classification?
Specifically, I have a new hospital pharmacy which has provided certification documentation that the small anteroom leading into the hazardous drug preparation area (negative pressure ISO Class 7 buffer area containing ISO Class 5 PEC) meets the established guidelines for ISO Class 7 with the presence of a sink with a drain (located next to the doorway separating the anteroom from the buffer area). This was in a pre-operational, non-dynamic state. There are now some conflicting opinions about the sink and its impact on the ISO classification of the anteroom. Any guidance on this situation would be much appreciated.
RJLG Answer 6: USP<797> states “The buffer area shall not contain sources of water (sinks) or floor drains.” This is intended to reduce airborne microbial and other particulate contamination adjacent to critical sites such as ISO Class 5 primary engineering controls (PECs). The ante area sink is a critical component to personnel cleansing and garbing prior to entrance into the buffer area. Your environmental sampling programs (non-viable and viable particle testing), conducted before commissioning of the pharmacy and periodically thereafter during dynamic operating conditions, will determine the impact of a sink or other objects on the ISO classifications of your ante and buffer areas.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mailto:613-2709mzock@rjlg.com
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : mailto:info@usp797.org
Q & A on usp 797: Low Volume of Chemotherapy Drugs
Questions and Answers on USP 797
RJLG Question 5: I read somewhere in the USP 797 that it was acceptable to mix a low volume of chemotherapy agents without a separate negative pressure room as long as CSTD's were used. Is this correct? Also--what is considered a low volume?
RJLG Answer 5: When a closed system transfer device (CSTD) is used within the ISO Class 5 biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) for low volume hazardous drug preparation only, a non-negative pressure room is acceptable provided other precautions and recommendations are followed. For instance: all hazardous drugs shall be separate from non-hazardous drugs in storage (separate storage area) and handling (dedicated BSC or CACI); the BSC or CACI shall be placed in a restricted access ISO Class 7 non-negative pressure buffer area, or a CACI may be used outside of the ISO Class 7 buffer area provided it is in a restricted access room that meets the conditions in the section of USP<797> entitled Placement of Primary Engineering Controls; proper procedures, training, and personal protective equipment (PPE) are employed; and containment should be verified by routine monitoring. The Hazardous Drugs as CSPs section of USP<797> does not describe low volume. Our interpretation is, if the use of a CACI (100% vented glovebox) or two tiers of containment (CSTD within a CACI or BSC) will allow for the ability to handle the total peak volume of hazardous drugs at the given facility without compromising safety, sterility, quality, or workflow, then the non-negative pressure room is acceptable as described above.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mzock@rjlg.com
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org
RJLG Question 5: I read somewhere in the USP 797 that it was acceptable to mix a low volume of chemotherapy agents without a separate negative pressure room as long as CSTD's were used. Is this correct? Also--what is considered a low volume?
RJLG Answer 5: When a closed system transfer device (CSTD) is used within the ISO Class 5 biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) for low volume hazardous drug preparation only, a non-negative pressure room is acceptable provided other precautions and recommendations are followed. For instance: all hazardous drugs shall be separate from non-hazardous drugs in storage (separate storage area) and handling (dedicated BSC or CACI); the BSC or CACI shall be placed in a restricted access ISO Class 7 non-negative pressure buffer area, or a CACI may be used outside of the ISO Class 7 buffer area provided it is in a restricted access room that meets the conditions in the section of USP<797> entitled Placement of Primary Engineering Controls; proper procedures, training, and personal protective equipment (PPE) are employed; and containment should be verified by routine monitoring. The Hazardous Drugs as CSPs section of USP<797> does not describe low volume. Our interpretation is, if the use of a CACI (100% vented glovebox) or two tiers of containment (CSTD within a CACI or BSC) will allow for the ability to handle the total peak volume of hazardous drugs at the given facility without compromising safety, sterility, quality, or workflow, then the non-negative pressure room is acceptable as described above.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mzock@rjlg.com
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org
Q & A on usp 797: Privately Owned Physician's Office
Questions and Answers on USP 797
RJLG Question 4: We are a privately owned physicians office and do not have pharmacy or pharmacist. We have (2) RN's that are trained and certified to mix and give chemo drugs. We follow NIOSH guidelines. De we have to follow the USP797 guidelines?
RJLG Answer 4: If your institution prepares compounded sterile preparations (CSPs) which meet the definition of the specific categories described in USP797 (low-risk level, medium-risk level, high-risk level, or immediate use), including hazardous drugs as CSPs, you must comply with USP797. The standards are intended to apply to all persons who prepare CSPs and all places where CSPs are prepared including physicians offices.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mzock@rjlg.com
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org
RJLG Question 4: We are a privately owned physicians office and do not have pharmacy or pharmacist. We have (2) RN's that are trained and certified to mix and give chemo drugs. We follow NIOSH guidelines. De we have to follow the USP797 guidelines?
RJLG Answer 4: If your institution prepares compounded sterile preparations (CSPs) which meet the definition of the specific categories described in USP797 (low-risk level, medium-risk level, high-risk level, or immediate use), including hazardous drugs as CSPs, you must comply with USP797. The standards are intended to apply to all persons who prepare CSPs and all places where CSPs are prepared including physicians offices.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mzock@rjlg.com
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org
Q & A on usp 797: Immediate Use Exemption
Questions and Answers on USP 797
RJLG Question 3: I work in a Nuclear Medicine Department and we use unit dose for everything but emergency scans. We have changed our policy to receive multiple separate syringes with varying activities to produce several single dose kits. During preparation aseptic techniques will be followed. The kit will be used within an hour, for only one patient and no more than two entries into any one vial. My concern is preparing an Ultra tag kit for a G.I.Bleed. If we follow the manufacturer's preparation and use the correct personal protective equipment are we covered under the immediate use exemption?
RJLG Answer 3: The Immediate use provision is intended for those situations which call the immediate administration of a compounded sterile product. The important factor here is that these items can not be prepared and stored in advance for any anticipated needs. If the compounds you are referring to are considered hazardous all hazardous materials must be manipulated within a bio safety hood or glove box. If preparation is done outside of a BSC or similar device, to meet the requirements for immediate use, preparations must: 1. Follow Aseptic technique. 2. Be limited to simple manipulations admixing no more than 3 ingredients. 3. Not exceed more than 2 entries into any 1 vial 4. Begin to be administered within 1 hour of starting preparation. 5. If the administration of the compounded product will not be completed by the person who prepared it, the compounded product must be properly labeled with patient name, all ingredient names and strengths, the initials of the preparer and the exact beyond use date (BUD) and time. 6. Be properly and safely discarded if administration does not begin within 1 hour following the start of preparation. The procedure you have outlined appears to meet these requirements and can be considered immediate use.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Royston Browne, PharmD is currently the Manager of the oncology Pharmacy at Montefiore Medical Center in the Bronx New York. He has worked in this capacity for the past 11 years and has provided leadership in complying with USP 797 policies at this institution .
Royston Browne, BS PharmDManager, Oncology PharmacyMontefiore Medical CenterHoffheimer 100 - 111 East 210 StreetBronx, NY 10467Tel: (718) 920-5778Fax: (718) 515-9529Pager: (917) 898-1918E-Mail: RBrowne@Montefiore.org
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org
RJLG Question 3: I work in a Nuclear Medicine Department and we use unit dose for everything but emergency scans. We have changed our policy to receive multiple separate syringes with varying activities to produce several single dose kits. During preparation aseptic techniques will be followed. The kit will be used within an hour, for only one patient and no more than two entries into any one vial. My concern is preparing an Ultra tag kit for a G.I.Bleed. If we follow the manufacturer's preparation and use the correct personal protective equipment are we covered under the immediate use exemption?
RJLG Answer 3: The Immediate use provision is intended for those situations which call the immediate administration of a compounded sterile product. The important factor here is that these items can not be prepared and stored in advance for any anticipated needs. If the compounds you are referring to are considered hazardous all hazardous materials must be manipulated within a bio safety hood or glove box. If preparation is done outside of a BSC or similar device, to meet the requirements for immediate use, preparations must: 1. Follow Aseptic technique. 2. Be limited to simple manipulations admixing no more than 3 ingredients. 3. Not exceed more than 2 entries into any 1 vial 4. Begin to be administered within 1 hour of starting preparation. 5. If the administration of the compounded product will not be completed by the person who prepared it, the compounded product must be properly labeled with patient name, all ingredient names and strengths, the initials of the preparer and the exact beyond use date (BUD) and time. 6. Be properly and safely discarded if administration does not begin within 1 hour following the start of preparation. The procedure you have outlined appears to meet these requirements and can be considered immediate use.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Royston Browne, PharmD is currently the Manager of the oncology Pharmacy at Montefiore Medical Center in the Bronx New York. He has worked in this capacity for the past 11 years and has provided leadership in complying with USP 797 policies at this institution .
Royston Browne, BS PharmDManager, Oncology PharmacyMontefiore Medical CenterHoffheimer 100 - 111 East 210 StreetBronx, NY 10467Tel: (718) 920-5778Fax: (718) 515-9529Pager: (917) 898-1918E-Mail: RBrowne@Montefiore.org
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org
Q&A on usp 797: Minimum Time for a Settle Plate Sample
Questions and Answers on USP 797
RJLG Question 2: What is the minimum time for a settle plate sample. We are currently using 15 min is this enough.
RJLG Answer 2: Although some still use settling plates to qualitatively assess viable airborne microorganisms, this method is not adequate for quantifying airborne microbial burden in clean environments such as ISO classified hoods (clean benches, BSCs, CAIs), buffer or clean rooms, or ante areas. Your USP 797 sampling plan should include active air sampling using appropriate electronic air sampling equipment and trained personnel. For more information you may refer to Environmental Viable Airborne Particle Testing Program under USP<797> Pharmaceutical Compounding – Sterile Preparations, and Methodology and Instrumentation for Quantitation of Viable Airborne Microorganisms under USP<1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environment.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mzock@rjlg.com
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org
RJLG Question 2: What is the minimum time for a settle plate sample. We are currently using 15 min is this enough.
RJLG Answer 2: Although some still use settling plates to qualitatively assess viable airborne microorganisms, this method is not adequate for quantifying airborne microbial burden in clean environments such as ISO classified hoods (clean benches, BSCs, CAIs), buffer or clean rooms, or ante areas. Your USP 797 sampling plan should include active air sampling using appropriate electronic air sampling equipment and trained personnel. For more information you may refer to Environmental Viable Airborne Particle Testing Program under USP<797> Pharmaceutical Compounding – Sterile Preparations, and Methodology and Instrumentation for Quantitation of Viable Airborne Microorganisms under USP<1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environment.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mzock@rjlg.com
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org
Q & A on USP 797: Fingertip Sampling
Questions and Answers on USP 797
RJLG Question 1: Question on fingertip sampling: I have a question regarding fingertip sampling. On page 34, the recommended action levels for microbial contamination states that the action levels for ISO Class 5 sampling is >3. Yet when I look at the appendix I for gloved fingertip sampling it states that "All employees shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (0 cfu) no less than three times before initially being allowed to compound CSPs for human use". I'm confused as to which one applies. Can you clarify for me? Thanks.
RJLG Answer 1: USP<797> clearly states that the initial competency evaluation and gloved fingertip/thumb sampling procedure does require 0 CFU for successful completion (performed at least three times) as quoted in your question.Table 4. Recommended Action Levels for Microbial Contamination, which shows >3 CFU as an action level for fingertip samples in an ISO Class 5 environment, applies to annual re-evaluation of compounding personnel who compound low and medium-risk level CSPs, and semi-annual re-evaluation for high-risk level CSPs. However, USP<797> states that the tables of recommended action levels are intended to be used as guidelines only, and “Action levels are determined on the basis of CFU data gathered at each sampling location and trended over time.”
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew Zock RJ Lee Group, Inc. 350 Fifth Avenue, Suite 5820 New York, NY 10118 (212)613-2709 mzock@rjlg.com
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org
RJLG Question 1: Question on fingertip sampling: I have a question regarding fingertip sampling. On page 34, the recommended action levels for microbial contamination states that the action levels for ISO Class 5 sampling is >3. Yet when I look at the appendix I for gloved fingertip sampling it states that "All employees shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (0 cfu) no less than three times before initially being allowed to compound CSPs for human use". I'm confused as to which one applies. Can you clarify for me? Thanks.
RJLG Answer 1: USP<797> clearly states that the initial competency evaluation and gloved fingertip/thumb sampling procedure does require 0 CFU for successful completion (performed at least three times) as quoted in your question.Table 4. Recommended Action Levels for Microbial Contamination, which shows >3 CFU as an action level for fingertip samples in an ISO Class 5 environment, applies to annual re-evaluation of compounding personnel who compound low and medium-risk level CSPs, and semi-annual re-evaluation for high-risk level CSPs. However, USP<797> states that the tables of recommended action levels are intended to be used as guidelines only, and “Action levels are determined on the basis of CFU data gathered at each sampling location and trended over time.”
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew Zock RJ Lee Group, Inc. 350 Fifth Avenue, Suite 5820 New York, NY 10118 (212)613-2709 mzock@rjlg.com
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org
Sunday, November 23, 2008
New Article on USP 797 Pharmacy Design and Construction
New Article on USP 797 Pharmacy Design and Construction
Bernstein & Associates, Architects is pleased to announce the publication of a new article about recent trends in pharmacy design, including the design of pharmaceutical compounding suites.
The article includes discussion of the design and construction implications of the 2008 version of USP 797.
It also features details of the new pharmacy and pharmaceutical compounding suite designed by the firm for the Roswell Park Cancer Institute in Buffalo, NY.
Entitled "Clean Spaces: A Look at the Revised and Reissued USP 797 Pharmacy Design Regulation", it was written by the firm's principal --- William N. Bernstein, AIA --- and was published in the October issue of Health Facilities Management.
To view this article: http://www.hhnmag.com/hhnmag_app/jsp/articledisplay.jsp?dcrpath=HFMMAGAZINE/Article/data/10OCT2008/0810HFM_DEPT_Codes&domain=HFMMAGAZINE
About Bernstein & Associates, Architects:
Founded in 1990, *Bernstein & Assoc., Architects - PLLC* is an award-winning architectural firm specializing in healthcare and laboratories, with a sub-specialty in the design and construction of USP 797-compliant pharmacy facilities. Over the last three years, the firm has designed over (20) usp 797-compliant pharmacies. For more more information about pharmacy design and construction, please contact:
William N. Bernstein, AIA
Principal
Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A New York, NY 10011
Office: 212.463.8200 Cell: 917.747.2924 Fax: 212.463.9898
Email: wb@bernarch.com
www.bernarch.com
Bernstein & Associates, Architects is pleased to announce the publication of a new article about recent trends in pharmacy design, including the design of pharmaceutical compounding suites.
The article includes discussion of the design and construction implications of the 2008 version of USP 797.
It also features details of the new pharmacy and pharmaceutical compounding suite designed by the firm for the Roswell Park Cancer Institute in Buffalo, NY.
Entitled "Clean Spaces: A Look at the Revised and Reissued USP 797 Pharmacy Design Regulation", it was written by the firm's principal --- William N. Bernstein, AIA --- and was published in the October issue of Health Facilities Management.
To view this article: http://www.hhnmag.com/hhnmag_app/jsp/articledisplay.jsp?dcrpath=HFMMAGAZINE/Article/data/10OCT2008/0810HFM_DEPT_Codes&domain=HFMMAGAZINE
About Bernstein & Associates, Architects:
Founded in 1990, *Bernstein & Assoc., Architects - PLLC* is an award-winning architectural firm specializing in healthcare and laboratories, with a sub-specialty in the design and construction of USP 797-compliant pharmacy facilities. Over the last three years, the firm has designed over (20) usp 797-compliant pharmacies. For more more information about pharmacy design and construction, please contact:
William N. Bernstein, AIA
Principal
Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A New York, NY 10011
Office: 212.463.8200 Cell: 917.747.2924 Fax: 212.463.9898
Email: wb@bernarch.com
www.bernarch.com
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