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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.
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