USP<797> Compliance Solutions
As of June 1, 2008, a second revision of USP<797> became official. Sterile Compounding Pharmacies around the country, in conjunction with State Boards of Pharmacy, started integrating the new USP<797> into their overall requirements to help protect patients from microbiological contamination of sterile compounded drugs.
USP<797> is a valuable tool and benchmark that will impact pharmacy design, engineering controls, and procedures.
The revised USP<797> provides new challenges and opportunities to sterile compounding pharmacies. As pharmacies move toward compliance, opportunities exist to design an overarching Quality System that can maintain compliance while streamlining operations and procedures.
Quality Solutions, LLC can assist your pharmacy with USP<797> compliance in a comprehensive and cost-effective manner. Drawing from its validation, certification, cleanroom, and technical services expertise, we can:
- Accurately assess your facilities engineering controls
- Provide consulting services to ensure Cleanroom design parameters deliver a controlled air environment
- Provide Project Management assistance in working with contractors and hospital staff for design and renovation of a pharmacy to recommended design criteria
- Perform a thorough gap analysis
- Audit your Quality Assurance and training program
- Create an action plan to strengthen procedures and policies
- Implement or revise the necessary procedures to your Quality Assurance program to provide continued support of USP<797>
- Execute all testing requirements on an on-going basis
- Develop and manage key training programs including Media Fill, Gloved Fingertip/Gowning, and customized Compliance Training
Once an action plan is in place, or if your pharmacy needs assistance with your current testing, Quality Solutions, LLC can conduct all required testing and environmental monitoring including, but not limited to:
- NSF Certification of Laminar Flow Hoods and Biological Safety Cabinets
- Challenging of HEPA Filters and repair as necessary
- Determination of Air Changes and Room Differential Pressure
- Room Temperature and Humidity Testing
- Cleanroom Viable and Non-Viable Particulate Testing
- Trending of Viable and Non-Viable Particulate Testing Data
- Gloved Fingertip Sampling
- Media Fill Training Testing
What is the benefit of using Quality Solutions, LLC as your USP<797> compliance provider?
Quality Solutions, LLC will provide all the required testing equipment and experienced staff to execute all implementation and testing activities. This approach reduces capital costs and full-time staffing requirements.
Who is enforcing compliance?
In 2003 the Maryland Board of Pharmacy along with other states developed regulations for Sterile Pharmaceutical Compounding that are harmonized with USP<797>. In many cases, this harmonization has brought USP <797> guidance into the State Code of Regulations. Refer to the Code of Maryland Regulations (COMAR) 10.34.19.01 - .16.
In addition, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is in the process of requiring compliance with USP<797> in order to maintain accreditation.
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