As of November 2023, a third revision of USP<797> became official along with USP<800>. Sterile Compounding Pharmacies around the country, in conjunction with State Boards of Pharmacy, started integrating the new standards into their overall requirements to help protect patients from microbiological contamination of sterile compounded drugs and protect staff from exposure to Hazardous Drugs.

USP<797> <800> is a valuable tool and benchmark that impacts pharmacy design, engineering controls, and procedures.

The revised USP<797> <800> 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 can assist your pharmacy with USP<797> <800> 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> <800>.
• Execute all testing requirements on an on-going basis.

Testing Services

Once an action plan is in place, or if your pharmacy needs assistance with your current testing, Quality Solutions can conduct all required testing and environmental monitoring including, but not limited to:

• Semi-Annual Certification of Primary Engineering Controls (PECs) including Laminar Flow Hoods, Biological Safety Cabinets, and Isolators/Gloveboxes to CETA and NSF Standards
• Semi-Annual Certification of Cleanrooms including:
  • 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
• Gloved Fingertip Sampling Testing inclusive of incubation and enumeration
• Media Fill Training and Testing inclusive of incubation and enumeration

What is the benefit of using Quality Solutions as your USP<797> <800> compliance provider?

Quality Solutions will use calibrated testing equipment and provide experienced staff to execute all implementation and testing activities. This approach reduces capital costs and full-time staffing requirements.

Who is enforcing compliance?

In 2023, USP<797> and USP<800> became the standard of practice for compounding and were adopted by state boards of pharmacy. Based on the National Association Boards of Pharmacy (NABP) Survey of Pharmacy Law, at least 87 percent of boards of pharmacy either require full compliance with USP General Chapter <797> or incorporate USP General Chapter <797> into their state regulations in some way. For the boards that do not have such requirements, most have regulations pending or consider it as a standard of practice.

In addition to State Boards of Pharmacy, the Food and Drug Administration (FDA) has adopted USP<797> and inspect based on the standard. In addition, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and other accreditation organizations require compliance with USP<797> in order to maintain accreditation.

Environmental Monitoring (EM) & Hazardous Drug (HD) Kits

Our EM and HD Kits are a reliable, cost-effective solution for pharmacy compliance. You can achieve your environmental monitoring requirements at a fraction of the cost with no long-term commitments. As an added bonus, clients using our monthly kits can also submit personnel testing samples, removing the need for incubators.

Environmental monitoring and hazardous drug surface sampling are critical to maintaining a safe, compliant pharmacy environment. Quality Solutions makes it simple with EM and HD Kits designed for accuracy, efficiency, and easy of use.

EM Kits

Our EM Kits help you assess environmental quality, meet USP<797> requirements, and maintain sterility assurance. Each kit includes:

• Contact Plate Testing: Expert testing for microbial contamination.
• Assessment of Up to 10 Locations: Evaluate multiple areas of your cleanroom or compounding space.
• Custom Testing Protocol Development: A tailored plan for your facility’s unique needs, ensuring compliance without unnecessary complexity.
• Seamless Program Integration: Simple implementation with full support from our team, saving you time and reducing long-term costs.

HD Kits

Exposure to hazardous drugs can present serious health risks. Our HD Kits help identify and manage contamination risks in alignment with USP<800> requirements.

• Surface Sampling for Hazardous Compounds: Detect and assess exposure levels in compounding and handling areas.
• Clear, Actionable Results: Gain insights to guide corrective measures and protect staff and patients.
• Support from Industry Experts: Our team partners with you to interpret results and strengthen safety protocols.