“From the time a medication is compounded until the moment the patient takes it, we want to help ensure the patient benefit and reduce risks,” said Ronald T. Piervincenzi, Ph.D., chief executive officer, USP. “The updated USP standards will help ensure quality preparations for patients who rely on compounded medicines while minimizing the risk of exposure to hazardous drugs for healthcare personnel.”## USP 797 vs 800 ; Compliance and Certification
USP 797 and USP 800 both focus on a key area of lab safety. While requirements within each of these chapters change occasionally, the overall over-arching themes of each tend to remain the same. Lets take a closer look at UPS 797 vs 800 and some recent changes that have occurred.
USP 797
USP 797 is designed to protect both patients and pharmacists, USP 797 classifies sterile compounding into three risk groups: low, medium, and high. It applies to all pharmacies that produce compound sterile preparations including those in hospitals and retail settings. Specifically, this chapter of 797 is designed to prevent harm and fatality from microbial contamination (non-sterility), excessive bacterial endotoxins, and large content errors in the strength of correct/incorrect ingredients in compound sterile preparations.
The most recent update to this regulation effects:
- Calibrations, certifications and qualifications of equipment and classified areas
- Requirements for certification of classified clean room areas
- Testing performed as part of the facility certification
- Scenarios requiring Investigations and Corrective Actions
USP 800
This chapter expands on USP 797 and is intended to describe the requirements and responsibilities for handling hazardous drugs; facility and engineered controls; procedures for deactivating, decontaminating and cleaning, spill control and documentation.
The most recent update to this regulation effects:
- Vented biological safety cabinet requirements
- Containment secondary engineering control (C-SEC)
- Control requirements
- Compliance under these regulations is critical for the safety of technicians and patients.
USP 797 Vs 800 : Is Your Lab In Compliance?
While there are many factors to consider, let's start by looking at Secondary Engineered Controls (SECs). The graphics below illustrate typical setups for non-sterile, sterile, and containment hazardous drug compounding labs. Each of these setups require different secondary controls to properly control the lab environment. These graphics note required HVAC equipment and environment conditions.
Non-Sterile HD Room
Sterile HD Room
Containment Segregated Compounding Area
USPS ARE MAKING A DIFFERENCE
Both USP-797 and USP-800 pharmaceutical regulations are helping healthcare practitioners by making compounding safer. All together, USP General Chapters are standards to assist practitioners in creating high-quality medicine and practices. They ensure patients are getting the right dosage, quality, and contaminant-free medication every time they go into their pharmacy.
“From the time a medication is compounded until the moment the patient takes it, we want to help ensure the patient benefit and reduce risks,” said Ronald T. Piervincenzi, Ph.D., chief executive officer, USP. “The updated USP standards will help ensure quality preparations for patients who rely on compounded medicines while minimizing the risk of exposure to hazardous drugs for healthcare personnel.”
While each facility will require different updates to stay compliant, new, or recently renovated pharmacies should be especially careful.
Hear To Help
At BalCon, we are available for consultation to help you through all stages, from design to occupancy of your cleanroom suites. We’ll work with you to:
- Avoid costly changes and delays during your project.
- Assist with cleanroom monitoring needs such as room pressurization, temperature, and humidity.
- Discuss certification strategies to minimize downtime.
- Discuss documentation and report reviews to help you better understand your cleanroom reports.
- Assist with GAP Analysis to evaluate your pharmacy for compliance.
