Filtech Testing Division - USP 797 Key Changes (2022)

USP <797> 2022 Key Changes

Enhancing Patient Safety Through Stringent Standards

At Filtech, we're committed to keeping you informed about the latest changes in pharmaceutical compounding regulations. The 2022 revision of USP <797> brings significant updates designed to enhance patient safety by improving the sterility and quality of Compounded Sterile Preparations (CSPs). Below, we outline the major changes in the 2022 standard and their impact on your compounding practices.

Introduction and Scope

The 2022 revision allows for the use of validated technologies, techniques, materials, and procedures different from those described in the standard, provided they are noninferior. The definition of CSPs is expanded, and handling hazardous drugs and radiopharmaceuticals sees significant alterations.

Personnel and Settings

Stricter requirements are set for anyone entering a sterile compounding area, even if not directly involved in CSP preparation. Designated personnel are now responsible for facility performance in CSP preparation.

Administration and Immediate-Use CSPs

The definition of 'administration' is clarified, and the administration window following preparation is extended. New conditions are introduced for CSPs involving multiple sterile products.

CSP Microbial Categories

CSPs are categorized differently, with emphasis on environmental factors, rather than manipulation type or complexity.

Personnel Training and Evaluation

Updates to personnel training include evaluation criteria for garbing and aseptic manipulation. New competency evaluation criteria are established.

Facilities and Engineering Controls

Changes encompass ISO classification of particulate matter, isolator usage, air exchange requirements, precision, accuracy of pressure differentials, and humidity specifications.

Certification and Recertification

Procedures for certification of Primary Engineering Controls (PECs) and Secondary Engineering Controls (SECs) are modified. Viable air and surface sampling timing and locations are adjusted.

Cleaning, Disinfecting, and Sterilization

Updated standards include incubation for gloved fingertip and thumb sampling, media-fill testing, handwashing and garbing order, and cleaning and disinfecting supply types.

Release Inspections and Testing

Maximum batch size for CSPs requiring sterility testing is set. The number of CSPs sent for testing is specified based on batch size.

Labeling and Beyond-Use Dates (BUDs)

New labeling requirements emphasize compounded preparations. Factors determining BUDs are expanded, with specific requirements for Category 3 CSPs.

Handling, Storage, Packaging, and Shipping

Practices remain consistent, with detailed guidelines available in official USP documents.

Use of Components and Quality Control

Guidelines cover single-dose containers, pharmacy bulk packages, compounded multiple-dose CSPs, and CSP stock solutions.

Quality Assurance and Quality Control

Procedures for notification and recall of CSPs with out-of-specification limits are introduced, including disposal, documentation, and investigation steps.

SOPs for Compounding Allergenic Extracts

The 2022 standard introduces specific training and competency evaluation requirements for personnel preparing allergenic extracts.

USP 800 Hazardous Drug Room and USP 797 IV Buffer Room Pressure Changes

Requirements change from -0.01"w.g. to having a cap -0.01"w.g. to -0.03"w.g. for Hazardous Drug rooms, while IV Buffer rooms see changes from 0.02"w.g. to 0.05"w.g. to greater than 0.02"w.g.

Environmental Monitoring

Viable air sample pass/fail criteria shift to total CFU count, with action organisms no longer an automatic fail.

These comprehensive changes are essential for facilities to maintain compliance with USP <797> standards, ensuring the safety and quality of Compounded Sterile Preparations (CSPs).

Monthly Surface Sampling

A procedure must be in place for Environmental Surface sampling to be performed once per month with documentation of the results

Stay Compliant, Ensure Patient Safety

Understanding and implementing these changes is crucial. Stay compliant and enhance patient safety by adopting the latest standards in pharmaceutical compounding