USP 797 Scope and Requirements

Understand when USP <797> applies to IV vitamin therapy and other compounded sterile preparations.

Review key definitions; the responsibilities of the designated person; immediate-use preparations; Category 1, Category 2, and Category 3 compounded sterile preparations; and the difference between compounding and administration.

Facility Design and Compounding Areas

The course examines how facility design influences the types of preparations permitted for compounding and the assignment of beyond-use dates.

The course reviews segregated compounding areas, cleanroom suites, buffer rooms, anterooms, primary engineering controls, compounding aseptic isolators, airflow, pressure differentials, temperature, humidity, sink placement, material flow, and lines of demarcation.

Primary Engineering Controls

Understand the role of the laminar airflow workbench, compounding aseptic isolator, biological safety cabinet, and other primary engineering controls used to create an ISO Class 5 environment.

Instruction covers placement, certification, cleaning, maintenance, and documentation requirements.

Hand Hygiene, Garbing, and Aseptic Technique

Step-by-step procedures are provided for hand hygiene, garbing, sterile glove use, disinfection, vial access, syringe preparation, material transfer, first-air protection, and contamination prevention.

The course addresses how minor lapses in aseptic technique can introduce risks to the final compounded preparation.

Personnel Training and Competency

Review the training and competency requirements for each person involved in sterile compounding.

The course covers written assessments, observed aseptic technique, gloved fingertip and thumb sampling, media-fill testing, corrective action, retraining, competency frequency, and documentation.

Cleaning and Disinfection

Instruction is provided on establishing cleaning schedules for primary engineering controls, compounding surfaces, floors, walls, ceilings, shelving, and equipment.

Review cleaning agents, disinfectants, sporicidal agents, contact times, cleaning sequence, supply storage, and documentation.

Environmental Monitoring

Understand air sampling, surface sampling, viable and nonviable particle testing, pressure monitoring, temperature, humidity, certification, action levels, investigations, and corrective actions.

The course details required testing parameters, testing frequency, and appropriate documentation and review procedures.

Beyond-Use Dating and Storage

Instruction covers the impact of compounding category, facility design, preparation conditions, sterility testing, storage temperature, product stability, and container-closure systems on beyond-use dating.

The course explains the difference between a manufacturer’s expiration date and a compounded preparation’s beyond-use date.

Quality Assurance and Risk Management

Build a quality assurance program addressing sterility, accuracy, adverse events, complaints, recalls, deviations, contamination events, personnel failures, corrective actions, and ongoing process improvement.

Supplies and Vendor Qualification

Instruction is provided on evaluating pharmacies, medication sources, sterile supplies, cleaning products, personal protective equipment, testing laboratories, certifiers, and other vendors.

Review storage, lot tracking, expiration dates, certificates of analysis, recalls, and supply documentation.

Inspection Preparation

Understand what state inspectors and accrediting organizations commonly review during an IV therapy or sterile compounding inspection.

The course covers organizing records, identifying compliance gaps, conducting internal audits, correcting deficiencies, and preparing staff to respond to questions regarding daily procedures.

Standard Operating Procedures and Documentation

The course provides guidance on creating, organizing, reviewing, updating, and maintaining records required to support sterile compounding programs.

These resources support personnel competency, environmental monitoring, cleaning, equipment maintenance, preparation records, quality assurance, adverse event management, and inspection readiness.