A collection of over 70 articles from 14 years of the International Journal of Pharmaceutical Compounding focused on USP <797> issues and solutions.

This archive contains the following articles:

STANDARDS

• A Primer on USP Chapter <797>, "Pharmaceutical Compounding - Sterile Preparations," and USP Process for Drug and Practice Standards.
• Overview of Chapter <797> "Pharmaceutical Compounding - Sterile Preparations": The Potential Impact for Compounding Pharmacists
• Proposed Revisions to USP Chapter <797> Pharmaceutical Compounding-Sterile Preparations
• Misinterpretation of United States Pharmacopeia Chapter <797>
• Application of USP-NF Standards to Pharmacy Compounding
• Quality Control Analytical Methods: USP Chapter <797> Compounded Sterile Preparations Sterility Requirements and Their Relationship to Beyond-Use Dating
• USP Chapter <797> and Preparing for JCAHO Survey
• Questions and Answers: USP Chapter <797> and JCAHO Compliance
• Sterile Product Compounding: A Comparison of ASHP and USP Guidelines
• Pharmacy Cleanroom Project Management Consideration: An Experience-Based Perspective Pharmacy Compounding Urban Legends
• PostScription: Cleanroom Standards
• Putting the Science Back into the "Art and Science" of Compounding
• Using Purified Water for Reconstitutions
• PostScription: GMPs and GCPs: A Topical Comparison
• PreScription: GMPs vs. GCPs: Manufacturing and Compounding Definitions
• Compounding Pharmacies: Before and After an Inspection
• PostScription: GMPs vs. GCPs: United States Pharmacopeia General Chapters
• Determination of Risk for Sterile Preparations
• Pharmaceutical Compounding or Pharmaceutical Manufacturing? A Regulatory Perspective
• Basics of Compounding Sterile Preparations: Nomenclature and Considerations
• PostScription: Responsibilities of a Compounding Pharmacist

TESTING

• Quality Assurance for Sterile Products
• USP Chapter <797>: Practical Solutions for Microbiology, Sterility, and Pyrogen Testing
• Sterilization and Depyrogenation Principles and Methods
• Quality Control Analytical Methods: Chemical Testing Aspects of USP 797 for Compounded Sterile Preparations
• Quality Control Analytical Methods: A Guide to Quality Control Testing for the Compounding Pharmacist
• Quality Control Analytical Methods: Particulate Matter in Injections: What is it and What are the Concerns?
• Standard Operating Procedure: Calculating the Endotoxin Load in Compounded Sterile Preparation
• Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations
• Comparison of Endotoxin Testing Methods for Pharmaceutical Products
• Evaluating and Selecting an Analytical Testing Laboratory
• Analytical Testing Facilities and Products
• Analytical Testing of Extemporaneously Compounded Preparations
• Particulate Testing for Sterile Products
• Particulates in Parenterals
• Preservation, Sterilization, and Sterility Testing of Ophthalmic Preparations
• Standard Operating Procedure: Sterility Test for Ophthalmic Solutions
• Sterile Compounding of Respiratory Inhalation Solutions
• Quality-Control Analytical Methods: The Quality of Sterility Testing
• Quality-Control Analytical Methods - Quality Control, Quality Assurance, and Quality Improvement--What is the Difference
• PreScription: Quality Improvement in Pharmaceutical Compounding
• Pharmacopeial Bacterial Endotoxins Test Chapters
• Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations
• Quality Control Analytical Methods: Strategies to Ensure a Robust Quality-control Microbiology Program
• Establishing Benchmark Rates of Microbial and Bacterial Endotoxin Contamination for Radiopharmaceuticals Compounded in Commerical Nuclear Pharmacy Settings
• Assessing the Stability of Common Radiopharmaceuticals Compounded and Utilized Outside Package Insert Guidelines
• Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations
• Quality Control Analytical Methods: A Growing Codependency: Compounding Pharmacy and Safety
• Quality Control Analytical Methods: Laboratory Considerations of United States Pharmacopeia Chapter <71> Sterile Tests and Its Application to Pharmaceutical Compounding
• Quality Control Analytical Methods: The Essentials of United States Pharmacopeia Chapter <51> Antimicrobial Effectiveness Testing and Its Application in Pharmaceutical Compounding
• Quality Control Analytical Methods: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 1
• Quality Control: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 2
• Quality Assurance and Quality Control, Part 1
• Quality Assurance and Quality Control, Part 2
• Quality Control Analytical Methods: Physical Quantitative Verification of Nonsterile Compounded Preparations: Individualized Dosage Units
• Development and Validation of an Inexpensive, Simple, and Rapid Technique for Measuring the Accuracy of Extemporaneously Compounded Pharmaceuticals
• Microbial Identification in Pharmaceutical Compounding
• Quality Control Analytical Methods: Method Validation

EQUIPMENT

• Bacterial Isolators: A New, High-tech Option for the Preparation of Sterile Admixtures
• Cleaning, Inspecting and Flow-Accuracy Testing of Ambulatory Pumps
• Consideration for Choosing a Primary Engineering Control for Compounding Sterile Products
• Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 1
• Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 2
• Local Ventilation for Safe Containments in the Pharmaceutical Industry
• Sterile Compounding with Barrier-Isolation Technology
• Technology Spotlight: A USP-Grade Water System
• Using Automated Compounding Devices in the Practice of Pharmacy
• Microbial Air-Sampling Equipment, Part 1: Meeting USP Chapter <797> Standards
• Microbial Air-Sampling Equipment, Part 2 - Experiences of Compounding Pharmacists
• Tips for Cleanroom Construction and Renovation
• Aqua Pura: Water Purification Systems and United States Pharmacopeia Waters for the Compounding Pharmacy, Part 1
• Aqua Pura: Water Purification Systems and United States Pharmacopeia Waters for the Compounding Pharmacy, Part 2: USP Waters: Experts at the United States Pharmacopeia Answer Compounders' Questions
• Quality-Control Analytical Methods: Aqua Pura: Water Purification Systems and United States Pharmacopeia Waters for the Compounding Pharmacy, Part 3: Testimonials and Comparisons
• Quality Control: Analytical Methods: Calibration of Equipment and Calibration Curves
• Sterilization of Compounded Parenteral Products: Verification of Autoclaves
• A Needle-free Reconstitution and Transfer System for Compounded Sterile Intravenous Drug Solutions: In Compliance with United States Pharmacopeia Chapter <797> Standards
• Basics of Compounding: Certification of Sterile Equipment and Facilities: What Pharmacists Need to Know
• Dry-heat Depyrogenation Ovens for Pharmaceutical Compounding Facilities
• Safer Sterile Compounding: Choosing and Using Disinfectants for the Cleanroom

IMPLEMENTATION

• Sterile Preparations, Part 1
• Sterile Preparations, Part 2: The Responsibilities of Compounding Personnel in Implementing USP Chapter <797> Pharmaceutical Compounding
• Sterile Preparations, Part 3: Considerations for Implementing USP Chapter <797> Pharmaceutical Compounding
• Sterile Preparations, Part 4: Considerations in Selection and Use of Disinfectants and Antiseptics
• Sterile Preparations, Part 5: Verification of Accuracy, Sterility, and Sterilization of Compounded Preparations
• Sterile Preparations, Part 6: 2008 Revisions to Chapter <797>
• Sterile Preparations, Part 7: Microbial Contamination Risk Levels, 12-Hour Use, and Immediate Use
• Sterile Preparations, Part 8: Stability and Beyond-Use Dating
• Sterile Preparations, Part 9: Immediate Use Compounded Sterile Preparations
• Sterile Preparations, Part 10: First Revision: The Main Changes, Events, and Rationale
• Overview of Beyond-Use Dating for Compounded Sterile Preparations
• Sterile Preparations, Part 11: Hazardous Drugs
• Sterile Preparations, Part 12: Sterilization Methods
• Sterile Preparations, Part 13: Environmental Quality and Control
• Sterile Preparations, Part 14: Environmental Quality and Control (Continued)
• Sterile Preparations, Part 15: Personnel Training, Cleansing, and Garbing
• Sterile Preparations, Part 16: Suggested Standard Operating Procedures
• Sterile Preparations, Part 17: Elements of Quality Control
• Sterile Preparations, Part 18: Verification of Automated Compounding Devices for Parenteral Nutrition Compounding and Finished Preparation Release Checks and Tests
• Quality Control: 5 Steps to Improve Quality in the Compounding Lab
• Beyond-use Date: Establishment and Maintenance
• Depyrogenation Options for the Compounding Cleanroom
• Standards of Practice, Professional Judgment, and Scientific Evidence to Establish and Extend a Beyond-Use Date
• Basics of Compounding: Unique and Special Characteristics of Sterile Dosage Forms
• Basics of Sterile Compounding: Aseptic Processing
• Applying Quality of Design Concepts to Pharmacy Compounding
• Introduction to Quality Control in a Compounding Pharmacy

OPERATIONS

• Quality Control Analytical Methods: Quality Issues Related to Compounding with Commercial Products
• Sterile - Product Preparations: Mix or Buy?
• Improving the Management, Operations and Cost Effectiveness of Sterile-Product Compounding
• Training and Competency Consideration for Pharmacies Providing Compounded Sterile Preparations
• PostScription: Experts Everywhere
• PostScription: Sterile Product Admixture Preparation
• Purchasing Chemicals for Pharmaceutical Compounding
• Compliance by Hospitals and Healthcare Facilities with the Revised United States Pharmacopeia Chapter <797>
• Contract Sterilization and Validation Companies Offer New Options for Sterile Compounded Preparations
• Preparing Nonsterile and Sterile Hazardous Compounds in an Institutional Setting
• Compounding with Hydrates and Solvates
• PreScription: Beginning of a New United States Pharmacopeial Convention, Inc., Cycle
• PreScription: Sterile Product Outsourcing: Growing Trend in Hospitals
• Compounding with Organic Salts
• Compounding with Esters
• PreScription: Compounding with Manufactured Products
• Home Infusion: Overcoming the Barriers to Entry
• Basics of Compounding: Repackaging, Part 1
• Basics of Compounding: Repackaging, Part 2
• Decontamination Technology: The Missing Element
• Standarized Compounding: The Importance of Doing it the Same Way Every Time
• Basics of Sterile Compounding: Sterilization Methods in Sterile Product Manufacturing
• Basics of Sterile Compounding: Contamination Control
• Root Cause Analysis, Part 2: Sterile Compounding
• Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 1
• Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 2