Understanding USP 795 and USP 797: Essential Standards for Pharmacy Compounding 

Introduction to Master Formula Records

USP 795 and USP 797 are pivotal standards that govern hospital pharmacy compounding practices in the United States. To ensure safety and efficacy in compounding practices, the U.S. Pharmacopeia (USP) has established two key standards: USP 795 and USP 797. These standards regulate non-sterile and sterile compounding, respectively, and are vital for safeguarding patient health and maintaining quality in hospital pharmacy operations. This article provides an overview of these standards, highlighting their importance and the key requirements they impose on hospital pharmacies. 

USP 795: Non-Sterile Compounding 

USP 795 outlines the standards for non-sterile compounding, which involves preparing medications like topical creams, oral liquids, or capsules. These medications are not intended to be sterile, as they are used on or ingested by patients but do not enter sterile body compartments. The primary goals of USP 795 are to ensure product consistency, prevent contamination, and maintain medication efficacy. 

Key requirements under USP 795 include: 

  1. Facility and Equipment: Maintain a clean, organized compounding area with appropriate, well-maintained equipment to ensure the quality of non-sterile compounded medications. 
  1. Personnel Training and Competency: Undergo staff training in compounding techniques and safety procedures, with regular competency assessments. 
  1. Formulation and Ingredients: Use approved formulations and source high-quality ingredients from trusted suppliers, ensuring proper storage to prevent contamination or degradation. 
  1. Compounding Process: Follow documented standard operating procedures for accurately measuring, mixing, and preparing medications to ensure consistency and safety. 
  1. Beyond-Use Dating (BUD): Assign appropriate beyond-use dates based on the stability of ingredients and compounding methods to ensure product safety and efficacy. 
  1. Labeling: Label compounded preparations with critical information, including active ingredients, strength, dosage form, storage instructions, and the beyond-use date. 
  1. Quality Control and Assurance: Implement quality control measures, including inspections and checks, to ensure the consistency and accuracy of compounded products. 
  1. Documentation and Record-Keeping: Maintain detailed records of all compounding activities, ingredients used, and preparation procedures for traceability and compliance. 
  1. Cleaning and Sanitation: Regularly clean and sanitize the compounding area and equipment to prevent cross-contamination and ensure product integrity. 

USP 797: Sterile Compounding 

USP 797 focuses on sterile compounding, which is vital for medications administered via injection, infusion, or other routes where sterility is critical, such as eye drops and inhalation treatments. These guidelines are designed to prevent microbial contamination and ensure the sterility and safety of compounded products. 

Key requirements of USP 797 include: 

  1. Facility Design and Environmental Controls: Maintain cleanrooms with specific air quality levels (ISO Class 5, 7, or 8), positive pressure, and HEPA filtration systems to prevent contamination. 
  1. Personnel Training and Competency: Provide training in aseptic techniques and regularly demonstrate competency through testing and ongoing assessments. 
  1. Aseptic Technique and Hand Hygiene: Follow strict hand hygiene and garbing procedures, including the use of sterile gowns, gloves, masks, and covers to ensure a sterile environment. 
  1. Cleaning and Disinfection Procedures: Implement and adhere to regular cleaning and disinfection schedules using approved agents to maintain sterile conditions in the compounding areas. 
  1. Beyond-Use Dating (BUD) and Stability: Assign proper beyond-use dates based on sterility, stability, and risk factors, and must be used or discarded accordingly. 
  1. Risk Levels of Compounding: Categorize sterile compounding activities into low, medium, or high-risk levels and follow specific procedures for each to ensure safety. 
  1. Quality Assurance and Monitoring: Implement a quality assurance program that includes environmental monitoring and regular equipment checks to ensure compliance with sterile compounding standards. 
  1. Documentation and Record-Keeping: Maintain detailed records of all compounding activities, staff training, environmental monitoring, and equipment maintenance for traceability and regulatory compliance. 

Importance of USP 795 and USP 797 Standards 

Compliance with USP 795 and USP 797 is not only a legal requirement but also a critical aspect of patient safety in hospital pharmacies. Both guidelines are designed to ensure that compounded medications meet strict quality and safety standards. By following these guidelines, pharmacies can prevent errors, reduce the risk of contamination, and deliver high-quality, tailored medications to patients in need. 

In conclusion, adherence to USP 795 and USP 797 standards ensures that hospital pharmacies operate with the highest levels of care and accountability, contributing to better patient outcomes and maintaining public trust in pharmaceutical services. Regular training, proper documentation, and robust quality control practices are vital components in achieving and maintaining compliance with these critical guidelines. 

If you have any questions or would like to learn how MFR Library redefines Master Formula Record management, please reach out to us using the contact form at the bottom of this page. 

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