The course describes the scope of USP <795>, outlines the responsibilities of compounders, defines the criteria for component selection and describes the facility requirements for nonsterile compounding. In addition, the course reviews the dispensing and quality assurance control requirements for nonsterile compounding described in the standard.

Subject area:
Healthcare Quality & Safety

Objectives (If applicable):
Explain the scope of USP <795> including who it applies to, the basic aspects of nonsterile compounding, and the roles and responsibilities of designated persons.
Identify USP <795> requirements for personnel qualification including training, evaluation, and requalification.
Describe USP <795> standards that apply to compounding spaces, equipment, and components used in nonsterile compounding.
Examine the quality assurance and quality control program requirements to achieve consistently high-quality compounded nonsterile preparations (CNSPs)
Explain how to handle complaints and report adverse events.
Determine the proper cleaning and sanitizing processes to ensure a clean, orderly, and sanitary environment for preparing quality CNSPs.
Use USP <795> requirements for establishing Beyond-Use Dates for various types of CNSPs.
State the requirements for master formulation records and compounding records to be used for compounding the CNSPs.

Target Audience (If applicable):
– Pharmacists
– Pharmacy technicians
– Nurses
– Physicians
– Veterinarians
– Persons involved in compounding