Sterile Compounding

 

HWCP has a USP 797 and PCAB compliant clean room and have been safely compounding sterile medications for the last 30+ years.  Compounded Sterile Preparations (CSPs) require greater care, cleaner facilities and are standardized by USP 797.

 

What is USP 797 and Why is it Important?

USP 797 is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

 

Under the revised USP 797 clean room regulation, Compounding Pharmacies are required to protect your products by utilizing a laminar airflow workbench within the clean room. USP Chapter 797 was released to the public in 2004 and has classified Sterile Compounding into 3 risk groups: Low, Medium and High Risk. For each risk level, the Chapter establishes staff responsibilities and training, quality control processes, competence assessment, environmental quality and control, and quality assurance program requirement.

 

PCAB Accrediation for Clean Rooms

 

The mission of PCAB is to promote high quality in pharmacy compounding through a voluntary accreditation program that recognizes adherence to established principles, policies and standards.