Sterile Compounding Compliance
(USP 797/800)

Provide patients with high quality compounded medications and improve your bottom line

Safely compounded medications are essential to patient care. Hospitals and clinics need to evaluate the best way to optimize care and meet regulatory and safety requirements, while managing the costs of these important medicines. Visante can help you evaluate external sources as well as the opportunity and requirements of insourcing this critical function.

Visante’s Sterile and Non-Sterile Compounding Consulting Services:

Our experts prepare you for compliance with USP Chapters 797 and 800, and will assist you in passing inspections by CMS, FDA, DEA and The Joint Commission. Our services include:

  • USP 797: Gap analysis and planning
  • USP 800: Gap analysis and planning
  • Facility design, including redesign, improvements or new design
  • Improved operational policies and procedures
  • Analysis of insourcing and outsourcing opportunities

Fred Massoomi, drug compounding expert, provides a monthly blog “The Road to USP 800 Compliance” to help guide hospitals along the path to compliance. Read it here.

CONTACT US TODAY to get started.

What our clients say

“The Visante team assisted us in conducting a USP 797 and 800 gap analysis across all our sterile compounding locations.  The expertise and detailed knowledge they demonstrated provided very valuable information and action items.  The Visante team helped educate our team about solutions and considerations for remodeling to meet not only the proposed guidelines and standards, but also future improvements incorporating best practices.  The engagement was so successful we have decided to have the Visante team continue to assist us in our clean room design and implementation phases.”

Desi Kotis –  PharmD, Director of Pharmacy, Northwestern Memorial Hospital

Looking for more information? Check out these links to helpful articles and information from our experts:

General information

Articles by Visante consultants

Visante webinars

Visante blogs

Visante New Series – Road to USP 800