Skip to content

USP 797 Guidelines and Compliance

USP 797, Pharmaceutical Compounding: Sterile Preparations, details the guidelines for compounding sterile pharmaceutical preparations in pharmacy environments. The United States Pharmacopeia (USP) Convention, which is a non-profit, scientific organization that works to help ensure a quality drug supply in the U.S., established the standard. USP 797 also delineates the necessary procedures for the compounding of sterile drug preparations. All pharmacies that produce these preparations are covered under the USP 797 regulations. This includes those in ambulatory care centers, hospitals, long-term care facilities, nuclear/radio pharmacies, retail environments and other settings such as operating rooms, nursing stations in hospitals, and chemotherapy units.

Our LicenseTrak compliance management software helps you achieve compliance with existing USP 797 and other USP standards.

Compliance With USP 797 Guidelines

The USP 797 compliance standards are designed to protect both pharmacists and patients. It focuses on three main categories of compliance:

  • Training of staff and continuing guidance
  • Category determinations
  • Creation and implementation of proper policies and procedures

The use of a task management system is recommended to ensure every requirement is properly met as described in the policies and procedures.

Staff Training

USP 797 covers all pharmaceutical personnel involved in sterile compounding work. These include pharmacists, physicians, nurses, and pharmacy technicians. Training procedures for USP 797 compliance should cover best practices and primary competencies for every type of employee. This should be done, ideally, through a situation-based, hands-on, learning process that includes written and practical examinations. Certain techniques should be reviewed at specified intervals – some every six months and others every 12 months.

Policies and Procedures

Specific policies and procedures are beneficial for pharmacies to implement in order to more effectively comply with USP 797 regulations. Reference resources and templates make the creation of these procedures and policies easier and assist staff in properly documenting their activities. Policy areas to be addressed include environmental quality and control, verification of sterilization and accuracy, verification of automated compounding instruments, proper processes in a particular compounding setting, final checks before CSP release, patient monitoring, quality control, and reporting of adverse effects.

Contact Us

To learn about how our LicenseTrak software can help you achieve compliance with the USP 797 guidelines, give us a call today at 480.500.6236 or fill out our contact form.