What are USP 797 guidelines?

The objective of the USP <797> Standard is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations (CSPs).

What does it mean to be USP 797 compliant?

Pharmaceutical Compounding – Sterile Preparations
USP 797 refers to chapter 797 “Pharmaceutical Compounding – Sterile Preparations,” in the USP National Formulary. 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.

What are the 3 risk levels USP 797?

As of today, USP 797 (2008) is the currently official chapter and low, medium, or high-risk levels apply.

What is the current USP 797 version?

The currently official <797>, last revised in 2008, remains official. On June 1, 2019, USP published revisions to General Chapter <795> for nonsterile compounding and General Chapter <797> for sterile compounding, as well as a new General Chapter <825> for radiopharmaceuticals.

What is Category 2 CSP?

A Category 2 CSP is defined as: “A CSP that is assigned a BUD of greater than 12 hours at controlled room temperature or greater than 24 hours refrigerated that is compounded in accordance with all applicable requirements for Category 2 CSPs in this chapter.” The vast majority of compounding pharmacies will be …

What is the difference between USP 797 and USP 800?

The purpose of USP 797 is a general protection of sterile compounds and spaces from contamination. USP 800 expands controls for the protection of workers and environments against hazardous drug compounds.

Does USP 800 replace USP 797?

USP <800> is designed to complement both USP <795> and USP <797>. Some facility requirements will necessitate a revision to USP <797>. All future revisions of USP standards will use this language.

What is a Category 1 and Category 2 CSP?

Category I and Category II Compounding Sterile Preparations Explained. Category 1 CSPs do not require sterility testing while Category 2 CSPs may require a sterility test depending on the beyond use date assigned.

What does USP 795 mean?

USP 795 indicates that “areas used for sterile preparations shall be separated and distinct from the nonsterile compounding area.” Now, areas for sterile preparations are covered under USP 797 and USP 800, and require a completely separate ISO suite, so that automatically sets up a separate sterile compounding area.

What is the purpose of USP 797?

USP develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. September 23, 2019 – Revised General Chapter <797> is postponed until further notice. Click here for more information.

What is Chapter 797 of the CPT code 797?

General Chapter <797> Pharmaceutical Compounding – Sterile Preparations. Compounding provides access to medication for patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. Medications that are required to be sterile include those administered through injection,…

What are the USP 797 CSP contamination risk levels?

Compounding Sterile Preparations (CSP) Microbial Contamination Risk Levels USP 797 assigns each CSP one of five potential contamination risk levels: immediate use, low, low with 12 hours or less beyond use date (BUD), medium, high.

Is there an official version of General Chapter <797>?

*IMPORTANT NOTE: The currently official version of General Chapter <797> (last revised in 2008) remains official. For more information on other compounding chapters click here.