What is considered low risk compounding?

Low-risk compounding includes using sterile needles and syringes to transfer sterile liquids from manufacturer-sealed ampules or vials to sterile devices or other sterile packages. It also covers manually mixing and measuring up to three manufactured products to create a CSP or nutritional solution.

How many risk levels are found in USP 797?

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. The risk level depends on the CSPs compounding environment; its potential for microbial, chemical, and physical contamination; the nature of production of the CSP.

What are the 4 risk levels that compounded sterile preparations can be classified as?

The revised chapter changed the categorization of Compounded Sterile Preparations (CSPs) from microbial contamination risk levels (i.e. low-, medium-, and high-risk level) to Category 1 and Category 2 CSPs.

What is considered medium risk compounding?

Medium Risk Level Compounding: Products are compounded with aseptic manipulations entirely within an ISO Class 5 or better air quality device, usually within an ISO Class 7 environment, using sterile products, components, and devices.

What are the USP 797 guidelines?

Designed to protect both patients and pharmacists, USP 797 requires attention to three main areas to ensure compliance: staff training and ongoing guidance, determination of categories, and development and implementation of appropriate policies and procedures.

What is an immediate use CSP?

The immediate-use provision allows for the preparation and dispensing of compounded sterile products (CSPs) without the need to be in compliance with USP <797> requirements such as ISO Class 5 hood or isolator, facility design, environmental controls, personnel cleansing and garbing.

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.

What is compounding according to USP?

COMPOUNDING—The preparation, mixing, assembling, alter- • dosage forms. ing, packaging, and labeling of a drug, drug-delivery de- • complexity of calculations.

What is considered sterile compounding?

Sterile compounding are medications made in an environment free from infectious microorganisms. This method is used for drugs that are administered by injections, through an IV, or directly into the eyes.

What is USP compounding?

USP Compounded Preparation Monographs contain formulations and quality standards for specific preparations to assist practitioners in compounding preparations for which there is no suitable commercially available product.

What is the main purpose of USP 797?

The purpose of USP Chapter <797> Pharmaceutical Compounding is to provide standards for the protection and safety of patients and healthcare workers involved in sterile compounding preparations such as pharmacists, nurses, physicians and pharmacy technicians by reducing the potential for microbial contamination caused …

What is the difference between USP 795 and USP 797?

Chapter 795 focuses on applying good compounding practices to the process of preparing nonsterile compounded formulations, while Chapter 797 provides procedures and requirements for compounding sterile preparations.

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

When will USP 797 revisions become effective?

On June 1, 2019 the United States Pharmacopeia (USP) published revisions to USP Chapters 795 and 797, which were slated to become effective on December 1, 2019. USP also announced that USP Chapter 800 would become effective on December 1, 2019.

What is USP <797>?

USP 797 is the set of standards pharmacies are to follow when compounding sterile drug products . It covers both nonhazardous and hazardous drugs and deals primarily with protecting staff, facilities, and sterile compounds from contamination.