subject: Understanding Usp 797 Standards [print this page] The benchmark for sterile compounding is USP 797. The USP Chapter 797 was codified by Mike Hurst, for pharmaceutical supplier Baxa Corp., and is the first implemented standard for sterile compounding and became effective from January1, 2004. The basic idea of USP 797 was to lay down procedures and practical requirements for safe compounding of sterile preparations, keeping in view patient safety concerns following professional guidelines and recommendations.
The USP 797 standards are valid to all settings where sterile preparations are compounded, but few raised concerns about the cost and ease of complying. However, as opined by Hurst it is important to recognize that the goal of USP 797 is to improve the compounding of sterile products. Similar to any change, USP 797 was misunderstood and certain misconceptions creeped in. The biggest misconception was that USP 797 requires a sophisticated clean room.
The application of USP 797 standards is not restricted to any particular profession or any particular type or types of sterile compounding location. Sterile compounding can be done at any place. This is prepared for patient safety, since every patient has the right to a safe, correct and sterile dose; regardless of who prepares it or where the dose is prepared.
As recommended by USP Chapter 797 low risk Compound Sterile Preparations (CSPs) can be formulated and compounded with sterile manipulations within ISO Class 5 standards. The compounding should be prepared using aseptic ingredients, products, components and devices. This type of compounding pertains to transfer, measuring and mixing manipulations using at the most only three commercially manufactured packages of sterile products and limiting two entries into any one sterile container or package.
A mid level risk CSP can be compounded aseptically in low risk conditions. CSP involves accumulating the said product for patients with multiple use or for many people to use. Any product to be defined as a commercially manufactured sterile drug or nutrient has to be evaluated and certified by FDA for protection and efficacy. Such products are available with full prescribing information, commonly understood as the FDA approved manufacturer's labeling or product package insert.
Any CSP that meets the stipulation of the Sterility Test is considered a high-risk level CSP. This high-risk level product has to conform to BUD. The BUD for any CSP, whether low, medium or high risk that meet to the requirements of Sterility Test may be based on the chemical strength of the CSP, rather than microbial stability.
The personnel involved in preparing CSPs in the buffer area or clean room should be fully garbed with appropriate protective equipment. A typical clean room garb are shoe covers, gown, hair cover, mask and sterile gloves.
