Pharmacy OneSource Blog

Components of USP 797 That Are Often Overlooked

The issuance of USP 797 established the first broad and comprehensive quality and compliance standards for compounded sterile preparations (CSPs). It provided a clear set of behavioral and procedural activities to help healthcare institutions achieve and maintain a state of control. Faithful compliance with USP 797’s procedures, policies and guidelines help minimize the risk of patients suffering from potentially fatal errors such as microbial or chemical contamination.

There are many components of USP 797 that must be followed in order to obtain complete compliance. Here are a few USP 797 compliance reminders to help you stay in control.

1. Floors must be cleaned daily even when compounding is not taking place.

Proper cleaning must take place on a regular basis to maintain appropriate environmental control and compliance. Personnel should be trained so that cleaning proceeds from the cleanest to the dirtiest, beginning in the buffer area (i.e. cleanroom) and moving to the ante area. Floors in the cleanroom and the anteroom must be cleaned daily, even when compounding is not occurring. Ensuring environmental compliance also means that walls, ceilings, shelving and shipping containers should be cleaned at least monthly.1

2. Properly trained personnel are more critical than a perfect compounding environment.

Here’s an important conclusion from a review of contamination rates. “The most important variable affecting microbial contamination of admixtures was the aseptic technique of personnel, not the environment in which the drugs were compounded.”2 Two studies of cleanroom microbial contamination conducted 16 years apart concluded that the most common source of contamination was personnel.1 Make personnel training and ongoing evaluation a central part of your USP 797 compliance program.

3. Caulked ceiling tiles are required.

USP 797 states that ceiling tiles must be caulked so as to prevent them from moving or dislodging contaminating materials. This is especially critical in ISO 7 negative pressure buffer areas so that dirty, non-filtered air does not get introduced through the ceiling plenum.1

4. Comply with beyond use dates (BUDs).

The beyond-use date marks the time by which the CSP should be used in order to minimize the risk of contamination with microorganism growth, chemical degradation or even a sterile packaging breach.1 Fortunately, USP 797 has a useful table that helps personnel determine risk as it relates to the specific type of CSP. Staff should be familiar and compliant with BUD guidelines, as failure to do so can result in negative patient safety outcomes, or at minimum, a citation by the state pharmacy board and/or other accrediting organizations.

The most important part of ensuring USP 797 compliance is to view it as an ongoing process that requires complete staff commitment. Developing a culture of compliance helps protect staff, institution and most importantly, patient health.

How do you ensure compliance?


1. Kastango, Eric. “The Top Ten Things You Need to Know About USP 797” Infusion. May/June 2009.

2. Sanborn, Thomas et al. IV admixture contamination rates: Traditional practice site versus a class 1000 cleanroom. Am J Health-Syst Pharm. 2005; 62:2386-92.

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