What the Updates to USP 797 Mean to Your Pharmacy

Written by ATSC230@545404 on . Posted in Uncategorized

Pharmacists on the East CoastIf you work at a pharmacy, then it's important to know the proposed updates to USP 797. These updates come from the United States Pharmacopeia (USP). These compliance requirements and standards minimize health risks to patients and staff members in the pharmacy. Here are some of the updates that affect your pharmacy that you should know about.


The pharmacy needs to follow certain procedures in order to follow the USP 797 guidelines. The procedure begins with determining the risk level of the substances that are being compounded. Once this is determined, it's important to complete a gap analysis. Then the pharmacy should develop an action plan with simple procedures for handling CSPs (Compounded Sterile Preparations) based on their risk level. During this process, it's also important to monitor the air quality of the pharmacy.

CSP Risk Levels

USP 797 states that there are 3 risk levels for CSPs. The levels are low, medium, and high. In general, anything that is classified as ISO Class 5 is high risk, 7 are medium risk, and ISO Class 8 is low risk. The risk level refers to the chances of not achieving the sterility level that is required for that classification. Of course, these levels are only guidelines. The actual risk depends on the viable data gathered through sampling the location. Proposed changes to USP 797 collapse the three CSP risk levels into two categories.  Category 1 CSPs have a shorter maximum beyond use date (BUD), while Category 2 CSPs have a longer maximum BUD.  These are based upon several factors such as sterility considerations.

Viable Sampling

Pills on the East CoastThere are 2 types of viable sampling that a pharmacy can complete. The first type of sample that can be used is from the air. These are gathered through impaction on a media plate using a viable sampler machine. The other types of sample that can be used are surface samples. These are required for ISO classified areas. According to USP 797, samples should be periodically taken from the clothing and gloves used in the pharmacy. It's also important to have all employees complete media tests in order to ensure that they're sampling everything correctly. Currently USP 797 requires routine viable sampling be performed.  A proposed change is for viable sampling to be required monthly.

About the Proposed Changes

Other proposed changes include more stringent requirements on gowning, personnel training and facility design.  These changes coupled with changes to CSP risk levels and viable sampling requirements are all designed with safety in mind.  Pharmacies and other ISO classified facilities need to know this information for the best cleanroom management. In order to properly sterilize the area and minimize the risk of infections, diseases, and other issues to patients and staff members of the pharmacy, it's important to know about the proposed updates to USP 797. Following these guidelines will protect your pharmacy and yourself. Make sure to read the updates to USP 797 and understand all of the points to ensure that you're in compliance to all regulations and standards when they are enacted.