By Cami Allen, CPhT, CSPT-Adv, Pharmacy Management Specialist

In September, a number of proposed edits to USP General Chapter 797 were released to the public. The edits are currently open for discussion until January before they could potentially become official. It is important for your pharmacy to be aware of these potential updates and understand how they may affect current systems and processes.

Let’s take a look at what changes could be around the corner. But first, a primer:

What is USP 797?

The main objective USP Chapter 797 is to describe the minimum standards to follow when compounding sterile preparations (CSPs). The USP 797 standards were written and published to ensure patient safety and reduce the risks for contamination, infection or even death when sterile medications are not prepared according to USP 797 Standards.

It is important to acknowledge USP 797 Standards should be followed regardless of where the compound is prepared, and aseptic technique should be used at all times. In addition, administration of sterile compounds is out of the scope of USP 797 and not applicable.

If you are working with CSPs, the most current revised changes of USP 797 could directly affect your operations. This includes pharmacists, technicians, nurses, physicians, and veterinarians.

What are the proposed changes?

The proposed edits make clarifications to the official version of USP Chapter 797 that was released in May 2020.

There are five major edits to the existing chapter:

  1. The expansion of the guidance for assigning Beyond Use Dates (BUDs) 

For immediate use preparations, the chapter proposed to increase the beyond use date/time to four hours instead of one-hour BUD in the current chapter. Immediate use preparations must not include more than 3 different sterile ingredients and must be for emergency situations.

  1. The renaming of CSP microbial risk levels to Categories 1, 2 and 3

The changes to the risk levels include a transition to Categories 1, 2 and 3 from the low, medium and high-risk levels used previously. These categories are determined by the environment in which the sterile compound is prepared and determines the maximum BUD that can be assigned to a sterile compound.

Category 1 includes CSPs that may be prepared in the least controlled environments, which may include containment aseptic isolators that are located in a non-classified segregated compounding area. The CSP can be assigned a 12-hour-or-less BUD at a controlled room temperature or a 24-hour BUD when refrigerated and prepared in a non-classified space. The BUD would not include hang time as applicability of the chapter ends once administration begins. Category 1 preparations cannot include more than 3 different sterile ingredients.

Category 2 CSPs must be prepared in a clean room suite. If sterility testing is not completed prior to release, the BUD assigned is four days at room temperature and 10 days refrigerated.

Category 3 CSPs have the highest opportunity for microbial growth because of the complexity of the sterile preparation. With the complexity of Category 3 preparations, a sampling of the preparation must undergo sterility testing supplemented by endotoxin testing where applicable.  In addition, personnel who prepare Category 3 preparations are required to complete competencies more frequently and wear sterile garb when preparing Category 3 medications.

  1. The addition of guidance on use and storage of entered and punctured conventionally manufactured products

For the use of conventionally manufactured multi-dose containers, the beyond use time remains 28 days once the container is punctured. If you are using a conventionally manufactured single dose container, it may be used up to 12 hours after initial puncture when prepared in an ISO Class 5 or better environment and the storage requirements are met. The exception is that open-dose ampules should never be stored for any time period and discarded.

  1. The addition of requirements for maintaining master formulations and compounding records

Many times, master formulation (MFR) and compounding records are used simultaneously. Understanding the differences between them and how they apply to USP 797 will be important for applying these edits.

An MFR is a detailed record of procedures that describe how a CSP should be prepared. Master formulations should be completed for all sterile compounds, including Category 1, Category 2, Category 3 and Immediate Use CSPs.

There are 7 aspects to a successful MFR that must be included every time. MFRs must include the following:

  • Name, strength and dosage form of the CSP
  • Identities and amounts of all ingredients
  • Type and size of container closure system
  • Complete instructions for preparing the CSP, including equipment, supplies, a description of the compounding steps and any special precautions
  • Physical description of the final CSP
  • BUD and storage requirements including reference for stability
  • Quality control procedures (black/white field light, visual inspection)

Ultimately, an MFR should thoroughly describe the steps personnel should take when preparing a sterile compound, which includes what the final product should look like.

Just like an MFR, a compounding record must also be created for all sterile preparations, but a compounding record is for preparations that are being prepared for more than one patient at a time or created from non-sterile ingredients. Compounding records also have a list of requirements and include all of the following:

  • Name, strength or activity, and dosage form of the CSP
  • Date/time of the CSP
  • Assigned internal identification number (can be prescription order #)
  • Person preparing CSP and pharmacist sign off for verification
  • Name of each component and amounts used of each
  • Vendor, lot number and expiration date for each component for CSPs prepared
  • Weight or total volume
  • Strength of each component

This is not an exhaustive list of the things that need to be included, but it is the minimum information required for a compounding record.

  1. The removal of information related to handling hazardous drugs 

The last piece of the proposed changes would remove hazardous medications from the USP 797 chapter. However, the USP 800 chapter builds off of USP 797 and includes receiving, handling, storing and preparing hazardous medications (not specifically sterile).

The proposed changes are not a huge departure from the first revised 797 chapter, but it is important to understand the details of the changes so you and your staff can best manage your pharmacy sterile compounding procedures according to the new proposed 797 standards.

Questions and Concerns?

We at PharmD on Demand are here to help you navigate these changes and would be happy to lend a hand in understanding what these edits mean for your pharmacy. 

Feel free to reach out with any questions or concerns. You can email me at allenc@pharmdondemand.com