Pharmacy OneSource Blog

The Crosswalk of Changes to 2019 USP <797>

For the last decade, USP Chapter <797> has gone unchanged. Until now.  Monitoring compliance with these requirements is the responsibility of state and federal regulators, including the Joint Commission and FDA. Pharmacies are expected to have adopted the new requirements when the standard becomes official and enforceable. As the official and enforceable date approaches, it’s important to understand the chapter changes and how they affect your organization.

In a recent webinar, Eric Kastango BS Pharm, MBA, FASHP, explored five major areas of change that have come about since USP <797> was first introduced in 2008.

1. Three risk levels have been changed to only two categories

In 2008, USP designated three levels of risk as it related to compounded pharmaceuticals, classifying those three levels as low, medium, and high. But now the chapter focuses on where the compounded preparation is being made, making the lines completely clear and eliminating frustration when trying to achieve compliance.

Category 1 would be any primary engineering control (PEC) located in a segregated compounding area (SCA), which is not ISO classified. This would be your typical satellite or oncology unit that doesn’t have HEPA filtered air or an anteroom. Category 2 becomes everything else. This would be any PEC located in an ISO classified buffer room, which is supplied by HEPA filtered air, and it is supported by an ante-room. The facility category determines the Beyond Use Date (BUD) of the compounded sterile preparation (CSP).

A Category 1 Facility (PEC/C-PEC located in an SCA or C-SCA)beyond use date (BUD) is:

  • 12 hours or less at controlled room temperature
  • 24 hours or less when refrigerated


A Category 2 Facility (located in a Buffer Room with an Anteroom) beyond use date can be:

  • Greater than 12 hours at controlled room temperature
  • Greater than 24 hours when refrigerated


However, it is important to keep in mind the chemical stability of the drugs being compounded. Please note that the chemical stability of some drugs may be shorter than the chapter default BUDs.


2. Personnel qualifications

Personnel qualifications are the same for both Category 1 and 2. It’s important that organizations are observing personnel ensure compliance with standards and documented practices. Minimum personnel qualification requirements include:

Every six months

  • Visual observation of hand hygiene and garbing. Garbing order is no longer specified in the chapter and must be defined in the organization’s standard operating procedures.
  • Gloved fingertip and thumb sampling (GFS) clarify that GFS is done after “separate and complete hand hygiene and full garbing.” It also indicates that fingers and thumb are to be rolled over the surface. Multiple options for devices to use for the sampling process are provided. Also, incubation parameters are longer and require two temperatures.
  • Media fill testing. This procedure must simulate the most difficult and challenging compounding procedures and processing conditions encountered by the person replacing all the components used in the CSPs with soybean–casein digest media.


Every twelve months

  • Training in appropriate sterile compounding principles and practices
  • Return demonstration of competency


It’s important to note than the training should not be limited to compounders. There may be other personnel handling CSPs or accessing the compounding area, including housekeeping, certifiers, and guests. All personnel accessing compounding areas must demonstrate competency in proper behavior to maintain the environment.

If any of your personnel fail one or more of these tested areas, it’s up to the facility to determine the next steps. However, CriticalPoint believes they must document the evaluation of the failure, what actions are being taken, and the rationale for those steps. Also new is that a designated person, or persons, are required to ensure that any person who enters the sterile compounding area can maintain its quality. They are responsible for ensuring that the day-to-day operations are being conducted according to the chapter requirements.


3. Facility requirements

One of the major changes of note on the facility side is that CAI/CACI systems are now called Restricted Access Barrier Systems (or RABS) and they must be placed in the cleanroom suite to get Category 2 BUDs . For compounding robots to qualify for the full dating, they must be placed in a cleanroom suite.

So, what is a cleanroom suite according to the 2019 USP <797> chapter? It will consist of at least two rooms, an anteroom and buffer room. For the room to qualify as an ISO-classified anteroom, it must have fixed walls and doors. It can no longer have separation using plastic sheeting because the temperature and pressure cannot be maintained with a soft wall system. There must also be controls to minimize the flow of lower-quality air into those more controlled spaces. This control is achieved by pressure differential. Another important distinction is that the air supply into the controlled spaces must be introduced through HEPA filters located in the ceiling rather than in the air handler. There must be low wall returns unless a visual smoke study is performed to show there is no stagnation. Also made clear in this latest iteration is the requirement for a pressure-differential monitoring system and a line of demarcation in the anteroom.

While that covers some of the must do’s, there are also several should do’s to keep in consideration when designing the facility. These include:

  • Cleanroom suites should be at a temperature of 20 degrees or cooler and a relative humidity below 60%.
  • Cleanroom suites should provide comfortable conditions for personnel in the required garb.
  • Facility and pass-through doors should be interlocked. For those facilities without interlocking doors, both doors must never be opened at the same time.
  • For air exchanges, facilities should be designed for the number of personnel and their movements, as well as equipment, supplies, and components. This may require a higher air change per hour rate than the minimums required by the chapter.
  • Sinks should be hands free either inside or outside the anteroom.


4. Air and surface sampling

The first change to this section of the chapter was a renaming from Environmental Monitoring to Microbial Air and Surface Monitoring. Viable air sampling must occur every six months, and surface sampling must be done monthly. For sampling, organizations do not need to use two different types of media. TSA is the only type of media listed for testing purposes. However, the option is given to use two different types of growth media for each sample location. If any microorganisms are recovered from the sample and only when they exceed action levels, do they need to be speciated.

When action levels are exceeded, organizations must take corrective action and should be consistent with the deviation and should include evaluation of the trends. Don’t forget that there must be documentation to go along with the corrective action plan.

As it relates to cleaning and disinfecting, the frequency is not dependent on the CSP category. Organizations are responsible for maintaining clean and disinfected facilities. All cleaning materials must be disposable, and all cleaning tools must be cleanable, cleaned before and after each use, and dedicated for use in the classified area or SCA. Any tools that are used must be in good condition and replaced as needed.

Cleaning and disinfection of the sink surface, pass-through, work surfaces, and floors must be done daily and a sporicidal agent must be used at least monthly. For wall, doors, ceilings, and storage, cleaning and disinfecting must be done every month.

The table is provided by Kastango Consulting Group.


5. All the other

Beyond Use Dates

Defined as the date and hour after which a CSP must not be used, or administration began, BUDs must be established based on Tables 10 and 11 of the USP <797> chapter. BUDs must not exceed the shortest remaining expiration date.

The BUDs in Category 1, the PEC placement is not in an ISO classified area. In this instance, sterility and endotoxin testing are not required, and the maximum BUDs at room temperature is 12 hours, and refrigerated is 24 hours. For BUDs in Category 2, the table below is a summary of the information from the chapter.

The table is provided by Kastango Consulting Group


Aseptic Preparation versus Terminal Sterilization

Aseptic preparation and terminal sterilization definitions are made clearer in this latest iteration of USP 797.  The definition of terminal sterilization is when the CSP is filled into its final container, and expose it to steam, heat or radiation. If you use a filter or transfer ingredients from a vial to a final container, that defines aseptic processing.

If you decide to extend the dating by performing sterility testing, the testing process hasn’t changed, but special allowances have been made for batch sizes under 40.

Master Formulation Requirement

This is an area of major change in USP <797> if organizations are making batches for more than one patient or if any CSP is made with nonsterile ingredients. This change indicates there must be master formulation and compounding records for these cases. Documentation is required.

Additionally, there are now expanded descriptions and requirements for quality assurance and control, including specifics on notification and recall of out-of-specification dispensed CSPs, as well as specifics about complaint handling and adverse event reporting handling.

If you missed it, Eric Kastango BS Pharm, MBA, FASHP, from the Kastango Consulting Group, goes into even more detail on these changes in Navigating the Revised USP Chapter <797> — How to Ensure Compliance.

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