USP <795> and <797> exist to reduce medication risks, including contamination, infection, or incorrect dosing when preparing both non-sterile and sterile preparations. These standards were last updated in 2014 and 2008, respectively, and the USP’s revision schedule covers much of the past decade. The organization has worked out proposed revisions to both standards to incorporate new scientific insights, technological advances and input from stakeholders.
The last proposed review was released in September 2021, followed by a lengthy public comment period ending March 17, 2022. At their meeting on April 19, 2022, the USP Compounding Expert Committee announced the conclusion of the review of the comments and progress to the next steps to make the revisions official. This marks an important milestone in this long journey and indicates that USP is likely to approve and issue the revised standards by 2023.
Based on previous concepts and the introduction of USP <800> in 2016, many pharmacies invested in facility updates, while delaying other aspects, such as training and environmental monitoring, until the revisions became official. With a new review date on the horizon, it’s time to dust off those reviews and prepare to implement the new standards.
However, making changes to their standard operating procedures requires no small effort. A recent poll of 227 users of Wolters Kluwer’s Simplifi 797 solution—using more than 2,000 pharmacies in the United States to test USP compliance <795>, <797> and <800> to ensure – raised serious concerns. When asked to rate the difficulty of implementing the proposed revisions on a scale of 1-10, 28% ranked it between 8 and 10 for <795>; in front of <797> more than a third of the participants, 34%, placed the difficulty between 8 and 10.
Clearly, the time has come for compounding pharmacies to understand what the changes to their particular facility will demand and start acting to ensure their operations are fully compliant so they can continue to keep patients safe and medications effective.
Understanding the USP Revisions
The proposed revisions to USP <795> and <797> are setting new standards for nearly every aspect of compounding pharmacy operation, including staff training and management, facility cleanliness, and testing and preparation of containers and drug components. In fact, all sections of both chapters were edited in some way during the comments review period. A few items stand out.
In front of <795> non-sterile compositions:
- Education: The revisions emphasize new levels of training that employees must demonstrate knowledge of and can perform essential core competencies.
- Cleaning and disinfecting: New focus on the non-sterile preparation environment, including new schedules for cleaning and sanitizing ‘frequently touched surfaces’.
- Beyond-Use-Dates: While in the past the primary focus for Beyond-Use-Dates (BUDs) has been the chemical and physical properties of the active pharmaceutical ingredient, the proposed revisions also emphasize the container sealing system, particularly how it interacts with the composite non-sterile preparation and the potential risks of microbial contamination or loss of potency. The revisions also focus on measuring water activity levels as part of determining a BUD, including a comprehensive table of common dosage forms and their water activity. Additional clarity and criteria have also been proposed to extend BUDs beyond the chapter defaults, including stability indication assays and antimicrobial efficacy testing.
As for USP <797>Sterile Compounding, many of the proposed revisions to the 2019 design remain, but with a number of additional reasons to support their inclusion.
- Cleaning, disinfecting: The use of sterile products within the Primary Engineering Control (PEC) and the use of sporicidal agents is required.
- Environmental Control: no change from the previous design requiring monthly surface samples in classified environments.
- Out of Use Dates (BUDs): Category 1 and Category 2 remain in dating with some minor concessions. However, a new Category 3 has been introduced to provide a framework for the longest BUDs allowed under the USP <797>standards.
- Sterile Category 3 preparations may have longer BUDs compared to those for Category 1 and Category 2. Additional criteria for Category 3 preparations include: more frequent cleaning, more frequent environmental monitoring, more frequent competency assessments, sterility testing, and a batch size limited to 250 units .
The impact on pharmacies
Each of the revisions will have at least some impact on the people, processes and technology at compounding pharmacies. In a recent article in Pharmacy Purchasing & Products, the authors estimate the resource impact of most of the major proposed changes, both on a pharmacy’s people (work equipment to be implemented) and on the cost to an organization in actual dollars. In many cases the impact will not be trivial and as such it explains the types of issues that have come to light in our survey of Simplifi 797 users.
For USP <795> 36 percent of respondents named training and competence as their top concern. This was followed by policies and procedures (25%), quality assurance and general oversight (23%) and implementation of a BUD renewal methodology (16%). For USP <797> 30% had training and competence as their top concern, followed by quality assurance and control (29%), environmental monitoring (24%) and policies and procedures (16%).
The time to prepare for USP enforcement is now
Many of these actions have been proposed for years and the direction of USP is clear as they strive to raise the minimum standard for higher quality CSPs. Given the potential impact and level of concern, waiting for the USP review schedule to complete appears to be a risky strategy. First, waiting will not allow enough time to identify new products, formulate new processes and workflows, or identify new supplier partners who may already have contracts pending.
Another strategy is to test changes in one compounding area or facility to validate the effects and workflows before a more widespread implementation. By adopting suggested practices early, you can make changes over time rather than making many changes at once, which can ease the mental strain on staff.
For those lacking the resources, working with composite compliance experts and deploying technology closely aligned with USP standards can significantly ease the burden of change. At Simplifi 797, we actively update our content and tools to ease your transition to the latest USP standards, while also allowing pharmacies to tailor their capabilities to their specific workflows. For example, with the flexibility of Simplifi 797, you can prepare updated competencies and tasks for the changes and assign them as soon as the USP revisions become official. In this time of change, having that kind of support can be invaluable.