
Reviewing the Main Changes to USP <797> in 2024
By Roberto Juarez Jr. BS, M(ASCP)CM
On November 1st, 2023, the United State Pharmacopeia (USP) made several changes to general chapter <797> which describes the minimum requirements for the preparation of compounded sterile preparations (CSP’s) for human and animal drugs. The purpose of these guidelines is to reduce the chance of harm and/or death to human and animal patients resulting from microbial contamination, the presence of excessive bacterial endotoxins, and physical contaminants to name a few. USP <797> covers a broad range of topics ranging from the design and maintenance of the compounding area to training and competency of personnel. Today, we’re going to summarize a few changes to the training and competency of personnel that went into effect on 11/1/2023.
Personnel and Facilities Affected
To whom and what facilities does USP <797> apply? Anyone who prepares CSPs including pharmacists, pharmacy technicians, nurses, physicians, veterinarians, and dentists must meet the minimum requirements in this chapter. Facilities where CSPs are prepared such as pharmacies, hospitals, physician, and veterinarian practice sites must also follow the updated guidelines.
Personnel Have Increased Training and Competency Evaluations
One of the main changes to USP <797> has been the increased training and competency evaluations of personnel involved in sterile compounding. The guidelines require compounding personnel to perform competencies more often to ensure they can compound sterile drugs safely and effectively.
Those who have direct oversight over compounders must also perform competency evaluations. The compounding facility should designate an individual who is accountable and responsible for creating and implementing a training program that ensures compounders and other personnel are trained and qualified before allowed to perform their job duties independently.
Initial Garbing Competency Requirements
Before starting to process CSPs, compounders and those who oversee compounders must complete an initial garbing competency glove fingertip evaluation at least 3 separate times in succession with an action limit of > 0 cfu total from both hands. Failure to pass 3 separate initial garbing competency glove fingertip evaluations requires personnel to repeat testing until they successfully complete 3 evaluations in a row. This requirement is not new, but a similar single garbing competency glove fingertip is. The single garbing competency glove fingertip with an action limit of > 0 cfu total from both hands must be completed either annually, semi-annually, or quarterly.
Another new requirement for USP <797> is if the facility purchases or receives sterile commercial microbial media from a supplier, a Certificate of Analysis (COA) must be obtained that states the specific lot of media can support microbial growth. The media should be stored according to manufacturer’s instructions and used before the expiration date.
Ongoing Competency Requirements
The table below summarizes the new periodicity for ongoing garbing and aseptic technique competency requirements once the compounder has passed the initial garbing competency evaluation.
Personnel | CSP Category | Testing Frequency |
Compounder | 1 & 2 | At least every 6 months |
Compounder | 3 | At least every 3 months |
Direct oversight of compounders | N/A | Initially & at least every 12 months |
Initial Aseptic Technique Competency Evaluation
Compounders must also successfully complete an aseptic technique competency evaluation prior to processing CSP categories 1, 2 and 3. The initial aseptic technique evaluation consists of visual observation, media-fill testing, followed by a gloved fingertip and thumb sampling on both hands and surface sampling of the compounding area. Per USP <797>, “A failure in the media fill, gloved fingertip, and thumb sampling, or surface sample constitutes an overall failure of the aseptic manipulation competency.” See the above table for ongoing aseptic technique competency testing requirements.
Updated Incubation Standards for Gloved Fingertip and Media Fill Testing
Gloved fingertip, thumb sampling, and media fill testing incubation temperature and duration have been revised.
Test | Temperature: 30° to 35° C | Temperature: 20° to 25° C |
Gloved Fingertip | Incubate for no less than 48 hours | Incubate an additional 5 days |
Media-Fill | Incubate a minimum of 7 days | Incubate a minimum of 7 days |
Note: The compounding facility must describe the order of incubation times for media fill testing in their SOPs. A media fill test failure is indicated by visual turbidity of growth in the media on or before 14 days incubation.
Action Levels for Gloved Fingertip Testing
USP <797> has revised the action levels for gloved fingertip testing (Page 5, table 1)
Gloved Fingertip & Thumb Sampling | Action levels (Total CFU count from both hands) |
After garbing | > 0 |
After media-fill testing | > 3 |
New CSP Microbial Categories
Gone are the days when we had low, medium, and high risk CSP microbial levels. The updated Chapter now distinguishes 3 categories of CSPs that depend on the state of environmental control under which they were compounded, the chance of microbial growth during storage, and the period in which they must be used.
Category | Environmental Conditions | CSP Beyond Use Date (BUD) |
1 | Least controlled | ≤ 12 hours at room temp,
≤ 24 hours refrigerated |
2 | More controls than category 1 | > 12 hours at room temp,
> 24 hours refrigerated |
3 | More personnel qualifications than category 2 | May be assigned longer
BUDs than category 2 |
In this post, we highlighted the major changes to USP <797> that went into effect on November 1st, 2023. Microbiology Specialists Inc. is your Houston-based full-service clinical and environmental microbiology laboratory established in 1984 offering Pharmaceutical (USP) compliance testing solutions to pharmacies nationwide. Visit our website for other services we offer such as clinical, environmental and infection prevention services or get in touch with us today at (713) 663 – 6888 to see how we can serve your facility, so you remain in compliance with regulatory and accrediting bodies.
Sources:
ASHP.org – Key Changes to USP <797>