Upcoming Revisions to USP <797>
In the world of Compounding Pharmacies, maintaining the sterility and safety of compounded sterile preparations (CSPs) is top priority. The United States Pharmacopeia (USP) has long played a crucial role in setting the standards for Compounding Pharmacy practices, with USP <797> being the fundamental chapter dedicated to sterile compounding. Coming November 1, 2023, several updates to the USP <797> guidelines will go into effect, bringing significant changes to the practice as well as your facility. Cost of additional supplies, increased points of failure, as well as more time required to manage competencies will all be new challenges to consider.
This blog post will provide an overview of some of the key changes to the chapter and provide guidance as well as compliance solutions to assist in your transition to the new requirements.
Table of contents
What is USP <797> and why is it important?
Some Key Changes to USP <797> for 2023 and Compliance Solutions
Enhanced Training and Competency Evaluations
Viable Volumetric Impact Air Sampling Requirements
Garbing Competency Evaluations
What can happen if you do not meet the new USP <797> regulations?
What is USP <797>?
USP <797> is a set of guidelines developed by the United States Pharmacopeia to ensure the safe handling, preparation, and administration of sterile medications. These guidelines are applicable to all healthcare facilities where compounding of medications are performed, including hospital pharmacies, 503A and 503B compounding facilities, Animal Health compounding pharmacies found in Vet Hospitals, University Colleges of Pharmacy education programs and more.
USP <797> covers a broad range of practices and procedures, from the design and maintenance of the compounding area to the training and competency of personnel. It also includes guidelines for environmental monitoring, quality assurance and testing, as well as documentation and record-keeping. By providing a comprehensive framework for the preparation of sterile medications, USP <797> plays a vital role in safeguarding patient safety, standardizing practices, and ensuring compliance with regulatory bodies.
Some Key Changes to USP <797> for 2023 and Compliance Solutions
*The following represents key changes from the currently enforceable version of USP Chapter (last major revision in 2008) to the revised USP Chapter (official as of November 1, 2023). The following are the major changes and are not meant to be an exhaustive list of the entirety of all changes made.
Enhanced Training and Competency Evaluations
One of the significant updates in USP Chapter <797> coming November 1st, 2023, is the emphasis on enhanced training and competency evaluation for personnel involved in sterile compounding. The guidelines require personnel to undergo regular competency evaluations to ensure they are capable of performing sterile compounding procedures safely and effectively. Those with oversight of sterile compounders must also now perform competency evaluations according to the new guidelines and the frequency for which your operators will need to conduct these evaluations has increased in all categories. As a result, your facility will now likely require an increase in competency evaluation supplies in order to comply with the new guidelines. In short, you are duplicating your most difficult, complex process and substituting your active ingredients with growth media to ensure your technicians and team are competent in performing your most challenging procedures.
Refer to the chart below to understand what your facility may need to be up to date with the latest requirements for aseptic technique testing and the Hardy Diagnostics USP Chapter <797> Compliance products suite for support:
Expanded Environmental Monitoring Requirements
The November 2023 revisions will introduce increased requirements for environmental monitoring. This includes regular testing of the air, surface and gloved fingertip (Garbing) sampling in the compounding area.
Viable Volumetric Impact Air Sampling Requirements
Viable volumetric impact air sampling is the preferred method for detecting microorganisms in the clean room and on the clean bench. This is a requirement for USP <797> compliancy as gravimetric sampling (settling plates) is not sufficient for meeting the air monitoring requirements of the chapter. While air sampling requirements have not changed much for categories 1 and 2, the frequency for which category 3 compounders must sample the air has increased significantly. If a third party company has been used previously to perform your air monitoring, bringing an instrument in-house may now be more cost effective. TRIO.BAS™ active impact air samplers utilize standard agar plates (accommodate both contact and 100mm plates) for collecting, incubating and identifying bacterial and/or fungal colony count(s) and offer a range of different sampler designs to satisfy different customer needs and environments.
Refer to the chart below to understand how often your facility may now need to conduct viable impact air sampling and check out the Hardy Diagnostics TRIO.BAS product suite to find the instrument that meets your needs:
Hardy Diagnostics Products for Viable Volumetric Impact Air Sampling
Gloved Fingertip Sampling (Garbing competency evaluations)
Gloved fingertip sampling is performed as part of garbing competency evaluations in USP Chapter <797> and the overall environmental monitoring process to ensure the cleanliness of the compounding environment and identify potential sources of contamination via personnel. Studies conclude that personnel represent the greatest source of microbial contamination in a cleanroom, thus expert attention should be given to the personnel garb compliance process to achieve and maintain USP Chapter <797> compliance. Come November 1 2023, compounders and those who have direct oversight of compounders will be required to perform garbing competency evaluations. The evaluations are now required to be given before beginning to prepare compounded sterile preparations as well as ongoing evaluations.
Hardy Diagnostics SterEM™ TSA plates with Lecithin and Tween are compliant to the guidelines of USP Chapter <797> to perform gloved fingertip sampling for garbing competency evaluations and are irradiated as well as triple bagged to ensure sterility when transitioned in to your compounding environment.
Refer to the chart below to understand how often your facility may now need to conduct Gloved fingertip sampling and garbing competency evaluations and check out the Hardy Diagnostics products suite for all the products available to support this need:
Hardy Diagnostics Products for Gloved Fingertip Sampling
Viable Surface Sampling
Your general Controlled Environmental monitoring program must include surface sampling per USP Chapter <797> and the frequency for surface sampling is now better defined and required. These changes may increase the frequency than what was previously being performed in your facility prior to the 2023 revision. Monitoring surfaces for microbial contamination can include taking samples from any surface that personnel, materials, or produced compounds are exposed to. Surface samples can be collected using LokTight Tryptic Soy Agar Contact Plates with Lecithin and Tween (Cat. No. P520). LokTight plates are Irradiated and triple bagged for sterility assurance.
Refer to the chart below to understand how often your facility may now need to conduct surface sampling and check out the Hardy Diagnostics environmental monitoring and surface sampling products suite for support:
Hardy Diagnostics Products for Viable Surface Sampling
LokTight™ Tryptic Soy Agar (TSA), w/Lecithin and Tween, USP, Irradiated, Triple Bagged, 15mlTryptic Soy Agar (TSA) with Lecithin and Tween® , USP is recommended for use as a general growth medium for establishing microbiological trends, alerts, and action levels in biologically controlled environments.
What can happen if you do not meet the new USP Chapter <797> regulations?
Failure to follow USP Chapter <797> CSP guidelines could cause harm, or even death to patients due to microbial contamination. The FDA does not always provide advanced notice on when it will perform inspections and some states have an automatic fail policy if enforcement agencies come to inspect your facility and it is identified as out of compliance, which is not something you want to take lightly!
Final Note
In a world where medical errors are a leading cause of death, adherence to USP Chapter <797> is not just a regulatory requirement, but an ethical obligation to protect patient safety. By ensuring the sterility and safety of compounded medications, we can help to prevent harm and improve patient outcomes. And in the end, that is what healthcare is all about. Hardy Diagnostics has been in business for over 40 years and offers high Quality culture media tested for performance, pH and sterility and is ISO 13485 Certified. We pride ourselves on expert sales and technical support and look forward to the opportunity to help you and your facility be USP Chapter <797> compliant.
Browse our products, download our USP <797> Key Changes Guide, or complete the form below to contact our team of experts to assist you.
Available Support for Compounding Pharmacies
Hardy Diagnostics is dedicated to providing comprehensive support to Compounding Pharmacies and contract laboratories in meeting their USP Chapter <797> requirements. With our advanced environmental monitoring tools, quality control solutions, and expertise in the field, we are committed to helping Compounding Pharmacies uphold the highest standards of compliance and patient safety in their sterile compounding practices.
Additional Resources
USP <797> Key Changes Guide
Pharmaceutical Microbytes Magazine
USP <797> Catalog
Meet the author
PHARMACEUTICAL PRODUCT MANAGER at HARDY DIAGNOSTICS
Joelle Brackeen, B.S. Marketing
Joelle Brackeen is the Pharmaceutical Product Manager at Hardy Diagnostics and has over a decade of experience in Marketing and Product Management. Before transitioning to the pharma sector, Joelle had the privilege of co-founding and helping to grow a business into a highly profitable, multinational enterprise. Her unique blend of entrepreneurial spirit and product management expertise contributes to her innovative approach and ability to drive successful products and strategic initiatives in the pharmaceutical industry. In her free time, she enjoys playing the piano and spending time at the beach.
