Two Trees Consulting reviews the proposed compounding guidelines. Have you read through all of the proposed USP Chapter 795 and 797 changes? Listen to a great review from Dr. Amy Summers on behalf of Two Trees Consulting.
Proposed USP Chapter 795 and 797 changes Compounding Updates
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Summary
Lisa Faast and Dr. Amy Summers discussed proposed revisions to USP 795 and 797 chapters, focusing on non-sterile and sterile compounding guidelines. Key changes include clarifications on non-sterile compounding, personnel training and competency, and the introduction of water activity to determine stability. For non-sterile preparations, beyond use dates (BUDs) are now 90 days for aqueous and 180 days for non-aqueous preparations. Sterile compounding introduces new categories: Category 1 (12 hours at room temperature, 24 hours refrigerated), Category 2 (varies based on sterilization methods), and Category 3 (up to 180 days with stringent requirements). Comments on these proposals are due by January 31, 2023.
Action Items
- Review and study the detailed proposed changes, particularly the new BUD tables and water activity requirements for non-sterile compounding.
- Assess current compounding operations against the proposed Category 1, 2, and 3 requirements to determine compliance readiness.
- Submit comments on the proposed USP revisions through the USP portal if there are concerns, questions, or suggestions.
- Contact Two Trees Consulting for specific questions about the proposed changes or compounding compliance needs.
Outline
Proposed Revisions to USP 795 and 797
- Lisa Faast introduces the meeting, focusing on proposed updates to USP 795 and 797 chapters.
- Lisa mentions the complexity of understanding these guidelines and introduces Dr. Amy Summers, a compounding pharmacist, to help explain the changes.
- Dr. Amy Summers provides a brief introduction about her background and experience in compounding.
- Lisa emphasizes the importance of understanding these guidelines, especially for compounding pharmacies, and introduces Dr. Amy to delve into the details.
Overview of USP 795 Changes
- Dr. Amy Summers begins by discussing the proposed revisions to USP 795, which were released in September.
- The changes include clarifications, additional information, and a focus on bioavailability limits and water activity.
- Dr. Amy explains the difference between non-sterile and sterile compounds, emphasizing the inclusion of otic, nasal irrigations, and other local preparations in non-sterile compounds.
- The new chapter removes hazardous drug compounding guidelines, referring users to USP 800 and 825 for radio pharmaceuticals.
Personnel and Settings in USP 795
- Dr. Amy discusses the introduction and scope section, highlighting the need for proactive identification and remedy of potential problems in dispensing and transporting non-sterile preparations.
- The chapter now requires designating a responsible person for non-sterile compounding operations.
- Dr. Amy explains the removal of hazardous drug compounding guidelines and the focus on sterile compounding in the upcoming section.
- She provides examples of compounding activities, such as flavoring, which are considered compounding and can affect product stability.
Personnel Qualification and Hygiene in USP 795
- Dr. Amy emphasizes the need for initial and annual training and competency for all personnel involved in compounding.
- She discusses the importance of being trained and competent in the specific procedures and equipment of the facility.
- Dr. Amy explains the new requirements for personnel hygiene and garbing, including the need for appropriate hand hygiene and cleanliness.
- The chapter now allows for provisions for certain items, such as wedding rings, if they do not disrupt the environment.
Building and Facilities in USP 795
- Dr. Amy highlights the need for a designated space for non-sterile compounding, including the ability to wear gowns.
- The chapter includes new requirements for cleaning and sanitizing, with more defined minimum frequencies.
- Dr. Amy discusses the need for equipment and components to comply with USP monographs and be manufactured in FDA-registered facilities.
- She explains the importance of labeling and the need to document received dates for packages without labeled supplier expiration dates.
Master Formulas and Release Inspections in USP 795
- Dr. Amy explains the need for a master formulation and compounding record, emphasizing the importance of cohesion between the master formula, compounding record, and medication order.
- The chapter includes requirements for visual inspections of preparations and container closures.
- Dr. Amy discusses the need for labeling to display certain information prominently and legibly, with the option to use outer packaging labels if necessary.
- She emphasizes the importance of confirming that the labeling matches the compounding record and conducting appropriate inspections.
Establishing Beyond Use Dates in USP 795
- Dr. Amy introduces the concept of water activity and its impact on stability, including chemical and physical stability, compatibility with the container closure system, and microbial proliferation.
- The chapter includes a table for establishing beyond use dates based on the type of preparation and water activity.
- Dr. Amy explains the default beyond use limits for aqueous and non-aqueous dosage forms, emphasizing the need for a risk assessment.
- She discusses the importance of considering the properties of active ingredients and the need for stability studies.
USP 797 Overview and Definitions
- Dr. Amy explains the definition of compounding in USP 797, which aligns more with the FDA 503A definition, excluding the concept of administration.
- The chapter includes a section on immediate use compounding sterile products (CSPs), which are not subject to the requirements for Category One, Two, or Three.
- Dr. Amy discusses the need for personnel preparing immediate use CSPs to be trained and demonstrate competency in aseptic technique and processes.
- The chapter includes requirements for aseptic technique, physical and chemical compatibility, and the use of sterile garb.
Category One, Two, and Three CSPs in USP 797
- Dr. Amy introduces the concept of Category One, Two, and Three CSPs, based on a risk assessment of the environmental control under which they are compounded.
- Category Three CSPs enjoy extended beyond use dates for up to 180 days but require additional stringent requirements, similar to cGMP standards.
- The chapter includes new requirements for personnel qualification, garbing, and environmental monitoring for Category Three CSPs.
- Dr. Amy emphasizes the importance of conducting stability-indicating studies and meeting stringent sterility testing requirements for Category Three CSPs.
Microbiological Monitoring and Cleaning in USP 797
- Dr. Amy discusses the requirements for microbiological air and surface monitoring, including the need for more frequent monitoring for Category Three CSPs.
- The chapter includes requirements for clean, disinfecting, and applying sporicide, with more frequent sporicide use for Category Three CSPs.
- Dr. Amy explains the need for master formula and compounding records to be cohesive with the prescription and medication order or label.
- The chapter includes requirements for visual inspection and sterility testing for Category Two and Three CSPs.
Establishing Beyond Use Dates for CSPs in USP 797
- Dr. Amy explains the need to consider parameters that may affect stability, including chemical and physical stability, compatibility with the container closure system, and sterility.
- The chapter includes new beyond use limits for Category One and Two CSPs, with more stringent limits for Category Three CSPs.
- Dr. Amy emphasizes the importance of conducting stability-indicating studies and meeting stringent sterility testing requirements for Category Three CSPs.
- The chapter includes requirements for antimicrobial effectiveness testing for multiple dose CSPs and specific limits for ophthalmic preparations.
Submitting Comments and Final Thoughts
Lisa Faast thanks Dr. Amy and encourages participants to reach out to Two Trees Consulting for further assistance and to post comments.
Dr. Amy encourages participants to submit comments on the proposed revisions to USP 795 and 797 by January 31.
She provides links for submitting comments and emphasizes the importance of specific and detailed feedback.
Dr. Amy reiterates that the changes are not official and are subject to further review and comment.