usp 795 vs 797 vs 800. What is USP 795 vs 797 vs 800. usp 795 vs 797 vs 800

February 7, 2020 USP Chapters <797> and <800> New and Revised Compounding Standards At A Glance At Issue The United States Pharmacopeia (USP) in June 2019 released several new and revised pharmacy compounding standards. As the leading provider of sterile and nonsterile compounding resources in the industry, we are dedicated to providing our members and customers with. Revisions to USP Compounding Standards 〈795〉and 〈797〉 Brian Serumaga, D. USP <795> and <797> FACT Sheet; FAQs for each General Chapter: <795> FAQs <797> FAQs <800> FAQs; Summary of comments and CMP EC responses <795> Commentary <797> Commentary . USP encourages early implementation of these revised standards. Previous Important <795> Updates Developing USP General Chapter <795> USP General Chapters 795, 797, 800 Effective June 26, 2019, the Board will require compliance with USP 800 for hazardous drug handling along with the existing requirement of compliance with USP Chapters 795 for nonsterile compounding and Chapter 797 for sterile compounding, currently under revision by USP. USP 795/797/800. Our four-part series continues with Part 2, USP 795 revisions and impacts on compounding pharmacies. Exclusion of specific practices from being categorized as Compounded. Who determines which drugs are hazardous. Jul 25, 2022 Ashley Gallagher, Associate Editor Conference | AAPT Annual Pharmacy Technician Convention Kevin Straughn, PharmD, clinical pharmacist at Duke. , Ph. Developing USP General Chapter <797>. Components 9. Access the USP <795> Compliance Guide Annie Lambert, PharmD, BCSCP Pharmacy Times® interviewed Annie Lambert, PharmD, BCSCP, clinical program manager of clinical surveillance and compliance at Wolters Kluwer Health, who has been working closely with hospitals to ensure they are ready for the revisions to USP guidelines for <797>, <795>, and <800> when they go into effect. Many State Boards of Pharmacy have laws governing the act of compounding and more recently have adopted the USP <795> standards directly. Additionally, surface sampling is now mandated to occur monthly. Jul 25, 2022 Ashley Gallagher, Associate Editor Conference | AAPT Annual Pharmacy Technician Convention Kevin Straughn, PharmD, clinical pharmacist at Duke Regional Hospital, said once the 2 compounding chapters, <797> and <795> become enforceable, there will be a 6-month grace period before USP <800> becomes enforceable. of USP 795: Nonsterile Compounding JANUARY 2014 VERSION VERSUS JUNE 2019 VERSION SEPTEMBER 25, 2019 BOARD OF PHARMACY MEETING Summary Easier to read More clear about documentation requirements No categories of compounding (simple, moderate, complex) Clearer definition of compounding, does not include reconstitution, Safety first! The United States Pharmacopeia (USP) is constantly looking for ways to increase the safety of personnel who handle hazardous and nonhazardous drugs. The process is public health focused, leveraging current science and technology, and draws on the expertise. Please check back regularly for notifications and updates. usp 800 While the patient is the focus of protection with the USP 797 standard related to sterile compounding concerns, the USP 800 focuses on. These two standards relate to the preparation of nonsterile and sterile compounded formulations, respectively. USP encourages early implementation of these revised standards. However, state board of pharmacy regulations vary and may include this requirement. 2 á797ñ / Physical Tests Second Supplement to USP 42–NF 37 This guide, developed by Simplifi 797 compounding compliance expert Annie Lambert, PharmD, BCSCP, explains the USP <795> standards in detail, and provides actionable steps your facility can take to meet best practices and ensure successful regulatory inspection outcomes. PQAC aims to provide licensees clarity around its expectations with the new compounding rule. United States Pharmacopeia (USP) Background Wednesday, November 16, 2022 Share | Updated files: USP_Compounding_BUD_Fact_Sheet. Accreditation or credentialing organizations may adopt and enforce USP standards. , Ph. 1-4 How do the supplemental engineering controls in <800> difer from those in <797>? The term supplemental engineering control does not appear in <797>, although CSTDs are included. Wednesday, November 16, 2022 Share | Updated files: USP_Compounding_BUD_Fact_Sheet. Jul 25, 2022 Ashley Gallagher, Associate Editor Conference | AAPT Annual Pharmacy Technician Convention Kevin Straughn, PharmD, clinical pharmacist at Duke Regional Hospital, said once the 2 compounding chapters, <797> and <795> become enforceable, there will be a 6-month grace period before USP <800> becomes enforceable. September 1, 2021: BUD Scientific Rationale for the 2021 Proposed Revisions to <797>. Safety first! The United States Pharmacopeia (USP) is constantly looking for ways to increase the safety of personnel who handle hazardous and nonhazardous drugs. This requires a line of demarcation within the ante room, separating the ante room into clean and dirty areas across which shoe covers must be donned with handwashing and further gowning on the clean side. 2 á797ñ / Physical Tests Second Supplement to USP 42–NF 37 71 72 THE CHAPTER <800> ANSWER BOOK 12. Further, Annie explains what to. g. USP has no role in enforcement. 21. Many State Boards of Pharmacy have laws governing the act of compounding and more recently have adopted the USP <795> standards directly. Lets take a closer look at UPS 797 vs 800 and some recent changes that have occurred. In contrast to USP 797, which only remedies sterile compounding activities, USP 800 takes a. pdf Below is the message sent out earlier this month by USP Healthcare Quality & Safety. Revisions to USP Compounding Standards 〈795〉and 〈797〉 Brian Serumaga, D. e. g. While the patient is the focus of protection with the USP 797 standard related to sterile compounding concerns, the USP 800 focuses on protecting healthcare workers who interact with hazardous drugs. Fewer components for admixture or a lower level of product manipulation indicate low-risk conditions. They recently published their latest revisions to the compounding USP chapters <797> and <795>, which will be made official on November 1, 2023. Exclusion of specific practices from being categorized as Compounded. November 2022 2 USP, Chapter <797>: Pharmaceutical Compounding – Sterile Preparations, (It is important to note that while FDA states that compounding does not include products prepared according to package labeling, FDA-approved labeling (i. The United States Pharmacopeia (USP) develops standards for preparing compounded drugs to help ensure patient benefit and reduce risks, such as contamination, infection, or incorrect dosing. 's secure,. The date also triggers potential enforcement of USP 800, which addresses CNSPs using hazardous drugs. United States Pharmacopeia (USP) Background The purpose of USP 797 is a general protection of sterile compounds and spaces from contamination. Liquid oral preparations. Over the past few years, USP has introduced USP 800 and adjusted USP 797 to ensure the highest level of safety is being taken at in-hospital pharmacies. . Does anyone have a Master Formulation Record/compounding log template you'd be willing to share that is in compliance with the new USP 795/797 regs on nonsterile and sterile compounding? Not sure how in-depth these master formulation logs need to be and was hoping any of y'all could share what you use. As the leading provider of sterile and nonsterile compounding resources in the industry, we are dedicated to providing our members and customers with. USP 797 specifies when hand washing should occur in the gowning procedure. USP 797 SCOPE AND PURPOSE Sterile compounding Pharmacy Times® interviewed Annie Lambert, PharmD, BCSCP, clinical program manager of clinical surveillance and compliance at Wolters Kluwer Health, who has been working closely with hospitals to ensure they are ready for the revisions to USP guidelines for <797>, <795>, and <800> when they go into effect. pdf USP22_HQS_Compounding_797_FAQ. Otic preparations Click the card to flip 👆 1 / 233 Flashcards Learn Test Match Created by Mindayx Terms in this set (233) Non-sterile compounding Is for making. Specifically, USP published revisions to general chapter <797> (Pharmaceutical Compounding and Sterile Preparations) and published a new general chapter <800>. The Oregon Board of Pharmacy Division 045 regulations related to drug compounding are currently under review and revision. On November 1, 2022, the USP published updates to their general chapters on compounding nonsterile and sterile preparations. , the product package insert) rarely describes environmental quality (e. November 2022 USP 797 specifies when hand washing should occur in the gowning procedure. Access the USP <795> Compliance Guide Annie Lambert, PharmD, BCSCP Pharmacy Times® interviewed Annie Lambert, PharmD, BCSCP, clinical program manager of clinical surveillance and compliance at Wolters Kluwer Health, who has been working closely with hospitals to ensure they are ready for the revisions to USP guidelines for <797>, <795>, and <800> when they go into effect. Compounding pharmacies are reminded that the Board will continue conducting compliance inspections using the current version of USP 797 (last revised in 2008) and USP 795 (last revised in 2014) and Answer: This appears to be a question relating to USP 795 or 797, relating to compounding not handling of hazardous drugs. Changes from USP 795 to USP 797 USP 797 builds. USP 800 expands controls for the protection of workers and environments against hazardous drug compounds. Changes include: Elimination of confusing “Categories of Compounding”. The currently official version of Chapter <797> does not require recording of lot and expiration dates for sterile preparation components. Non-sterile compounding. 20The change from a chapter numbered above 1000 to a chapter below 1000 marked a change from an advisory stan- dard to an enforceable one. Whether these standards are required is determined by state pharmacy boards. T. USP 797 is an extension of the requirements that were put in place with USP 795. Revisions to USP Compounding Standards 〈795〉and 〈797〉 Brian Serumaga, D. The pharmacy compounding rules do not enforce newer versions of USP 797 and USP 795 that are still under review by USP. Chapters 795 (USP 795) and 797 (USP 797), it expects pharmacists engaging in compounding to adhere to those guidelines that apply to their practice setting and in all situations to comply with the spirit of USP 795 and USP 797. 30 Legal Recognition, assuring compliance with USP standards is the responsibility of regulatory bodies. 5 microns in diameter per cubic foot of air). Rectal preparations. , ISO Class air designation, As part of its rules rewrite project PQAC adopted a rule identifying USP 795, USP 797, USP 800, and USP 825 as comprising the minimum standards for drug compounding (WAC 246-945-100). Accreditation or credentialing organizations may adopt and enforce USP standards. As such the changes are less extensive than the changes to <797>. Exclusion of specific practices from being categorized as Compounded. Design of Compounding Facilities 12. Mandatory Testing USP <797> now requires that mandatory checks, such as media fill testing or glove fingertip testing, must now be conducted semi-annually as opposed to annually. He said once the 2 compounding chapters, <797> and <795> become enforceable, there will be a 6-month grace period before USP <800> becomes enforceable. Pursuant to General Notices, 2. Click the card to flip 👆. Review their work plan and past meeting summaries. Vaginal preparations. ≥1-carcinogenicIt can shed dust when a cart or equipment penetrates the paint surface allowing sheetrock dust into the clean space. Although the chapters written by US Pharmacopeia (USP) for USP <795>, USP <797>, USP <800>, and USP <825> are old, in some cases, there are still some. 16 At the time of writing, the USP standards for non‐sterile (USP Chapter <795>) and sterile (USP Chapter <797>) BUDs are undergoing revision and may change significantly with the new updated chapters. . The Board voted to send the proposed rules to the 9/24/19 rulemaking hearing. There is more detail in USP <797>. The requirements for USP 797 focus on patient safety by keeping contaminants out of injections, drops, and other sterile compounding preparations; whereas, USP 800 regulations emphasize worker safety during the handling of hazardous compounds, like chemotherapy drugs. e. This article will provide a brief overview of the USP, review the highlights of <800>, describe differences between USP <797> and USP <800>, and describe the impact that <800> will have on sterile compounding programs in health systems. As such the changes are less extensive than the changes to <797>. As such the changes are less extensive than the changes to <797>. For information on other compounding chapters click here. USP <795> and USP <797> are standards designed to keep compounded preparations safe. This requires a line of demarcation within the ante room, separating the ante room into clean and dirty areas across which shoe covers must be donned with handwashing and further gowning on the clean side. 9/26/2019 5 Training January 2014 Training to include: Reading and be familiar with USP 795 and other relevant publications Read and interpret SDS Read and be familiar with procedures June 2019 Training to include: Read and understand USP 795 and other relevant literature Understand and interpret SDS and COA, if neededMeta Pharmacy Services is a 503A, USP 795/797, USP 800 compliant non-sterile and sterile compounding facility with a state of the art clean room technology which meet the highest standards set forth by state boards of. November 2022 of USP 797: Sterile Compounding JUNE 2008 VERSION VERSUS JUNE 2019 VERSION SEPTEMBER 25, 2019 BOARD OF PHARMACY MEETING Summary Easier to read More clear about documentation requirements and processes Have designated person (DP) No risk categories – was low, medium, and high Now Category 1 or Category 2 compounded sterile preparations The United States Pharmacopeia (USP) provides guidelines that inform pharmacies on best practices. Not creating space for non-sterile. May 14, 2022 – Compounding Expert Committee Update on <795> and <797>. Characteristics that make a drug hazardous. Compounding of hazardous drugs must follow the standards within USP <795> and <797>, and. , ISO Class air designation, The United States Pharmacopeia (USP) provides guidelines that inform pharmacies on best practices. However, state board of pharmacy regulations vary and may include this requirement. Further, Annie explains what to. USP has no role in enforcement. Scope of USP <795> 5. The. In contrast to USP 797, which only remedies sterile compounding activities, USP 800 takes a 360-degree approach for processing hazardous drugs. Over. Combining three or more ingredients or packages, multiple additive injections, or non-sterile ingredients indicate medium to high risk. 30 Legal Recognition, assuring compliance with USP standards is the responsibility of regulatory bodies. USP <795> deals with nonsterile pharmaceutical compounding preparations, including oral medicines, topicals, nasal sprays and otic. It is numerically equal to 1/100 of the relative humidity (RH) generated. USP <795> deals with nonsterile pharmaceutical compounding preparations, including oral medicines, topicals, nasal sprays and otic. A recent poll of 227 users of Wolters Kluwer’s Simplifi 797 solution – which more than 2,000 pharmacies in the United States use to help ensure compliance with USP <795>, <797> and <800> –. PQAC aims to provide licensees clarity around its expectations with the new compounding rule. USP 797 and USP 800 both focus on a key area of lab safety. September 1, 2021: BUD Scientific Rationale for the 2021 Proposed Revisions to <797>. In USP 797 (2008), the risk level is defined primarily on the complexity of the compounding process. NIOSH: National Institute for Occupational Safety and Health. They recently published their latest revisions to the compounding USP chapters <797> and <795>, which will be made official on November 1, 2023. USP 795 and USP 797 Standards. standards for medicines, food ingredients, and dietary supplements. USP 800expands controls for the protection of workers and environments against hazardous drug compounds. The advent of United States Pharmacopeia (USP) 797 and USP 800 has driven many hospitals and compounding pharmacies to develop and/or revise policies on sterile compounding of hazardous. USP Compounding <795> and <797> revisions include updates to beyond-use dates (BUDs), highlight advancements in science and clinical practice, clarify topics that may have caused confusion, and incorporate. Exclusion of specific practices from being categorized as Compounded. 2 á797ñ / Physical Tests Second Supplement to USP 42–NF 37 Health August 23, 2021 USP 797: A breakdown of low, medium and high compounding risks By: Annie Lambert, PharmD, BCSCP USP Chapter 797 sets compounding risk levels based on the likelihood of contamination of a compounded sterile preparation (CSP). November 2022 2 USP, Chapter <797>: Pharmaceutical Compounding – Sterile Preparations, (It is important to note that while FDA states that compounding does not include products prepared according to package labeling, FDA-approved labeling (i. What is USP 795 vs 797 vs 800. Garb and Hand Hygiene 8. They recently published their latest revisions to the compounding USP chapters <797> and <795>, which will be made official on November 1, 2023. R. Revisions to USP Compounding Standards 〈795〉and 〈797〉 Brian Serumaga, D. Due to provisions of USP numbered below 1000 being legally enforceable, following the adoption of these rules by individual state boards, USP <800> may subject pharmacies to both state board and FDA inspections. Mandatory Testing USP <797> now requires that mandatory checks, such as media fill testing or glove fingertip testing, must now be conducted semi-annually as opposed to annually. USP General Chapter <797> Informational Documents. 1 On the other hand, USP 800 highlights recommendations. g. Solid oral preparations Liquid oral preparations Rectal preparations Vaginal preparations USP 797 specifies when hand washing should occur in the gowning procedure. Over the past few years, USP has introduced USP 800 and adjusted USP 797 to ensure the highest level of safety is being taken at in-hospital pharmacies. For access to USP 795 revisions, USP offers two purchase options: the USP Compounding. , the product package insert) rarely describes environmental quality (e. This will essentially double the workload for quality assurance employees and double supply costs. See their website for more information. USP 797: Revisions & Impacts, Part 1 Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services, reviews USP 797 revisions and impacts on compounding pharmacies in the third of a four-part series. Updated: USP 800 is a cleanroom standard issued in March of 2014 by the United States Pharmacopeial Convention (USP). , ISO Class air designation, On January 1, 2004, USPchapter 797, Pharmaceutical Compounding—Sterile Preparations,15became official, re- placing USPchapter 1206, Sterile Drug Products for Home Use. However, state board of pharmacy regulations vary and may include this requirement. . Supplemental Documents: Stability Study Reference Document for the 2021 Proposed Revisions to <795> and <797> June 13, 2023 (Updated): Formulation and Stability Reference Document for Pharmaceutical Compounding USP General Chapter <795> Informational Documents September 1, 2021: BUD Scientific Rationale for the 2021 Proposed Revisions to <795> Pharmacies compounding nonsterile medications have been required to follow USP <795> requirements since 2000. The pharmacy compounding rules do not enforce newer versions of USP 797 and USP 795 that are still under review by USP. While requirements within each of these chapters change occasionally, the overall over-arching themes of each tend to remain the same. As part of its rules rewrite project PQAC adopted a rule identifying USP 795, USP 797, USP 800, and USP 825 as comprising the minimum standards for drug compounding (WAC 246-945-100). See their website for more information. May 14, 2022 – Compounding Expert Committee Update on <795> and <797> Important Note: The currently official version of General Chapter <795> (last revised in 2014) remains official. Like USP <797> and USP <795>, the provisions of proposed USP <800> deal with product. About the Revisions The revisions to <795> and <797> reflect advancements in science and practice to help ensure quality compounded preparations, promote public health, and protect patients and healthcare workers. In the future, if the revised USP <795> and <797> contain reference to USP <800>, <800> would be applicable and compendiallyUSP 797 vs 800 ; Compliance and Certification. pdf USP22_HQS_Compounding_795_FAQ. 1. September 1, 2021: Compounding Expert Committee Responses to Stakeholder Engagement Themes for the 2021 Proposed. . 2 á797ñ / Physical Tests Second Supplement to USP 42–NF 37 This guidance is based on USP<1112>: Application of Water Activity Determination to Nonsterile Pharmaceutical Products,8 which states: Water activity, aW, is the ratio of vapor pressure of H 2 O in product (P) to vapor pressure of pure H 2 O (Po) at the same temperature. 2 USP, Chapter <797>: Pharmaceutical Compounding – Sterile Preparations, (It is important to note that while FDA states that compounding does not include products prepared according to package labeling, FDA-approved labeling (i.