There are several trends in the revisions of usp 797 that can be highlighted based on recent progress. Understanding usp 797 conclusion the current usp 797 regulations emphasize the need to maintain highquality standards for processes, components, and environments for sterile compounding preparations. It improves the health and wellbeing of our patients and 2. Pharmaceutical compoundingsterile preparations uspnf. The 2018 usp compliance study results are now available. Compliance to usp 797 regarding pharmacy compounding is an ongoing and increasingly important issue for all compounding pharmacies to address as quickly as possible. Compliance with bmbl guidelines would be required if they were referenced. Introduction to usp pharmaceutical compounding sterile preparations 2. Usp allows an exception to the rule of placing the pec in an iso class 7 buffer area if.
If you entered this email by mistake, enter the correct email to sign in with your simplifi email and password. This site is set up to use enterprise credentials for sign in. Office of manufacturing qualityoffice of compliance. Usp chapter 797 requires a compound record to be created and maintained, however, does not define the specific elements to be included in the compound record. The benefits of usp 797 compliance include the minimization of contamination of csps, improved aseptic proficiency of hospital pharmacy personnel. Developing usp general chapter 797 usp is a notforprofit, sciencedriven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards. D assistant director sterile products may 2, 2017 oshp annual meeting. Usp 797 hazardous cleanroom design usp 800 while usp 797 previously established requirements for hazardous drug compounding, usp chapter 800 sets forth new requirements.
The failure to adhere to usp and standards increases. Usp 797 compliance common challenges and potential solutions angela yaniv, pharm. May 05, 2016 there are several trends in the revisions of usp 797 that can be highlighted based on recent progress. Simplifi 797 for compounding hazardous drugs and csps. Regulators may choose to enforce the requirements of with respect to veterinary. Introduction to usp general chapter 797 slideshare. Please reiterate what is enforceablesurveyed to regarding im. The use of category 1 and 2 is intended to simplify the. Sterile preparations, became effective january 1, 2004 6. Prlog henry ford macomb hospital selects simplifi 797 to. What is usp 797 and how to stay compliant pharmacy onesource. Interested parties may submit comments by mail or commercial carrier by august 15 to. Criticalpoint has developed a document on the peer network which compares the currently enforceable version of usp 797 2008 to the 2019 version that was made final but has now been sent back to the.
If you are at all involved in anesthesia, you are also probably generally aware of what 797 is all about. The comment period for this revision ends on november 30, 2018. Open comments on the chapter closed on january 31, 2016, and the expert. Provide simplified overall plan identifying all department boundaries and location of project. Here is a brief overview of 797 and the impact it will have on daily operations within ascs. Usp general chapter pharmaceutical compoundingsterile preparations background usp general chapter pharmaceutical compounding sterile. Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings. The updated policies and procedures, competency assessments and facilityspecific formulary are key to helping your cleanroom mitigate the risks from hazardous drug compounding. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. Posted on february 21, 2017 february 21, 2017 author bob miller categories pharmacy consulting. Upon unanimous recommendation of the sterile compounding task force and adopted by the kentucky board of. This course provides a better understanding of the upcoming revision to usp 797 and new usp 800. Usp 797 compliance with usp 797 is our duty because.
Adoption of and compliance with existing regulations although compliance with usp has improved over time, current legislation governing sterile product compounding is a patchwork of. Free usp poster for pharmaceutical and environmental professionals. Proposed fingertip sampling is just one addition within the revised usp chapter that will have a direct impact on many areas of your pharmacy. Discover the power of the combined solution of wolters kluwers simplifi 797 and omnicells ivx workflow to address quality, accuracy and safety when compounding sterile preparations. Simplifi 797 is a turnkey webbased quality management system that simplifies and automates ongoing compliance with essential usp chapter 795, 797 and. By carefully adhering to usp 797 standards, pharmacies are reducing the risk of causing patient harm and keeping staff safe. Best practices and compliance with usp for nonsterile compounding course curriculum. Criticalpoint has expanded our offerings to include nonsterile compounding. Simplifi 797 is all you need to provide your staff premium instruction and complete. Lintfree wipes dipped in diluted cleaning agent can be used to clean iso class 5 to 8 areas. Understanding usp 797the united states pharmacopeia usp states, it is the ultimate responsibility of all personnel who prepare csps to understand these fundamental practices and precautions, to. In june 2019, the united states pharmacopeia usp released several new and revised pharmacy compounding standards. New revision of usp 797 key changes contec healthcare. The joint commission requirements for meeting usp usp 797 standards frequently asked questions gnyha webinar october 7, 2019 1.
Simplifi 797 usp compliance reimagined on the solesource platform, simplifi 797 provides an enhanced user experience, workflows and analytics to improve compliance confidence with usp, and. The objective of the usp 797 guidelines is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly. Simplified compounded sterile preparation csp microbial risk levels from three. Nov 16, 2018 this course provides a better understanding of the upcoming revision to usp 797 and new usp 800. Usp 797 usp 800 pharmacy design compliance youtube. The immediateuse provision allows for the preparation and dispensing of compounded sterile products csps without the need to be in compliance with usp requirements such as iso class 5 hood or isolator, facility design, environmental controls, personnel cleansing and garbing. Pharmacopeia 12601 twinbrook parkway rockville md 208521790. Usp chapter 797 requires a compound record to be created and maintained, however, does not define the specific. Cleaning products and procedures for compliance by kate douglass cleaning should generally occur from the cleanest area to the dirtiest from an iso class 6 or 7 cleanroom to the iso class 8 anteroom. Preserved intradermal and subcutaneous sdvs and mdvs are exempt from personnel, environmental and storage requirements if all criteria are met. Pharmaceuticalthan those described in this chapter is not prohibited so long as they have been proven to be equivacompounding lent or superior with statistical significance to sterile preparationsthose described herein.
Usp select requirements for sterile compoundingpage 19. Access this brochure to learn more on how these solutions address compliance and iv workflow with features including. Ivx cloud will also be integrated with simplifi 797, a. Apr 18, 2019 usp 797 hazardous cleanroom design usp 800 while usp 797 previously established requirements for hazardous drug compounding, usp chapter 800 sets forth new requirements. Please reiterate what is enforceablesurveyed to regarding im methotrexate, crushing or. This course outlines general design aspects of changes, the intent of the standard, facility impact. Usp chapter, and apply them in a variety of nuclear pharmacy practice settings. Key changes in cleaning, disinfecting, and garbingrelated activities hca029 070819. Henry ford macomb hospital selects simplifi 797 to help with usp chapter 797 compliance software helps hospital pharmacy be in compliance with new compounding guidelines aug. Pass through cabinets and chambers are vital components meeting pharmacy usp 800 797 requirements. Proposed fingertip sampling is just one addition within the revised usp chapter 797 that will have a direct impact on many areas of your pharmacy.
Cleaning products and procedures for compliance by kate douglass cleaning should generally occur from the cleanest area to the dirtiest from an iso class 6. While the regulations were initially introduced in 2004, this is only the second revision to. Usp 797 applies to everyone involved in sterile compounding. Mar 18, 2015 usp chapter, pharmaceutical compounding. Sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a. Usp 800 is the latest united states pharmacopeia usp revision which clarifies and expands upon hazardous drug compounding both sterile and nonsterile. Simplifi 797 provides the tools and resources needed to ensure compliance with hazardous compounding standards mandated by usp chapter. Pharmaceuticalthan those described in this chapter is not prohibited so long as they have been proven to be equivacompounding lent or superior with statistical significance to sterile. Proposed revision to usp chapter 797 for sterile compounding will be.
Usp just released the revised general chapter pharmaceutical compounding sterile preparations. The revisions to the chapters, including updates to the beyonduse dates. Let emsl analytical, inc provide microbiological testing services in support of your usp activities. View usp sample report the new usp guidelines are designed to prevent the improper handling and contamination of sterile compounds for certain drugs or biologic preparations. However, only one out of six graduates 1 are typically prepared for. Describe both the general responsibilities of compounding personnel and those specific to the.
The immediateuse provision allows for the preparation and dispensing of compounded sterile products csps without the need to be in compliance with usp requirements such as iso class 5 hood. The intent of usp 797 is to prevent patient harm and death through minimum practice and quality standards expected of any entity or individual involved in storage, handling, preparation and transportation of csps. The usp proposed chapter 797 on november 27, 2007, placing an emphasis on individual training and evaluation of sterile compounding standards. Compounding of total parenteral nutrition fluids using manual or automated.
The 2018 usp 797 compliance study results are now available. Kastango, rph, mba, fashp now provides an expertbased sterile compounding education program by criticalpoint. D uring the 1960s, the practice of pharmacy began growing and evolving. Usp compounding standards and beyonduse dates buds on june 1, 2019, usp published updates to the usp general chapters on compounding nonsterile and sterile preparations alongside new standards for compounding radiopharmaceutical drugs. Usp compounding standards and beyonduse dates buds on june 1, 2019, usp published updates to the usp general chapters on compounding nonsterile and sterile preparations alongside new. Despite the fact that usp 797 emerged in 2008, the pharmaceutical industry has been slow to adopt sterilization standards. Ismp guidelines for safe preparation of compounded sterile.
This definition brings usp 797 in line with the institute of environmental sciences and technology iestrecommended practice iestrpcc004. The joint commission requirements for meeting usp standards frequently asked questions gnyha webinar october 7, 2019 1. This course outlines general design aspects of changes, the intent of the standard, facility. We would like to thank everyone that participated in this years study. The enclosure possess interlocking doors that is positioned between two spaces for the purpose of reducing particulate transfer while moving materials from one space to another. Csps are to be administered within 12 hours of compounding, or per physicians orders, whichever sooner csps meet the definition of lowrisk per usp. Specifically, usp published revisions to general chapter 797 pharmaceutical compounding and sterile preparations and published a new general chapter hazardous drugs handling in healthcare settings. Criticalpoint has developed a document on the peer network which compares the currently enforceable version of usp 797 2008 to the 2019 version that was made final but has now been sent back to the usp sterile compounding expert committee. A timeline of sterile compounding events and actions taken.
Usp position paper this technical bulletin provides information on the classification of preparations of ambulatory pain pumps as compounded sterile as defined in usp 28nf 23. Usp chapter 797 was the first set of enforceable sterile compounding standards created by the united states pharmacopeia. Performing operational and financial impact analyses now will allow your pharmacy to properly address what will be required to comply with the chapter when it is released. Best practices and compliance with usp for nonsterile. Observations in the proposed usp 797 revisions pharmacy. Sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile medication.
Usp compliance common challenges and potential solutions angela yaniv, pharm. New small pass through chambers usp 800 and 797 interlock cmp. Developing usp general chapter usp is a notforprofit, sciencedriven organization that has an established process for convening independent experts in the development and maintenance of. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. If you entered this email by mistake, enter the correct email to sign in with your simplifi email. The failure to adhere to usp and standards increases preventable incidents that result in infections or death, as well as increases the risk to exposure of hazardous drugs for. Institute of standards and technology nist document nistir 8060. Identify the key acronyms and state the definition of key terms associated with usp 797. To open the report in a separate browser, click here.
In response to an increasing number of patient injuries due to. A webbased quality management solution, simplifi 797 simplifies and automates usp 797 and 800 compliance processes, including the risk. Simplifi 797 is a comprehensive webbased quality management system that helps to meet the requirements of both usp chapters 797 and for compounding sterile preparations. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from. The enclosure possess interlocking doors that is positioned between two. Performing operational and financial impact analyses. Simplifi 797 is a comprehensive webbased quality management system that helps. In accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations 797.
By now, you have probably heard about usp 797 or simply 797. Usp position paper this technical bulletin provides information on the classification of preparations of ambulatory pain pumps as compounded sterile as defined in usp 28nf 23 pharmaceutical compoundingsterile preparations when filled with drug products in accordance with a licensed practitioners prescription. Adoption of and compliance with existing regulations although compliance with usp 797 has improved over time, current legislation governing sterile product compounding is a patchwork of statespecific regulations with wide variations between jurisdictions. Usp chapter is a set of enforceable sterile compounding standards issued by the united states pharmacopeia usp that set the standards that apply to all settings in which sterile preparations are compounded. Best practices and compliance with usp 795 for nonsterile compounding course curriculum. The standards in this chapter do not pertain to the clinical administration of. Staff usp 797 training should cover best practices and core competencies for each type of employee, ideally in a handson, situationbased learning format with both practical and written exams. The united states pharmacopeia usp creates standards for. Wolters kluwer expands simplifi 797 functionality to create a.
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