They have been used by many safety professionals, industrial hygienists, facility engineers and quality control personnel for everything from training, to helping understand a standard or guideline better, as well as their primary purpose which is to educate and apply the forefront of our combined knowledge pertaining to the applicable. Understanding contaminants and how to remove them usp and you pharmaceutical compoundingsterile preparations this general chapter provides procedures and requirements for compounding sterile preparations. To determine if you are engaged in compounding please refer. In accordance with the rules and procedures of the 2015 2020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations. Usp pharmaceutical compounding sterile preparations. Pharmaceutical compoundingsterile preparations, usp 41 page 6554.
A united states pharmacopeia usp, national formulary nf, or food chemicals codex fcc substance is the recommended source of ingredients for compounding all preparations. Usp 797 requires compounding pharmacies to determine the risk level of the compounding done in their facilities and to perform the compounding in cleanrooms or other controlled environments as specified for the risk level. Having a physical plant that is compliant with usp requirements is the most important determinant to reducing the risk of contamination to csps. This handbook contains iso standards and iest recommended practices to assist clinical and pharmaceutical personnel as well as cleanroom design and operations professionals in implementing controlled environments that comply with the requirements of usp chapter 797 pharmaceutical compounding sterile preparations usp 797. Identify the key acronyms and state the definition of key terms associated with usp. Proper identification of compounding risk levels and. With the proper facilities, personnel training and monitoring, work practices and sops, environmental monitoring, and certification, compounding professionals can go a long way toward protecting patientsand themselvesfrom significant harm from csps. Usp remains committed to keeping stakeholders and the general public informed of the progress of these standards, which are anticipated to become official on december 1, 2019. In accordance with the rules and procedures of the 20152020 council of experts, usp. It sets guidelines on the health care products that are created or sold in the us on over the counter and prescription medicines. To download the complimentary usp general chapter 797 pharmaceutical compounding sterile preparations, please click here. Usp 797 compliance in the laminar flow workstation cabinet design attributes and best practices chambre, andre. Comments will be accepted until january 31, 2016, the end of the comment period for pf 416. View usp 797 gowning and donning requirements and garbing order.
Some differences between standards for sterile compounding in this chapter and those. Effective environmental monitoring microbiology network. For sterile processing, additional precaution is needed to assure that no sterile surfaces contact nonsterile surfaces during gowning, processing, or cleaning. Pdf on oct 1, 2004, eric s kastango and others published usp chapter 797. Its the best way to have your voices heard and your concerns addressed to ultimately benefit your patients and the practice of compounding. Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings. Pharmaceutical compoundingsterile preparations, usp 39.
Usp is the standard by which to prevent harm and death to patients who are administered compounded sterile preparations csps. As a user of, i encourage you to get involved in usps the standardsetting process and comment on the revised chapter, which was preposted for public comment on september 25, 2015. The usp standard for gowning protocols is a target in motion. Comments should include corresponding line number to the proposed revisions to the general chapter. The return is located in the in the ceiling the back of the room away from the entry door. What you need to know about proposed changes to usp 797.
Office of manufacturing qualityoffice of compliance. 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 develop and implement appropriate procedures, and to continually evaluate these procedures and the quality of. 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 healthcare quality standards. Cleaning the compounding pharmacy presented by david nobile contec, inc. Understanding the impact to home infusion connie sullivan, bspharm vice president of research and innovation. The usp compounding expert committee is responsible for the development of general chapter 797. Mar 18, 2015 in addition, usp chapter requires that a pec provide an iso class 5 environment while compounding csps. The intent and scope of usp is much broader than some of the requirements found in usp, says patricia c. Allergen extracts as csps for at least 10 seconds and allowed to dry be fore they are used to compound allergen ex allergen extracts as csps are singledose andtracts as csps. Based on the number and significance of public comments received in response to. Proposed revisions to usp chapter 797 for sterile compounding date.
Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Understanding pharmacy cleanroom design requirements. Revisions to chapters and 797 and the implementation of the new chapter reflect new science and evidence based on updated guidance documents, best practices and new learnings. In 2008, the united states pharmacopeia usp revised usp general chapter and its standards for the pharmaceutical compounding of sterile preparations. Usp is a public standardsestablished authority called the united states pharmacopeia. Preserve the concentrate in a refrigerator for making subsequent dilutions for not more than 14 days. Sterile compounding is done in a 6 xxhlf horizontal laminar flow hood. Background on june 1, 2019, usp published major revisions to general chapters and 797, which are intended to minimize the risk. The usp endotoxin rs has a defined potency of 10,000 usp endotoxin units eu per vial. United states pharmacopeia required below informational specific for dietary supplements usp 2010 2015 council of experts, destefano aj. Usp 797 pharmaceutical compounding sterile preparations proposed revision.
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. Wa pharmacy quality assurance commission 2020 responsible. Confidential and proprietary for internal use only. Usp chapter, and apply them in a variety of nuclear pharmacy practice settings. Usp chapter provides suggested standard operating procedures sops designed to ensure the quality of the environment in which a csp is prepared several procedures are recommended within usp chapter 20. Usp 797 compliance with usp 797 is our duty because. In the interim, the currently official version of 797 last revised in 2008 including the section. Licensees should remember that usp chapters are applicable when they are engaged in the preparation of compounding products. The home infusion compounders guide to the second proposed. However, the details of a pharmacy em program are subject to some confusion in the current regulatory environment, leaving many to wonder what sample sites, testing frequency, and investigations. Pharmaceutical compoundingsterile preparations revision bulletin.
Standard operating procedures sops medisca network. When written properly, they should tell the reader exactly what to do as well as. These cleanrooms feature terras standard hardwall construction configured in two standard sizes. Before you begin designing your cleanroom, you need to understand the performance parameters that measure hepa filters, cleanroom classification, air changes, and pressurization. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. Usp publishes new and revised compounding standards. Detailed standard operating procedures are the foundation of a robust sterile compounding practice. Pharmaceutical compounding sterile preparations usp.
Nov 22, 2019 in accordance with the rules and procedures of the 2015 2020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations. Usp chapter gap analysis page 6 of 16 x medical center confidential and proprietary for internal use only entry door. List three factors identified in the 2018 proposed revision of usp 797 that may impact the quality of a compounded sterile preparation. It improves the health and wellbeing of our patients and 2. Iso classification of particulate matter in room air limits are in particles of 0. Single and multidose vial management mary mcgoldrick, ms, rn, crni vials mdvs continues to be problematic. Provide a report and recommendations for an action plan in order to meet both shortterm and longterm goals for compliance with the requirements of usp chapter 797. Compare and contrast the changes between the first and second proposed revisions to usp 797 standard for sterile compounding. 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 chapter 797 gap analysis page 7 of 16 x medical center. Usp 797 compliance evaluations cleanroom construction. The united states pharmacopeia usp has proposed changes to be required of all sterile compounding, including allergen extract preparation. Usp 800 adds significant safety standards solid oral dosage forms that require only counting or packag.
Kienle, rph, mpa, fashp, who served on the usp 2015 2020 compounding expert committee that wrote the chapter. Allergen extract compounding requirements updates aaaai. The below chart shows suggested revisions and previous standards. As is evident in this program, achieving 100% compliance to current and future and future requirements can be difficult. Furthermore, chapter is not a strong standardfor example, it does not require. Kastango, mba, rph, fashp dont just know about it these changes may have a significant impact on the daytoday practices of all persons involved in the handling, preparation, and storage of csps. Usp 797 hazardous cleanroom design usp 800 while usp 797 previously established requirements for hazardous drug compounding, usp chapter 800 sets forth new requirements. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. Usp chapter is not law, rather it is a standard synthesized from accepted evidencebased science and best practices. Your participation is integral to the standard setting process. Sign up for healthcare quality standards updates and stay current on our work in compounding, medicare model guidelines, pictograms, medication safety and.
Proper identification of compounding risk levels and notification to the board of pharmacy pharmacies that hold a permit from the north carolina board of pharmacy that engage in any type of compounding are required to notify the board. Constitute the entire contents of 1 vial of the rse with 5 ml of lal reagent water 3, mix intermittently for 30 minutes, using a vortex mixer, and use this concentrate for making appropriate serial dilutions. Usp has undergone one revision that was published in 2008 and is currently undergoing a second revision, which was started in july 2010. 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 develop and implement appropriate procedures, and to. Establishing a practice standard for compounding sterile. Overview of chapter for surveyors and inspectors kate douglass october 9, 20. Based on the number and significance of public comments received in response to the revision proposal published in pf 416, the usp compounding expert committee is. The applicable standards of practice for safe sterile compounding are, at a. Identify the key acronyms and state the definition of key terms associated with usp 797. Based on the number and significance of public comments received in response to the revision proposal published in pf 416, the usp compounding expert committee is proposing to revise this chapter. Free download usp gc 797 appeals updates millions of medications are compounded each year in the us to meet the unique needs of patients. Usp 797 is one of the most popular standards that prevent excessive microbial contaminations and bacterial endotoxins.
Usp articles, or within 10 % if not specified, until their buds. The multipledose containers section of usp chapter states that the bud for an opened or entered e. The sterile compounding room is approximately 11 x 14 with an 8 ceiling. Compounding provides access to medication for patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. If the labeling does not specify an inuse time or if the sterile drug product being repackaged is an unapproved product on fdas drug shortages list, the guidance advises pharmacies to assign a bud according to the standards in the 2015 proposed revision of usp chapter 797 or the expiration date on the original container, whichever results in. Sep 28, 2015 as a user of, i encourage you to get involved in usps the standardsetting process and comment on the revised chapter, which was preposted for public comment on september 25, 2015. As previously reported to aaaai members, the practice of allergen immunotherapy as we know it is at risk. No plans for compliance polling question how compliant is your site with usp. Join ceta to be able to access the below documents in their entirety.
A rewritten with patient safety in mind quality matters. Establishing a practice standard for compounding sterile preparations in pharmacy find, read and cite all the research. As of january 2012, ceta application guides are available to ceta members as a free download. Inspection, regulation, and oversight of sterile compounding pharmacies.
Model sterile compounding standard operating procedures, developed by criticalpoint. Usp 800 is the latest united states pharmacopeia usp revision which clarifies and expands upon hazardous drug compounding both sterile and nonsterile. It employs unidirectional airflow, so used properly it should offer adequate isolation and. General guidelines for matching csps and components to appropriate. Fda outlines conditions for pharmacies to repackage drug. Introduction to usp general chapter 797 slideshare. Ceo, air science llc october 2016 introduction regulatory compliance procedures abound for the pharmaceutical industry, but perhaps one of the bestknown in the compounding side of the industry is usp 797. Stay involved and sign up to receive updates from usp. Usp chapter requirements, iso standard 14644, and institute for environmental sciences and technology iest recommended practices rp. Sterile garments and gloves are recommended during aseptic workflows. The changes to these usp chapters should improve the quality of compounded products and help protect public health. In light of these appeals, and in accordance with our bylaws, usp is postponing the official date of 797 until further notice. Facilities cag0032006, revised may 20, 2015, which is hereby. October 20, 2015 proposed revision to usp chapter 797 for sterile compounding will be published for comment on november 2, 2015 and comments will be accepted until january 31, 2016.
Usp 797 clean room guidelines standards for sterile. The revised section on environmental monitoring discusses requirements. Describe both the general responsibilities of compounding personnel and those specific to the. The revisions also incorporate stakeholder input and clarify topics that are frequently misunderstood. Medisca networks unique series of standard operating procedures sops are the foundation to improving the quality of your compounding practice by facilitating your daytoday compliance with the most current regulatory guidelines and standards of practice. Uspnf establishes standards for medicines, food ingredients and dietary supplements. Performed risk assessments and investigation of failures due to microbial contamination. The standards in this chapter do not pertain to the clinical administration of. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. March 2015 home healthcare now 171 infection prevention.
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