Proposed major revision to 797 garnered more than 8000 comments july 27, 2018. Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that include baths and soaks. 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. Iso classification of particulate matthalmic drops and ointments, and tissue ter in room air limits are in particles of 0. Proposed revisions to usp chapter 797 for sterile compounding date. Jan 04, 2017 chapter 797 is a pharmaceutical compounding document produced by the united states pharmacopeia usp. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. Usp 797 compliance handbook institute of environmental.
General chapter usp 797 establishes best practices and regulations for the production of compounded sterile preparations. Millions of medications are compounded each year in the us to meet the unique needs of patients. In accordance with the rules and procedures of the 20152020 council of experts, usp. It seems good but i was disappointed that it was written in 2015. Review the history of usp 797 and the milestones that led to the development of. The usp 797 gap tool has been updated to reflect the version of usp general chapter 797 that was published on june 1, 2020. Usp 797 sterile compounding study guide flashcards quizlet. Licensees should remember that usp chapters are applicable when they are engaged in the. Identify the key acronyms and state the definition of key terms associated with usp 797. 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. Understanding usp 797 csps include the following types of preparations. Compounding sterile preparations 1 t he revision bulletin to usp chapter 797, pharmaceutical compounding.
Aside from high, medium and lower risk categories, a separate section detailed standards for compounding of allergen immunotherapy, reflecting both how allergen immunotherapy is. Usp chapter 797 was the first set of enforceable sterile. Downloadable documents for compliance use these documents to aid in compliance with standards, whether state boards of pharmacy, usp or fda. 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. Like usp 797 and usp, the provisions of proposed usp deal with product transport, product storage, compounding, preparation, and administration of parenteral products. Based on the public comments, 797 revised and republished for public comment june 2019. Oct 27, 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. The usp received appeals on specific provisions of the chapter, and those appeals were subsequently granted, effectively sending this version of the chapter back to the expert committee. 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. Chapter outlines minimal cleaning and disinfecting requirements for the typical sterile compounding pharmacy environment. March 12, 2020 appeals panel issues decisions on the appeals to usp, and see faqs on usp compounding appeals. Sterile preparations, was released in late 2007 and will become official on june 1, 2008. 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. 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.
Understanding pharmacy cleanroom design requirements. Completely reorganizes the chapter and groups like sections together, eliminating redundancies, and clarify requirements. Medical the best way to sample the air is to use electronic air samplers in a process known as volumetric air photo courtesy of biotest sampling. Mar 18, 2015 usp chapter, pharmaceutical compounding. Our recommendations are based on a class 7 buffer zone, however, facilities with class 5.
Usp sets standards for the quality of drug products and works with healthcare providers to help them meet the standards. Usp chapter 797 and inoffice compounding of allergen. However, usp builds on earlier regulations by focusing on hds and occupational safety. Compounding of total parenteral nutrition fluids using manual or automated. General chapter pharmaceutical compounding sterile usp. Compounding of total parenteral nutrition fluids using manual or. Pharmacopeia usp chapter 797 for preparing sterile compounded drugs. Pharmaceutical compoundingsterile preparations notificaton. 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. Take advantage of this popular training tool and stay fully compliant with ashp and niosh guidelines, as well as usp 797. Usp is a comprehensive set of standards designed to improve patient safety by reducing the number of transmitted infections due to improperly compounded pharmaceuticals. The current usp chapter 797 on sterile compounding had three levels of safety protocols for compounding reflecting increasing levels of potential risk to patients. United states pharmacopeia, 36th revision adopted by fl board of pharmacy october 1, 2014 includes chapters 797, 71, 85, 731 these standards are intended to apply to all sterile pharmaceuticals, notwithstanding. The revised section on environmental monitoring discusses requirements.
Usp 797 pharmaceutical compounding sterile preparations proposed revision. Usp general chapter usp anticipates publishing a summary of the comments received, along with the expert committees responses, when the revision to general chapter 797 becomes official. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. However, a requirement statement from usp has been added in blue. There is no record of room particle counts for estimation of room cleanliness.
Pha 334 exam 1 learn with flashcards, games, and more for free. Ashps video guide to chapter provides a concise video overview of the essential components, procedures, and standards of the revised and updated chapter. Interested parties may submit comments by mail or commercial carrier by august 15 to. Reorganized existing chapter to group similar topics together, eliminate redundancies, and clarify requirements. Usps mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.
Guidelines for pharmaceutical sterile preparations chapter 797. Recently, a new chapter was proposed for addition to the united. September 23, 2019 revised general chapter is postponed until further notice. Usp chapter 797, pharmaceutical compoundingsterile. 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. Chapters 1 through 999 are enforceable standards that describe how certain functions and processes are to be performed. Describe both the general responsibilities of compounding personnel and those specific to the. A rewritten with patient safety in mind quality matters. It improves the health and wellbeing of our patients and 2. Those that must be sterilized before administration. Medical the best way to sample the air is to use electronic air samplers in a process known. Inspection, regulation, and oversight of sterile compounding pharmacies article pdf available in journal of parenteral and. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare.
Updated crosswalk between usp 797 and joint commission 2010 standards and npsgs. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. Its the best way to have your voices heard and your concerns addressed to ultimately benefit your patients and the practice of compounding. Nonengineering controls selecting the appropriate engineering controls is not the only consideration in meeting usp 797 standards. The return is located in the in the ceiling the back of the room away from the entry door. Introduction to usp general chapter 797 linkedin slideshare. It is proposed to revise this chapter to improve clarity, respond to stakeholder input, and reflect new science. United states pharmacopeia required below informational specific for dietary supplements usp 2010 2015 council of experts, destefano aj.
Understanding usp chapter 797 engineering control certification requirements and environmental sampling and remediation strategies chs pharmacy education series proce, inc. To download the complimentary usp general chapter pharmaceutical compounding sterile preparations, please click here. Understanding the impact to home infusion connie sullivan. The safety of your patients begins by ensuring that you understand the practice requirements set forth in usp chapter 797. This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. Ashps video guide to chapter 797 provides a concise video overview of the essential components, procedures, and standards of the revised and updated chapter 797. Usp 797 compliance with usp 797 is our duty because. No plans for compliance polling question how compliant is your site with usp 797. Wa pharmacy quality assurance commission 2020 responsible.
Sterile preparations 797 tightens patient safety guidelines. Usp chapter 797 from usp 40, nf 35 official until may 1 st, 2018 usp chapter 800 from usp 40, nf 35 official until may 1 st, 2018 proposed usp chapter 797 published september 25 th 2015 the usp compliance study by critical point webinar sponsored by pharmacy one source fda. Pharmaceutical compoundingsterile preparations revision bulletin table 1. As a user of 797, i encourage you to get involved in usp s the standardsetting process and comment on the revised chapter, which was preposted for public comment on september 25, 2015. Usp 800 is the latest united states pharmacopeia usp revision which clarifies and expands upon hazardous drug compounding both sterile and nonsterile. Those prepared according to the manufacturers label instructions that expose original contents to potential contamination. Concepts in sterile preparations and aseptic technique examines the current standards and best practices for sterile compounding, along with the fundamentals of aseptic technique, in a manner accessible to pharmacy and pharmacy technician students and professionals. Unless there are clear and concise understanding and agreement on the definitions, concepts. Pharmacopeia 12601 twinbrook parkway rockville md 208521790.
Learn vocabulary, terms, and more with flashcards, games, and other study tools. To help ensure clarity and consistency, the faqs are being revised. I will read it and study it but i dont know if this will be enough to prepare me for the exam. Uspnf establishes standards for medicines, food ingredients and dietary supplements.
Pharmacopeial usp convention is a nonprofit organization that sets legally recognized standards for drugs. While there are some exceptions for prescribers, the board considers reconstitution by pharmacies to be. Usp continues to improve chapter 797 by collecting comments from users and having technical. Revised 797 anticipated to be published in the usp nf december 2019. Thus, their testing procedures must be verified to meet the usp requirements stated in the individual monograph for the component being tested. Iso classification of particulate matter in room air limits are in particles of 0. A timeline of sterile compounding events and actions taken. Concepts in sterile preparations and aseptic technique. Office of manufacturing qualityoffice of compliance. Let emsl analytical, inc provide microbiological testing services in support of your usp activities. Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings. This interactive program is designed to reduce risk by demonstrating recommended procedures for hazardous drug preparation, administration, spill cleanup, and hazardous waste management. Pharmaceutical compoundingsterile preparations, usp 39 page 626. Usp nf establishes standards for medicines, food ingredients and dietary supplements.
Sep 18, 2014 usp chapter 797 is a standard that has been difficult for many sterile compounding facilities to follow. Blueprint for implementing chapter 797 for compounding. Overview of chapter for surveyors and inspectors kate douglass october 9, 20. Originally written in 2004, chapter 797 is popularly agreed to increase the safety of the compounding setting and its ingredients. This period has come to a close, with the updated version of the chapter posted on.
Usp 797 cleaning guidelines for sterile compounding. Microbiology behind usp 797 personnel glove fingertip sampling was added as a requirement in the proposed changes to 797. Usp 797 pharmaceutical compoundingsterile preparations. As with all medications, the compounding of radiopharmaceuticals must comply with these standards whether in a hospital nuclear medicine department or by an outsourced. Sterile preparations, became effective january 1, 2004 6. The safety of your patients begins by ensuring that you understand the practice requirements set forth in usp chapter.
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