Usp chapter 797 was the first set of enforceable sterile. 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. 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. Ashps video guide to chapter provides a concise video overview of the essential components, procedures, and standards of the revised and updated chapter. It seems good but i was disappointed that it was written in 2015. Reorganized existing chapter to group similar topics together, eliminate redundancies, and clarify requirements. 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. A timeline of sterile compounding events and actions taken. Compounding of total parenteral nutrition fluids using manual or automated. Compounding of total parenteral nutrition fluids using manual or. Jan 04, 2017 chapter 797 is a pharmaceutical compounding document produced by the united states pharmacopeia usp. General chapter pharmaceutical compounding sterile usp. Overview of chapter for surveyors and inspectors kate douglass october 9, 20. It is proposed to revise this chapter to improve clarity, respond to stakeholder input, and reflect new science.
Recently, a new chapter was proposed for addition to the united. September 23, 2019 revised general chapter is postponed until further notice. Usp 800 is the latest united states pharmacopeia usp revision which clarifies and expands upon hazardous drug compounding both sterile and nonsterile. 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. Usp chapter 797, pharmaceutical compoundingsterile.
Understanding the impact to home infusion connie sullivan. In accordance with the rules and procedures of the 2015 2020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations 797. Chapters 1 through 999 are enforceable standards that describe how certain functions and processes are to be performed. Pharmacopeia 12601 twinbrook parkway rockville md 208521790. To help ensure clarity and consistency, the faqs are being revised. Those prepared according to the manufacturers label instructions that expose original contents to potential contamination. While there are some exceptions for prescribers, the board considers reconstitution by pharmacies to be.
Millions of medications are compounded each year in the us to meet the unique needs of patients. 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 is a comprehensive set of standards designed to improve patient safety by reducing the number of transmitted infections due to improperly compounded pharmaceuticals. Completely reorganizes the chapter and groups like sections together, eliminating redundancies, and clarify requirements. Iso classification of particulate matter in room air limits are in particles of 0.
Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that include baths and soaks. Usp chapter 797 gap analysis page 6 of 16 x medical center confidential and proprietary for internal use only entry door. The return is located in the in the ceiling the back of the room away from the entry door. Pharmaceutical compoundingsterile preparations revision bulletin table 1. Microbiology behind usp 797 personnel glove fingertip sampling was added as a requirement in the proposed changes to 797. 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. Those that must be sterilized before administration. Thus, their testing procedures must be verified to meet the usp requirements stated in the individual monograph for the component being tested.
Aside from high, medium and lower risk categories, a separate section detailed standards for compounding of allergen immunotherapy, reflecting both how allergen immunotherapy is. Blueprint for implementing chapter 797 for compounding. Usp 797 pharmaceutical compounding sterile preparations proposed revision. 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. The revised section on environmental monitoring discusses requirements. However, a requirement statement from usp has been added in blue. 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.
Licensees should remember that usp chapters are applicable when they are engaged in the. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. Proposed major revision to 797 garnered more than 8000 comments july 27, 2018. Introduction to usp general chapter 797 linkedin slideshare. 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 nf establishes standards for medicines, food ingredients and dietary supplements. Pharmacopeia usp chapter 797 for preparing sterile compounded drugs. 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. Chapter outlines minimal cleaning and disinfecting requirements for the typical sterile compounding pharmacy environment. This period has come to a close, with the updated version of the chapter posted on. Sterile preparations 797 tightens patient safety guidelines. Usp chapter 797 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. For example, under dextrose injection, the following is stated.
Understanding pharmacy cleanroom design requirements. To download the complimentary usp general chapter pharmaceutical compounding sterile preparations, please click here. General chapter usp 797 establishes best practices and regulations for the production of compounded sterile preparations. Mar 18, 2015 usp chapter, pharmaceutical compounding. The safety of your patients begins by ensuring that you understand the practice requirements set forth in usp chapter 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. As with all medications, the compounding of radiopharmaceuticals must comply with these standards whether in a hospital nuclear medicine department or by an outsourced. Usp 797 compliance with usp 797 is our duty because. 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. Iso classification of particulate matthalmic drops and ointments, and tissue ter in room air limits are in particles of 0. Usp 797 compliance handbook institute of environmental. Take advantage of this popular training tool and stay fully compliant with ashp and niosh guidelines, as well as usp 797. This interactive program is designed to reduce risk by demonstrating recommended procedures for hazardous drug preparation, administration, spill cleanup, and hazardous waste management. Proposed revisions to usp chapter 797 for sterile compounding date. Uspnf establishes standards for medicines, food ingredients and dietary supplements. It improves the health and wellbeing of our patients and 2. 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. Updated crosswalk between usp 797 and joint commission 2010 standards and npsgs. Pharmacopeial usp convention is a nonprofit organization that sets legally recognized standards for drugs. Its the best way to have your voices heard and your concerns addressed to ultimately benefit your patients and the practice of compounding.
Pharmaceutical compoundingsterile preparations notificaton. The safety of your patients begins by ensuring that you understand the practice requirements set forth in usp chapter. 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. Review the history of usp 797 and the milestones that led to the development of. Pharmaceutical compoundingsterile preparations uspnf. In accordance with the rules and procedures of the 20152020 council of experts, usp. Revised 797 anticipated to be published in the usp nf december 2019. Sterile preparations, became effective january 1, 2004 6. 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.
The usp 797 gap tool has been updated to reflect the version of usp general chapter 797 that was published on june 1, 2020. Like usp 797 and usp, the provisions of proposed usp deal with product transport, product storage, compounding, preparation, and administration of parenteral products. Pha 334 exam 1 learn with flashcards, games, and more for free. Downloadable documents for compliance use these documents to aid in compliance with standards, whether state boards of pharmacy, usp or fda.
Based on the public comments, 797 revised and republished for public comment june 2019. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. Guidelines for pharmaceutical sterile preparations chapter 797. There is no record of room particle counts for estimation of room cleanliness. Unless there are clear and concise understanding and agreement on the definitions, concepts. Usp 797 sterile compounding study guide flashcards quizlet.
Understanding usp 797 csps include the following types of preparations. However, usp builds on earlier regulations by focusing on hds and occupational safety. Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. No plans for compliance polling question how compliant is your site with usp 797. Interested parties may submit comments by mail or commercial carrier by august 15 to. Concepts in sterile preparations and aseptic technique. Pharmaceutical compoundingsterile preparations, usp 39 page 626. Describe both the general responsibilities of compounding personnel and those specific to the. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Compounding sterile preparations 1 t he revision bulletin to usp chapter 797, pharmaceutical compounding. Inspection, regulation, and oversight of sterile compounding pharmacies article pdf available in journal of parenteral and.
A rewritten with patient safety in mind quality matters. 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. March 12, 2020 appeals panel issues decisions on the appeals to usp, and see faqs on usp compounding appeals. Originally written in 2004, chapter 797 is popularly agreed to increase the safety of the compounding setting and its ingredients. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare. Nonengineering controls selecting the appropriate engineering controls is not the only consideration in meeting usp 797 standards. United states pharmacopeia required below informational specific for dietary supplements usp 2010 2015 council of experts, destefano aj. Sep 18, 2014 usp chapter 797 is a standard that has been difficult for many sterile compounding facilities to follow. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use.
This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. Pharmaceutical compounding sterile preparation, united stated pharmacopeia 36national formulary 31. Identify the key acronyms and state the definition of key terms associated with usp 797. Revision status of usp chapter 797 pharmaceutical compounding.
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. The gap analysis for the current usp, 797 and are available now in microsoft word. Medical the best way to sample the air is to use electronic air samplers in a process known. Usp 797 pharmaceutical compoundingsterile preparations.
Understanding usp chapter 797 engineering control certification requirements and environmental sampling and remediation strategies chs pharmacy education series proce, inc. Based on the number and significance of public comments received in response to the. Wa pharmacy quality assurance commission 2020 responsible. Let emsl analytical, inc provide microbiological testing services in support of your usp activities. Office of manufacturing qualityoffice of compliance. 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. Usp continues to improve chapter 797 by collecting comments from users and having technical. The current usp chapter 797 on sterile compounding had three levels of safety protocols for compounding reflecting increasing levels of potential risk to patients. 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.
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