Ashps video guide to chapter provides a concise overview of the essential components of the revised and updated chapter. The sterile compounding room is approximately 11 x 14 with an 8 ceiling. Usp chapter 797, pharmaceutical compoundingsterile. Completely reorganizes the chapter and groups like sections together, eliminating redundancies, and clarify requirements.
These tools can help build the foundation for a corrective action plan that details the activities and resources needed to comply with usp compounding requirements. Based on the number and significance of public comments received in. Usp continues to improve chapter 797 by collecting comments from users and having technical. Recently, a new chapter was proposed for addition to the united. Guidelines for pharmaceutical sterile preparations chapter 797. Proposed revisions to general chapter will be preposted. The 2015 sterile compounding inspections were educational but full compliance with usp 797 is expected and any noncompliance found during the 2016 sterile compounding inspections may result in disciplinary action. At the january 2015 board meeting, the board adopted the revised. Pharmaceutical compoundingsterile preparations revision bulletin table 1. Pharmacopeia 12601 twinbrook parkway rockville md 208521790. 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.
Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings. Usp allows an exception to the rule of placing the pec in an iso class 7 buffer area if. Interested parties may submit comments by mail or commercial carrier by august 15 to. Sep 18, 2014 usp chapter 797 is a standard that has been difficult for many sterile compounding facilities to follow. Free download usp gc 797 appeals updates millions of medications are compounded each year in the us to meet the unique needs of patients.
Millions of medications are compounded each year in the us to meet the unique needs of patients. Sterile compounding is done in a 6 xxhlf horizontal laminar flow hood. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. To help ensure clarity and consistency, the faqs are being revised. Here is a brief overview of 797 and the impact it will have on daily operations within ascs. 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. The revised section on environmental monitoring discusses requirements.
Introduction to usp general chapter 797 slideshare. All rights reserved 21 i would like to comment on the hazardous drugs as csp. It improves the health and wellbeing of our patients and 2. Confidential and proprietary for internal use only. 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. Chapter 797 is a pharmaceutical compounding document produced by the united states pharmacopeia usp. Process must simulate the most challenging or stressful conditions encountered during initial media fill testing, a minimum of 3 mediafill tests must be completed. 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. Office of manufacturing qualityoffice of compliance. On january 1, 2004, the first version of usp chapter 797, pharmaceutical compounding. Uspnf establishes standards for medicines, food ingredients and dietary supplements. The safety of your patients begins by ensuring your entire staff understands the practice requirements set forth in usp chapter. Proposed revisions to usp chapter 797 for sterile compounding date.
Vigorous hand washing with antimicrobial soap for 2 minutes up to the elbows before donning gloves. Understanding usp chapter engineering control certification requirements and environmental sampling and remediation strategies chs pharmacy education series proce, inc. The standards in this chapter do not pertain to the clinical administration of. Usp 797 compliance with usp 797 is our duty because. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Sterile preparations became official,1 which details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all practice settings in which sterile preparations are compounded. Pharmaceutical compounding sterile preparations usp. Usp chapter 797 gap analysis page 7 of 16 x medical center. If you are at all involved in anesthesia, you are also probably generally aware of what 797 is all about. 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.
Kentucky board of pharmacy state office building annex, suite. Pharmacopeial usp convention is a nonprofit organization that sets legally recognized standards for drugs. Shoe covers, head and facial hair covers, face masks, tyvek nonshedding gown and sterile gloves required. Mar 18, 2015 usp chapter, pharmaceutical compounding. Dix, esquire, on behalf of adventist health system for florida hospital altamonte and winter park memorial hospital, seeking a variance or waiver of the requirement of rule 64b16 27. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from. Bowling department of veterans affairs contracting office, 4th. By now, you have probably heard about usp 797 or simply 797. Iso classification of particulate matthalmic drops and ointments, and tissue ter in room air limits are in particles of 0.
General guidelines for matching csps and components. 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. Revision status of usp chapter 797 pharmaceutical compounding. Agenda item ix compounding regulations california state board. Compounding expert committee september 9, 2015 uspu. Csps are to be administered within 12 hours of compounding, or per physicians orders, whichever sooner csps meet the definition of lowrisk per usp compounding must be nonhazardous. In accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical. 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. Usp 797 800 compliance click to enlarge in 2005, usp 797 will require these are regulations, not guidelines a cleaner environment for health care institutions, pharmacies, physicians practice facilities and other facilities where compounded sterile preparations are prepared, stored and dispensed. The usp 797 gap tool has been updated to reflect the version of usp general chapter 797 that was published on june 1, 2020. No plans for compliance polling question how compliant is your site with usp 797. Although usp provides guidelines for preparing sterile. Products that are to be injected carry the greatest risk of serious health effects.
Learn vocabulary, terms, and more with flashcards, games, and other study tools. Usp chapter general overview personnel cleansing and garbing requirements. Comments will be accepted until january 31, 2016, the end of the comment period for pf 416. Usp 797800 compliance pharmaceutical compounding nci. However, if you dump a bunch of flour, butter, eggs, sugar and nuts in a bowl. General chapter 797, pharmaceutical compounding sterile preparations usp, the latest version of which was issued in 2008. Sterile preparations, became effective january 1, 2004 6. October 30, 2015 language added to the pharmaceutical services section to require compliance with usp chapter 797 when compounding sterile preparations language added to the nursing services section to require compliance with usp chapter 797 when compounding sterile preparations outside the pharmacy immediateuse csps. This legal pathway should be recognized as a future enforcement tool against practitioners who do not respect usp 797 guidelines. Sterile compounding webinar california hospital association. 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. Compounding personnel are encouraged to participate in adverse event reporting and product defects programs of the food and drug administration fda and united states pharmacopeia usp. Usp 797 pharmaceutical compoundingsterile preparations. The lowest risk level required under usp 797 for a critical area is an iso class 5 area designation.
Usp 797 is a farreaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound sterile preparations are prepared, stored, and dispensed. Originally written in 2004, chapter 797 is popularly agreed to increase the safety of the compounding setting and its ingredients. Usp 797 clean room guidelines standards for sterile. Comments should include corresponding line number to the proposed revisions to the general chapter. Usp general chapter pertains to the compounding of both hazardous.
Identify the key acronyms and state the definition of key terms associated with usp 797. Usp chapter 797 is a standard that has been difficult for many sterile compounding facilities to follow. 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. 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. April 14, 2015 page 3 70 27 26 immediate usea sterile preparation that is not prepared according to usp 797 71 standards i. In accordance with usp s bylaws, the responsible expert committees worked with a sense of.
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