On january 1, 2004, the first version of usp chapter 797, pharmaceutical compounding. Understanding the impact to home infusion connie sullivan, bspharm vice president of research and innovation. Cleaning schedules should at least meet the minimum requirements outlined in usp if a sink is located in the ante room, it should be disinfected frequently and surface sampled for viable organisms. Usp 797 hazardous cleanroom design usp 800 while usp 797 previously established requirements for hazardous drug compounding, usp chapter 800 sets forth new requirements. Expert committee general chaptersstatistics in accordance with the rules and procedures of the 2015 2020 council of experts, the general chaptersstatistics expert committee has postponed limit on number of large deviations when assessing content uniformity in large samples 1099. New revision of usp 797 key changes contec healthcare. 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 lowest risk level required under usp 797 for a critical area is an iso class 5 area designation. Usp chapter is a set of enforceable sterile compounding standards issued. Weve previously published a host of articles in regards to the usp.
Section 20 633b of the general statutes is repealed and the following is substituted in lieu thereof effective january 1, 2020. Millions of medications are compounded each year in the us to meet the unique needs of patients. Sterile preparations, became effective january 1, 2004 6. 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. 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. It is proposed to revise this chapter to improve clarity, respond to stakeholder input, and reflect new science.
Sep 18, 2014 usp chapter 797 is a standard that has been difficult for many sterile compounding facilities to follow. 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 purpose of this chapter is to provide compounders with guidance on applying good compounding practices for the preparation of compounded formulations for dispensing andor administration to humans or animals. Revision bulletins are transferred to the accelerated revision history section when the standard is published and becomes official in the next uspnf book or supplement. Usp 797 provides protection for sterile compounding activities and their environments from contaminations. Guidelines for pharmaceutical sterile preparations chapter 797. Usp chapter, and apply them in a variety of nuclear pharmacy practice settings. Uspnf establishes standards for medicines, food ingredients and dietary supplements.
What are the differences between usp 795, 797, and 800. General chapter usp establishes best practices and regulations for the. 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. The purpose of usp 797 is a general protection of sterile compounds and spaces from contamination. However, only one out of six graduates 1 are typically prepared for. Sterile preparations became official,1 which details the.
The usp 797 gap tool has been updated to reflect the version of usp general chapter 797 that was published on june 1, 2020. Confidential and proprietary for internal use only. Usp 797 pharmaceutical compoundingsterile preparations. 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. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. 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. Usp and cgmps agree that compounding personnel represent the impact of usp on environmental monitoring comprehensive monitoring is essential both usp and cgmps require. Revision status of usp chapter 797 pharmaceutical compounding. Do not print and file copy a downloaded from this website.
Usp chapter 797 was the first set of enforceable sterile compounding standards created by the united states pharmacopeia. The usp published revisions to usp 795, 797, and 825 on june 1, 2019. Products that are to be injected carry the greatest risk of serious health effects. Cgmp usp crosswalk 2 subpart b organization and personnel is this requirement of 21 cfr 211 required in usp chapter. Vigorous hand washing with antimicrobial soap for 2 minutes up to the elbows before donning gloves. 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.
Included among usps standards are those related to the practice and quality standards for compounded sterile preparations, usp 797. Understanding usp chapter 797 engineering control certification requirements and environmental sampling and remediation strategies chs pharmacy education series proce, inc. Iso classification of particulate matter in room air limits are in particles of 0. Usp chapter 797 was the first set of enforceable sterile. 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. To help ensure clarity and consistency, the faqs are being revised. Jan 04, 2017 the guidelines for pharmaceutical sterile preparations this entry was posted in compounding pharmacy and tagged chapter 797, compounding pharmacy, health news, pharmacy safety, sterile pharmacy on january 4, 2017 by matt poteet, pharm. Usp chapter 797 gap analysis page 7 of 16 x medical center. Shoe covers, head and facial hair covers, face masks, tyvek nonshedding gown and sterile gloves required. 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. Usp 800 protects healthcare workers, patients and environments against hazardous.
Interested parties may submit comments by mail or commercial carrier by august 15 to. Pharmaceutical compoundingsterile preparations revision bulletin. By now, you have probably heard about usp 797 or simply 797. 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. Here is a brief overview of 797 and the impact it will have on daily operations within ascs. Reorganized existing chapter to group similar topics together, eliminate redundancies, and clarify requirements. The comment period for this revision ends on november 30, 2018. A timeline of sterile compounding events and actions taken. Compounding of total parenteral nutrition fluids using manual or automated. Although usp provides guidelines for preparing sterile. Completely reorganizes the chapter and groups like sections together, eliminating redundancies, and clarify requirements. The expertise and detailed knowledge they demonstrated provided very.
Office of manufacturing qualityoffice of compliance. Usp general chapter pertains to the compounding of both hazardous. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Understanding contaminants and how to remove them usp and you pharmaceutical. This period has come to a close, with the updated version of the chapter posted on. Preserved intradermal and subcutaneous sdvs and mdvs are exempt from personnel, environmental and storage requirements if all criteria are met. This legal pathway should be recognized as a future enforcement tool against practitioners who do not respect usp 797 guidelines. Review the history of usp 797 and the milestones that led to the development of. 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. Iest handbook for usp 797 compliance contains the standards and recommended practices you need to meet requirements for cleanrooms and other controlled environments. Mar 18, 2015 usp chapter, pharmaceutical compounding. 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. It improves the health and wellbeing of our patients and 2.
United states pharmacopeia required below informational specific for dietary supplements usp 2010 2015 council of experts, destefano aj. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from. Usp 797 compliance with usp 797 is our duty because. Free download usp gc 797 appeals updates millions of medications are compounded each year in the us to meet the unique needs of patients. General guidelines for matching csps and components. Sterile preparations 797 tightens patient safety guidelines. Sterile compounding is done in a 6 xxhlf horizontal laminar flow hood. This chapter is intended to provide information as a supplement to other relevant chapters. The standards in this chapter do not pertain to the clinical administration of.
Based on the number and significance of public comments received in. The visante team assisted us in conducting a usp 797 and 800 gap analysis across all our sterile compounding locations. 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. Sterile compounding webinar california hospital association. Usp 800 expands controls for the protection of workers and environments against hazardous drug. Usp allows an exception to the rule of placing the pec in an iso class 7 buffer area if. Key changes in cleaning, disinfecting, and garbingrelated activities hca029 070819. Pharmaceutical compoundingsterile preparations, usp 39 page 626. Kastango served on the usp sterile compounding committee from 20052010 and 2010 2015 usp council of experts, compounding expert committee until april 20. In accordance with the rules and procedures of the 20152020 council of experts, usp. In accordance with usp s bylaws, the responsible expert committees worked with a sense of. Identify the key acronyms and state the definition of key terms.
If you are at all involved in anesthesia, you are also probably generally aware of what 797 is all about. Compliance with usp chapter 797 was added as a requirement on 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. Compounding sterile preparations 2 executive summary on january 1, 2004, the first version of usp chapter, pharmaceutical compounding. The documents are available for free download until december 2019. Upon completion of this course the participant will be able to discuss the general concepts and principles associated with the provision of compounded sterile preparations csps as specified by. Usp chapter general overview personnel cleansing and garbing requirements. 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. 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. Usp continues to improve chapter 797 by collecting comments from users and having technical. Pharmacopeia 12601 twinbrook parkway rockville md 208521790. General chapter 797, pharmaceutical compounding sterile preparations usp, the latest version of which was issued in 2008. Usp chapter 797, pharmaceutical compoundingsterile.
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. 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. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. For more information on the revision bulletins and the accelerated revision process, see usps guideline on the use of accelerated processes for revisions to uspnf. Strategies for ensuring compliance with revised usp. Cleaning the compounding pharmacy presented by david nobile contec, inc. Blueprint for implementing chapter 797 for compounding. 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. Overview of chapter for surveyors and inspectors kate douglass october 9, 20. Introduction to usp general chapter 797 slideshare. 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.
Section 1 4 usp chapters means chapters 797, 800 and 825 of. Usp pharmaceutical compounding sterile preparations proposed revision. Another major change within the new usp revision is the frequency at which environmental and personnel viable monitoring must be done. To download the complimentary usp general chapter 797 pharmaceutical compounding sterile preparations, please click here. 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. Current usp protocols state that media fill testing and fingertip testing of all compounding personnel must be done either annually or semiannually depending on the risk level. Pharmaceutical compoundingsterile preparations, usp 39.
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