Usps compounding committee was well received by pharmacists and pharmacy boards usp administration pressed for a sterile compounding chapter and, in 2004, the compounding committee published. Usp also released a newly developed chapter regarding the preparation, compounding, dispensing, and. It improves the health and wellbeing of our patients and 2. Download 797 pharmaceutical compoundingsterile preparations book pdf free download link or read online here in pdf. This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. Compounding sterile preparations 2 executive summary on january 1, 2004, the first version of usp chapter, pharmaceutical compounding.
Compounding personnel usp and cgmps agree that compounding personnel represent the impact of usp on environmental monitoring comprehensive monitoring is essential both usp and cgmps require concentrated em efforts to ensure the facility is maintained in a manner that does not adversely affect the quality and safety of csps. Usp chapters and new and revised compounding standards at issue the united states pharmacopeia usp in june 2019 released several new and revised pharmacy compounding standards. The applicable standards of practice for safe sterile compounding are, at a minimum, the standards published in the united states pharmacopeia national formulary chapter pharmaceutical compounding sterile preparations and other relevant uspnf chapters usp. Select and appropriately don protective gloves, goggles, gowns, masks, and. The use of technologies, techniques, materials, and procedures other.
United states pharmacopeia usp usp nonsterile compounding usp sterile compounding usp nonsterile and sterile hazardous drugs related chapters,, etc. September 23, 2019 revised general chapter is postponed until further notice. United states pharmacopeia 12601 twinbrook parkway rockville, md 208521790 re. General chapter pharmaceutical compounding sterile preparations free download usp gc appeals updates millions of medications are compounded each year in the us to meet the unique needs of patients. September 23, 2019 revised general chapter 797 is postponed until further notice. Usp develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Cnsps with a usp nf monograph or stability information. Usp 797 state specific language citation notes idaho state board of pharmacy no yes idaho pharmacy regulations in consideration of the applicable provisions of usp 795 concerning pharmacy compounding of nonsterile preparations, usp 797 concerning sterile preparations, chapter 1075 of the uspnf concerning good compounding.
Specific questions about usp cleansing, garbing and. Segregated compounding area sca low and medium risk level hds may be prepared in a c. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. Perform antiseptic hand cleansing and disinfection of nonsterile compounding surfaces. Together, our organizations represent approximately,500 physicians who provide care to millions of patients suffering from asthma and allergic diseases. Usp revisions for compounding nonsterile medicines the. Usp chapter does not define the specific elements to be included in the. A focus on antimicrobial risk level activity description on june 1, 2008, the revision bulletin to usp chapter 797, pharmaceutical compounding. In accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations. All books are in clear copy here, and all files are secure so dont worry about it. Usp pharmaceutical compounding sterile preparations proposed revision. Usp 797 provides minimum practice and quality standards for csps of drugs and nutrients, based on current scientific information and best sterile compounding. Learn about bd compliance with usp general chapter pharmaceutical compoundingsterile preparations.
Would a facility be in compliance with usp if a turbulent airflow compounding aseptic isolator cai is employed to compound or dispense sterile drug preparations assuming that the placement of the above cai and personnel cleansing meet the requirements as. Review of requirements for sterile compounding usp 797. Reorganized existing chapter to group similar topics together, eliminate redundancies, and clarify requirements. Specifically, usp published the final revised version of general chapter pharmaceutical compounding of sterile preparations to accompany the. On june 1, 2019, the united states pharmacopeia usp released new and revised standards aimed at ensuring the quality of compounded medicines. Disclosure speaker has no disclosure 2 objectives objectives for the pharmacists.
Usp 797 scope and purpose sterile compounding combining, admixing, diluting, pooling, reconstituting, repackaging or other alterations of a drug or bulk drug substance to create a sterile compound purpose of the chapter is to minimize harm aseptic technique must be followed administration is out of scope. Failure to complete this addendum within the month of march or within 30 days of. Uspnf establishes standards for medicines, food ingredients and dietary supplements. Usp chapter 797, pharmaceutical compoundingsterile. Usp general chapter 797 pharmaceutical compounding sterile preparations provides official standards for compounding quality sterile preparations. Sep 23, 2019 in 2004, usp revised the chapter, which became a general chapter devoted specifically to sterile compounding, pharmaceutical compoundingsterile preparations general chapter or. Specific questions about usp 797 cleansing, garbing and disinfecting. Usp general chapter pharmaceutical compoundingsterile preparations. Use these documents to aid in compliance with standards, whether state boards of pharmacy, usp or fda. It was issued by the united states pharmacopeia and endorsed by the joint commission on accreditation of healthcare organizations jcaho. Usp regulation is the first enforceable standard for sterile compounding. Usp 797 compliance with usp 797 is our duty because.
Washington law holds the responsible manager and all pharmacists on duty responsible for ensuring pharmacy compliance with all state and federal laws governing the practice of pharmacy. Read online usp 797 pharmaceutical compounding sterile. The applicable standards of practice for safe sterile compounding are, at a minimum, the standards published in the united states pharmacopeia national formulary chapter 797 pharmaceutical compounding sterile preparations and other relevant usp nf chapters usp 797. Usp compounding standards and beyonduse dates buds june 3, 2019 comparing buds between the official and the revised the revised chapter addresses compounded nonsterile preparations cnsps requiring shorter buds and buds for cnsps that may be extended e. The gap analysis for the current usp, and are available now in microsoft word. Wa pharmacy quality assurance commission 2020 responsible. Mar 22, 2020 download 797 pharmaceutical compoundingsterile preparations book pdf free download link or read online here in pdf. In addition to addressing personnel, facility, and monitoring requirements, the chapter sets forth. The revisions to the chapters, including updates to the beyonduse dates. Review of requirements for sterile compounding usp 797 and. Download usp 797 pharmaceutical compounding sterile. The objective of 797 is to describe conditions and practices to prevent harm, including death, to patients that could result.
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. Beyond use dating for sterile compounding beyond use date bud is very different from expiration date. Introduction and scope this chapter describes the minimum standards to be followed when preparing compounded sterile human and animal drugs based on current scientific information and best practices for sterile compounding. Best practices and compliance with usp proposed revisions. Specifically, usp published revisions to general chapter pharmaceutical compounding and sterile preparations and published a new general chapter hazardous drugs handling in healthcare settings. In accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compounding sterile preparations 797. Usp pharmaceutical compounding sterile preperations. Pharmaceutical compounding sterile preparations pharmacy. Would a facility be in compliance with usp 797 if a turbulent airflow compounding aseptic isolator cai is employed to compound or dispense sterile drug preparations assuming that the placement of the above cai and personnel cleansing meet the requirements as stated in usp 797. Read online 797 pharmaceutical compoundingsterile preparations book pdf free download link book now.
Usp response to shortages of garb and personal protective. Usp and coverage for many other types of health care entities. Office of manufacturing qualityoffice of compliance. Compounding sterile preparations 1 t he revision bulletin to usp chapter 797, pharmaceutical compounding. Pharmaceutical compounding sterile preparations revision bulletin table 1. Aan appreciate this opportunity to submit comments on proposed revisions to usp general chapter on sterile compounding as published in the pharmacopeial forum. It was originally enacted in 2004i, and the latest revision became official in 2008ii. Simplifi 797 customers need to reach out to their customer success manager to find out when the elearning will be available. Usp chapter 797 defines bud as the date or time after which a compounded sterile preparation csp may not be stored or transported and is calculated from the date or time of compounding. Usp compounding standards and beyonduse dates buds on june 1, 2019, usp published updates to the usp general chapters on compounding nonsterile and sterile preparations alongside new standards for compounding radiopharmaceutical drugs. Predictably, they are taking different approaches to the implementation of the requirements set forth in usp chapter, because of the many differing approaches the states are taking with regard to recognizing, implementing and enforcing usp chapter compounding. The united states pharmacopeia and the national formulary uspnf is a compilation of drug monographs, biologics, medical devices, dietary supplements, reference tests and standards, and standards for compounding of sterile and nonsterile.
Inspection, regulation, and oversight of sterile compounding pharmacies article pdf available in journal of parenteral and enteral nutrition 362 suppl. The longawaited new usp chapter 797 standards on sterile compounding were released june 1 and take effect dec. On june 1, the united states pharmacopeia usp released the longawaited. Compounding record and master formulation record for sterile compounds usp chapter 797 requires that a compounding record be created and maintained for sterile products. This site is like a library, you could find million book here by using search box in the header. General chapter pharmaceutical compounding sterile preparations. Some of these measures are not in compliance with usp 797, so let your state board of pharmacy or other. Compounding personnel are adequately skilled, educated, instructed, and trained to correctly perform and document the following activities in their sterile compounding duties. The updates pertain to the usp general chapters on compounding nonsterile medicines usp pharmaceutical compoundingnonsterile preparations, and compounding sterile medicines usp pharmaceutical. Sca provided it meets the requirements in usp chapter and the csp is assigned a bud of 12 hours or less.
We are pleased to report that thanks to the vigorous collective advocacy of the allergy community, the final standards mirror the proposed standards released last july. The purpose of usp chapter pharmaceutical compounding is to provide standards for the protection and safety of patients and healthcare workers involved in sterile compounding preparations such as pharmacists, nurses, physicians and pharmacy technicians by reducing the potential for microbial contamination caused by an unclean. In june 2019, the united states pharmacopeia usp released several new and revised pharmacy compounding standards. Usp 797 clean room guidelines standards for sterile. Understanding the impact to home infusion connie sullivan, bspharm vice president of research and innovation. Sterile preparations became official,1 which details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all prac. Describe the differences in the requirements for usp 797. Usp pharmaceutical compoundingsterile preparations. Compounding personnel usp 797 and cgmps agree that compounding personnel represent the impact of usp 797 on environmental monitoring comprehensive monitoring is essential both usp 797 and cgmps require concentrated em efforts to ensure the facility is maintained in a manner that does not adversely affect the quality and safety of csps. Pharmaceutical compoundingsterile preparations1 change to read. Review of requirements for sterile compounding usp 797 and 800 hoda masmouei, ms, pharmd pgy2 healthsystem pharmacy administration resident jackson memorial hospital march 2016. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from.
Usp 797 state specific language citation notes idaho state board of pharmacy no yes idaho pharmacy regulations in consideration of the applicable provisions of usp 795 concerning pharmacy compounding of non sterile preparations, usp 797 concerning sterile preparations, chapter 1075 of the usp nf concerning good compounding. Brenda jensen cpht, cnmt, mba sdshp annual conference april 78, 2017 disclosure the views and opinions expressed are those of the speaker and are not endorsed by or affiliated with usp. Usp articles, or within 10% if not specified, until their buds. Jul 08, 2019 on june 1, 2019, the united states pharmacopeia usp released new and revised standards aimed at ensuring the quality of compounded medicines. 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. Sterile compounding and room design by douglas theobald, cfm health care organizations that compound sterile formulations are getting a head start on compliance with the usp 797 guidelines, courtesy of the jcaho joint commission on accreditation of healthcare organizations. All csps are prepared in a manner that maintains sterility and minimizes the introduction of particulate matter. Sterile compounding june 2008 version versus june 2019 version september 25, 2019 board of pharmacy meeting summary easier to read more clear about documentation requirements and processes have designated person dp no risk categories was low, medium, and high. Predictably, they are taking different approaches to the implementation of the requirements set forth in usp chapter 797, because of the many differing approaches the states are taking with regard to recognizing, implementing and enforcing usp chapter 797 compounding. Compounding record and master formulation record for sterile compounds usp chapter requires that a compounding record be created and maintained for sterile products. Sterile preparations, was released in late 2007 and will become official on june 1, 2008.
Personnel training and competency evaluation of garbing, aseptic work practices, and cleaning and disinfection procedures section. If one or more of the starting components being used to compound is not sterile, the sterility of the compounded preparation must be achieved. Nov 22, 2019 in accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. In 2004, usp revised the chapter, which became a general chapter devoted specifically to sterile compounding, pharmaceutical compoundingsterile preparations general chapter or. Specifically, usp published revisions to general chapter 797 pharmaceutical compounding and sterile preparations and published a new general chapter hazardous drugs handling in healthcare settings. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations.
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