In accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations. Beyond use dating for sterile compounding beyond use date bud is very different from expiration date. 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. This site is like a library, you could find million book here by using search box in the header. September 23, 2019 revised general chapter is postponed until further notice.
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. Pharmaceutical compoundingsterile preparations1 change to read. Usp chapter 797 does not define the specific elements to be included in the compounding record. 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 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. All books are in clear copy here, and all files are secure so dont worry about it. 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. Usp 797 provides minimum practice and quality standards for csps of drugs and nutrients, based on current scientific information and best sterile compounding. 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. In june 2019, the united states pharmacopeia usp released several new and revised pharmacy compounding standards. 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 chapter does not define the specific elements to be included in the. The longawaited new usp chapter 797 standards on sterile compounding were released june 1 and take effect dec.
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. Read online usp 797 pharmaceutical compounding sterile. 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. Usp also released a newly developed chapter regarding the preparation, compounding, dispensing, and. Review of requirements for sterile compounding usp 797 and. 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. 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.
Simplifi 797 customers need to reach out to their customer success manager to find out when the elearning will be available. Usp and coverage for many other types of health care entities. 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. Segregated compounding area sca low and medium risk level hds may be prepared in a c.
Pharmaceutical compounding sterile preparations pharmacy. This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. Downloadable documents for compliance compounding today. Understanding the impact to home infusion connie sullivan, bspharm vice president of research and innovation. 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. Sca provided it meets the requirements in usp chapter and the csp is assigned a bud of 12 hours or less.
Usp general chapter pharmaceutical compoundingsterile preparations. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from. Review of requirements for sterile compounding usp 797 and 800 hoda masmouei, ms, pharmd pgy2 healthsystem pharmacy administration resident jackson memorial hospital march 2016. Review of requirements for sterile compounding usp 797.
Specifically, usp published revisions to general chapter pharmaceutical compounding and sterile preparations and published a new general chapter hazardous drugs handling in healthcare settings. Usp revisions for compounding nonsterile medicines the. All csps are prepared in a manner that maintains sterility and minimizes the introduction of particulate matter. 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. United states pharmacopeia 12601 twinbrook parkway rockville, md 208521790 re. Read online 797 pharmaceutical compoundingsterile preparations book pdf free download link book now. In 2004, usp revised the chapter, which became a general chapter devoted specifically to sterile compounding, pharmaceutical compoundingsterile preparations general chapter or. 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. Specifically, usp published the final revised version of general chapter pharmaceutical compounding of sterile preparations to accompany the.
Download usp 797 pharmaceutical compounding sterile. Compounding sterile preparations 2 executive summary on january 1, 2004, the first version of usp chapter, pharmaceutical compounding. 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. 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. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. It was issued by the united states pharmacopeia and endorsed by the joint commission on accreditation of healthcare organizations jcaho. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. The revisions to the chapters, including updates to the beyonduse dates. Perform antiseptic hand cleansing and disinfection of nonsterile compounding surfaces. 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. On june 1, the united states pharmacopeia usp released the longawaited. Usp 797 clean room guidelines standards for sterile. On june 1, 2019, the united states pharmacopeia usp released new and revised standards aimed at ensuring the quality of compounded medicines.
The gap analysis for the current usp, and are available now in microsoft word. Usp develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. Pharmaceutical compounding sterile preparations revision bulletin table 1. 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. Reorganized existing chapter to group similar topics together, eliminate redundancies, and clarify requirements. Final standards for allergen extract compounding under usp. Sterile preparations, was released in late 2007 and will become official on june 1, 2008. Use these documents to aid in compliance with standards, whether state boards of pharmacy, usp or fda. 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. Uspnf establishes standards for medicines, food ingredients and dietary supplements. 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. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. Usp pharmaceutical compounding sterile preparations proposed revision. If one or more of the starting components being used to compound is not sterile, the sterility of the compounded preparation must be achieved.
Usp regulation is the first enforceable standard for sterile compounding. Wa pharmacy quality assurance commission 2020 responsible. Learn about bd compliance with usp general chapter pharmaceutical compoundingsterile preparations. United states pharmacopeia usp usp nonsterile compounding usp sterile compounding usp nonsterile and sterile hazardous drugs related chapters,, etc. 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.
Mar 22, 2020 download 797 pharmaceutical compoundingsterile preparations book pdf free download link or read online here in pdf. 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. It was originally enacted in 2004i, and the latest revision became official in 2008ii. Specific questions about usp cleansing, garbing and. 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. Personnel training and competency evaluation of garbing, aseptic work practices, and cleaning and disinfection procedures section. 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. Usp pharmaceutical compoundingsterile preparations. Best practices and compliance with usp proposed revisions. It improves the health and wellbeing of our patients and 2. Usp articles, or within 10% if not specified, until their buds. Cnsps with a usp nf monograph or stability information. The use of technologies, techniques, materials, and procedures other.
Specific questions about usp 797 cleansing, garbing and disinfecting. Disclosure speaker has no disclosure 2 objectives objectives for the pharmacists. 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. 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. Office of manufacturing qualityoffice of compliance. 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. Usp pharmaceutical compounding sterile preparations. The updates pertain to the usp general chapters on compounding nonsterile medicines usp pharmaceutical compoundingnonsterile preparations, and compounding sterile medicines usp pharmaceutical. Compounding record and master formulation record for sterile compounds usp chapter 797 requires that a compounding record be created and maintained for sterile products. Download 797 pharmaceutical compoundingsterile preparations book pdf free download link or read online here in pdf.
Together, our organizations represent approximately,500 physicians who provide care to millions of patients suffering from asthma and allergic diseases. 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. 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. Select and appropriately don protective gloves, goggles, gowns, masks, and. 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. Aan appreciate this opportunity to submit comments on proposed revisions to usp general chapter on sterile compounding as published in the pharmacopeial forum. Compounding personnel are adequately skilled, educated, instructed, and trained to correctly perform and document the following activities in their sterile compounding duties.
September 23, 2019 revised general chapter 797 is postponed until further notice. The objective of 797 is to describe conditions and practices to prevent harm, including death, to patients that could result. Usp general chapter 797 pharmaceutical compounding sterile preparations provides official standards for compounding quality sterile preparations. 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. Usp chapter 797, pharmaceutical compoundingsterile. Inspection, regulation, and oversight of sterile compounding pharmacies article pdf available in journal of parenteral and enteral nutrition 362 suppl. Usp 797 compliance with usp 797 is our duty because. A focus on antimicrobial risk level activity description on june 1, 2008, the revision bulletin to usp chapter 797, pharmaceutical compounding. 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. Compounding sterile preparations 1 t he revision bulletin to usp chapter 797, pharmaceutical compounding.
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