The handbook and calendar for the 2015 academic year is now available online here. Kastango, mba, rph, fashp the top 10 gaps in usp chapter compliance understand regulation assess risk level develop action plan implement compliance plan control measure communicate ve state of compliance point in time figure 1. The usp 797 gap tool has been updated to reflect the version of usp general chapter 797 that was published on june 1, 2020. Pharmaceutical compoundingsterile preparations, usp 39. Mar 18, 2015 usp chapter, pharmaceutical compounding.
If you are at all involved in anesthesia, you are also probably generally aware of what 797 is all about. This period has come to a close, with the updated version of the chapter posted on. Guidelines have been produced on both drug shortage management and iv. Physician anesthesiologists have encountered usp under the socalled onehour rule that required the administration of all immediateuse. Tuesday, march 31, 2015 and wednesday, april 1, 2015 8. Both cite provisions of usp 797 and usp 71, the compounding guidelines produced. Blueprint for implementing chapter 797 for compounding. Physician anesthesiologists have encountered usp under the socalled onehour rule that required the administration of all immediateuse compounded sterile products csps begin within one hour.
The existing chapter had provided procedures for allergen immunotherapy extracts as a separate element to processes applicable to three levels of risk for other sterile compounded products. 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. The usp and chapter 797 the united states pharmacopeia national formulary uspnf recognized in the 1938 federal food, drug, cosmetic act. Usp chapter gap analysis page 5 of 16 x medical center confidential and proprietary for internal use only although it was stated that daily cleaning was occurring in the xx pharmacy, the floor and the legs of the xx pharmacy compounding isolator were soiled with a brownish residue suspected to be. Further information, visit the corporate identity page. All requests for the production of promotional materials must be sent to the communications manager at communications atusp. Until usp, no consistent or enforceable compounding practice standard existed ashp published technical assistance bulletin and guidelines in 1993 and 2000 which became basis for usp usp chapter to prevent patient harm and. Usp select requirements for sterile compoundingpage 19. Products that are to be injected carry the greatest risk of serious health effects.
We will discuss the history of 797, how infection rates are impacted by the implementation of 797 and policies and procedures surrounding clean room utilization, sterile preparation and administration. The usp received appeals on specific provisions of the chapter, and those appeals were subsequently granted, effectively sending this version of. U this rule does not apply to nuclear pharmacies, unless the pharmacy meets the. Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings. Understanding usp chapter 797 engineering control certification requirements and environmental sampling and remediation strategies chs pharmacy education series proce, inc. Pharmaceutical compoundingsterile preparations, usp 39 page 626.
Join ceta to be able to access the below documents in their entirety. General chapter 797, pharmaceutical compounding sterile preparations usp, the latest version of which was issued in 2008. Originally written in 2004, chapter 797 is popularly agreed to increase the safety of the compounding setting and its ingredients. 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. Usp 797 hazardous cleanroom design usp 800 while usp 797 previously established requirements for hazardous drug compounding, usp chapter 800 sets forth new requirements. 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 provides access to medication for patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. Describe both the general responsibilities of compounding personnel and those specific to the. Failure to complete this addendum within the month of march or within 30 days of. Agenda item vii california state board of pharmacy ca. Wa pharmacy quality assurance commission 2020 responsible. Compounding pharmacy products and information resources. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from. The current usp chapter 797 on sterile compounding had three levels of safety protocols for compounding reflecting increasing levels of potential risk to patients.
United states pharmacopeial convention usp proposed revisions to general chapter pharmaceutical. 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. Kienle, rph, mpa, fashp director, accreditation and medication safety cardinal health innovative delivery solutions disclosure patricia kienle is an employee and stockholder of cardinal health she is an elected member of the usp comppgpounding expert committee. These include proposed revisions to usp chapter, the creation of. Sterile preparations, became effective january 1, 2004 6.
Completely reorganizes the chapter and groups like sections together, eliminating redundancies, and clarify requirements. Guidelines for pharmaceutical sterile preparations. The walls and ceilings of the sca must be cleaned on a schedule. Compounding sterile preparations 2 executive summary on january 1, 2004, the first version of usp chapter, pharmaceutical compounding. A subscription to ijpc includes a print copy delivered by postal mail and online access to electronic pdf copies of your subscribed issues. Compounding of total parenteral nutrition fluids using manual or automated.
As of january 2012, ceta application guides are available to ceta members as a free download. Jan 19, 2015 2015 calendar and handbook now available. This period has come to a close, with the updated version of the chapter posted on on december 3, 2007, and scheduled to become official on june 1, 2008. Six full issues of the journal published during the respective calendar year. Usp 797 clean room guidelines standards for sterile. Understanding usp 797 conclusion the current usp 797 regulations emphasize the need to maintain highquality standards for processes, components, and environments for sterile compounding preparations. Usp chapter 797 and inoffice compounding of allergen. 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. Chapter 797 is intended to decrease the risk of a patient receiving an infected medication in addition to guarding the health care professional in.
By now, you have probably heard about usp 797 or simply 797. Revision status of usp chapter 797 pharmaceutical compounding. In september 2015, usp 797 was completely rewritten and will most likely have a similar effective date of july 2018. 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.
The guidelines for pharmaceutical sterile preparations. But its a big issue with many facets, so regardless, you may be wondering when, what, who, where and how this will affect your. Pharmacopeia 12601 twinbrook parkway rockville md 208521790. Before entering a compounding area, at a minimum, individuals must. The communications unit produces a range of publications for the university. The benefits of usp 797 compliance include the minimization of contamination of csps, improved aseptic proficiency of hospital pharmacy personnel. Usp chapter 797 gap analysis page 5 of 16 x medical center. No plans for compliance polling question how compliant is your site with usp.
Identify the key acronyms and state the definition of key terms associated with usp. T the pharmacy shall comply with the drug database reporting requirements for chapter 472937 of the administrative code. The standards in this chapter do not pertain to the clinical administration of. Although it was stated that daily cleaning was occurring in the xx pharmacy, the floor and the legs of the xx pharmacy compounding isolator were soiled with a brownish residue suspected to be dextrose.
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 preparationsthose described herein. Two draft fda guidance documents stir controversy ncbi. 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. Usp 797 compliance with usp 797 is our duty because.
General guidelines for matching csps and components. In addition, the sops must include a schedule and method for establishing and. Overview learn or refresh your knowledge on usp 797 guidelines for compounding sterile products. This handbook and calendar is the universitys document of authority. 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. 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 healthcare quality standards. Based on the number and significance of public comments received in response to. May 27, 2015 usp 1116 and its implications for measuring microbial recovery rates may 27, 2015 the recently revised united states pharmacopoeia usp chapter microbiological control and monitoring of aseptic processing environments includes a thorough description, definitions and guidance on microbiological control and monitoring in aseptic. The handbook and calendar for the 2015 academic year is now available online here note. Cag000 application guide creation flowchart revised 2019. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. Facilities cag0032006, revised may 20, 2015, which is hereby. United states pharmacopeia required below informational specific for dietary supplements usp 20102015 council of experts, destefano aj. Included among usps standards are those related to the practice and quality standards for compounded sterile preparations, usp 797.
Sterile compounding webinar california hospital association. Interested parties may submit comments by mail or commercial carrier by august 15 to. Sterile compounding webinar june 28, 2016 cha webinar welcome liz mekjavich. View usp sample report the new usp guidelines are designed to prevent the improper handling and contamination of sterile compounds for certain drugs or biologic preparations. Sterile preparations became official,1 which details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all prac. Usp plan to revise chapter on sterile compounding preparations. Until usp, no consistent or enforceable compounding practice standard existed ashp published technical assistance bulletin and guidelines in 1993 and 2000 which became basis for usp usp chapter to prevent patient harm and fatality from microbal contamination nonsterility. Editorial calendar for the international journal of pharmaceutical. T his twoday, interactive training is designed for hospital pharmacists and pharmacy technicians, and will provide best practice education and the skills necessary to perform usp chapter compliant sterile compounding. Usp 800 is the latest united states pharmacopeia usp revision which clarifies and expands upon hazardous drug compounding both sterile and nonsterile. Office of manufacturing qualityoffice of compliance. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Proposed revisions to chapter were introduced in september 2015.
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, and apply them in a variety of nuclear pharmacy practice settings. To download the complimentary usp general chapter 797 pharmaceutical compounding sterile preparations, please click here. Free download usp gc 797 appeals updates millions of medications are compounded each year in the us to meet the unique needs of patients. Compounding of total parenteral nutrition fluids using manual or.
Understanding usp chapter engineering control certification requirements and environmental sampling and remediation strategies chs pharmacy education series proce, inc. 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. In accordance with the rules and procedures of the 20152020 council of experts, usp is postponing. 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.
Aside from high, medium and lower risk categories, a separate section detailed standards for compounding of allergen immunotherapy, reflecting both how allergen immunotherapy is. On june 1, the us pharmacopeial convention usp released its wellanticipated revisions to chapter the chapter that addresses pharmaceutical compounding sterile preparations. 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. Oct 10, 2015 overview learn or refresh your knowledge on usp 797 guidelines for compounding sterile products. Due to pending appeals, 797 remains postponed until further notice, and remains informational until 797 is finalized. 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. In accordance with usp s bylaws, the responsible expert committees worked with a sense of.
It improves the health and wellbeing of our patients and 2. Let emsl analytical, inc provide microbiological testing services in support of your usp activities. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. Confidential and proprietary for internal use only. Remove all hand, wrist, and other exposed jewelry including piercings that could interfere with the effectiveness of garbing. It is strongly recommended that you have copies of usp ready for reading. Under usp 797 and the sixsystem model, a pharmacy must demonstrate control of microbes and particles through a robust em program, start ing with a written plan for differential pressure monitoring, nonviable particle counts, and viable particle counts to assess the functionality of the air handling system. Guidelines for pharmaceutical sterile preparations chapter 797. The lowest risk level required under usp 797 for a critical area is an iso class 5 area designation. Uspnf establishes standards for medicines, food ingredients and dietary supplements.
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