The usp seeks public comments about the revisions, which could take a year to finalize. Unless there are clear and concise understanding and agreement on the definitions, concepts. Posted on february 21, 2017 february 21, 2017 author bob miller categories pharmacy consulting. Some facility requirements will necessitate a revision to usp. There is no record of room particle counts for estimation of room cleanliness. Revision status of usp chapter 797 pharmaceutical compounding. So far no inspections have occurred that we are aware of regarding usp compliance. Uspnf establishes standards for medicines, food ingredients and dietary supplements. Feb 25, 2016 the majority of responding schools 88% taught students about united states pharmacopeia usp standards for sterile compounding chapter 797. As the article notes, even though usp is legally enforceable and the industry standard despite state legislation, less than half of state regulations specifically reference usp for sterile compounding. 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. 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 or 7 cleanroom to the iso class 8 anteroom.
Jan 04, 2017 chapter 797 is a pharmaceutical compounding document produced by the united states pharmacopeia usp. Please complete the andor compliance survey for the busiest sterile compounding location at your facilityorganization in the event your facility has more than one compounding location as the survey starts, you will be asked a series of questions in the demographic information and general compounding domains. Proposed revisions to usp chapter 797 for sterile compounding date. Compounding sterile preparations 1 t he revision bulletin to usp chapter, pharmaceutical compounding. Guidelines for pharmaceutical sterile preparations. Pharmaceutical ited so long as they have been proven to be equiva lent or superior with. It is no longer acceptable for facilities that prepare a low number of hds to use a biologic safety cabinet bsc or a compounding aseptic containment isolator caci in a nonnegative pressure room. Usp 797 compliance with usp 797 is our duty because. Identify the key acronyms and state the definition of key terms associated with usp 797. The led temperature display on the xx freezer read 21c, but the tempscribe read 10 c to 14 c. Those that must be sterilized before administration.
Pharmacopeia usp has published proposed revisions to chapter 797, which outlines procedures and requirements for compounding sterile preparations. Usp sets standards for the quality of drug products and works with healthcare providers to help them meet the standards. Chapter 797 is a pharmaceutical compounding document produced by the united states pharmacopeia usp. As the article notes, even though usp 797 is legally enforceable and the industry standard despite state legislation, less than half of state regulations specifically reference usp 797 for sterile compounding. Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that include baths and soaks. Proposed revisions to usp 797 overview and current status.
Establishing a practice standard for compounding sterile preparations in pharmacy. It improves the health and wellbeing of our patients and 2. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. Those prepared according to the manufacturers label instructions that expose original contents to potential contamination. Usp chapter 797 general overview personnel cleansing and garbing requirements.
This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. Apr 01, 2015 usp is designed to complement both usp and usp 797. Sterile compounding webinar california hospital association. Usp 800 expands controls for the protection of workers and environments against hazardous drug compounds. Office of manufacturing qualityoffice of compliance. Usp chapter 797 gap analysis page 6 of 16 x medical center confidential and proprietary for internal use only entry door. A stepby step guide to a usp 797 compliant pharmacy details the core. Let emsl analytical, inc provide microbiological testing services in support of your usp activities. The revisions are based on input received by the usp, but the standardssetting group hopes to receive. Guidelines for pharmaceutical sterile preparations chapter 797. Based on the number and significance of public comments received in. 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. Lintfree wipes dipped in diluted cleaning agent can be used to clean iso class 5 to 8 areas.
Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Interested parties may submit comments by mail or commercial carrier by august 15 to. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. Pdf on oct 1, 2004, eric s kastango and others published usp chapter 797. In september 2015, the united states pharmacopeia usp released a proposed updated chapter 797 on procedures for sterile compounding. Wa pharmacy quality assurance commission 2020 responsible. Originally written in 2004, chapter 797 is popularly agreed to increase the safety of the compounding setting and its ingredients. The usp received appeals on specific provisions of the chapter, and those appeals were subsequently granted, effectively sending this version of. Reorganized existing chapter to group similar topics together, eliminate redundancies, and clarify requirements. Developing usp general chapter 797 usp is a notforprofit, sciencedriven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards. The revised section on environmental monitoring discusses requirements. To download the complimentary usp general chapter pharmaceutical compounding sterile preparations, please click here. Iso classification of particulate matter in room air limits are in particles of 0. Another major change within the new usp revision is the frequency at which environmental and personnel viable monitoring must be done.
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. Compliance to usp 797 regarding pharmacy compounding is an ongoing and increasingly important issue for all compounding pharmacies to address as quickly as possible. Wolters kluwer publishes guide for achieving compliance with usp guidelines for pharmaceutical compounding. The majority of responding schools 88% taught students about united states pharmacopeia usp standards for sterile compounding chapter 797. Compounding sterile preparations 1 t he revision bulletin to usp chapter 797, pharmaceutical compounding. Wolters kluwer, a leading global provider of information for healthcare professionals and students, announced today the release of a complementary guide designed to help healthcare organizations stay compliant with u. Even if you had no income tax withheld from your wages during the year, you may be eligible for the eic. 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. Wolters kluwer publishes guide for achieving compliance. Chapters 1 through 999 are enforceable standards that describe how certain functions and processes are to be performed. Llongterm action items require significant planning and fiscalhuman resources and resolution will take longer.
All rights reserved 21 i would like to comment on the hazardous drugs as csp. United states pharmacopeia, 36th revision adopted by fl board of pharmacy october 1, 2014 includes chapters 797, 71, 85, 731 these standards are intended to. Thus, their testing procedures must be verified to meet the usp requirements stated in the individual monograph for the component being tested. Pharmaceutical compoundingsterile preparations revision bulletin table 1. 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. 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. For example, under dextrose injection, the following is stated.
Establishing a practice standard for compounding sterile preparations in pharmacy article pdf available in american journal of healthsystem pharmacy 6118. Clerks and secretaries education network fiscal offices information officers information. Sterile preparations, was released in late 2007 and will become official on june 1, 2008. Usp 800 is the latest united states pharmacopeia usp revision which clarifies and expands upon hazardous drug compounding both sterile and nonsterile. D uring the 1960s, the practice of pharmacy began growing and evolving. Understanding usp chapter engineering control certification requirements and environmental sampling and remediation strategies chs pharmacy education series proce, inc.
Some facility requirements will necessitate a revision to usp 797. However, a requirement statement from usp has been added in blue. Identify the key acronyms and state the definition of key terms associated with usp. The compounding expert committee of usp began a new set of revisions in july 2010, and on september 25, 2015, usp issued a set of proposed revisions to usp 797 for public comment. Usp plan to revise chapter on sterile compounding preparations. The benefits of usp 797 compliance include the minimization of contamination of csps, improved aseptic proficiency of hospital pharmacy personnel. Proposed revisions unveiled for compounding usp 797. Wolters kluwer publishes guide for achieving compliance with. Pharmacopeia 12601 twinbrook parkway rockville md 208521790. Brief history of usp 797 and the current, proposed revisions. All content in this area was uploaded by eric s kastango on jul, 2015. The fiscal impact of this regulation is much more than anticipated, and in. Agenda item vii california state board of pharmacy ca. Sterile compounding also requires cleaner facilities.
Most schools at that point would only have been in the process of addressing the chapter. Usp proposed revisions to general chapter pharmaceutical. No plans for compliance polling question how compliant is your site with usp 797. Pharmacopeia chapter pharmaceutical compounding sterile preparations usp 797. 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. Overview of chapter for surveyors and inspectors kate douglass october 9, 20. Vigorous hand washing with antimicrobial soap for 2 minutes up to the elbows before donning gloves. Preserved intradermal and subcutaneous sdvs and mdvs are exempt from personnel, environmental and storage requirements if all criteria are met. In accordance with the rules and procedures of the 2015 2020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations 797. No plans for compliance polling question how compliant is your site with usp. Guidelines for pharmaceutical compounding wolters kluwer.
In response to an increasing number of patient injuries due to medication delivery and sterile compounding, the industry began calling attention to safety. Mar 18, 2015 usp chapter, pharmaceutical compounding. Introduction to usp general chapter 797 linkedin slideshare. General guidelines for matching csps and components. The usp compounding guideline, chapter 800, clarifies and expands upon the hazardous drug guidelines found in usp 797. Blueprint for implementing chapter 797 for compounding. March 12, 2020 appeals panel issues decisions on the appeals to usp, and see faqs on usp compounding appeals september 23, 2019 revised general chapter is postponed until further notice. 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. 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. Usp chapter gap analysis page 6 of 16 x medical center confidential and proprietary for internal use only entry door. The return is located in the in the ceiling the back of the room away from the entry door. Understanding usp 797csps include the following types of preparations. In accordance with the rules and procedures of the 20152020 council of experts, usp. General chapter 797, pharmaceutical compounding sterile preparations usp, the latest version of which was issued in 2008.
Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings. Possible federal tax refund due to the earned income. Included among usps standards are those related to the practice and quality standards for compounded sterile preparations, usp 797. Changes focus on air quality, clarifications the u. Millions of medications are compounded each year in the us to meet the unique needs of patients. 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. Sterile preparations, became effective january 1, 2004 6. 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. United states pharmacopeia, 36th revision adopted by fl board of pharmacy october 1, 2014 includes chapters 797, 71, 85, 731 these standards are intended to apply to all sterile pharmaceuticals, notwithstanding. Shoe covers, head and facial hair covers, face masks, tyvek nonshedding gown and sterile gloves required.
Usp chapter, and apply them in a variety of nuclear pharmacy practice settings. Design considerations of a compounded sterile preparations course. Describe both the general responsibilities of compounding personnel and those specific to 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. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. Sterile compounding differs from nonsterile compounding see pharmaceutical compoundingnonsterile preparations 795 and good compounding practices 1075 primarily by requiring a test for sterility. 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 general overview personnel cleansing and garbing requirements. Pennsylvania board of pharmacy update created date. Design considerations of a compounded sterile preparations. 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. It is proposed to revise this chapter to improve clarity, respond to stakeholder input, and reflect new science. The last official revision to usp 797 became official on june 1, 2008.
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