Nnusp 797 sterile compounding pdf

Bulk component containers are labeled with appropri. North carolina board of pharmacy rules have always required a compounding record and did so well before implementation and enforcement of usp. Compounding sterile pharmaceuticals, which includes definitions and abundant language found in the united states pharmacopeias general chapter. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from. Cnsps with a usp nf monograph or stability information. When working with nonhazardous sterile compounding, its important to keep in mind all details to safely prepare csps. Usp chapter requires that a compounding record be created and maintained for sterile products. Compounding aseptic containment isolators cacis or class ii, type a1 or a2 nuclear pharmacy isolators meet usp 797 and iso class 5 for sterile compounding of. Specialty areas such as radiopharmaceuticals require special 3. Usp nonsterile compounding usp sterile compounding usp nonsterile and sterile hazardous drugs related chapters,, etc. Compounding sterile preparations 1 t he revision bulletin to usp chapter, pharmaceutical compounding. One of our main goals as a 503a usp 797 usp 800 compliant facility is to provide medications which are in short supply to improve patient care. In june 2019, the united states pharmacopeia usp released several new and revised pharmacy compounding standards.

Review of requirements for sterile compounding usp 797. Best practices and compliance with usp proposed revisions. Aseptic technique, sterile compounding, and iv admixture programs. New fda sterile compounding draft guidance documents released this year 1.

For emergent use, no storage or batch compounding, administer within 1hr of preparation, simple transfer of sterile non hazardous dry e. Standard operating procedures sops medisca network. Select and appropriately don protective gloves, goggles, gowns, masks, and. Pharmaceutical compounding sterile preparations pharmacy. 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. Office of manufacturing qualityoffice of compliance. The inspection process for pharmacies compounding sterile. Note that if there is a discrepancy between the bud limits and the stability time found in the package insert or other reference, the sterile compounding professional must use the shorter of the two for the bud.

For sterile compounding areas used for low and mediumrisk preparations, a minimum of monthly evaluation is appropriate. Understanding the impact to home infusion connie sullivan, bspharm vice president of research and innovation. Usp develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. Jcaho compliance with usp is required by all jcahoaccredited pharmacies. Usp just released the revised general chapter pharmaceutical compounding sterile preparations. Review of sterile compounding per usp 797 and related. Usp chapter standard applies to sterile compounding without regard to the location or profession of the compounding personnel.

In addition, defines buds for csps that have a preservative added or have had sterility testing performed. Pharmaceutical compoundingsterile preparations uspnf. 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. Among other things, these standards currently require that. Ashps video guide to chapter provides a concise overview of the essential components of the revised and updated chapter. Eastern states compounding pharmacy also complies with the very stringent, nationallyaccepted quality control, quality assurance, and quality improvement standards defined in the usp 797. While the regulations were initially introduced in 2004, this is only the second revision to the rules, which have been widely adopted by various regulatory bodies as the safety standards for compounded sterile preparations csps. Compounded sterile preparation usp 797 and usp 800. Cleaning the compounding pharmacy presented by david nobile contec, inc. Sterile preparations, was released in late 2007 and will become official on june 1, 2008.

There has been no commercial support for this activity. Handling in healthcare settings update on appeals panel decision general chapters and the appeals panel has granted the appeals to general chapters and and is remanding the chapters to the compounding expert committee. Usp develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. September 23, 2019 revised general chapter is postponed until. Simplifi 797 customers need to reach out to their customer success manager to find out when the elearning will be available. Blueprint for implementing chapter 797 for compounding.

Evolution of sterile compounding standards, 19702010. Describe the differences in the requirements for usp 797. Sterile and nonsterile compounding online practice exam. Usp797 guidelines raise concerns anesthesia patient. 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. Pharmacy compounding of human drug products under section 503a of the fdc act guidance 062016 2. Usp standards should concentrate on the hands as the greatest source of potential contamination. Compounding technique,54 getting started in aseptic compounding,55 and compounding sterile preparations. Prescription requirement under section 503a of fdc act 042016. Sterile compounding practices are enforceable by both the fda and jcaho. See pharmaceutical compoundingsterile preparations sources and are properly stored according to manu. Sterile compounding and room design february 19, 2016 copaadmin 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. Augustine, pharmd, is a member of the 20002005 sterile compounding committee scc, of the council of experts of the united states pharmacopeial convention, inc. As of 20, 22 state boards of pharmacy specifically require compliance with usp standards for.

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. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. Usp response to shortages of garb and personal protective. Chemical testing aspects of usp chapter for compounded sterile preparations the regulations set forth by the united states pharmacopeia usp chapter,1 in effect since january 1 of 2004, have generated a great deal of interest because they have established the first practice standards of sterile. Twelve respondents 28 percent reported that when inspecting sterile compounding pharmacies in the state, they prioritized inspections for pharmacies where highrisk sterile compounding occurs. Participants need to have a valid username and password to claim credit. Establishing a practice standard for compounding sterile preparations in pharmacy find, read and cite all the research. In many sections, the reader is advised to complete training programs or to consult usp chapter 797 or other professional publications. Cms appears to be supporting usp guidelines regarding the compounding of sterile medications usp 797 that was written in 2007, raising concerns that setting up an iv bag or pressure line or cardiopulmonary bypass machine more than an hour in advance of a procedure increases infectious risk. 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 797 usp 795 nonsterile compounding procedures and guidelines usp 797 sterile compounding procedures and guideline first chapters are enforceable by agencies such as the fda and tjc hint. Perform antiseptic hand cleansing and disinfection of nonsterile compounding surfaces. Introduction competency only no ce pre2019 based on the popular ashp training video and workbook, this first course in a three course series introduces the learner to the basics of usp chapter 797, describes the purpose and function of the sterile compounding facility, and demonstrates how to maintain a sterile compounding area. Proper identification of compounding risk levels and.

Sterile compounding sometimes takes place in physician offices or clinics, which are normally regulated by a state board of medicine. Jan 04, 2017 chapter 797 scrutinizes the behavior of compound pharmacists, resulting in an optimal level of quality assurance. September 23, 2019 revised general chapter is postponed until further notice. Understanding contaminants and how to remove them usp and you pharmaceutical compoundingsterile preparations this general chapter provides procedures and requirements for compounding sterile preparations. 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. Medisca networks unique series of standard operating procedures sops are the foundation to improving the quality of your compounding practice by facilitating your daytoday compliance with the most current regulatory guidelines and standards of practice. Understand safety data sheets sds, formerly known as msds.

Participants who successfully complete the entire sterile compounding elearning series within a year before taking the live training, attend the entire onsite training and successfully pass a test administered through criticalpoints lms will be eligible to earn the nabpcriticalpoint certification in sterile compounding for inspectors cisci. Following a series of highprofile events in recent years, national healthcare governing bodies and state boards of pharmacy have increased regulatory scrutiny on compounding practices in light of harmful outcomes that have resulted from errors. Failure to complete this addendum within the month of march or within 30 days of. Shall or must requirement should recommendation csp compounded sterile preparation. Sterile compounding quality management pharmacy onesource. Timeline of the regulation of csps in texas 11920 2005 tsbp establishes a second task force on sterile compounding to provide new recommendations to the board. Examine importance of sterility when utilizing aseptic technique to prepare iv products and the role of usp chapter 797 in maintaining infection.

Criticalpoint has updated the sterile compounding elearning curriculum to include new course material covering chapter along with new and revised content covering 797. 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 pharmaceutical compounding sterile preperations. Under usp, healthcare facilities may repackage sdvs into smaller doses, each intended for use with one patient. Sterile compounding facility usp 797800 meta pharmacy.

This is because no patient should have to give up their right to an accurate, safe, sterile dose no matter where that dose is prepar ed or who prepares it. Usp 797 sterile compounding study guide flashcards quizlet. Section 1 4 usp chapters means chapters 797, 800 and 825 of the united states pharmacopia that pertain to compounding sterile pharmaceuticals and their referenced. In fact, this workbook and video should be considered more as an organizer or overview of sterile compounding programs, rather than a detailed reference text. To download the complimentary usp general chapter pharmaceutical compounding sterile preparations, please click here. 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. Mcn healthcares compounded sterile preparation usp and usp compliance manual provides practical policies and procedures outlining usp and usp requirements as well as joint commission and niaho medication management standards. To ensure everyone follows the same procedures and protocols, facilities may choose to post a checklist that covers all the key elements of proper aseptic technique according to eric kastango, rph, mba, fashp, pharmacists and technicians should.

Summarize the major changes between the current standard and the final revision to chapter pharmaceutical compoundingsterile. The tentative changes were published in may 2006, with the public comment period opened through august 15, 2006. Pharmacists engaged in compounding sterile products in compliance with usp chapter 797 must demonstrate aseptic manipulation skills. A guide to sterile compounding for pharmacy personnel this activity is for pharmacists and is sponsored by postgraduate healthcare education, llc phe. Disclosure speaker has no disclosure 2 objectives objectives for the pharmacists. 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. For instance, a hospital with a sterile compounding lab in one building and a smaller, non sterile facility next door could register the sterile compounding lab, but under the new 503b guidance, would be required to meet 503b cgmp standards for products produced in the non sterile facility as well. Pdf on oct 1, 2004, eric s kastango and others published usp chapter 797. This innovative video program is an ideal competency assessment and training tool for everyone concerned with safety and quality issues related to sterile compounding. Guidelines for pharmaceutical sterile preparations chapter 797. Usp chapter 797 was released to the public in 2004 and has classified sterile compounding into 3 risk groups. Compounding personnel are adequately skilled, educated, instructed, and trained to correctly perform and document the following activities in their sterile compounding duties.

Review of requirements for sterile compounding usp 797 and 800 hoda masmouei, ms, pharmd pgy2 healthsystem pharmacy administration resident jackson memorial hospital march 2016. Management and practical compliance with usp training program has been accredited for a total of 16hours of live continuing education credit. Our comprehensive sets of nonsterile and sterile sops are built within a logical. Pharmaceutical compoundingsterile preparations revision bulletin level for air, surface, and personnel gear are notexposed to unidirectional hepafiltered air, also exceeded for a specified cleanliness class. 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. As part of this process, all content has been extensively revised with additional information, high resolution images and interactivity. 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. 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. For each risk level, the chapter establishes staff responsibilities and training, quality control processes, competence assessment, environmental quality and control, and quality assurance program requirements. To obtain credit for completing usp 797 pharmaceutical compoundingsterile preparations for compounding professionals, complete the activity, evaluation questions, and then claim credit. Pharmaceutical compounding sterile preparations, usp 41 page 6554 and pf 416 nov.

This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. Usp general chapter provides standards for compounding quality nonsterile preparations. It is designed to teach student technicians important theory and concepts of sterile compounding and to keep seasoned. Usp 797 requires compounding pharmacies to determine the risk level of the compounding done in their facilities and to perform the compounding in cleanrooms or other controlled environments as specified for the risk level.

Summary of usp 797 pharmaceutical compounding sterile preparations source of base information pharmacopeial form vol 29 4 july aug. The revised usp sterile compounding standards nhia. Usp and coverage for many other types of health care entities. Pharmacists and technicians involved in nonsterile compounding must have documented training appropriate for the type of compounding occurring. If the room is clean, the clinical benefits of sterile gowns and sleeves are minimal. Insanitary conditions at compounding facilities 082016 3.

Compounding process includes complex aseptic manipulations other than the singlevolume transfer compounding process requires unusually long duration the sterile csps do not contain broadspectrum bacteriostatic agents, and are administered over several days in. The use of technologies, techniques, materials, and procedures other. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. 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. Usp chapter does not define the specific elements to be included in the compounding record. Accurate reporting of this information is crucial for at least two reasons. Section 20 633b of the general statutes is repealed and the following is substituted in lieu thereof effective january 1, 2020. General chapter pharmaceutical compounding sterile preparations.

Compounding aseptic containment isolatordisinfectantan agent that frees from infec. Ashp guidelines on compounding sterile preparations. Sterile compounding manual single copy now includes a 17page usp 797 update 2008 as the didactic component of the aseptic technique verification exercise, the compounding manual is organized in accordance with accepted educational principles and includes selfassessment exercises to assist the participant in identifying problem areas. States pharmacopeia usp chapter 797,1 in effect since january 1 of 2004, have generated a great deal of interest because they have established the first practice standards of sterile pharmacy compounding in us history that are enforceable at both the federal and state levels. We learned nonsterile compounding before sterile compounding. Pharmaceutical compounding sterile preparations revision bulletin table 1.

All compounding personnel are trained in and educated about the importance of this environmental monitoring process. In sterile compounding areas, a bactericidal disinfectant e. This list represents a small portion of the products meta is able to supply under the authority granted by the state board of pharmacy so feel free to contact us with any questions regarding this aspect. Primers usp chapter 797 1930 am j healthsyst pharmvol 61 sep 15, 2004 may be inspected for complicity with these standards by state boards of pharmacy, fda, and accreditation organizations. 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. A national study of sterile compounding practices douglas k, kastango e, cantor p pharmacy purchasing and products. Pharmaceutical compoundingsterile preparations revision bulletin table 1. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. For sterile compounding areas used for highrisk preparations, at least weekly evaluation is appropriate. In addition to addressing personnel, facility, and monitoring requirements, the chapter sets forth. 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. Usp chapter 797, pharmaceutical compoundingsterile. Whether your pharmacist is responsible for creating a sterile medication every couple of months or 50 sterile medications daily, chapter 797 demands adherence to these sterile techniques.