Reorganized existing chapter to group similar topics together, eliminate redundancies, and clarify requirements. Compounding of total parenteral nutrition fluids using manual or automated. Drug manufacturers are regulated primarily under the federal food, drug, and cosmetic act, which requires compliance with usp standards. Compounding sterile preparations 1 t he revision bulletin to usp chapter 797, pharmaceutical compounding.
You are required to file a 2015 minnesota income tax return if you. Identify the key acronyms and state the definition of key terms associated with usp 797. Department of the treasuryinternal revenue service. General chapter 797, pharmaceutical compounding sterile preparations usp, the latest version of which was issued in 2008. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. Pharmasystems solutions for usp compliance sterile preparations for compounding pharmacies usp chapter, sterile preparations for pharmaceutical compounding, details the quality standards, conditions and procedures for compounding sterile preparations csps of drugs and nutrients in a cleanroom. 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. 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. Pharmaceutical compoundingsterile preparations revision bulletin table 1. Revision status of usp chapter 797 pharmaceutical compounding. Physicians, pharmacy practitioners, and nurses, in contrast, are regulated primarily by the states, which may elect to cite.
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. March 12, 2020 appeals panel issues decisions on the appeals to usp, and see faqs on usp compounding appeals. Key procedural information is placed in boxes so that. A timeline of sterile compounding events and actions taken. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings. Usp articles, or within 10% if not specified, until.
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. Possible federal tax refund due to the earned income. The benefits of usp 797 compliance include the minimization of contamination of csps, improved aseptic proficiency of hospital pharmacy personnel. Vigorous hand washing with antimicrobial soap for 2 minutes up to the elbows before donning gloves. Usp 797 compliance with usp 797 is our duty because. 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.
Overview of chapter for surveyors and inspectors kate douglass october 9, 20. Usp 800 history and compliance linkedin slideshare. Possible federal tax refund due to the earned income credit \eic\ created date. Uspnf establishes standards for medicines, food ingredients and dietary supplements. Another major change within the new usp revision is the frequency at which environmental and personnel viable monitoring must be done. Usp allows an exception to the rule of placing the pec in an iso class 7 buffer area if. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. Let emsl analytical, inc provide microbiological testing services in support of your usp activities. Usp chapter 797 provides suggested standard operating procedures sops designed to ensure the quality of the environment in which a csp is prepared several procedures are recommended within usp chapter 797 20. United states pharmacopeia required below informational specific for dietary supplements usp 2010 2015 council of experts, destefano aj. Usp general chapter usp general chapter 797 is among the unusual usp general chapters that applies to practitioners rather than to drug manufacturers. Current good manufacturing practiceguidance for human. Describe both the general responsibilities of compounding personnel and those specific to the.
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. 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. Usp chapter 797 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 dextrose. No plans for compliance polling question how compliant is your site with usp 797. If the drug is compounded from an approved drug product, and the. It is proposed to revise this chapter to improve clarity, respond to stakeholder input, and reflect new science. Usp chapter 797 gap analysis page 6 of 16 x medical center confidential and proprietary for internal use only entry door.
Usp chapter 797, pharmaceutical compoundingsterile. September 23, 2019 revised general chapter is postponed until further notice. Completely reorganizes the chapter and groups like sections together, eliminating redundancies, and clarify requirements. Chapters 1 through 999 are enforceable standards that describe how certain functions and processes are to be performed. As with all medications, the compounding of radiopharmaceuticals must comply with these standards whether in a hospital nuclear medicine department or by an outsourced. The revised section on environmental monitoring discusses requirements. If you are eligible, claim the eic on your 2015 income tax return. Sterile preparations, was released in late 2007 and will become official on june 1, 2008. Specifically, when applied to em, the sixsystem model does not significantly differ from 797, and using both demonstrates that the pharmacy is cognizant of cgmps and applies them to 797. Pharmaceutical ited so long as they have been proven to be equiva lent or superior with. 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. Interested parties may submit comments by mail or commercial carrier by august 15 to. There is no record of room particle counts for estimation of room cleanliness. The return is located in the in the ceiling the back of the room away from the entry door.
Usp nf establishes standards for medicines, food ingredients and dietary supplements. At the end of 2015, the child was under age 19 and younger. It describes a number of requirements, including responsibilities of compounding personnel, training, environmental monitoring, storage and testing of finished preparations. 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. Usp is a public standardsestablished authority called the united states pharmacopeia. Included among usps standards are those related to the practice and quality standards for compounded sterile preparations, usp 797.
Pharmaceutical compoundingsterile preparations, usp 39 page 626. It improves the health and wellbeing of our patients and 2. Pharmacopeial convention, 20152020 resolutions april 25, 2015. Pharmasystems solutions for usp compliance sterile. The usp 797 gap tool has been updated to reflect the version of usp general chapter 797 that was published on june 1, 2020. Office of manufacturing qualityoffice of compliance. Discuss usp 797 importance of workflow in the sterile compounding area.
Usp chapter 797 was the first set of enforceable sterile. Usp is a comprehensive set of standards designed to improve patient safety by reducing the number of transmitted infections due to improperly compounded pharmaceuticals. Introduction to usp general chapter 797 linkedin slideshare. Sterile preparations, became effective january 1, 2004 6. On june 1, 2019, usp published revisions to general chapter for nonsterile compounding and general chapter 797 for sterile compounding, as well as a new general chapter for radiopharmaceuticals.
Usp 797 helps to ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency. 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. 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. Massachusetts was one of the states that required compliance with usp 797 for sterile. Pharmacopeia 12601 twinbrook parkway rockville md 208521790. Iso classification of particulate matter in room air limits are in particles of 0. 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. Based on the number and significance of public comments received in. This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. In addition, usp chapter 797 requires that a pec provide an iso class 5 environment while compounding csps. Unless there are clear and concise understanding and agreement on the definitions, concepts.
For example, under dextrose injection, the following is stated. Shoe covers, head and facial hair covers, face masks, tyvek nonshedding gown and sterile gloves required. Federal hazard communications standard hcs defines a hazardous drug. It sets guidelines on the health care products that are created or sold in the us on over the counter and prescription medicines.
This information offers insights into key compliance measures that prevent contamination of the work environment and thus protect the workers who handle the nioshlisted drugs than can cause health problems for laboratory and pharamacy workers. Csps are to be administered within 12 hours of compounding, or per physicians orders, whichever sooner csps meet the definition of lowrisk per usp compounding must be nonhazardous. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. Purified water, usp, is considered acceptable for use with equipment or utensils. General guidelines for matching csps and components. This period has come to a close, with the updated version of the chapter posted on. Sterile preparations 797 tightens patient safety guidelines. Usp chapter 797 general overview personnel cleansing and garbing requirements. Usp 797 clean room guidelines standards for sterile. Usp 797800 compliance pharmaceutical compounding nci. Mar 18, 2015 usp chapter, pharmaceutical compounding.
Pharmaceutical compoundingsterile preparations uspnf. Review the history of usp 797 and the milestones that led to the development of. Usp 797 is one of the most popular standards that prevent excessive microbial contaminations and bacterial endotoxins. Thus, their testing procedures must be verified to meet the usp requirements stated in the individual monograph for the component being tested. After publication of the revised and new compounding standards, usp received appeals on certain provisions in, 797, and. General chapter usp 797 establishes best practices and regulations for the production of compounded sterile preparations. Usp 797 800 compliance click to enlarge in 2005, usp 797 will require these are regulations, not guidelines a cleaner environment for health care institutions, pharmacies, physicians practice facilities and other facilities where compounded sterile preparations are prepared, stored and dispensed.
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