In 2004, the usp published general chapter 797, pharmaceutical compounding. Pharmaceutical compounding sterile preparations, unless additional or different standards are established by this article. Background 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 radiopharmaceutical compounding. The conditions of organism preparation and storage must be standardized for the neutralizer evaluamicrobial recovery from tion and should reflect the conditions of. Finalized revisions to usp general chapters and 797 were released on june 1, 2019. Usp chapters, 797, and effective july 1, 2018 for nonsterile, sterile, and hazardous. General chapter 797 for sterile compounding, as well as a new general chapter for radiopharmaceuticals. Piervincenzi, phd january 29, 2016 page 3 to general chapter 797 as currently drafted, if it were to become enforceable. Usp general chapter impact on nuclear medicine technology. The objective of this chapter is to describe con scribed in this chapter. Objectives by the end of this presentation you should be able to. Both chapters provide guidelines that if followed, ensure product protection and patient safety. As one chapter ends, another begins cardinal health.
Must be downloaded with registration directly from this text is a courtesy copy of general chapter hazardous drugs. At the time this monograph was posted, the usp nf had delayed the effective dates of general chapter 797 indefinitely. Sep 23, 2019 general chapter is referenced in many state and national laws and regulations. Information on usp general chapter usp general chapter faqs usp general chapter education courses sign up for usp updates authorized reprint for individual use only. Usp nf general chapter 797 pharmaceutical compounding sterile preparations the objective of the usp 797 standard is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations csps. Usp general chapter pharmaceutical compoundingnonsterile preparations, 2 usp general chapter 797 pharmaceutical compoundingsterile preparations, 3 usp general chapter hazardous. The potential impact of usp general chapter journal of.
General responsibilities mdcgr chapter the organizations leaders are responsible for the safety and quality of care provided through its pharmaceutical compounding services. Specifically, usp published the final revised version of general chapter pharmaceutical. Understanding usp 797 in order to comply with the chapter, you have to understand it. Usp pertains to handling of hazardous drugs and contains policies to protect healthcare workers. Usp general chapter microbial characterization, identification, and strain typing. The standards in this chapter are intended to approducts are to be prepared for administraply to all persons who prepare csps and all places tion.
The general chapters numbered to are enforceable by the fda and official monographs and standards of the usp nf. 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 latest and greatest on usp 797 800 an update alyssa donadio, pharm. The recent release of a revised general chapter titled. All stakeholders opinions matter, and all received comments are considered. In accordance with usps bylaws, the responsible expert. Sep 10, 2019 usp 797 is the chapter on sterile nonhazardous sterile medications. Strains of the test microorganisms suitable for use in for products containing a mercurial preservative that cannot the growth promotion test and the method suitability be tested by the membrane filtration method, fluid thiogtest continued. The revisions to and 797 published on june 1, 2019 and which make reference to, have been. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Nov 25, 2020 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.
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 now category 1 or category 2 compounded sterile preparations. And like the story of preparing tc99m rbcs, the usp 797 chapter didnt always fit radioactive drug preparation because of the short halflives and radioactivity of these unique drugs. Enforceable guidance according to usp 27nf 22, general chapters numbered from 1 to 999 include general requirements for tests and assays, whereas general chapters that. The requirements for antimicrobial effectiveness are met if the criteria specified under table 3 are met see significant figures and tolerances under general notices.
Because of the interference of some protein particles and their physical characteristics fragile or translucent, the results. Usp remains committed to keeping stakeholders and the general public informed of the status of these standards. Vigorous hand washing with antimicrobial soap for 2 minutes up to the elbows before donning gloves. Apr 24, 2020 general chapter 797 for sterile compounding, as well as a new general chapter for radiopharmaceuticals. Pharmacopeia chapters for selected quality testing methods and procedures continued chapter title chapter chromatography column chromatography cc chromatography. Learn how moses cone memorial hospital is enhancing clean room workflows with an interlock refrigerator. Pharmaceutical compoundingsterile preparations revision bulletin table 1. In addition, the ashps discussion guides for both the original and revised chapters provide a. Chapter 797 was previously titled sterile drug products for home use 1206. Sterilerisk level iii see highrisk level in usp general chapter 797 category 6. Learn about bd compliance with usp general chapter 797 pharmaceutical compoundingsterile preparations. See lowrisk level in usp general chapter 797 category 4. Although compliance with usp 797 has improved over time, current legislation governing sterile product compounding is a patchwork of statespecific regulations with wide variations between jurisdictions. General chapter usp 797 establishes best practices and regulations for the production of compounded sterile preparations.
We do not believe it is the intent of usp to restrict patient access and substantially increase the cost of care. Introduction to usp general chapter 797 slideshare. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists. Its predecessor document, general chapter sterile drug products for home use, was first developed in the 1990s as an informational general chapter. Usp general chapter pharmaceutical compoundingnonsterile preparations, 2 usp general chapter 797 pharmaceutical compoundingsterile preparations, 3 usp general chapter hazardous drugshandling. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. United states pharmacopeial convention usp publishes the usp compounding compendium. Pharmacopeia, general chapter 797 pharmaceutical compounding sterile preparations. Usp general chapter 825 impact on nuclear medicine. During the postponement and pending resolution of the appeals of and 797, is information compendially applicable. Iso class 7 positivepressure areas and the general area.
Therefore, usp is postponing the official dates of the revised and 797, and the new general chapter until further notice. Background on june 1, 2019, usp published major revisions to general chapters and 797, which are intended to minimize the risk. Usp is a notforprofit, sciencedriven organization that has an established process for convening independent experts. As pharmacists, we have been given the right to compound, but as professionals, we have the obligation to compound right. Updates to usp 797 pharmaceutical compounding sterile preparations inclusion of standards for specific practices, including.
Pharmaceutical compoundingste rile preparations introduction the objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from 1. The ashp discussion guide for compounding sterile preparations. 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 companion documents, as amended from time to. Usp general chapter 825 impact on nuclear medicine technology. Each chapter of the usp nf is assigned a number, which appears in brackets along with the chapter name. Moreover, according to the usp, the recent publication of usp 797 changes the landscape, making it redundant to have a separate general chapter to address the compounding of radiopharmaceuticals 12. The decisions on the appeals to, 797, and do not foreclose the possibility of future revisions to these chapters. Radiopharmaceuticals preparation of radiopharmaceuticals. Repackaging, which must be performed in accordance with the requirements in the chapter. Usp s bylaws provide that the official date of a standard under appeal must be postponed while an appeal is pending. Adoption of and compliance with existing regulations.
Both chapters contain updated standards that hospitals and health systems will need to implement by december 1, 2019. In june 2019, the united states pharmacopeia usp released several new and revised pharmacy compounding standards. Commentary usp general chapter 797 pharmaceutical compounding. Conclusion there is no doubt that 797 has established a set of wellthoughtout procedures and standards. Usp chapter 797 the dispenser shall, when appropriate.
Usp chapter 797, pharmaceutical compoundingsterile. Pharmaceutical compoundingste rile preparations introduction the objective of this chapter is to describe conditions and practices to prevent harm, including death, to. After publication of the revised and new compounding standards, usp received appeals on certain provisions in, 797, and. Usp 797 usp chapter 797, pharmaceutical compoundingsterile preparations, provides the first set of enforceable sterile compounding standards issued by the united states pharmacopeia usp. According to usp 27nf 22, general chapters numbered.
In the interim, the currently official chapters of last revised in 2014 and 797. Rinse thoroughly all glassware with warm dilute nitric acid this general chapter contains test methods for propel1 in 2 followed by water. Shoe covers, head and facial hair covers, face masks, tyvek nonshedding gown and sterile gloves required. Expanded previous provisions related to preparation of allergenic extract prescription sets. Usp chapter general overview personnel cleansing and garbing requirements. 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. General chapter is not subject to any pending appeals and will become official on december 1, 2019.
This continuing pharmacy education program focuses on compounded sterile preparations csps as related to the currently official general chapter. For more than a decade, radiopharmaceuticals have fallen under the standards of usp general chapter 797 pharmaceutical compounding sterile preparations. General chapters general information add the following. The objective of the usp standard is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or. Excluded from this chapter is a discussion of controlled environments for use by licensed pharmacies in the preparation of sterile products for home use, which is covered under pharmaceutical compoundingsterile preparations 797. Accreditation or credentialing organizations may adopt and enforce usp standards. 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. Mar 09, 2020 795 pharmaceutical compounding nonsterile preparations reprinted from usp42nf37 last revised 2014 797 pharmaceutical compounding sterile preparations reprinted from usp42nf37 last revised 2008 800 hazardous drugs handling in healthcare settings informational 825 radiopharmaceuticals preparations, compounding, dispensing, and repackaging as published june 1, 2019.
Usp nf establishes standards for medicines, food ingredients and dietary supplements. Usp chapter 797 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. It is proposed to revise this chapter to improve clarity, respond to stakeholder input, and reflect new science. Beyonduse exposure and storage dates where csps are prepared e. Usp general chapter 797 pharmaceutical compounding. Sterile preparations, which specifies that sterile compounding applies to all preadministration manipulations preparation, storage, and transport of compounded sterile preparations, including radiopharmaceuticals. Usp general chapter pharmaceutical compounding sterile preparations.
Sterilerisk level ii see mediumrisk level in usp general chapter 797 category 5. The chapter is divided into the following main sections. Hence, chapter 797 of the united states pharmacopoeia usp national prescription should be respected and enforced in clinical practices. Commentary newsline the potential impact of usp general. Usp chapter 797 describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which. Enforceable guidance according to usp 27nf 22, general chapters numbered from 1 to 999 include general requirements for tests and assays, whereas general chapters that are informational are numbered from to 1999 2. In 2004, 797 was published as an official standard. Sterile preparations, became effective january 1, 2004 6. Pharmaceutical compoundingsterile prepara tions 797 in the united states pharmaco peia 27 and. Usp pharmaceutical compounding sterile preparations. Identify the proposed changes to usp chapter 797 that will most impact home. To download the complimentary usp general chapter pharmaceutical compounding sterile preparations, please click here. Pharmaceutical compoundingsterile preparations 1 change to read.
Usp just released the revised general chapter 797 pharmaceutical compounding sterile preparations. Pharmacopeias usp revised general chapter 797 pharmaceutical compoundingsterile preparations, which sets practice standards to help ensure that compounded sterile preparations are of high quality, is available in the second supplement to usp 31nf 26, this revised version became official on june 1, 2008. Mar 18, 2015 usp chapter 797, pharmaceutical compounding. Avoid using on the separator any lants, pressurized topical aerosols, nasal sprays, meteredlubricants that dissolve in chloroform. When compounding hazardous sterile drugs, both usp 797 and usp, and. Usp conventions currently established effective dates for both general chapter 797 pharmaceutical compounding sterile preparations and general chapter hazardous drugs handling in healthcare setting, as well as the proposed revisions to general chapter 797. The contents are intended forsingleunit container for articles see general no. Usp articles, or within 10% if not specified, until. Usp remains committed to keeping stakeholders and the general public informed of the progress of these standards, which are anticipated to become official on december 1, 2019. 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. Section 20 633b of the general statutes is repealed and the following is substituted in lieu thereof effective january 1, 2020. May 31, 2019 general chapter was published in usp nf on february 1, 2016 and will become official on december 1, 2019.
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