Usp received more than 8,000 comments on the rule from more than 2,500 stakeholders from sept. Unless there are clear and concise understanding and agreement on the definitions, concepts. With the proper facilities, personnel training and monitoring, work practices and sops, environmental monitoring, and certification, compounding professionals can go a long way toward protecting patientsand themselvesfrom significant harm from csps. The usp metal impurities expert panel has proposed new limits on the elemental impurities in pharmaceutical products based on concerns surrounding potential health toxicity. Iso classification of particulate matter in room air limits are in particles of 0. Understanding pharmacy cleanroom design requirements. Clinical iq provides an online reference to determine the reg. Basics of compounding for the implementation of united states pharmacopeia chapter. On march 28, 2014, the united states pharmacopeia and the national formulary uspnf published usp general chapter hazardous drugshandling in healthcare settings, as open for public comment in the usp pharmacopeial forum pf 403. Downloadable documents for compliance use these documents to aid in compliance with standards, whether state boards of pharmacy, usp or fda. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. The united states pharmacopeial convention usp is revising its 797 standard, which governs sterile preparation spaces for pharmaceutical compounding. The usp 797 gap tool has been updated to reflect the version of usp general chapter 797 that was published on june 1, 2020.
Compounding requirements are included in the cms conditions of participation. The hospital or institutional chemistry laboratories must validate their methods to apply. Pharmaceutical compoundingsterile preparations add the following. Positron emission tomography drugs for compounding, investigational, and research uses usp 23, rev usp 35. Sterile preparations, was released in late 2007 and will become official on june 1, 2008. Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that include baths and soaks. Heavy metals deletion date o jan 1, 2018 publish omission of general chapter o published in usp 38nf 33 with an official date of december 1, 2015. Chapter is published in the combined united states pharmacopeia 27national formulary 22 uspnf of 2004 5 as either a 2. They are consistent with the joint commissions ic standards,1 current centers for disease control and prevention cdc handhygiene guidelines2 see npsg 7 in chapter 6, and the provisions of the united states pharmacopeia usp chapter. The usp received appeals on specific provisions of the chapter, and those appeals were subsequently granted, effectively sending this version of.
On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. The gap analysis for the current usp, 797 and are available now in microsoft word. Usp 800 is the latest united states pharmacopeia usp revision which clarifies and expands upon hazardous drug compounding both sterile and nonsterile. Usp provides safety data sheets sds for all reference standards and usp certificates for some reference standards. Aseptic mediafill testing is part of an effective quality assurance program to ensure pharmaceutical processes and personnel. Access free usp 37 free download compendial approvals for usp37nf32 2s book pdf free download link or read online here in pdf. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. Sterile preparations pharmacy practices okeke claudia c, barletta frank, newton david w, allen loyd v jr. 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. The applicable standards of practice for safe sterile compounding are, at a minimum, the. Revised usp standards for product dating, packaging, and temperature monitoring.
General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. 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. Establishing a practice standard for compounding sterile preparations in pharmacy find, read. Allergen extracts as csps for at least 10 seconds and allowed to dry be fore they are used to compound allergen ex allergen extracts as csps are singledose andtracts as csps. Blueprint for implementing chapter 797 for compounding. Usp articles, or within 10 % if not specified, until their buds. Hardy diagnostics val mediafill challenge kits are for usp 797 compliance testing for compoundingsterile preparations csps. Cgmp usp crosswalk 2 subpart b organization and personnel is this requirement of 21 cfr 211 required in usp chapter. Usp 797 compliance with usp 797 is our duty because. Pharmacopeia 12601 twinbrook parkway rockville md 208521790.
Lalanine united states pharmacopeia usp reference standard. Click on any product description to access the sds and the usp certificate, if available. Usp chapter, and apply them in a variety of nuclear pharmacy practice settings. Usp 797 is a comprehensive set of standards that provides guidance on the appropriate procedures and requirements for compounding sterile preparations. 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. To download the complimentary usp general chapter pharmaceutical compounding sterile preparations, please click here. United states pharmacopeia 35 national formulary 30 published november 2011. Pdf impact of united states pharmacopeia chapter 797. The usp seeks public comments about the revisions, which could take a year to finalize.
Prepare now for usp standard on handling hazardous drugs. Compounding of total parenteral nutrition fluids using manual or. It improves the health and wellbeing of our patients and 2. Pharmaceutical compoundingsterile preparations uspnf.
Chapter 797 is a pharmaceutical compounding document produced by the united states pharmacopeia usp. This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. This means that state boards of pharmacy and other regulatory entities can require regulated facilities to comply with chapter 800. Csps are to be administered within 12 hours of compounding, or per physicians orders, whichever sooner csps meet the definition of lowrisk per usp the pec is not located near potential contamination e. Participants will take home sample electronic templates for policies, procedures and documentation that can be customized to their facilitys needs. In accordance with usp s bylaws, the responsible expert committees worked with a sense of. In addition, usp chapter requires that a pec provide an iso class 5 environment while compounding csps. Nonengineering controls selecting the appropriate engineering controls is not the only consideration in meeting usp 797 standards.
Confidential and proprietary for internal use only. Understanding contaminants and how to remove them usp and you pharmaceutical compoundingsterile preparations this general chapter provides procedures and requirements for compounding sterile preparations. Pharmaceutical compoundingsterile preparations revision bulletin. Secure pdf files include digital rights management drm software. Originally written in 2004, chapter 797 is popularly agreed to increase the safety of the compounding setting and its ingredients. Identify the key acronyms and state the definition of key terms associated with usp. All books are in clear copy here, and all files are secure so dont worry about it. Usp chapter 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 20. Reorganized existing chapter to group similar topics together, eliminate redundancies, and clarify requirements. The sterile compounding room is approximately 11 x 14 with an 8 ceiling. For example, under dextrose injection, the following is stated.
Office of manufacturing qualityoffice of compliance. Total revision august 2015 usp 1094 capsulesdissolution testing and related quality attributes usp 2040 disintegration and dissolution of dietary supplements. Model standards for pharmacy compounding of nonhazardous sterile preparations. Usp 724 drug release 1985 usp 1088 in vitro and in vivo evaluation of dosage forms 1995 usp 1092 the dissolution procedure development and validation. The usp compounding guideline, chapter 800, clarifies and expands upon the hazardous drug guidelines found in usp 797. In accordance with the rules and procedures of the 20152020 council of experts, usp. In 2004, the united states pharmacopeia usp published its general chapter 797 pharmaceutical compoundingsterile preparations, which set a more rigorous and enforceable standard for sterile. Attendees completing this program will gain an understanding of how to develop and implement an operation that meets or exceeds usp chapter requirements. Drug generic name, compounded, dosage form, veterinary e. Usp allows an exception to the rule of placing the pec in an iso class 7 buffer area if. Evolution of the united states pharmacopeia chapter. Jul 03, 2014 in s article, cleaning protocols for usp 797 compliance, karen bonnell writes, it is required that the surfaces of bscs, cais, cacis, and lafws be cleaned and disinfected at the beginning of each shift, before each batch of product is compounded, not longer than 30 minutes following the previous surface disinfection when. Read online compendial approvals for usp37nf32 2s book pdf free download link book now.
As defined in usp, any pharmacy that engages in the practice of compounding is required to have standard operating procedures sop in place to state how different areas of practice are handled. 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. They are consistent with the joint commissions ic standards,1 current centers for disease control and prevention cdc handhygiene guidelines2 see npsg 7 in chapter 6, and the provisions of the united states pharmacopeia usp. Usp 797 clean room guidelines standards for sterile.
Changes focus on air quality, clarifications the u. Usp sets standards for the quality of drug products and works with healthcare providers to help them meet the standards. The usp chapter standards are not limited in their application to any specific profession or to any specific types of sterile compounding site. Pdf on oct 1, 2004, eric s kastango and others published usp chapter 797. Usp is a public standardsestablished authority called the united states pharmacopeia.
It is proposed to revise this chapter to improve clarity, respond to stakeholder input, and reflect new science. Based on the number and significance of public comments received in response to the. As is evident in this program, achieving 100% compliance to current and future and future requirements can be difficult. 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. Participants will take home sample electronic templates for policies, procedures and documentation that can be. Describe both the general responsibilities of compounding personnel and those specific to the. Cleaning the compounding pharmacy presented by david nobile contec, inc. Guidelines for usp 797 the cleanroom and laminar airflow workbench are certified biannually by a thirdparty to ensure proper function a class 5 environment is utilized for critical areas where compounded sterile preparations csps are exposed to air in the physical environment. It sets guidelines on the health care products that are created or sold in the us on over the counter and prescription medicines.
Usp chapter 797 gap analysis page 7 of 16 x medical center. For example, the bulk preparation of compounded preparations in the. Usp currently offers more than 3,500 reference standardshighly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators. Usp to revise sterile compounding facility standards again. As stated in usp, all significant procedures in the compounding area should be covered by written standard operating procedures sops. Interested parties may submit comments by mail or commercial carrier by august 15 to. Usp 800 expands controls for the protection of workers and environments against hazardous drug compounds.
One important issue that was part of the original proposal and that remains unchanged is that usp 797 allows lowvolume compounding of hazardous drugs hds in a positivepressure room, but proposed usp, both before and after revisions, does not. These standards describe in detail the acceptable conditions and practices that will help prevent issues with. Usp chapter standard applies to sterile compounding without regard to the location or profession of the compounding personnel. Aug 06, 2014 essentially summary of usp 797 no specific statues related to hazardous compounding utah no separate regulations for outpatient oncology. Usp reference standards are specified for use in conducting official uspnf tests and assays. Usp 797 helps to ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency. Some differences between standards for sterile compounding in this. The gap analysis for the current usp, and are available now in microsoft word. The readytouse mediafill challenge kits are for use in validating pharmacy compounding personnel in accordance with usp 797 guidelines. Those that must be sterilized before administration. All content in this area was uploaded by eric s kastango on jul, 2015. Secure pdf secure pdf is an electronic, downloadable format that can be downloaded from the bookstore.
All hd compounding must be conducted in a separate designated area, and it. The united states pharmacopeia usp has developed dozens of verified compounded preparation formulas specifically for veterinary use. We can help your cleanroom employees comply with usp chapter 797. Proposed revisions unveiled for compounding usp 797. Usp 797 is one of the most popular standards that prevent excessive microbial contaminations and bacterial endotoxins. An overview of the role and risks of pharmacy compounding 3. Standard operating procedures sops medisca network.
Chapters 1 through 999 are enforceable standards that describe how certain functions and processes are to be performed. Please call usp customer service at 18002278772 or 3018810666 to order. It describes a number of requirements, including responsibilities of compounding personnel, training, environmental monitoring, storage and testing of finished preparations. Uspnf establishes standards for medicines, food ingredients and dietary supplements. 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. Pharmaceutical compoundingsterile preparations revision bulletin table 1. Apr 01, 2015 usp chapter 800, like chapters 795 and 797, will be an enforceable standard. A guide for the compounding practitioner, usp 36nf 31. Guidelines for pharmaceutical sterile preparations. Understanding usp 797csps include the following types of preparations. In order to read a secure pdf, you will need to install fileopen plugin on your computer available online. No plans for compliance polling question how compliant is your site with usp. Pharmaceutical compounding sterile preparation, united stated pharmacopeia 36national formulary 31.
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. 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. Currently, 20 states require compliance with usp chapter and these states are actively assessing compliance during inspections. However, a requirement statement from usp has been added in blue. Compounding sterile preparations 1 t he revision bulletin to usp chapter, pharmaceutical 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. Pdf a primer on usp chapter 797 pharmaceutical compounding. We offer literature introductions to usp 797 compliance. General guidelines for matching csps and components to appropriate. The revisions are based on input received by the usp, but the standardssetting group hopes to receive.