The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. Radiopharmaceuticals and injection safety excerpts from radiopharmaceuticals as compounded sterile preparations csp p. 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. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. Usp 797 clean room guidelines standards for sterile. Although usp provides guidelines for preparing sterile. A jcaho clarification says surveys will not cover the requirements. Usp general chapter pertains to the compounding of both hazardous and nonhazardous drugs. 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.
Therefore, usp is postponing the official dates of the revised and 797, and the new general chapter until further notice. View usp sample report the new usp guidelines are designed to prevent the improper handling and contamination of sterile compounds for certain drugs or biologic preparations. Copyright 2008 2014 clinicaliq, llc all rights reserved sdvs, mdvs, pbp and point of care activated container type preservatives bud single dose ampule no na. Compounding of total parenteral nutrition fluids using manual or. In the interim, the currently official chapters of last revised in 2014 and 797 last revised in 2008 including the section radiopharmaceuticals as csps will remain official, usp said. Understanding pharmacy cleanroom design requirements. Although the mandate to use a cleanroom in pharmacy is new, the need to control the quality of. Bcca pharmacy practice standards for hazardous drugs february 2014 38 references. Usp nf establishes standards for medicines, food ingredients and dietary supplements.
Compounding personnel are encouraged to participate in adverse event reporting and product defects programs of the food and drug administration fda and united states pharmacopeia usp. Adoption of and compliance with existing regulations. Usp 797 states that hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure. Compounding sterile preparations 2 executive summary on january 1, 2004, the first version of usp chapter 797, pharmaceutical compounding. On march 28, 2014, the united states pharmacopeia and the national formulary. Radiation the principal radiation sources utilized for xray diffraction are vacuum tubes utilizing copper, molybdenum. 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. Compliance to usp 797 regarding pharmacy compounding is an ongoing and increasingly important issue for all compounding pharmacies to address as quickly as possible.
The purpose of this chapter is to provide compounders with guidance on applying good compounding practices for the preparation of compounded formulations for dispensing andor administration to humans or animals. No plans for compliance polling question how compliant is your site with usp 797. Usp chapter 797, pharmaceutical compoundingsterile. Despite the 9year tenure of usp 797 guidance and the presence of other guidelines aimed at improving safety and quality of injectable medications, 7,8 some of these practices persist as a result of their past success, convenience, and the comfort level of health care personnel. Quality standards for large scale sterile compounding facilities 6 producing large quantities of nonpatientspecific sterile injectable drugs from nonsterile bulk chemicals and they were not registered with the fda. Usp bioburden control of nonsterile drug substances. March 2014 usp 800 first published for comments december 2014. From a compendial standpoint, a usp general chapter numbered below becomes applicable and compendially required through reference in general. This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. Usp chapter 797 was the first set of enforceable sterile compounding standards created by the united states pharmacopeia. Faqs on the compounding appeals march 12, 2020 2 general chapter will be informational and not compendially applicable. Those prepared according to the manufacturers label instructions that expose original contents to potential contamination. Usp established usp was created in june 2008 enforced by the fda and 23 state boards of pharmacy recognized as a national standard of practice the joint commission and other accreditations organizations apply standards in their assessment of sterile compounding practices provides the minimum in practice. United states pharmacopeia usp 797 pharmaceutical compounding sterile preparations.
In the interim, the currently official chapters of last revised in 2014 and 797 last revised in 2008 including the section. Understanding usp 797 csps include the following types of preparations. 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. On march 28, 2014, the united states pharmacopeia and the national. Upon completion of this course the participant will be able to discuss the general concepts and principles associated with the provision of compounded sterile preparations csps as specified by. It sets guidelines on the health care products that are created or sold in the us on over the counter and prescription medicines.
By now, you have probably heard about usp 797 or simply 797. Usp reference standard is available, it is preferable to generate a primary reference pattern on the same equipment used for running the unknown sample, and under the same conditions. Pharmaceutical compoundingsterile preparations, usp 41 page 6554. 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. Sterile preparations, was released in late 2007 and will become official on june 1, 2008. Usp general chapter radiopharmaceuticals preparation, compounding, dispensing, and repackaging usp provides the minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and nonsterile radiopharmaceuticals for humans and animals that occur as part of statelicensed activities. The standards in this chapter do not pertain to the clinical administration of. Mar 18, 2015 usp chapter, pharmaceutical compounding. Usp general chapter pertains to the compounding of both hazardous and non. This monograph will focus on usp 797 as it pertains to antimicrobial risk level.
The design of stability studies during pharmaceutical product development and registration takes into account expected supplychain storage and distribution conditions in. 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. Usp nf compendial notices are designed to inform stakeholders of the changing status of usp nf monographs and general chapters and other usp nf standardssetting initiatives. Pharmaceutical compoundingsterile preparations, usp 39. General chapter usp 797 establishes best practices and regulations for the production of compounded sterile preparations. Jcaho backs off enforcement of usp 797 requirements briefings on accreditation and quality, july 1, 2006. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from. Sterile preparations, became effective january 1, 2004 6. The safety of your patients begins by ensuring that you understand the practice requirements set forth in usp chapter 797.
Uspnf establishes standards for medicines, food ingredients and dietary supplements. The joint commission medication compounding certification. It improves the health and wellbeing of our patients and 2. Instructions for using the chacshp compounding grids. International society of oncology pharmacy practitioners standards committee. Usp chapter 797 was released to the public in 2004 and has classified sterile compounding into 3 risk groups.
Usp 797800 compliance pharmaceutical compounding nci. A timeline of sterile compounding events and actions taken. Usp 800 adds additional guidelines to those specified in the usp 797 sterile compounding chapter and should be viewed as an addition not a replacement of usp 797. Ashps video guide to chapter 797 provides a concise video overview of the essential components, procedures, and standards of the revised and updated chapter 797. Pharma choice provides the best in disposable usp 797 clean room products and supplies for your laboratory or clean room. Prior to the recent publication of usp chapter 797 by the united states pharmacopeia, pharmacists were never required to work in a cleanroom when compounding sterile preparations. Nov 19, 2015 usp section on storage presents a change from the guidance of usp. Revision status of usp chapter 797 pharmaceutical compounding. Appeals panel decisions on usp, 797, and march 12, 2020 cmp ec are committed to moving forward in an open, transparent, and balanced manner as soon as practicable to enable the chapters to be.
Cfug, the total combined molds and yeasts count does not exceed 5x10. If you are at all involved in anesthesia, you are also probably generally aware of what 797 is all about. Introduction to usp general chapter 797 slideshare. The revised section on environmental monitoring discusses requirements. The chapters, which were set to go into effect on december 1 st, will now be postponed until further notice, usp said in a notice on its web site. The powder methods provide an advantage over other means of analysis in that they are usually nondestructive in nature specimen preparation is usually limited to grinding to ensure a randomly oriented sample, and deleterious effects of xrays on solid pharmaceutical compounds are not commonly encountered. General chapter was published in usp nf on february 1, 2016 and will become official on december 1, 2019. D assistant director sterile products may 2, 2017 oshp annual meeting. We are fearful for the outcomes of patients at organizations that.
Office of manufacturing qualityoffice of compliance. Compounding sterile preparations from nonsterile ingredients is a high risk activity that requires. Follow the manufacturers instructions for operation of the active air. Appeals panel decisions on usp, 797, and march 12, 2020 cmp ec are committed to moving forward in an open, transparent, and balanced manner as. Compounding sterile preparations 1 t he revision bulletin to usp chapter 797, pharmaceutical compounding. Usp general chapter usp anticipates publishing a summary of the comments received, along with the expert committees responses, when the revision to general chapter 797 becomes official. Usp797 guidelines raise concerns anesthesia patient. Pharmacopeia s usp revised general chapter pharmaceutical compoundingsterile preparations, which sets practice standards to help ensure that. 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. Ashps video guide to chapter provides a concise overview of the essential components of the revised and updated chapter. Speaker disclosure angela yaniv has no actual or potential conflict of interest with regard to this presentation.
The safety of your patients begins by ensuring your entire staff understands the practice requirements set forth in usp chapter. Usp general chapter 797 pertains to the compounding of both hazardous and nonhazardous drugs. This chapter is intended to provide information as a. Usp articles, or within 10% if not specified, until. The revisions to and 797 published on june 1, 2019 and which make reference to, have been. However, only one out of six graduates 1 are typically prepared for sterile compounding work. Pharmacopeia 12601 twinbrook parkway rockville md 208521790. The food and drug administration can enforce usp guidelines, but usually only intervenes in cases of death or specific complaints. To download the complimentary usp general chapter 797 pharmaceutical compounding sterile preparations, please click here. The benefits of usp 797 compliance include the minimization of contamination of csps, improved aseptic proficiency of hospital pharmacy personnel. To read the article in its entirety, please login or subscribe to briefings on accreditation and quality. Sterile garments and gloves are recommended during aseptic workflows. Formulary uspnf pf for further notice and comment, in. View usp 797 gowning and donning requirements and garbing order.
Interested parties may submit comments by mail or commercial carrier by august 15 to. Designing hospital pharmacy hvac systems t he furor over compliance with united states pharmacopoeia usp general chapter 797, pharmaceutical compoundingsterile preparations,1 has somewhat subsided with the joint commission for accreditation of healthcare organizations decision. For sterile processing, additional precaution is needed to assure that no sterile surfaces contact nonsterile surfaces during gowning, processing, or cleaning. Usp section on storage presents a change from the guidance of usp 797. Pharmaceutical compoundingsterile preparations, usp 39 page 626. Quality standards for largescale compounding facilities. New revision markup for reference changes in usp nfposted 25jul 2014. Usp 797 compliance common challenges and potential solutions angela yaniv, pharm. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. Usp describes hazardous drug handling related to the receipt.
Description of categories gov, and material safety data sheets msdss are available to compounding personnel. As a result, in march 2014, usp published a proposed set of guidance known. Usp states that hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure. Of grave concern, 16% of respondents said the time required to become compliant with the chapter was their major challenge. Cha and cshp created a task force in the fall of 2014 to develop a series of. 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. Usp 797 was developed in response to situations where patients became sick from contaminated csps. 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. A limited number of usp nf items have microbial limits controls indicated as part of the monograph, but others do not. Please check back regularly for notifications and updates. 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. Usp postponing chapters 795, 797, and 825 drug topics. Pharma choice usp 797 clean room disposables pharma. Usp 797 is one of the most popular standards that prevent excessive microbial contaminations and bacterial endotoxins.
Lets take a look at the history of usp 797, as well as milestones that led to the development of these compounding standards. Pharmaceutical compoundingnonsterile preparations official january 1, 2014 osha hazard communication labels see osha. Usp 797 and cgmps agree that compounding personnel represent the impact of usp 797 on environmental monitoring comprehensive monitoring is essential both usp 797 and cgmps require concentrated em efforts to ensure the facility is maintained in a manner that does not adversely affect the quality and safety of csps. Usp serves as a new standard to guide the handling of hazardous drugs in order to protect patients, health care personnel, and the environment. Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that include baths and soaks. Usp allows an exception to the rule of placing the pec in an iso class 7 buffer area if. Blueprint for implementing chapter 797 for compounding. Remember that usp 797 standards represent only minimum acceptable practice standards. Free download usp gc 797 appeals updates millions of medications are compounded each year in the us to meet the unique needs of patients. Usp 797 is a broad regulation, covering several pharmacy policies and procedures. The immediateuse provision allows for the preparation and dispensing of compounded sterile products csps without the need to be in compliance with usp requirements such as iso class 5 hood or isolator, facility design, environmental controls, personnel cleansing and garbing.
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