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. The benefits of usp 797 compliance include the minimization of contamination of csps, improved aseptic proficiency of hospital pharmacy personnel. Jcaho backs off enforcement of usp 797 requirements briefings on accreditation and quality, july 1, 2006. Usp articles, or within 10% if not specified, until.
We are fearful for the outcomes of patients at organizations that. Usp describes hazardous drug handling related to the receipt. It sets guidelines on the health care products that are created or sold in the us on over the counter and prescription medicines. The revised section on environmental monitoring discusses requirements.
Pharma choice provides the best in disposable usp 797 clean room products and supplies for your laboratory or clean room. The safety of your patients begins by ensuring that you understand the practice requirements set forth in usp chapter 797. Usp bioburden control of nonsterile drug substances. Compounding of total parenteral nutrition fluids using manual or automated. Usp nf establishes standards for medicines, food ingredients and dietary supplements. Usp 797 compliance with usp 797 is our duty because. Usp 797 is a broad regulation, covering several pharmacy policies and procedures. On march 28, 2014, the united states pharmacopeia and the national. Lets take a look at the history of usp 797, as well as milestones that led to the development of these compounding standards. 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. On march 28, 2014, the united states pharmacopeia and the national formulary. Bcca pharmacy practice standards for hazardous drugs february 2014 38 references. View usp 797 gowning and donning requirements and garbing order.
International society of oncology pharmacy practitioners standards committee. Ashps video guide to chapter provides a concise overview of the essential components of the revised and updated chapter. Radiation the principal radiation sources utilized for xray diffraction are vacuum tubes utilizing copper, molybdenum. Pharmaceutical compoundingsterile preparations, usp 39. However, only one out of six graduates 1 are typically prepared for sterile compounding work. Free download usp gc 797 appeals updates millions of medications are compounded each year in the us to meet the unique needs of patients. Let emsl analytical, inc provide microbiological testing services in support of your usp activities. Compounding of total parenteral nutrition fluids using manual or. 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 general chapter 797 pertains to the compounding of both hazardous and nonhazardous drugs. 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. The standards in this chapter do not pertain to the clinical administration of. 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.
General chapter usp 797 establishes best practices and regulations for the production of compounded sterile preparations. This monograph will focus on usp 797 as it pertains to antimicrobial risk level. Although usp provides guidelines for preparing sterile. 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. Usp chapter 797 was released to the public in 2004 and has classified sterile compounding into 3 risk groups. 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. Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that include baths and soaks. Here is a brief overview of 797 and the impact it will have on daily operations within ascs. Usp 797 compliance common challenges and potential solutions angela yaniv, pharm. 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. Those that must be sterilized before administration. Usp general chapter pertains to the compounding of both hazardous and nonhazardous drugs. Usp states that hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure. Usp chapter 797, pharmaceutical compoundingsterile.
Sterile preparations, was released in late 2007 and will become official on june 1, 2008. Please check back regularly for notifications and updates. Usp serves as a new standard to guide the handling of hazardous drugs in order to protect patients, health care personnel, and the environment. Compounding sterile preparations 2 executive summary on january 1, 2004, the first version of usp chapter 797, pharmaceutical compounding. Compounding provides access to medication for patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. A limited number of usp nf items have microbial limits controls indicated as part of the monograph, but others do not. Cha and cshp created a task force in the fall of 2014 to develop a series of. Usp is a public standardsestablished authority called the united states pharmacopeia. For sterile processing, additional precaution is needed to assure that no sterile surfaces contact nonsterile surfaces during gowning, processing, or cleaning. Nov 19, 2015 usp section on storage presents a change from the guidance of usp. 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.
Sterile preparations, became effective january 1, 2004 6. 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. Usp section on storage presents a change from the guidance of usp 797. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. Sterile garments and gloves are recommended during aseptic workflows. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations.
Usp general chapter pertains to the compounding of both hazardous and non. Usp chapter 797 was the first set of enforceable sterile compounding standards created by the united states pharmacopeia. The board requires the pharmacist to exercise professional judgment in these ways because it is less likely under these circumstances that the public will be harmed by an extended bud. Interested parties may submit comments by mail or commercial carrier by august 15 to. Those prepared according to the manufacturers label instructions that expose original contents to potential contamination. Compounding sterile preparations 1 t he revision bulletin to usp chapter 797, pharmaceutical compounding. The revisions to and 797 published on june 1, 2019 and which make reference to, have been. The food and drug administration can enforce usp guidelines, but usually only intervenes in cases of death or specific complaints.
Quality standards for largescale compounding facilities. Pharmaceutical compoundingsterile preparations, usp 39 page 626. 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 797 was developed in response to situations where patients became sick from contaminated csps. 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. 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. 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. Pharmacopeia s usp revised general chapter pharmaceutical compoundingsterile preparations, which sets practice standards to help ensure that.
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. 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. Sterile preparations became official,1 which details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all prac. This chapter is intended to provide information as a. Instructions for using the chacshp compounding grids. Usp allows an exception to the rule of placing the pec in an iso class 7 buffer area if. 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. Follow the manufacturers instructions for operation of the active air. Revision status of usp chapter 797 pharmaceutical compounding.
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. To download the complimentary usp general chapter 797 pharmaceutical compounding sterile preparations, please click here. Blueprint for implementing chapter 797 for compounding. Uspnf establishes standards for medicines, food ingredients and dietary supplements. Usp 797 is one of the most popular standards that prevent excessive microbial contaminations and bacterial endotoxins. 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. 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. 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. 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. 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. 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. 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. In the interim, the currently official chapters of last revised in 2014 and 797 last revised in 2008 including the section. 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.
Understanding pharmacy cleanroom design requirements. To read the article in its entirety, please login or subscribe to briefings on accreditation and quality. Office of manufacturing qualityoffice of compliance. Pharmacopeia 12601 twinbrook parkway rockville md 208521790.
Pharma choice usp 797 clean room disposables pharma. 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. Cfug, the total combined molds and yeasts count does not exceed 5x10. Introduction to usp general chapter 797 slideshare. United states pharmacopeia usp 797 pharmaceutical compounding sterile preparations. Usp 797 clean room guidelines standards for sterile.
Usp 797800 compliance pharmaceutical compounding nci. Compliance to usp 797 regarding pharmacy compounding is an ongoing and increasingly important issue for all compounding pharmacies to address as quickly as possible. A jcaho clarification says surveys will not cover the requirements. Jcaho backs off enforcement of usp 797 requirements. It improves the health and wellbeing of our patients and 2. If you are at all involved in anesthesia, you are also probably generally aware of what 797 is all about. New revision markup for reference changes in usp nfposted 25jul 2014. 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. Compounding sterile preparations from nonsterile ingredients is a high risk activity that requires. In accordance with usp s rules and procedures of the 20102015 council of experts rules and except as provided in section 7. Formulary uspnf pf for further notice and comment, in. Usp postponing chapters 795, 797, and 825 drug topics. Remember that usp 797 standards represent only minimum acceptable practice standards.
The design of stability studies during pharmaceutical product development and registration takes into account expected supplychain storage and distribution conditions in. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Although the mandate to use a cleanroom in pharmacy is new, the need to control the quality of. Description of categories gov, and material safety data sheets msdss are available to compounding personnel. Mar 18, 2015 usp chapter, pharmaceutical compounding. Understanding usp 797 csps include the following types of preparations. By now, you have probably heard about usp 797 or simply 797. Adoption of and compliance with existing regulations. 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.
Pharmaceutical compoundingnonsterile preparations official january 1, 2014 osha hazard communication labels see osha. From a compendial standpoint, a usp general chapter numbered below becomes applicable and compendially required through reference in general. 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. Of grave concern, 16% of respondents said the time required to become compliant with the chapter was their major challenge. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from.
D assistant director sterile products may 2, 2017 oshp annual meeting. A timeline of sterile compounding events and actions taken. 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. 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. Therefore, usp is postponing the official dates of the revised and 797, and the new general chapter until further notice. As a result, in march 2014, usp published a proposed set of guidance known. The safety of your patients begins by ensuring your entire staff understands the practice requirements set forth in usp chapter. No plans for compliance polling question how compliant is your site with usp 797. Pharmaceutical compoundingsterile preparations, usp 41 page 6554.
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. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. March 2014 usp 800 first published for comments december 2014. This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. 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. Radiopharmaceuticals and injection safety excerpts from radiopharmaceuticals as compounded sterile preparations csp p. 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. The joint commission medication compounding certification. General chapter was published in usp nf on february 1, 2016 and will become official on december 1, 2019. Faqs on the compounding appeals march 12, 2020 2 general chapter will be informational and not compendially applicable. Speaker disclosure angela yaniv has no actual or potential conflict of interest with regard to this presentation. Usp797 guidelines raise concerns anesthesia patient. Usp 797 states that hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure.