Adoption of and compliance with existing regulations although compliance with usp has improved over time, current legislation governing sterile product compounding is a patchwork of statespecific regulations with wide variations between jurisdictions. Usp 797 compliance with usp 797 is our duty because. Sep 23, 2019 general chapter 797 is referenced in many state and national laws and regulations. Pharmacy rulesregulations by state for compliance with usp 797. Compounding exemptions from usp exemption criteria immediate and direct. They are required to comply with both usp chapter and with the xx board of pharmacy practice act and regulations. New and revised usp compounding standards are published. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing.
The minimum practice and quality standards of the usp are adopted as the minimum. Nov 22, 2019 in accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations. 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. Jun 03, 2019 the united states pharmacopeia usp has released new and revised standards aimed at ensuring the quality of compounded medicines. Usp 797 is one of the most popular standards that prevent excessive microbial contaminations and bacterial endotoxins. Usp 800 is the latest united states pharmacopeia usp revision which clarifies and expands upon hazardous drug compounding both sterile and nonsterile. Uspnf establishes standards for medicines, food ingredients and dietary supplements. Wa pharmacy quality assurance commission 2020 responsible.
The revised usp sterile compounding standards nhia. Places where compounded sterile preparations are done are under usp 797 regulations. September 23, 2019 revised general chapter is postponed until further notice. Usp chapter 797 final requirements aaaai0619096 usp chapter 797 standards require that on december 1, 2019 and after, compounding of allergen extracts must occur in an iso class 5 pec primary engineering control or a dedicated allergenic extract compounding area. Adoption of and compliance with existing regulations 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 pharmaceutical compounding sterile. Usp response to shortages of garb and personal protective. Usp and coverage for many other types of health care entities. There is no formal definition of category 1 and 2, only requirements. Segregated compounding area sca low and medium risk level hds may be prepared in a c. Compounding requirements following usp appeal decisions. Any disruption in the flow pattern of the air through the cabinet can result in stagnant or contaminated air being able to come in contact with critical sites. As a resource, the community oncology pharmacy association is providing access to usp 797, pharmaceutical compoundingsterile preparations and usp 800, hazardous drugshandling in healthcare settings documents. There is a complete guidebook on these standards and the last version was released in 2008.
Almost every healthcare pharmacy nationwide will require structural and operational changes to comply with these regulations. 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. In consideration of the applicable provisions of usp 795 concerning pharmacy compounding of nonsterile preparations, usp 797 concerning. The comment period for this revision ends on november 30, 2018. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. Compliance to usp 797 regarding pharmacy compounding is an ongoing and increasingly important issue for all compounding pharmacies to address as quickly as possible. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Learn about how to properly clean and disinfect critical pharmacy surfaces with contec healthcares usp 797 guidelines overview. This announcement came on september 29 as usp stated that it would also postpone the official date of new standards on hazardous drug compounding chapter. The joint commission requirements for meeting usp standards are not limited in their application to any specific profession or to any specific types of sterile compounding site. Usp 797 is a farreaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound. Comments will be accepted until january 31, 2016, the end of the comment period for pf 416. Pharmacies in the state of xx are in a unique situation in terms of compliance with state and usp regulations.
General chapter pharmaceutical compounding sterile preparations. Ever since the 2012 meningitis outbreak that had been linked to the now defunct new england compounding center necc, increased legislation is constantly being introduced. The objective of the usp 797 guidelines is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations csps. Compounding sterile preparations 1 t he revision bulletin to usp chapter, pharmaceutical compounding. United states pharmacopeia usp chapters below compliance is mandatory chapters above informational and advisory usp 797 pharmaceutical compounding sterile preparations first released in 2004 revision in 2008 another revision pending anticipated to become official december 1, 2019. In 2004, 797 was published as an official standard. However, there are discrepancies between these two documents that need to be considered. Inspection, regulation, and oversight of sterile compounding pharmacies article pdf available in journal of parenteral and enteral nutrition 362 suppl. It improves the health and wellbeing of our patients and 2. Compounding requirements following usp appeal decisions may. Usp develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or. United states pharmacopeia usp chapters below compliance is mandatory chapters above informational and advisory usp pharmaceutical compounding sterile preparations first released in 2004 revision in 2008 another revision pending anticipated to become official december 1, 2019.
In many cases, the routine cleaning of the compounding environment and the proper garbing of staff represent major changes in practice, but also present the potential for immediate risk reduction. This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. Iso classification of particulate matter in room air limits are in particles of 0. In light of usps march 12, 2020, final decision on appeals of the proposed revised chapters and and the new chapter, the california state board of pharmacy board provides its stakeholders with this current status of the legal requirements for pharmacies. Usp chapter 797 final requirements aaaai0619096 usp chapter 797 standards require that on december 1, 2019 and after, compounding of allergen extracts must occur in an iso class 5 pec primary engineering control or a dedicated allergenic extract compounding area aeca. 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. Visante can help evaluate external sources or show you how insourcing can give you increased control and positive roi. Sep 24, 2019 the united states pharmacopeia usp develops standards for preparing compounded drugs to help ensure patient benefit and reduce risks, such as contamination, infection, or incorrect dosing. Comments should include corresponding line number to the proposed revisions to the general chapter. Well also assist you in preparing for inspections by the cms, fda, dea, and joint commission. A virtual clean room to teach usp 797 regulations for.
Meeting usp requirements in small and rural hospitals patricia c. Usp chapter 797, pharmaceutical compoundingsterile. Usp and cgmps agree that compounding personnel represent the impact of usp on environmental monitoring comprehensive monitoring is essential both usp 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. The united states pharmacopeia usp has announced its intent to publish new draft standards for sterile compounding chapter 797 in the septemberoctober 2018 issue of pharmacopeial forum. The updates pertain to the usp general chapters on compounding nonsterile medicines usp pharmaceutical compoundingnonsterile preparations, and compounding sterile medicines usp pharmaceutical compoundingsterile preparations. Usp does not have any direct role in enforcement of sterile compounding regulations or standards. Usp chapter standard applies to sterile compounding without regard to the location or profession of the compounding personnel.
Usp just released the revised general chapter pharmaceutical compounding sterile preparations. However, a requirement statement from usp has been added in blue. Compounding exemptions from usp 797 exemption criteria immediate and direct. In accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations 797. 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.
Usp develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. Sca provided it meets the requirements in usp chapter and the csp is assigned a bud of 12 hours or less. 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. To access these documents, click on the images below. Our team of experts will prepare you for compliance with usp chapters 795, 797, 800 and 825. Explain how and when to apply the standards in chapter when preparing compounded sterile products used in home infusion and other alternate infusion. Usp 797 clean room guidelines standards for sterile. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. Its predecessor document, general chapter sterile drug products for home use, was first developed in the 1990s as an informational general chapter. Usp data regarding scientific drug characteristics of identity, strength, quality, and purity have served as the basis of federal prosecutions for charges of adulteration usp is a private, voluntary, notforprofit, and purportedly scientific organization and cannot write laws or regulations usp drug standards do have legal implications. United states pharmacopeia required below informational specific for dietary supplements usp 20102015 council of experts, destefano aj. Sterile compounding and room design by douglas theobald, cfm health care organizations that compound sterile formulations are getting a head start on compliance with the usp 797 guidelines, courtesy of the jcaho joint commission on accreditation of healthcare organizations. Sterile preparations, was released in late 2007 and will become official on june 1, 2008.
They are required to comply with both usp chapter 797 and with the xx board of pharmacy practice act and regulations. Pharmaceutical compoundingsterile preparations revision bulletin table 1. Typical cabinet design features to meet usp 797 and iest standards in order to meet usp 797 and iest standards, most cabinet designs involve unidirectional flow across hepa filters. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. Click here to download the proposed revision to usp chap ter click here for usp chapter informa tion. While usp chapters numbered under are compendially applicable, it is up to state agencies or other regulatory authorities to provide enforcement. No plans for compliance polling question how compliant is your site with usp 797. Requirements in small and rural hospitals addressing the.
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