Understanding usp 797csps include the following types of preparations. All compounding must follow the standards of usp for nonsterile preparations and usp for sterile preparations. Pharmacy at the december 16, 2015, board meeting, the following is a best practice recommendation on the elements of a compound record. Modular hardwall cleanrooms designed to the requirements of usp 797 feature three fan filter units, which are factory set at medium speed. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. Unless there are clear and concise understanding and agreement on the definitions, concepts. Proposed revisions to usp chapter 797 for sterile compounding date. Blueprint for implementing chapter 797 for compounding. Wolters kluwer, a leading global provider of information for healthcare professionals and students, announced today the release of a complementary guide designed to help healthcare organizations stay compliant with u. To per form this evaluation, or gap analysis, the requirements of are compared line by line with current practices and operational facilities in order to identify differences or gaps. No plans for compliance polling question how compliant is your site with usp. 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.
Interested parties may submit comments by mail or commercial carrier by august 15 to. Usp 800 is the latest united states pharmacopeia usp revision which clarifies and expands upon hazardous drug compounding both sterile and nonsterile. Those that must be sterilized before administration. October 20, 2015 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. Usp chapter 797 media fill test form free pdf ebooks. Usp 797 is a farreaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound. Usp 797 compliance with usp 797 is our duty because. Usp pharmaceutical compounding sterile preparations. According to the usp chapter on sterile compounding, all ophthalmics, topical and injectable, are sterile preparations. Effective environmental monitoring microbiology network. During this period the system will be unavailable at times.
Nov 22, 2019 in accordance with the rules and procedures of the 2015 2020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations. As is evident in this program, achieving 100% compliance to current and future and future requirements can be difficult. It improves the health and wellbeing of our patients and 2. All product defects or serious adverse events associated with a bulkcompounded veterinary preparation must be reported on form 1932a within 15 days to the fda. Current status iso 8 with iso 5 work bench and anteroom usp 797 guidelines usp 797 proposed revisions est. Uspnf establishes standards for medicines, food ingredients and dietary supplements. Iso classification of particulate matthalmic drops and ointments, and tissue ter in room air limits are in particles of 0. Pharmacopeia chapter pharmaceutical compounding sterile preparations usp 797. Wolters kluwer publishes guide for achieving compliance. Usp 797 clean room guidelines standards for sterile. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations.
The return is located in the in the ceiling the back of the room away from the entry door. Sterile preparations, became effective january 1, 2004 6. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. 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. The usp compounding expert committee is responsible for the development of general chapter 797. Quality standards for large scale sterile compounding facilities. Those prepared according to the manufacturers label instructions that expose original contents to potential contamination.
The sterile compounding room is approximately 11 x 14 with an 8 ceiling. Quickstart operating guide usp 797 modular cleanroom. A cursory reading of usp 797 may leave the false impression that em plays a role only during the biannual certification of the classified areas, meaning the em program should include only two sampling intervals per year. According to the usp 797 chapter on sterile compounding, all ophthalmics, topical and injectable, are sterile preparations.
Like usp and usp, the provisions of proposed usp deal with product transport, product storage, compounding, preparation, and administration of parenteral products. In the scope of the new 795, usp clarifies that nasal sprays and nasal irrigations are considered nonsterile preparations. Usp 797 offers some potentially conllicting guidance on this point. Revision status of usp chapter 797 pharmaceutical compounding.
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. Usp and cgmps require that surface sampling be performed in all iso classified areas on a periodic basis using contact plates or swabs. Compound record name, strength, and dosage form of the compounded sterile preparation csp. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes. 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. Iso classification of particulate matter in room air limits are in particles of 0. Understanding usp 797the united states pharmacopeia usp states, it is the ultimate responsibility of all personnel who prepare csps to understand these fundamental practices and precautions, to develop and implement appropriate procedures, and to continually evaluate these procedures and the quality of. Usp published these revisions for comment on september 2015. Usp 797 requires compounding pharmacies to determine the risk level of the compounding done in their facilities and to perform the compounding in cleanrooms or other controlled environments as specified for the risk level. Oct 27, 2015 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. Usp chapter 797 gap analysis page 7 of 16 x medical center.
Your participation is integral to the standard setting process. Master formulation record reference for the csp, when used. Sterile compounding is done in a 6 xxhlf horizontal laminar flow hood. Compounding record official name, strength, and dosage form of the compounded sterile preparations csp. Usp 800 expands controls for the protection of workers and environments against hazardous drug compounds. Use your usp access point login credentials to register for events and courses, access your subscriptions to usps free resources, applications, and more. Introduction to usp general chapter 797 linkedin slideshare. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. Pharmaceutical compoundingsterile preparations revision bulletin table 1. In accordance with the rules and procedures of the 2015 2020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations 797. 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.
Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that include baths and soaks. On june 1, 2019, usp published updates to the usp general chapters on compounding nonsterile and sterile preparations alongside new standards for compounding radiopharmaceutical drugs. 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. Office of manufacturing qualityoffice of compliance. A cursory reading of usp may leave the false impression that em plays a role only during the biannual certification of the classified areas, meaning the em program should include only two sampling intervals per year. Examples include manufacturers of automated medication dispensing cabinets and pharmacies specializing in extemporaneous compounding. 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. The revisions represent more than nine years of deliberation.
Usp chapter gap analysis page 6 of 16 x medical center confidential and proprietary for internal use only entry door. Usp just released the revised general chapter pharmaceutical compounding sterile preparations. Direct and immediate application by injecting, infusing, or otherwise providing a sterile medication in its final form1 remains outside the scope of 797. Pharmaceutical compounding sterile preparation, united stated pharmacopeia 36national formulary 31. Inspection, regulation, and oversight of sterile compounding pharmacies article pdf available in journal of parenteral and enteral nutrition 362 suppl. September 23, 2019 revised general chapter is postponed until further notice. Combining, admixing, diluting, pooling, reconstituting, repackaging, altering1 definition of administration. Confidential and proprietary for internal use only. We appreciate your patience and understanding while we perform maintenance work. Completely reorganizes the chapter and groups like sections together, eliminating redundancies, and clarify requirements. To download the complimentary usp general chapter pharmaceutical compounding sterile preparations, please click here.
Pharmacopeia 12601 twinbrook parkway rockville md 208521790. 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. Implications of usp 797 for pharmacy facilities design. Understanding the impact to home infusion connie sullivan, bspharm vice president of research and innovation. The usp compounding guideline, chapter 800, clarifies and expands upon the hazardous drug guidelines found in usp 797. Downloadable documents for compliance use these documents to aid in compliance with standards, whether state boards of pharmacy, usp or fda.
In accordance with the rules and procedures of the 2015 2020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations. This is the same requirement as in the proposed revision of usp chapter 797 published september 2015. Usp will be performing maintenance work on friday, may 8th between 8. 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. The gap analysis for the current usp, and are available now in microsoft word. March 12, 2020 appeals panel issues decisions on the appeals to usp, and see faqs on usp compounding appeals. United states pharmacopeia required below informational specific for dietary supplements usp 2010 2015 council of experts, destefano aj. Stay involved and sign up to receive updates from usp. Usp chapter 797 media fill test form free pdf ebook. However, usp builds on earlier regulations by focusing on hds and occupational safety. Quality standards for largescale compounding facilities. There is no record of room particle counts for estimation of room cleanliness. Sample locations must be defined in the em plan or on a form and should include surface wipe sampling of the working areas in biological.
Compounding expert committee in accordance with section 7. The gap areas are then analyzed to identify specific practices that present the greatest. Mar 18, 2015 usp chapter, pharmaceutical compounding. 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. At this setting, these systems meet the requirements for internal pressure, air displacement, and cleanliness. Chapters 1 through 999 are enforceable standards that describe how certain functions and processes are to be performed. Usp sets standards for the quality of drug products and works with healthcare providers to help them meet the standards. On june 1, 2019, usp published major revisions to general chapters 795 and 797, which are intended to minimize the risk of patient harm in the areas of nonsterile and sterile compounding. Usp pharmaceutical compounding sterile preparations proposed revision.