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