Thus, their testing procedures must be verified to meet the usp requirements stated in the individual monograph for the component being tested. Jan 04, 2017 chapter 797 is a pharmaceutical compounding document produced by the united states pharmacopeia usp. Originally written in 2004, chapter 797 is popularly agreed to increase the safety of the compounding setting and its ingredients. United states pharmacopeia, 36th revision adopted by fl board of pharmacy october 1, 2014 includes chapters 797, 71, 85, 731 these standards are intended to apply to all sterile pharmaceuticals, notwithstanding. Sterile preparations 797 tightens patient safety guidelines. These include proposed revisions to usp chapter, the creation. Current usp protocols state that media fill testing and fingertip testing of all compounding personnel must be done either annually or semiannually depending on the risk level. Usp chapter gap analysis page 6 of 16 x medical center confidential and proprietary for internal use only entry door. 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. The louisiana board of pharmacys boards compliance officer conducted an onsite inspection on october 21, 2016 and found a variety of usp deficiencies. Pharmaceutical compoundingsterile preparations uspnf.
The usp and chapter 797 the united states pharmacopeia national formulary uspnf recognized in the 1938 federal food, drug, cosmetic act as the official compendia of drug standards in the united states chapters numbered 1999 are offici al monographs and standards, and are. Usp 797 is one of the most popular standards that prevent excessive microbial contaminations and bacterial endotoxins. Proposed revisions to usp chapter 797 for sterile compounding date. Pharmacopeia 12601 twinbrook parkway rockville md 208521790. Sep 18, 2014 usp chapter 797 is a standard that has been difficult for many sterile compounding facilities to follow. Describe both the general responsibilities of compounding personnel and those specific to the. Usp is a public standardsestablished authority called the united states pharmacopeia. It improves the health and wellbeing of our patients and 2. Jun 17, 2017 usp 797 compounding compliance update.
Usp 797 compliance with usp 797 is our duty because. Although the us pharmacopeial convention usp addressed hds in a 2008 update to usp for the issue of compounding sterile parenteral hds, the update fell short due to a lack of guidance for nonparenteral products. General chapter 797, pharmaceutical compounding sterile preparations usp, the latest version of which was issued in 2008. Usp 800 timeline march 2014 chapter first published for public comment december 2014 revisions published, round 2 of public comment february. Healthcare inspection sterile compounding environment and. A program to sample nonviable airborne particles differs from that for viable particles in that it is intended to directly measure the performance of the engineering controls used to create the various levels of air cleanliness, for example, iso class 5, 7, or 8. This period has come to a close, with the updated version of the chapter posted on. Interested parties may submit comments by mail or commercial carrier by august 15 to. 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. Pharmaceutical compoundingsterile preparations revision bulletin.
We believe this chapter is a very important one for the safety of patients, so we preposted the chapter to give stakeholders extra time, said schnatz. Apr 01, 2015 usp is designed to complement both usp and usp 797. United states pharmacopeia, 36th revision adopted by fl board of pharmacy october 1, 2014 includes chapters 797, 71, 85, 731 these standards are intended to. Those prepared according to the manufacturers label instructions that expose original contents to potential contamination.
Guidelines for pharmaceutical sterile preparations. Revision status of usp chapter 797 pharmaceutical compounding. Although the us pharmacopeial convention usp addressed hds in a 2008 update to usp 797 for the issue of compounding sterile parenteral hds, the update fell short due to a lack of guidance for nonparenteral products. The handbook and calendar for the 2015 academic year is now available online here note. It is proposed to revise this chapter to improve clarity, respond to stakeholder input, and reflect new science. Usp chapter 797 general overview personnel cleansing and garbing requirements. Understanding usp chapter 797 engineering control certification requirements and environmental sampling and remediation strategies chs pharmacy education series proce, inc. Review the history of usp 797 and the milestones that led to the development of. Overview of chapter for surveyors and inspectors kate douglass october 9, 20.
Another major change within the new usp revision is the frequency at which environmental and personnel viable monitoring must be done. 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. Identify the key acronyms and state the definition of key terms associated with usp 797. 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. Understanding usp chapter engineering control certification requirements and environmental sampling and remediation strategies chs pharmacy education series proce, inc. It is now five years since the new england compounding center necc tragedy brought compounding specialty pharmacies to the attention of the media and the us public. September 23, 2019 revised general chapter is postponed until further notice. All rights reserved 21 i would like to comment on the hazardous drugs as csp. Sterile compounding webinar california hospital association. Iso classification of particulate matter in room air limits are in particles of 0. Compounding sterile preparations 1 t he revision bulletin to usp chapter, pharmaceutical compounding. Blueprint for implementing chapter 797 for compounding. Usp articles, or within 10% if not specified, until. Scope of usp 800 7 receiving storage manipulating administration disposal background.
In september 2015, the united states pharmacopeia usp released a proposed updated chapter 797 on procedures for sterile compounding. Compounding of total parenteral nutrition fluids using manual or. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. It sets guidelines on the health care products that are created or sold in the us on over the counter and prescription medicines. 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 revised section on environmental monitoring discusses requirements. Those that must be sterilized before administration. Alternatively, you can download a pdf copy here 5 mb. The guidelines for pharmaceutical sterile preparations. Reorganized existing chapter to group similar topics together, eliminate redundancies, and clarify requirements. The usp and chapter 797 the united states pharmacopeia national formulary uspnf recognized in the 1938 federal food, drug, cosmetic act as the official compendia of drug standards in the united states chapters numbered 1999 are offici al monographs and standards, and are enforceable by the fda.
Allergen extracts as csps for at least 10 seconds and allowed to dry be fore they are used to compound allergen ex allergen extracts as csps are singledose andtracts as csps. The usp received appeals on specific provisions of the chapter, and those appeals were subsequently granted, effectively sending this version of. Millions of medications are compounded each year in the us to meet the unique needs of patients. Mar 18, 2015 usp chapter, pharmaceutical compounding. Uspnf establishes standards for medicines, food ingredients and dietary supplements.
Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. 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 general overview personnel cleansing and garbing requirements. Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that include baths and soaks.
There is no record of room particle counts for estimation of room cleanliness. The sterile compounding room is approximately 11 x 14 with an 8 ceiling. Pharmacopeial usp convention is a nonprofit organization that sets legally recognized standards for drugs. Compounding sterile preparations 1 t he revision bulletin to usp chapter 797, pharmaceutical compounding. Usp chapter 797 is a standard that has been difficult for many sterile compounding facilities to follow. The benefits of usp 797 compliance include the minimization of contamination of csps, improved aseptic proficiency of hospital pharmacy personnel. In accordance with usp s bylaws, the responsible expert committees worked with a sense of. Chapter 797 is intended to decrease the risk of a patient receiving an infected medication in addition to guarding the health care professional in. Pharmaceutical compoundingsterile preparations, usp 39 page 626. Usp 797 clean room guidelines standards for sterile. In accordance with the rules and procedures of the 20152020 council of experts, usp. Sterile compounding differs from nonsterile compounding see pharmaceutical compoundingnonsterile preparations 795 and good compounding practices 1075 primarily by requiring a test for sterility.
Usp chapter, and apply them in a variety of nuclear pharmacy practice settings. General chapter hazardous drugshandling in healthcare settings. Office of manufacturing qualityoffice of compliance. Proposed revisions to chapter were introduced in september 2015. Ec members discussed this new general chapter that will be on the october 2015 ballot for publication in usp 39 nf 34, first supplement. Usp chapter 797 gap analysis page 7 of 16 x medical center.
Guidelines have been produced on both drug shortage management and. Process must simulate the most challenging or stressful conditions encountered during initial media fill testing, a minimum of 3 mediafill tests must be completed. Based on the number and significance of public comments received in response to the. The boards compliance officer placed the permit on a restricted basis, limited to csp of lowrisk items to be used within 12 hours. March 12, 2020 appeals panel issues decisions on the appeals to usp, and see faqs on usp compounding appeals. The led temperature display on the xx freezer read 21c, but the tempscribe read 10 c to 14 c. 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. Chapters 1 through 999 are enforceable standards that describe how certain functions and processes are to be performed. Jan 19, 2015 2015 calendar and handbook now available. Preserved intradermal and subcutaneous sdvs and mdvs are exempt from personnel, environmental and storage requirements if all criteria are met. Based on the number and significance of public comments received in.
Reports usp chapter 797 1272 am j healthsyst pharmvol 62 jun 15, 2005 determine the pharmacys compounding risk level low, medium, or high risk using a risklevel assessment checklist, chapter 797, and professional judgment, perform a gap analysis by comparing chapter 797 requirements line by line with pharmacy operational proce. Usp chapter 797 from usp 40, nf 35 official until may 1 st, 2018 usp chapter 800 from usp 40, nf 35 official until may 1 st, 2018 proposed usp chapter 797 published september 25 th 2015 the usp compliance study by critical point webinar sponsored by pharmacy one source fda. It is no longer acceptable for facilities that prepare a low number of hds to use a biologic safety cabinet bsc or a compounding aseptic containment isolator caci in a nonnegative pressure room. Shoe covers, head and facial hair covers, face masks, tyvek nonshedding gown and sterile gloves required. The usp 797 gap tool has been updated to reflect the version of usp general chapter 797 that was published on june 1, 2020. Expiration date is a manufacturer defined term based on very specific testing used for commercially available. Sterile compounding also requires cleaner facilities. While there are some exceptions for prescribers, the board considers reconstitution by pharmacies to be compounding. Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings. Completely reorganizes the chapter and groups like sections together, eliminating redundancies, and clarify requirements. The usp received appeals on specific provisions of the chapter, and those appeals were subsequently granted, effectively sending this version of the chapter back to the expert committee. 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. Sterile compounding is done in a 6 xxhlf horizontal laminar flow hood.
Guidelines for pharmaceutical sterile preparations chapter 797. General guidelines for matching csps and components. Pharmaceutical ited so long as they have been proven to be equiva lent or superior with. Sterile preparations, became effective january 1, 2004 6. The existing chapter had provided procedures for allergen immunotherapy extracts as a separate element to processes applicable to three levels of risk for other sterile compounded products. Usp seeks feedback on american pharmacists association. Recently, a new chapter was proposed for addition to the united. Understanding usp 797csps include the following types of preparations. Pharmaceutical compoundingsterile preparations revision bulletin table 1. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. Confidential and proprietary for internal use only. Tf under usp 800 a low volume hd producing facility does not have to locate its bsc or caci in a negative pressure room false was true under 797 containment segregation. Usp chapter 797 defines bud as the date or time after which a compounded sterile preparation csp may not be stored or transported and is calculated from the date or time of compounding. For example, under dextrose injection, the following is stated.
Iso classification of particulate matthalmic drops and ointments, and tissue ter in room air limits are in particles of 0. 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. Sterile preparations, was released in late 2007 and will become official on june 1, 2008. Vigorous hand washing with antimicrobial soap for 2 minutes up to the elbows before donning gloves. Pharmacopeia usp chapter 797 for preparing sterile compounded drugs. A timeline of sterile compounding events and actions taken. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. The return is located in the in the ceiling the back of the room away from the entry door. Compounding of total parenteral nutrition fluids using manual or automated. Usp 795 and usp 797 compliance are not as frequently talked about recently, yet they are as important as ever. This discussion guide is a followup to a discussion guide that was developed when the original chapter became official. Identify the key acronyms and state the definition of key terms associated with usp. Some facility requirements will necessitate a revision to usp 797.
Usp sets standards for the quality of drug products and works with healthcare providers to help them meet the standards. Usp continues to improve chapter 797 by collecting comments from users and having technical. As a result, in march 2014, usp published a proposed set of guidance known as usp that dealt with hd handling in health. Included among usps standards are those related to the practice and quality standards for compounded sterile preparations, usp 797.