On january 1, 2004, the first version of usp chapter 797, pharmaceutical compounding. Download usp chapter 797 pharmaceutical compoundingsterile. United states pharmacopeia 39 national formulary 34. The led temperature display on the xx freezer read 21c, but the tempscribe read 10 c to 14 c. Sterile product preparation for nonpharmacy personnel dennis. New and revised usp compounding standards are published. You can sign up for updates from usp on their website. Pharmaceutical compoundingsterile preparations 1 change to read. In september 2015, the united states pharmacopeia usp released a proposed updated chapter 797 on procedures for sterile compounding. Reorganized existing chapter to group similar topics together, eliminate redundancies, and clarify requirements.
The united states pharmacopeia usp in 2005 sent members of the committee to public workshops to explain the practical applications of the chapter and the revisions under consideration. The united states pharmacopeia usp has released new and revised standards aimed at ensuring the quality of compounded medicines. Mar 18, 2015 usp chapter, pharmaceutical compounding. To download the complimentary usp general chapter pharmaceutical compounding sterile preparations, please click here. Sterile compounding cleanroom design, components, and procedure. To see our most current content about the new version of the chapter, please read our blog post notable changes in the new usp 797. Final standards for allergen extract compounding under usp chapter 797 under the new standards, to continue inoffice compounding of individual treatment sets for. General chapter will become official on december 1, 2019. Sterile compounding differs from nonsterile compounding see pharmaceutical compoundingnonsterile preparations 795 and good compounding practices 1075 primarily by requiring a test for sterility.
Usp announces chapter 797 standards ascent administrator. Trissel is a member of the 20002005 sterile compounding committeea of the. Jul 17, 2019 this is true for the practice of pharmacy compounding, with the latest addition being new guidelines for both sterile and nonsterile compounding from the united states pharmacopeia. 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. Compounding expert committee in accordance with section 7. While usp 800 will still be official on december 1, 2019, it will be informational only and not compendially applicable until the appeals are resolved. Many cited budgetary constraints and physical plant limitations as the primary barrier to their locations full compliance with. Like the jc, usp has historically been concerned with patient safety.
Usp chapter 797 enforceable but not often enforced. Developing usp general chapter usp is a notforprofit, sciencedriven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards. Comments should include corresponding line number to the proposed revisions to the general chapter. Usp chapter 797 enforceable but not often enforced american. Understanding the impact to home infusion connie sullivan. Sterile preparations radiopharmaceuticals preparation, compounding, dispensing, and repackaging the. At the time this monograph was posted, the uspnf had delayed the effective dates of general chapter indefinitely. Strategies for ensuring compliance by the december 2019 deadline at the conclusion of this activity, participants should be able to describe the primary changes to usp chapter that will be official on december 1, 2019. Sterile preparations, became effective january 1, 2004 6.
Strategies for ensuring compliance by the december 2019 deadline. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. 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. 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. However, usp has since released the new version of the chapter. Proposed usp general chapter 797 complete the form below to download the complimentary proposed usp general chapter.
What didnt change shift from low, medium, and high risk to. The chapter addresses usp 797 standards for cleaning and disinfecting the. A revision in 2008 included information on hds, but did not address the multitude of complex safehandling issues. Revised usp chapter pharmaceutical compoundingsterile preparations will become official i.
Clearly, usp chapter has had a positive influence on patient safety, as acknowledged by 97% of the participants in this years study. In january 2004, chapter in the united states pharmacopeia 27 became the first practice standards for sterile pharmacy compounding in us history that may be enforced by the us food and drug administration. An updated draft of usp chapter 797 was released today. Sterile preparations became official,1 which details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all practice settings in which sterile preparations are compounded. There is no record of room particle counts for estimation of room cleanliness. Usp posts revised pdfs for usp 795, 797, 800, 825 updated. All books are in clear copy here, and all files are secure so dont worry about it. The chapter was to have become official on december 1, 2019, but uspnf announced on september 23, 2019, that appeals were pending on provisions of the chapter regarding beyonduse dating, use of alternative. Free download usp gc 797 appeals updates millions of medications are compounded each year in the us to meet the unique needs of patients. The content below was based on a proposed version of usp general chapter 797. Sterile product preparation for nonpharmacy personnel. Usp general chapter read the final standards on the usp website.
Chapter 797 referred to as usp was published in 2004 and dealt exclusively with sterile compounding. Usp pharmaceutical compounding sterile preparations proposed revision. Blueprint for implementing usp chapter 797 for compounding sterile preparations article pdf available in american journal of healthsystem pharmacy 6212. It has been 11 years since the last revision to usp was published. Establishing a practice standard for compounding sterile preparations in pharmacy article pdf available in american journal of healthsystem pharmacy 6118. Read online usp chapter 797 pharmaceutical compoundingsterile. Usp general chapter 800 standards for hazardous drugs. The modifications will become official on december 1, 2019, to coincide with. Usp chapter gap analysis page 6 of 16 x medical center confidential and proprietary for internal use only entry door. Nonsterile preparations pharmaceutical compounding. The united states pharmacopeial convention usp recently communicated the postponement of the revised 795 and 797, and the new 825 chapters because of appeals put forth for chapters 795 and 797. Final standards for allergen extract compounding under usp chapter 797 under the new standards, to continue inoffice compounding of individual treatment sets for allergen immunotherapy, allergy practices will, beginning dec.
Strategies for ensuring compliance by the december 2019. This site is like a library, you could find million book here by using search. Despite the chapter being a standard of practice for 15 years, a 2017 survey on the state of pharmacy compounding indicated that just 37% of facilities reported that they meet or exceed all usp chapter requirements and 50% reported that they meet most. Currently, 20 states require compliance with usp chapter and these states are actively assessing compliance during inspections. By the end of november 2004, the committee that had written the chapter had revised it. United states pharmacopeia required below informational specific for dietary supplements usp 20102015 council of experts, destefano aj. Usp compounding changes are shown on the usp website. Usp chapter is a document published by the united states pharmacopea that provides procedures and requirements for preparing sterile products. Pdf blueprint for implementing usp chapter 797 for. Revised general chapter, 797 and are postponed until further notice.
A summary of the standards is below, and you can download the complete version on usp s website. Free download usp gc get the hazrx mobile app gc infographic. Usp chapter 797, pharmaceutical compoundingsterile. Usp chapter 797 cleanroom design requires that facilities pressurize nonhazardous compounding and storage areas. The purpose of usp chapter pharmaceutical compounding is to provide standards for the protection and safety of patients and healthcare workers involved in sterile compounding preparations such as pharmacists, nurses, physicians and pharmacy technicians by reducing the potential for microbial contamination caused by an unclean.
The national institute for occupational safety and health niosh considers a drug to be hazardous. As of november 22nd, 2019, the usp will delay implementing previously suggested changes to usp 795 and 797 chapters until further notice the usp published revisions to usp 795, 797, and 825 on june 1, 2019. Usp general chapter provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. Allergen extract compounding requirements updates aaaai. Usp chapter 797 revised and chapter 800 released june 05, 2019.
Usp general chapter pharmaceutical compoundingsterile preparations. These procedures are generally viewed as best practices for sterile product preparation and storage. Usp releases new and revised chapters for compounding. Read this short article to learn from two individuals who served on the usp expert panel and their perspectives on usp and what you can do now to prepare. Sterile compounding also requires cleaner facilities. Sep 23, 2019 in 2004, usp revised the chapter, which became a general chapter devoted specifically to sterile compounding, pharmaceutical compoundingsterile preparations general chapter or. The currently official versions of general chapter last revised in 2014 and general chapter 797 last revised in 2008 remain official until further notice. The objective of the usp 797 guidelines is to describe conditions and practices to. Some information sources have been revised or redacted. Us pharmacopeia 40national formulary 35 online subscription. Comments will be accepted until january 31, 2016, the end of the comment period for pf 416.
Pharmacopeia usp has published the new and revised usp compounding general chapters and made them available for free download. The pcca blog a summary of proposed changes to usp. 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. Pharmaceutical compoundingste rile preparations introduction the objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from 1. A summary of the standards is below, but we encourage you to download the complete version. Uspnf chapter 797 requirement siemens download center. Sample form for assessing hand hygiene and garbing related practices of compounding personnel, in usp general chapter pharmaceutical compoundingsterile. Introduction to usp general chapter 797 linkedin slideshare. To download the complimentary usp general chapter pharmaceutical compounding sterile preparations, please. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. The return is located in the in the ceiling the back of the room away from the entry door. Additionally, a reference in to will be aligned based on the revisions to. Final standards for allergen extract compounding under usp.
Strategies for ensuring compliance with revised usp chapter 797. Pharmaceutical compoundingsterile preparations revision bulletin table 1. It is proposed to revise this chapter to improve clarity, respond to stakeholder input, and reflect new science. Usp general chapter 800 standards for hazardous drugs mckesson. 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. We supported those standards in our comments to usp, and we. Sterile preparations radiopharmaceuticals preparation, compounding, dispensing, and repackaging the new and revised standards, in. Pharmaceutical compounding sterile preparations proposed revision. Citeseerx document details isaac councill, lee giles, pradeep teregowda. We are pleased to report that thanks to the vigorous collective advocacy of the allergy community, the final standards mirror the proposed standards released last july. Strategies for ensuring compliance with revised usp.
This muchanticipated chapter will have a significant impact on how you clean and disinfect your primary and secondary engineering controls. In 2004, united states pharmacopeia usp published in its usp compendium chapter 797, which became the first enforceable guideline in 2008. Adapted from the ashp discussion guide on usp chapter for. The updates pertain to the usp general chapters on compounding nonsterile medicines usp pharmaceutical compoundingnonsterile preparations, and compounding sterile medicines usp pharmaceutical compoundingsterile preparations. Separate requirements for inoffice compounding of allergen extract restored. 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.
Millions of medications are compounded each year in the us to meet the unique needs of patients. The longawaited new usp chapter 797 standards on sterile compounding were released june 1 and take effect dec. Separate requirements for inoffice compounding of allergen extract restored in september 2015, the united states pharmacopeia usp released a proposed updated chapter 797 on procedures for sterile compounding. 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. Iso 5, 7 and 8 environments support primary engineering controls, buffer rooms, and anterooms. Usp pharmaceutical compounding sterile preperations icdst. A summary of the standards is below, and you can download the complete version on usps website. On june 1 st, the revised usp chapter was released. General chapter pharmaceutical compoundingsterile preparations. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations.
The documents are available for free download until december 2019 weve previously published a host of articles in regards to the usp compounding cleanrooms, particularly. Pharmaceutical compoundingste rile preparations introduction the objective of this chapter is to describe conditions and practices to prevent harm, including death, to. The requirements in this chapter must be met to ensure the sterility of any csp. Postponed usp general chapters until further notice 795 pharmaceutical compounding nonsterile preparations reprinted from usp42nf37 last revised 2014 797 pharmaceutical compounding sterile preparations reprinted from usp42nf37 last revised 2008 800 hazardous drugs handling in healthcare settings 795 pharmaceutical compounding nonsterile preparations as published june. Uspnf establishes standards for medicines, food ingredients and dietary supplements. This is true for the practice of pharmacy compounding, with the latest addition being new guidelines for both sterile and nonsterile compounding from the united states pharmacopeia. Usp articles, or within 10% if not specified, until their buds. Complete the form below to download the complimentary proposed usp general chapter. Clinical iq provides an online reference to determine the reg.
58 256 415 1310 805 946 51 153 255 111 1172 1159 87 460 1320 444 1407 734 337 1349 269 270 372 980 313 953 325 952 1243 329