Provocholine methacholine chloride usp powder for solution. The standards in this chapter do not pertain to the clinical administration of. Pharmacys legal liability and usp risk reduction strategies. These guidelines are a revision of the 2000 ashp guidelines on quality assurance of pharmacyprepared sterile products, with the goals of providing more current recommendations and harmonizing the ashp guidelines with united states pharmacopeia usp chapter 797, pharmaceutical compoundingsterile preparations. Although this is the direction in which usp appears to be heading, it will take a substantial majority of practitioners to accept usp 797 as the standard of care before a res ipsa loquitur challenge is possible. Pharmaceutical compounding usp sterile preparations. There may be images in this book that feature models. Usp chapter 797 enforceable but not often enforced. The use of commercial reference laboratories that of fer qualitative and. By the end of november 2004, the committee that had written the chapter had revised it.
To download the complimentary usp general chapter 797 pharmaceutical compounding sterile preparations, please click here. This is particularly important in compounding the complex formulation of. The latest and greatest on usp 797800 an update alyssa donadio, pharm. This legal pathway should be recognized as a future. Using usp chapter pharmaceutical compoundingsterile preparations csp is now considered the standard for sterile compounding practice and safety in the united states. 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. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Usp chapter, and apply them in a variety of nuclear pharmacy practice settings. Pharmaceuticalthan those described in this chapter is not prohibited so long as they have been proven to be equivacompounding lent or superior with statistical significance to sterile preparationsthose described herein. Usp chapter 797 enforceable but not often enforced american. Comments will be accepted until january 31, 2016, the end of the comment period for pf 416. Jan 24, 2012 using usp chapter pharmaceutical compoundingsterile preparations csp is now considered the standard for sterile compounding practice and safety in the united states.
Usp 797 and usp 800 8 common mistakes to avoid when. Uspnf establishes standards for medicines, food ingredients and dietary supplements. Identify the key acronyms and state the definition of key terms associated with usp. Although the usp proposes standards for pharmaceutical compounding and handling, including usp pharmaceutical compounding nonsterile preparations and usp pharmaceutical compounding sterile preparations, the organization has no enforcement authority.
Wa pharmacy quality assurance commission 2020 responsible. Summary the quality of a compounded sterile preparation csp is directly related to the methods used to ensure that the csp achieves the desired goal of purity, potency, and sterility. General rule reference applies to all questions through worksheet. Physician anesthesiologists have encountered usp under the socalled onehour rule that required the administration of all immediateuse. General chapter 797, pharmaceutical compounding sterile preparations usp, the latest version of which was issued in 2008. The newly revised usp chapter on sterile medication guidelines was released december 2007 and becomes effective june 2008. The author is a member of the usp compounding expert committee, but this. Pdf on oct 1, 2004, eric s kastango and others published usp. Us pharmacopeia 40national formulary 35 online subscription. 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. Usp compounding compendium offers convenient electronic access to all compoundingrelated and supporting general chapters from the united states pharmacopeia national formulary, plus general notices and requirements and over 150 monographs relevant to compounding.
Specifically, usp published revisions to general chapter 797 pharmaceutical compounding and sterile preparations and published a new general chapter hazardous drugs handling in healthcare settings. 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. Traditional pharmacy compounding involves the modification of a dosage form to fit the needs of a patient, as prescribed by the patients physician, and serves a vital need within the health commun. Pdf ashp guidelines on compounding sterile preparations. In utahs pharmacy practice statutes and regulations. General chapter 797, pharmaceutical compounding sterile preparations usp 797, the latest version of which was issued in 2008. Physician anesthesiologists have encountered usp under the socalled onehour rule that required the administration of all immediateuse compounded sterile products. Citing the uspnf is definitely tricky because it is a twobook compilation the united states pharmacopeia and the national formulary of 4 volumes and ama doesnt provide an example for this in the manual of style, so we must improvise. Inspection, regulation, and oversight of sterile compounding pharmacies article pdf available in journal of parenteral and enteral nutrition 362 suppl. Citation machine helps students and professionals properly credit the information that they use. Millions of medications are compounded each year in the us to meet the unique needs of patients. Office of manufacturing qualityoffice of compliance.
It improves the health and wellbeing of our patients and 2. Oct, 2014 although the usp proposes standards for pharmaceutical compounding and handling, including usp pharmaceutical compounding nonsterile preparations and usp pharmaceutical compounding sterile preparations, the organization has no enforcement authority. Understanding the impact to home infusion connie sullivan, bspharm vice president of research and innovation. Inspection, regulation, and oversight of sterile compounding pharmacies article pdf available in journal of parenteral and. Guideline for referencing usp nf documentary standards. The revised usp 797 now has specific guidelines addressing immunotherapy vial preparation that are a significant change from the previous version. Concepts in sterile preparations and aseptic technique. Jun 01, 2006 usp chapter 797 became effective january 1, 2004. 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. This is particularly important in compounding the complex formulation of parenteral nutrition. Do you distribute or cause to be distributed into nm nonpatient specific compounded product.
Included among usps standards are those related to the practice and quality standards for compounded sterile preparations, usp 797. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Usp articles, or within 10% if not specified, until. Tracing from the print usp nf to the new usp nf online o when referencing a document in the print usp nf, you may reference the edition number e. Should hospital pharmacies that are not fully compliant. If only pharmacies fully compliant with general chapter were permitted to prepare compounded sterile products, few hospital pharmacies would be able to provide sterile compounding services. Identify the key acronyms and state the definition of key terms associated with usp 797. Describe both the general responsibilities of compounding personnel and those specific to the. Establishing a practice standard for compounding sterile preparations i we use cookies to enhance your experience on our website. Chapter that will most impact home infusion providers.
The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. Understanding the impact to home infusion connie sullivan, bspharm vice president of. Alaska state board of pharmacy no yes ak pharmacy rules 2016. Usp 797 compliance with usp 797 is our duty because. On june 1, 2019, a revised version of usp general chapter. Concepts in sterile preparations and aseptic technique is an independent publication and has not been authorized, sponsored, or otherwise approved by the owners of the trademarks or service marks referenced in this product. The chapter answer book provides an explanation of elements of usp hazardous drugshandling in healthcare settings and best practices to comply with the requirements and recommendations of the usp general chapter. United states pharmacopeia and national formulary usp 33nf 28 reissue cdrom.
Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from. Usp pharmaceutical compounding sterile preparations proposed revision. The goal was to better align these 2 chapters with usp 800 hazardous drugs handling in healthcare settings, which was published in 2016 and goes into effect december 1, 2019. Are products only labeled for use on a specific patient. Usp chapter 797, pharmaceutical compoundingsterile. Purpose guidelines for adopting and successfully implementing the requirements of the united states pharmacopeia usp chapter 797 for compounding sterile preparations are presented. After publication of the revised on june 1, 2019, usp received appeals on certain provisions of the chapter. In accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use.
Reference source to support the stability of the csp. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare. By continuing to use our website, you are agreeing to our use of cookies. Usp 797 pharmaceutical compounding sterile preparations proposed revision. In june 2019, the united states pharmacopeia usp released several new and revised pharmacy compounding standards. Free download usp gc 797 appeals updates millions of medications are compounded each year in the us to meet the unique needs of patients. Washington law holds the responsible manager and all pharmacists on duty responsible for ensuring pharmacy compliance with all state and federal laws governing the practice of pharmacy. Impact of newly revised sterile medication compounding. No plans for compliance polling question how compliant is your site with usp. The general chapter guidelines are an excellent set of standards and something to strive for, but they are not a requirement in canada. Comments should include corresponding line number to the proposed revisions to the general chapter. General chapter pharmaceutical compounding sterile.
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. Understanding contaminants and how to remove them usp and you pharmaceutical compoundingsterile preparations this general chapter provides procedures and requirements for compounding sterile preparations. In accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations 797. Jul 24, 2019 by dylan herr, eagle raqa development manager. In spring 2018, the united states pharmacopeia usp announced plans to revise general chapters 795 and 797, which set standards for compounding nonsterile and sterile preparations. Notethis tabular appendix selectively abstracts and condenses the full text of. When using the print usp nf, check the official text information posted on to ensure the text has not been superseded by an accelerated. 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. The library has developed these guides to assist with referencing in the styles most commonly used at usp. Included among usp s standards are those related to the practice and quality standards for compounded sterile preparations, usp 797. Cite your journal article in american medical association sorted alphabetically format for free. Usp ushers in changes to rules for hospital and retail. The return is located in the in the ceiling the back of the room away from the entry door. Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings.
Usp chapter gap analysis page 6 of 16 x medical center confidential and proprietary for internal use only entry door. Failure to complete this addendum within the month of march or within 30 days of. Traditional pharmacy compounding involves the modification of a dosage form to fit the needs of a patient, as prescribed by the patients physician, and serves a. On june 1, the us pharmacopeial convention usp released its wellanticipated revisions to chapter the chapter that addresses pharmaceutical compounding sterile preparations. Healthcare facilities that do not adhere to usp standards but reuse sdvs for multiple patients must be cited for deficiencies under the applicable infection control standards for each type of providersupplier. Cleaning the compounding pharmacy presented by david nobile contec, inc.