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 standards in this chapter do not pertain to the clinical administration of. Overview of chapter for surveyors and inspectors kate douglass october 9, 20. Ii 35 march 2014 manual of patent examining procedure. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use. Coverage of new usp chapter 800 on the compounding of hazardous drugs and the existing usp 797 which is undergoing revision updates on. Examples of designs for hazardous drug compounding areas, 2016. Ahp is highlighted in the united states pharmacopeia. Sterile preparations became official,1 which details the procedures and requirements for compounding sterile. After publication of the revised on june 1, 2019, usp received appeals on certain. Jan 15, 2014 proper aseptic technique, including successful mediafill test see appendix iv of usp chapter 797 15 for a sample assessment form.
Usp articles, or within 10% if not specified, until. However, a requirement statement from usp has been added in blue. It improves the health and wellbeing of our patients and 2. The us pharmacopeial convention recommendations for. Principal competencies, conditions, practices, and quality assurances that are required and recommended in usp chapter, in usp general chapter pharmaceutical compoundingsterile preparations. Alternative sampling plans with equivalent or better protection are acceptable. Principal competencies, conditions, practices, and quality assurances that are required and recommended in usp chapter 797, in usp general chapter 797 pharmaceutical compoundingsterile preparations.
Class ii bscs are further divided into types type a1, type a2, type b1, and type b2. 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. Appendix ii of usp chapter 79715 provides infor mation on types of. 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. Chapter outlines minimal cleaning and disinfecting.
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. United states pharmacopeia 39, national formulary 34 usp, general chapter 800, 2016 sterile hd and nonsterile hd compounding united states pharmacopeia 39, national formulary 34 usp, general chapter 800, appendix 2. The newest edition of this publication now includes. Describe both the general responsibilities of compounding personnel and those specific to the. A method not described in the usp may be used if verification results demonstrate that the alternative is at least as effective and reliable as the usp membrane filtration method or the usp direct inoculation. Pharmaceutical compoundingsterile preparations, usp 39. See appendix ii for a list of roundtable participants and appendix iii for a list of parties that submitted written comments. Note that if there is a discrepancy between the 797 bud limits and the stability time found in the package insert or other reference, the sterile compounding professional must use the shorter of the two for the bud. United states pharmacopeia usp usp nonsterile compounding usp sterile compounding usp nonsterile and sterile hazardous drugs.
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. These tools can help build the foundation for a corrective action plan that details the activities and resources needed to comply with usp compounding requirements. Identify requirements for environmental monitoring. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. General inspection level ii, single sampling plans for normal inspection with an aql of 0. These items should be properly cleansed of any visible soil, blood, or other extraneous matter and then disinfected with a proper disinfecting agent. Cleaning products and procedures for compliance by kate douglass cleaning should generally occur from the cleanest area to the dirtiest from an iso class 6 or 7 cleanroom to the iso class 8 anteroom. Compounding provides access to medication for patients. Based on the number and significance of public comments received in response to the revision.
Not more than the specified number of units contains visible particulates. Collapsed compounded sterile preparations csp microbial risk categories from. Sterile 70% isopropyl alcohol is the most commonly used disinfecting agent, but other agents may also be used see appendix ii of usp 797. Specific engineering controls detailed in usp include.
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. As the system hepa filter clogs, you will notice in increase in blower noise and a reduction in the internal positive pressure. 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. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from. May 05, 2015 2 table of contents introduction a primer on usp 797 pages 34 environmental quality and control aspects of usp 797 pages 58 selecting and working with an environmental health lab pages 910 appendix i. Coverage of new usp chapter 800 on the compounding of hazardous drugs and the existing usp 797 which is undergoing revision updates on regulations related to the drug quality and security act dqsa seven new chapters and 16 new contributors appendices in the print edition offer more. The us pharmacopeial convention recommendations for diluted. Chapter outlines minimal cleaning and disinfecting requirements for the typical sterile compounding pharmacy environment. The usps guidelines for choosing a disinfectant technology. Table 2 taken from appendix ii of the usp 797 document highlights the. Products that are to be injected carry the greatest risk of serious health effects.
Pharmacopeia 12601 twinbrook parkway rockville md 208521790. Usp chapter, and apply them in a variety of nuclear pharmacy practice settings. Us pharmacopeial convention, usp 797, appendix ii lists sodium hypochlorite bleach in concentrations of 100 to 5000 ppm as the only disinfectant with microbial inactivation of bacteria, lipophilic viruses. Interested parties may submit comments by mail or commercial carrier by august 15 to. Don macdonald northern regional manager phoenix controls.
Sep 23, 2019 in addition, 797 defines buds for csps that have a preservative added or have had sterility testing performed. Ahp is highlighted in the united states pharmacopeia usp as the product with a. Compounding of total parenteral nutrition fluids using manual or automated. Comments should include corresponding line number to the proposed revisions to the general chapter.
Comments will be accepted until january 31, 2016, the end of the comment period for pf 416. Learn about how to properly clean and disinfect critical pharmacy surfaces with contec healthcares usp 797 guidelines overview. In accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations 797. Table 2 taken from appendix ii of the usp 797 document highlights the most commonly used surface disinfectant technologies and their respective attributes. Identify the key acronyms and state the definition of key terms associated with usp 797. In addition, defines buds for csps that have a preservative added or have had sterility testing performed. Cgmp usp crosswalk 2 subpart b organization and personnel is this requirement of 21 cfr 211 required in usp chapter. General chapter usp establishes best practices and regulations for the. Appendix ii list of decisions cited a, ex parte, 17 uspq2d 1716 bd. Realworld scenarios pages 14 about pathcon page 15 pathcon laboratories. Usp 797 compliance with usp 797 is our duty because. Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings. Identify the key acronyms and state the definition of key terms. Garbing related practices of compounding personnel see appendix iii and.
Usp and cgmps agree that compounding personnel represent the impact of usp on environmental monitoring comprehensive monitoring is essential both usp and cgmps require concentrated em efforts to ensure the facility is maintained in a manner that does not adversely affect the quality and safety of csps. Free download usp gc appeals updates millions of medications are compounded each year in the us to meet the unique needs of patients. Determining csp risk levels pages 1112 appendix ii. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov. Usp chapter 797, pharmaceutical compoundingsterile.
Usp and cgmps agree that compounding personnel represent the impact of usp on environmental monitoring comprehensive monitoring is essential both usp and cgmps require. Blueprint for implementing chapter 797 for compounding. A method not described in the usp may be used if verification results demonstrate that the alternative is at least as effective and reliable as the usp membrane filtration method or the usp direct inoculation of the culture medium method where the membrane filtration method is not feasible. Table 2 conclusions the usps guidelines for choosing a disinfectant technology emphasizes the importance of a well rounded product. Us pharmacopeia 40national formulary 35 online subscription. 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. On january 1, 2004, the first version of usp chapter, pharmaceutical compounding. To download the complimentary usp general chapter 797 pharmaceutical compounding sterile preparations, please click here. Us pharmacopeial convention, usp 797, appendix ii lists sodium hypochlorite bleach in concentrations of 100 to 5000 ppm as the only disinfectant with microbial inactivation of bacteria, lipophilic viruses, hydrophilic viruses, m.
Usp 797 cleaning guidelines for sterile compounding. 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 process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. Lintfree wipes dipped in diluted cleaning agent can be used to clean iso class 5 to 8 areas. In addition, 797 defines buds for csps that have a preservative added or have had sterility testing performed. Cleaning products and procedures for compliance by kate douglass cleaning should generally occur from the cleanest area to the dirtiest from an iso class 6. Usp was developed to provide guidance pertaining to. United states pharmacopeia 39, national formulary 34 usp, general chapter 800, 2016 sterile hd and nonsterile hd compounding united states pharmacopeia 39, national formulary 34 usp, general.
Office of manufacturing qualityoffice of compliance. Free download usp gc 797 appeals updates millions of medications are compounded each year in the us to meet the unique needs of patients. Wa pharmacy quality assurance commission 2020 responsible. Uspnf establishes standards for medicines, food ingredients and dietary supplements. Proper cleaning and disinfecting procedures, including successful surface sampling test see appendix v of usp chapter 797 15 for a sample assessment form and appendix ii for information about cleaning products. Procedures manual or policy and procedure manual with detailed. Christine acosta pharmd california state board of pharmacy 141,373 licensees drug rooms 38 hospital pharmacies 485 licensed correctional facilities 53. Note that if there is a discrepancy between the bud limits and the. Ashp guidelines on compounding sterile preparations. Usp was developed to provide guidance pertaining to the proper engineering controls for safely handling and preparing hds. These cabinets are divided into three general classes class i, class ii, and class iii.
1062 143 523 1295 1016 1589 275 442 1343 1363 778 1131 810 1382 567 1551 1127 1033 641 392 1200 923 67 158 697 110 162 618 72 1371 611 1314