When components meeting compendial quality standards are not obtainable, components of equivalent. The compounder should usp29 adopt appropriate storage requirements as provided in preservation, packaging, storage, and labeling under general notices and requirements. The decisions on the appeals to 795 do not foreclose the possibility of future revisions to this chapter. What are the differences between usp 795, 797, and 800. Background on june 1, 2019, usp published revisions to general chapter 795 for nonsterile compounding and general chapter for sterile compounding, as well as a new general chapter for radiopharmaceutical compounding. Because of the interference of some protein particles and their physical characteristics fragile or translucent, the results. Pharmaceutical compoundingnonsterile preparations3 7. The date is determined from the date or time the preparation is compounded. Usp was revised in 2004 and again in 2011, when good compounding practices was incorporated. 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. For further guidance, see general information chapter a1787n.
The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. Compounding is an integral part of pharmacy practice and is essential to the provision of health care. To download the complimentary usp general chapter pharmaceutical compoundingnonsterile preparations. Finalized revisions to usp general chapters 795 and were released on june 1, 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. Must comply with the criteria in the uspnf monograph, if one exists. Usp general chapter pharmaceutical compoundingsterile preparations. Usp just released the revised general chapter pharmaceutical compounding nonsterile preparations. For purposes of this chapter, nonsterile compounding is defined as. In june 2019, usp released revisions to the general chapter pharmaceutical compounding nonsterile preparations. The author is a member of the usp compounding expert committee, but this.
Usp general chapter provides standards for compounding quality nonsterile preparations. Consult usp for specific information regarding beyonduse dating for nonaqueous, aqueous, and other formulations. Developing usp general chapter 795 usp is a notforprofit, sciencedriven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards. In 20, united states pharmacopeia general chapter usp 795 was incorporated into washington law rcw 18. 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. Usp 797 builds upon the same 795 requirements for nhds, with the additional requirement of an externally vented laminar flow hood as a primary engineering control pec for hds. New and revised usp compounding standards are published. General chapter is referenced in many state and national laws and regulations.
The purpose of this chapter and applicable monographs on formulation is to help define what constitutes good compounding practices and to provide general information to enhance the compounders ability in the compounding facility to extemporaneously compound preparations that are of. On june 1, 2019, the united states pharmacopeia usp published a revised version of usp general chapter, which contains the standards for nonsterile compounding. Millions of medications are compounded each year in the us to meet the unique needs of patient, including. A reliable bud is established to ensure that the fin water, soap or detergent, and an airdrier or singleuse. The regulations were initially introduced in 2000 and recently published revisions further clarify the safety standards for compounded nonsterile preparations cnsps, such as oral and topical preparations. Therefore, usp is postponing the official dates of the revised and, and. In light of these appeals, and in accordance with our bylaws, usp is postponing the official date of 795 until further notice. Since 1820, a nongovernmental organization, the united states pharmacopeial con. 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 was retired when was published in usp 24nf 19 in 2000. A pharmacist who repackages under the state law needs to apply 1 the principal information provided in the usp general information chapter packaging practicerepackaging a single solid oral drug product into a unitdose container 1146 and 2 other beyonduse date. Pharmacy quality assurance commission guidance document. Usp general chapter 795 provides standards for compounding quality nonsterile preparations. Its predecessor document, general chapter sterile drug products for home use, was first developed in the 1990s as an informational general chapter.
Standard solutions weight in g of sodium chloride per kg of water osmolality mosmolkg mmolal osmotic coefficient fm, nacl freezing point depression dtf 3. Pharmaceutical dosage forms765 maceutical preparations, which are given elsewhere in thistent uniformity does not rely on the assumption of blend pharmacopeia. First supplement to usp 37nf 32 general information a1044n cryopreservation of cells 6395. In the interim, the currently official version of last revised in 2014 will remain official. In june 2019, the united states pharmacopeia usp released several new and revised pharmacy compounding standards. Jun 03, 2019 the united states pharmacopeia usp has released new and revised standards aimed at ensuring the quality of compounded medicines. Sep 23, 2019 general chapter is referenced in many state and national laws and regulations. Right as the compounding expert committee of the us pharmacopeial convention made some revisions and changes to the usp general chapter 797 for sterile compounding, they also made equally extensive revisions to the usp general chapter 795 pharmaceutical compounding nonsterile preparations the revised document has closed for public comments, and the changes are to become official and thus. For tests the purpose of this chapter, the date or time after. Watercontaining oral and sterile liquid formulations bud is not later than 14 days when stored at cold temperatures between 2 and 8 c 36 and 46 f. Usp chapter 795 provides standards for compounding quality nonsterile preparations. Us pharmacopeia 40national formulary 35 online subscription. Therefore, usp is postponing the official dates of the revised 795 and, and the new general chapter until further notice. September 23, 2019 revised general chapter 795 is postponed until.
Usps bylaws provide that the official date of a standard under appeal must be postponed while an appeal is pending. Specifically, usp published revisions to general chapter pharmaceutical compounding and sterile preparations and published a new general chapter hazardous drugs handling in healthcare settings. Usp announces proposed revision to usp general chapter mar 30, 2018 the proposed revision to usp general chapter pharmaceutical compounding nonsterile preparations is now available for public comment. The decisions on the appeals to do not foreclose the possibility of future revisions to this chapter. This revision is meant to reflect new available evidence and to clarify topics that are a frequent source of questions and confusion. General chapter pharmaceutical compoundingnonsterile preparations commenters name. Watercontaining externaluse liquid and semisolid formulations bud is not later than 30. Uspnf establishes standards for medicines, food ingredients and dietary supplements.
Pharmaceutical compoundingnonsterile preparations1. Nov 22, 2019 in the interim, the currently official version of 795 last revised in 2014 will remain official. In the interim, the currently official chapters of 795 last revised in 2014 and last revised in 2008 including the section radiopharmaceuticals as csps will remain official. The current usp chapter 795 only requires that when assigning a bud, compounders shall consult and apply drugspecific and general stability documentation and literature when available. Usp develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. Usp and began with usp pharmacy compounding practices when the 1997 food and drug administration modernization act became law. Usp 797 also expands environmental controls with positively pressured iso 5 pecs, iso 7 buffer rooms, and iso 8 anterooms. The proposed revision to usp general chapter pharmaceutical compounding nonsterile preparations is now available for public comment.
Usp general chapters 795, 797, 800 effective june 26, 2019, the board will require compliance with usp 800 for hazardous drug handling along with the existing requirement of compliance with usp chapters 795 for nonsterile compounding and chapter 797 for sterile compounding, currently under revision by. This chapter is intended to provide guidance to those engaged in repackaging of drug products in accordance with 21 cfr 10. Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. Failure to complete this report within the month of march or within. After publication of the revised on june 1, 2019, usp received appeals on. Successful development and manufacture of dosage forms requires careful. Both chapters contain updated standards that hospitals and health systems will need to implement by december 1, 2019. The concepts in general chapter began with usp pharmacy compounding practices when the 1997 food and drug administration modernization act became law. Pharmaceutical preparation of drugs or devices for the purposes of, or as an incident to, research clinical or academic, compoundingnonsterile teaching, or chemical analysis preparation of drugs and devices for prescribers office. Usp general chapters 795, 797, 800 effective june 26, 2019, the board will require compliance with usp 800 for hazardous drug handling along with the existing requirement of compliance with usp chapters 795 for nonsterile compounding and chapter 797 for sterile compounding, currently under revision by usp. Usp announces proposed revision to usp general chapter. The information in this article is adapted from usp and does not represent the entire chapter. Reconstitution or manipulation usp29 of commercial products that may require the addition of one usp29 or more ingredients as a result of a licensed practitioners prescription drug order preparation of drugs or devices for the purposes of, or as an incident. Usp published new versions of general chapters and on june 1, 2019, which you can download for free here.
General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. Usp proposed revisions to chapter 795 on nonsterile. The updates pertain to the usp general chapters on compounding nonsterile medicines usp pharmaceutical compoundingnonsterile preparations, and compounding sterile medicines usp pharmaceutical compoundingsterile preparations. Pharmaceutical compounding nonsterile preparations. For the purpose of this chapter, the date or time after which a csp shall not be stored or transported.
Compounders shall acquire and maintain knowledge and skills in all areas e. To download the complimentary usp general chapter pharmaceutical compoundingnonsterile preparations, please click here. 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. The regulations were initially introduced in 2000 and the revisions further clarify the safety standards for compounded nonsterile preparations cnsps, such as oral and topical preparations. The chapter describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training. For more information, please consult usp in its entirety in. This statutory provision requires full compliance with usp 795 when individuals and facilities licensed by the pharmacy quality assurance commission. It also provides general guidelines for assigning beyonduse dates to nonsterile preparations. 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. Sample form for assessing hand hygiene and garbing related practices of compounding personnel, in usp general chapter pharmaceutical compoundingsterile. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Open microphone session on usp general chapter usp general chapter 795 pharmaceutical compounding nonsterile preparations april 20, 2018. United states pharmacopeia usp general chapter 795 pharmaceutical compounding nonsterile preparations general chapter pharmaceutical compounding sterile preparations general chapter hazardous drugshandling in healthcare settings general chapter radiopharmaceuticals preparation.
Quality control and verification under pharmaceutical compoundingnonsterile preparations 795. The currently official version of general chapter last revised in 2008 remains official until further notice. Finalized revisions to usp general chapters and were released on june 1, 2019. Usp posts revised pdfs for usp 795, 797, 800, 825 updated. United states pharmacopeia usp general chapter pharmaceutical compounding nonsterile preparations general chapter pharmaceutical compounding sterile preparations general chapter hazardous drugshandling in healthcare settings general chapter radiopharmaceuticals preparation. Usp remains committed to keeping stakeholders and the general public informed of the status of these standards. Nov 12, 2018 the current usp chapter 795 only requires that when assigning a bud, compounders shall consult and apply drugspecific and general stability documentation and literature when available. Pharmaceutical compoundingnonsterile preparations 1. 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.
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