General guidelines for matching csps and components. Pharmaceutical compoundingsterile preparations, usp 39. Usp publishes new and revised compounding standards. Pharmaceutical compoundingsterile preparations, usp 39 page 626. Pdf on oct 1, 2004, eric s kastango and others published usp chapter 797. 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. General guidelines for matching csps and components to appropriate. Pharmaceutical compoundingsterile preparations, usp 41 page 6554 and pf 416 nov.
The board expects pharmaciespharmacists engaged in compounding to have policies and procedures to adhere to those guidelines that apply to. Additionally, usp general chapter hazardous drugs handling in healthcare settings is an official and informational chapter on handling hds and includes ppe recommendations for compounding and other activities. Updates to usp 795 pharmaceutical compounding nonsterile preparations elimination of the categories of compounding, which formerly included simple, moderate, and complex. Pharmaceutical compounding sterile preparations usp. Compounding of radiopharmaceuticals is not required to. After publication of the revised on june 1, 2019, usp received appeals on. Pharmaceutical compoundingsterile preparations, usp 41 page 6554. Usp 797 pharmaceutical compounding sterile preparations proposed revision. The categories of compounding did not impact how the standards were applied but frequently caused confusion on how to classify the preparations. Understanding the impact to home infusion connie sullivan, bspharm vice president of research and innovation. 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.
Sign up for healthcare quality standards updates and stay current on our work in compounding, medicare model guidelines, pictograms, medication safety and. 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. Inspection, regulation, and oversight of sterile compounding pharmacies article pdf available in journal of parenteral and enteral nutrition 362 suppl. In accordance with usps bylaws, the responsible expert committees worked with a sense of. Facilities cag0032006, revised may 20, 2015, which is hereby. Usp response to shortages of garb and personal protective. Iso classification of particulate matter in room air limits are in particles of 0. To download the complimentary usp general chapter 797 pharmaceutical compounding sterile preparations, please click here. In accordance with the rules and procedures of the 20152020 council of experts. Based on the number and significance of public comments received in. Pharmacy rulesregulations by state for compliance with usp 797. Usp articles, or within 10% if not specified, until their buds.
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