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Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Silver Spring, MD: US Food and Drug Administration; September 29, 2018.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; January 2015. Report No. OEI-01-13-00400.
A widely-reported meningitis outbreak in the United States uncovered quality and safety issues associated with the use of compounded sterile preparations. This publication describes an analysis of five accreditation organizations and their ability to provide oversight and inspection of Medicare hospitals that contract with compounding entities. The authors offer recommendations to help hospitals determine if their compounded sterile preparations contracts ensure products are prepared safely for use, including targeted training for surveyors related to compounding and improved contracting processes.
Office of the Inspector General. Washington, DC: US Department of Health and Human Services; August 2006. Report No. OEI-06-05-00060.
This report shares findings from an inspection of the FDA's National Drug Code Directory, which found that the directory is both incomplete and inaccurate in its listings of marketed prescription medications.