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dc.contributor.authorMattingly, Ashlee N.
dc.contributor.authorGianturco, Stephanie L.
dc.contributor.authorPavlech, Laura L.
dc.contributor.authorStorm, Kathena D.
dc.contributor.authorYoon, SeJeong
dc.contributor.authorYuen, Melissa
dc.date.accessioned2020-02-13T21:13:06Z
dc.date.available2020-02-13T21:13:06Z
dc.date.issued2020-02
dc.identifier.urihttp://hdl.handle.net/10713/11997
dc.descriptionThe University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. Our findings for the nominated substance brilliant blue G were summarized in this report.en_US
dc.description.sponsorshipU.S. Food and Drug Administration Clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: 2U01FD005946en_US
dc.language.isoen_USen_US
dc.rightsAttribution-NoDerivatives 4.0 Internationalen_US
dc.rights.urihttp://creativecommons.org/licenses/by-nd/4.0/*
dc.subjectBrilliant blueen_US
dc.subjectCompoundingen_US
dc.subjectBulk drug substancesen_US
dc.subjectFood, Drug and Cosmetic Acten_US
dc.subjectOutsourcing facilityen_US
dc.subjectFood and Drug Administrationen_US
dc.subjectFood, Drug and Cosmetic Act, Section 503Ben_US
dc.subject.meshCoomassie brilliant blueen_US
dc.subject.meshDrug compoundingen_US
dc.subject.meshUnited States Food and Drug Administrationen_US
dc.titleBrilliant Blue G: Summary Reporten_US
dc.typeReporten_US
dc.identifier.ispublishedNoen_US


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Attribution-NoDerivatives 4.0 International
Except where otherwise noted, this item's license is described as Attribution-NoDerivatives 4.0 International