Sodium phosphate monobasic anhydrous: Summary Report

Pavlech, Laura L.; Gianturco, Stephanie L.; Storm, Kathena D.; Yuen, Melissa V.; Mattingly, Ashlee N.

dc.contributor.author	Pavlech, Laura L.
dc.contributor.author	Gianturco, Stephanie L.
dc.contributor.author	Storm, Kathena D.
dc.contributor.author	Yuen, Melissa V.
dc.contributor.author	Mattingly, Ashlee N.
dc.date.accessioned	2022-01-21T16:03:15Z
dc.date.available	2022-01-21T16:03:15Z
dc.date.issued	2021-10
dc.identifier.uri	http://hdl.handle.net/10713/17710
dc.description	The 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, Sodium phosphate monobasic anhydrous, were summarized in this report.	en_US
dc.description.sponsorship	U.S. Food and Drug Administration clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: #U01FD005946	en_US
dc.language.iso	en_US	en_US
dc.rights	Attribution-NoDerivatives 4.0 International	*
dc.rights.uri	http://creativecommons.org/licenses/by-nd/4.0/	*
dc.subject	Sodium phosphate monobasic anhydrous	en_US
dc.subject	Compounding	en_US
dc.subject	Food, Drug and Cosmetic Act	en_US
dc.subject	Food, Drug and Cosmetic Act, Section 503B	en_US
dc.subject	Food and Drug Administration	en_US
dc.subject	Outsourcing facility	en_US
dc.subject.mesh	Sodium Phosphate	en_US
dc.subject.mesh	Drug Compounding	en_US
dc.subject.mesh	Legislation, Drug	en_US
dc.subject.mesh	United States Food and Drug Administration	en_US
dc.title	Sodium phosphate monobasic anhydrous: Summary Report	en_US
dc.type	Report	en_US
dc.identifier.ispublished	No	en_US