AuthorGianturco, Stephanie L.
Pavlech, Laura L.
Storm, Kathena D.
Yuen, Melissa V.
Mattingly, Ashlee N.
MetadataShow full item record
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, ornithine hydrochloride, were summarized in this report.
SponsorsU.S. Food and Drug Administration Clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: 2U01FD005946
Rights/TermsAttribution-NoDerivatives 4.0 International
Food, Drug, and Cosmetic Act, Section 503B
Food and Drug Administration
United States Food and Drug Administration
Identifier to cite or link to this itemhttp://hdl.handle.net/10713/12204
The following license files are associated with this item:
- Creative Commons
Except where otherwise noted, this item's license is described as Attribution-NoDerivatives 4.0 International