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Notes
see Reactions 1687 p1; 803298524
DQSA = Drug Quality and Security Act; is part of the Federal Food, Drug and Cosmetic Act
including physical and chemical characteristics, safety issues, likely efficacy (or lack of), and historical use of the drug.
Reference
Gottlieb S. Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA's oversight of drug compounding and implementing new laws governing outsourcing facilities. Internet Document : 23 Mar 2018. Available from: URL: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm602316.htm
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Critical draft guidance issued for bulk compounding drugs. Reactions Weekly 1696, 1 (2018). https://doi.org/10.1007/s40278-018-44189-7
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DOI: https://doi.org/10.1007/s40278-018-44189-7