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10.34.19.19. Office Use
Unless otherwise authorized, a person that prepares and distributes sterile compounded medications for office use into, out of, or within the State shall hold:
A. A manufacturer's permit or other permit designated by the U.S. Food and Drug Administration to ensure the safety of sterile compounded medications for office use; and
B. If applicable, a wholesale distributor's permit, issued by the Board under Health Occupations Article, Title 12, Subtitle 6C, Annotated Code of Maryland.
(Regulation .19 amended effective 41:13 Md. R. 752, eff. 1/1/2015; amended effective 43:2 Md. R. 127, eff. 2/1/2016)
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