FDA has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list. The proposal would materially limit 503B bulk compounding of these GLP-1 products. Comments on the ...
On September 28, 2013, the U.S. House of Representatives passed the Drug Quality and Security Act (H.R. 3204). The bill is compromise legislation crafted by the Senate Health, Education, Labor, and ...
The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency ...
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