US FDA proposes curbs on mass compounding of Novo, Lilly's weight-loss drugs - Reuters
US FDA proposes curbs on mass compounding of Novo, Lilly's weight-loss drugs Reuters
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"The agency's notice today reaffirms that compounding is meant to be a rare and limited exception to FDA's gold-standard drug approval framework."
— Mrinalika Roy , Executive
"Most telehealth companies use 503A pharmacies to fill their personalized compounded doses."
— Rosalie Hoyle , Academic
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<a href="https://news.google.com/rss/articles/CBMizAFBVV95cUxQeWlmZ2xWUm9YUUxKcHN6bHpkRXBXRWFicjhQUDBEeHpiSUFtekxrZEo2SGM0MjFaR1QxeWpjODYxZ0N4Umh3OV9ydTVTMFVUV3FUX1RNeFIySHFzTV9XSUR2eS1OamY0SHFhMi1HekNKOU1Ba3BMM0h0SWNSdlA0QnFicHF3cVBOSFRQNmJDOUZNZzFrYV9hTGxrcS1kMk9rS2d6cU0wYklQd1dvbldPQ0RFUWN0aWFIeFl1MWxyOVJZWHRlTll1SFJzVmE?oc=5" target="_blank">US FDA proposes curbs on mass compounding of Novo, Lilly's weight-loss drugs</a> <font color="#6f6f6f">Reuters</font>
The FDA proposed excluding active ingredients for Novo Nordisk and Eli Lilly's weight-loss drugs from the list of substances that outsourcing facilities can use for compounding, potentially limiting large-scale production by these facilities.
The FDA proposed excluding semaglutide and tirzepatide, active ingredients in Novo Nordisk's and Eli Lilly's weight-loss drugs, from the list of substances that large compounding facilities can use, citing no clinical need for such compounding.

Shares in Novo Nordisk climbed more than 6% after the FDA proposed restricting the compounding of weight-loss medications, including semaglutide, tirzepatide, and liraglutide, stating there is no clinical need for outsourcing facilities to compound these drugs.
The FDA proposed excluding active ingredients for Novo Nordisk and Eli Lilly's weight-loss drugs from the list of drugs outsourcing facilities can use for compounding, stating there is no clinical need for such compounding.
The FDA proposed excluding Novo Nordisk and Eli Lilly's weight-loss drugs from a key compounding list, potentially limiting large-scale production by outsourcing facilities and bolstering efforts against unauthorized versions that have been eating into sales of their blockbuster treatments.
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