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The FDA aims to exclude the active ingredients of these drugs from being used in compounding unless they are officially listed as in short supply.
The FDA has proposed new regulations targeting compounding of weight-loss drugs' active ingredients.
KEY POINTS
- Semaglutide, tirzepatide, and liraglutide will be excluded from compounding unless in shortage.
- This move specifically affects Novo Nordisk's Wegovy and Ozempic, and Eli Lilly formulations.
- FDA clarified compounding with bulk substances is unlawful without clinical need if drugs are available.
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