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When contacted for comment by email, Laney Landsman, Duchesnay USA spokeswoman, responded, "Duchesnay USA takes its regulatory responsibilities very seriously, and acknowledges that its communications, including in social media as in this particular instance, need to be in accordance with applicable rules and regulations
Under section 503B of the Federal Food, Drug, and Cosmetic Act, large outsourcing facilities may only compound from bulk active ingredients in two situations: the ingredient appears on the 503B bulks list, meaning FDA has found a clinical need for it, or the finished drug sits on FDA's shortage list at the time of compounding
Tirzepatide is a dual GIP and GLP-1 receptor agonist approved by the FDA under the brand names Mounjaro and Zepbound