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With branded products commanding having experienced intermittent supply constraints, compounding pharmacies stepped in to fill the gapoperating under Section 503A of the Federal Food, Drug, and Cosmetic Act, which exempts qualifying compounders from certain FDA requirements, including CGMP compliance, labeling requirements, and premarket approval

Serious but Rare Side Effects Less than 1% of patients experience serious side effects, which may include: Pancreatitis Severe abdominal pain that requires immediate medical attention