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Although some peptides like tesamorelin have received formal FDA approval, many others fall under compounding provisions of the Federal Food, Drug, and Cosmetic Act503A (patient-specific prescriptions by state-licensed pharmacies) and 503B (FDA-regulated outsourcing facilities operating under cGMP)

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Recently, animal models have been discovered that may provide a new insight into the pathogenesis of this disease and facilitate appreciation for novel treatment in PBC