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Section 2718(b)(3) of the PHS Act requires the Secretary of the Department of Health and Human Services (Secretary or HHS) to issue regulations to enforce the provisions of section 2718 of the PHS Act, and, in so doing, the Secretary may provide for appropriate penalties

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It is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2)