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These are FDA-approved finished drug products

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In this rulemaking, 428.400 through 428.405 implements section 1860D-14B(a)(1) of the Act with a reconciliation process that reflects the reconciliation described in section 1860D-14B(b)(6) of the Act and otherwise ensures that the agency's provision of information to each manufacturer of a Part D rebatable drug and the manufacturers' requirements to provide rebates are in accordance with section 1860D-14B(b) of the Act

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