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Medicaid program; multiple source drug definition. Final rule

    Federal Register
    |November 7, 2008
    PubMed

    Insights

    This final rule updates the definition of multiple source drugs to align with the Social Security Act. It addresses public feedback from a previous interim final rule.

    Area of Science:

    • Regulatory Science
    • Pharmaceutical Policy

    Background:

    • The definition of "multiple source drug" requires clarification to ensure regulatory alignment.
    • Previous interim final rules have been issued seeking public comment.

    Purpose of the Study:

    • To revise the regulatory definition of "multiple source drug."
    • To ensure the definition conforms to Section 1927(k)(7) of the Social Security Act.
    • To incorporate public comments received on the March 14, 2008 interim final rule.

    Main Methods:

    • Administrative rulemaking process.
    • Review and incorporation of public comments.
    • Legal and regulatory analysis of the Social Security Act.

    Main Results:

    • A revised definition of "multiple source drug" has been established.
    • Public comments have been considered and addressed in the final rule.

    Conclusions:

    • The updated definition provides regulatory clarity and statutory compliance.
    • The final rule reflects a responsive approach to stakeholder feedback.

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