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Updated: Jun 28, 2026
10:17
High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
Published on: April 23, 2019
Summary
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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