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Summary: Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products; Proposed Rule

The proposed rule would require all applicants of covered, approved prescription drug or biological products and all manufacturers of covered prescription drugs marketed without an approved application, to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States 6 months in advance of the permanent discontinuance or interruption in manufacturing, or, if that is not possible, as soon as practicable. The proposed rule also describes how to submit such a notification, the information required to be included in such a notification, the consequences for failure to submit a required notification, the disclosure of shortage-related information, and the meaning of certain terms.

Regulatory Impact Analysis

Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products; Proposed Rule (PDF - 405KB)

Federal Register: 78 FR 65904-65923, November 4, 2013

Docket: FDA-2011-N-0898