FDA Final Rule Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

Rx 360 has releases a summary of FDA's Final Rule Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products.

FDA recently issued a final rule Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products (see Final Rule) amending the regulations to implement certain drug shortage provisions of the FD&C Act, as amended by FDASIA. The final rule requires all applicants of covered approved prescription drugs or biological products (including certain applicants of blood or blood components for transfusion and all manufacturers of covered 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/blood components) of the product in the US.

The notification is to occur 6 months in advance of the permanent discontinuance or interruption in manufacturing, or if that is not possible, as soon as practicable, but no later than 5 business days after the permanent discontinuance or interruption occurs.

The final rule also covers:

• how to submit a notification
• the information required to be included in the notification
• the consequences for failure to submit a required notification
• the disclosure of shortage-related information
• the meaning/definition of certain terms, including "drug shortage", "biological product shortage", "meaningful disruption", "life supporting or life sustaining", and "intended for use in the prevention or treatment of a debilitating disease or condition".