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U.S. Department of Health and Human Services

Drugs

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Drug Shortages: Non-Compliance With Notification Requirement

With the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012, manufacturers of all covered prescription drugs are required to notify FDA of a permanent discontinuance or temporary interruption in manufacturing.  The notification is required six months in advance, or if that is not possible, as soon as practicable, to allow FDA Drug Shortage Staff time to collaborate with manufacturers to prevent or mitigate potential shortages. The Act also requires FDA to send a noncompliance letter to firms that fail to notify the Agency in accordance with FDASIA.

 

Drug NameFDA LetterManufacturer Response Letter

Lomustine

Non-Compliance Letter (PDF)

 Manufacturer Response Letter (PDF)