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Drug Shortages: Non-Compliance With Notification Requirement

Under section 506C of the Federal Food, Drug, and Cosmetic Act, manufacturers of all covered prescription drugs are required to notify FDA of a permanent discontinuance or temporary interruption in manufacturing that is likely to lead to a meaningful disruption in the supply of a covered drug in the United States. The notification is required six months in advance, or if that is not possible, as soon as practicable thereafter, but in no case later than 5 business days after the discontinuance or interruption in manufacturing. Advance notification allows FDA’s 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 section 506C.

Drug Name FDA Letter Manufacturer Response Letter
Etoposide Non-Compliance Letter (Teva Pharmaceutical) (PDF - 484 KB) Manufacturer Response Letter (Teva Pharmaceuticals) (PDF -  1.57MB)
Tretinoin  Non-Compliance Letter (Par Pharmaceutical) (PDF - 512 KB) Manufacturer Response Letter (Par Pharmaceutical) (PDF - 1.3MB)
Tretinoin  Non-Compliance Letter (Teva Pharmaceuticals)  (PDF - 505 KB) Manufacturer Response Letter (Teva Pharmaceuticals)  (PDF - 1.1MB)

Non-Compliance Letter Archive