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                Drug Shortages

Drug Shortages

                        Drug Shortages | Additional News and Information
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          Drug Safety and Availability
          Drug Shortages
          Drug Shortages: Non-Compliance With Notification RequirementDrug Shortages Drug Shortages: Non-Compliance With Notification Requirement
  
  	
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    PrintUnder 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 LetterCyclosporine Injection
			Non-Compliance Letter (Padagis US LLC) (PDF - 1.31 MB )
			Manufacturer Response Letter (Padagis US LLC) (PDF - 302 KB )Paclitaxel Injection (protein bound particles)
			Non-Compliance Letter - (Bristol Myers Squibb Company) (PDF - 64KB)
			Manufacturer Response Letter (Bristol Myers Squibb Company) (PDF - 137 KB)Zinc Acetate Capsules
			Non-Compliance Letter (Teva Pharmaceuticals) (PDF - 41 KB)
			Manufacturer Response Letter (Teva Pharmaceuticals) (PDF - 3 MB)Vincristine Sulfate Injection
			Non-Compliance Letter (Pfizer) (PDF - 775 KB)
			Manufacturer Response Letter (Pfizer) (PDF - 226 KB)Etoposide Injection
			Non-Compliance Letter (Teva Pharmaceuticals) (PDF - 484 KB)
			Manufacturer Response Letter (Teva Pharmaceuticals) (PDF - 1 MB)Tretinoin Capsules
			Non-Compliance Letter (Par Pharmaceutical) (PDF - 512 KB)
			Manufacturer Response Letter (Par Pharmaceutical) (PDF - 1 MB)Tretinoin Capsules
			Non-Compliance Letter (Teva Pharmaceuticals) (PDF - 505 KB)
			Manufacturer Response Letter (Teva Pharmaceuticals) (PDF - 1 MB)Non-Compliance Letter Archive

Non-compliance Letters 2014 Archive

                                                                                  Content current as of:
      01/18/2024
              
              
Regulated Product(s)
		 DrugsDrug Shortages

          
                        Drug Shortages | Additional News and Information
          Frequently Asked Questions about Drug Shortages
          Drug Shortages Infographic
 
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