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 In this section:

                Unapproved Animal Drugs

Unapproved Animal Drugs

                        FDA’s Concerns about Unapproved Animal Drugs
          Animal Drugs Marketed as Animal Devices
          Generic Animal Drugs:  Approved or Unapproved?
          Information for Veterinarians
          Regulatory Actions


                        Animal Drug Compounding Home
          Animal & Veterinary
          Compliance & Enforcement
          Unapproved Animal Drugs
          Should I report a problem with an unapproved animal drug to FDA?Unapproved Animal Drugs Should I report a problem with an unapproved animal drug to FDA?
  
  	
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Yes, FDA encourages you to report problems with any drug, even if it’s unapproved.  Problems include adverse events and product defects.

Adverse events are side effects or a lack of effectiveness—the drug doesn’t do what you expect it to do or the drug isn’t working as well as it did previously.  Adverse events also include reactions in people who handle the drug, such as needle stick injuries, rashes, or other side effects caused by exposure to the drug, and medication errors, such as giving the wrong drug or wrong dose or giving the drug too frequently.

Product defects are problems such as a broken seal, a leaking bottle, or the drug is off-color.  By reporting adverse events and product defects with animal drugs, including unapproved ones, you help FDA more easily identify and correct problems.

More information about How to Report Animal Drug and Device Side Effects and Product Problems.

                                                                                  Content current as of:
      01/02/2024Unapproved Animal Drugs

          
                        FDA’s Concerns about Unapproved Animal Drugs
          Animal Drugs Marketed as Animal Devices
          Generic Animal Drugs:  Approved or Unapproved?
          Information for Veterinarians
          Regulatory Actions


                        Animal Drug Compounding
 
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