Yes! No! Maybe So! – What FDA Does and Does Not Regulate
- the drug is safe and effective for a specific use in a specific animal species. If the drug is for use in food-producing animals, the drug company must also prove that food products made from treated animals are safe for people to eat;
- the manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity. The drug company must show that the drug can be consistently produced from batch to batch; and
- the labeling is appropriate and truthful. The drug company must make sure that the labeling contains all necessary information to use the drug safely and effectively, including the risks associated with the drug.
- the drug’s safety and effectiveness;
- the drug’s manufacturing process to make sure quality and consistency are maintained from batch to batch; and
- how the drug is marketed to make sure the advertisements are truthful and not misleading.
|For the complete definition of the term “drug,”
please see the Federal Food, Drug, and Cosmetic Act at Section 201(g) [21 U.S.C. 321]3.
For more information about the animal drug approval process, please visit:
From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process4
For an online database of FDA-approved animal drugs, please see Animal Drugs @ FDA6For more information about minor species, minor uses, conditional approval, and indexing, please visit:
|For the complete definition of the term “device,”
please see the Federal Food, Drug, and Cosmetic Act at Section 201(h) [21 U.S.C. 321]10.
For more information about animal devices, please visit: How FDA Regulates Veterinary Devices11
- produced under sanitary conditions; and
- truthfully labeled.
|For more information about animal feed, please visit: Animal Food & Feeds12|
|For more information about turtle safety, please visit: Pet Turtles - A Common Source of Salmonella13|
|For more information about vaccines for animal disease, please visit: Veterinary Biologics (USDA)14|
For more information about boards of pharmacy and for contact information for each state board of pharmacy, please visit the website of the National Association of Boards of Pharmacy (NABP)15
For more information about the compounding of animal drugs, please visit: Compounding of Animal Drugs16Please refer questions about a specific drug for your animal or drug pricing to your veterinarian or pharmacist.
|What does “extra-label” mean?When an approved drug is used in a manner other than what is stated on the label, it is an extra-label use. This is commonly called an “off-label” use because the drug is used in a way that is “off the label.”|
|For more information about veterinary licensing
boards and for contact information for each state veterinary licensing board,
please visit the website of the American Association of Veterinary State Boards (AAVSB)17 .
For more information about extra-label drug use in animals, please visit:|
For more information about flea and tick products, please visit:|
For more information about food and food safety, please visit:|
|Not on the Regulatory
RadarSome products on the market for animals don’t fall under the
regulatory authority of any government or non-government organization,
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