Animal & Veterinary
Animal Drug Safety Frequently Asked Questions
I gave my dog a drug and he got sick. How do I report this adverse reaction?
My vet prescribed a human drug for my cat. Is this legal?
What does extra – label use mean?
Where can I get information on a drug my veterinarian prescribed?
Ask your veterinarian for the Client Information Sheet (CIS) prepared by the drug manufacturer. If he/she cannot provide one, visit the drug manufacturers’ Website. Some CIS’s are posted on the CVM Current Labels Page. In addition you can search CVM’s Freedom of Information (FOI) Summaries and the Greenbook for dosage and safety information.
How do you determine if a veterinary drug is safe to market?
As mandated by the Federal Food, Drug, and Cosmetic Act, a new animal drug may not be sold in interstate commerce unless it is the subject of a New Animal Drug Application (NADA). In order to be approved, a New Animal Drug Application must include data that demonstrate the drug is safe and effective when used as directed on the label.
What does an approved NADA mean?
It means the product is safe and effective for its intended use and that the methods, facilities and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity.
The veterinary drug approval process consists of a series of consultative procedures and reviews.
How does CVM remove unsafe veterinary drugs from the market?
Why can’t I find information on vaccines on CVM’s Website?
FDA CVM does not regulate vaccines. Veterinary biologics (vaccines, bacterins, diagnostics, etc, which are used to prevent, treat, or diagnose animal diseases) are regulated by the U.S. Department of Agriculture, Center for Veterinary Biologics.
Why does the veterinarian have to examine my pet before prescribing a drug? Where can I find information about a valid veterinarian-client-patient relationship (VCPR)?
- Definition – 21 CFR 530.3(i)
- Compounding of Drugs for Use in Animals
- Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
Are generic animal drugs as safe as the original drugs?
Under the provisions of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA), the sponsor of a generic animal drug product must submit an Abbreviated New Animal Drug Application (ANADA) for review and approval before the product can be legally marketed. The generic product and its uses must be the same as those of an approved animal drug, with certain exceptions, and it must be demonstrated that the generic product is bioequivalent to the approved product.
Are veterinary drugs safe for the environment?
New Animal Drug Applications (NADAs) submitted to CVM must include a claim for categorical exclusion or an environmental assessment (EA). EAs focus on relevant environmental issues relating to the use and disposal of veterinary drugs. EAs are also prepared for certain Agency-initiated actions. If CVM determines that the information in the EA indicates that no significant environmental impacts are expected, then a Findings of No Significant Impact (FONSI) is prepared. If significant environmental impacts are identified, then an Environmental Impact Statement (EIS) is prepared. See Environmental Assessments, Findings of No Significant Impact, and Environmental Impact Statements.
What drugs are approved for the disease my dog has?
Search the FDA Approved Animal Drug Products Online Database System under Indications.
What is the difference between an over-the-counter (OTC) drug and a prescription (Rx) drug?
Would it be safer to use other pain-relief products approved for use in humans such as aspirin, ibuprofen, or naproxen sodium?
No, these pain-relief products are not good alternatives to the approved veterinary products. In fact, besides not being approved for use in companion animals, they can pose even more adverse reaction risks for dogs. The use of an approved product is always preferable because its safety and effectiveness have been reviewed. While it is true that approved products can have adverse events associated with them and reported to FDA, it is also true that FDA works with the sponsor to address these events and improve the ability of the product to be more safely used. There is no reporting requirement for unapproved products.