10 Ways to Follow FDA’s Drug Rules

We occasionally get questions from members about how to follow the U.S. Food and Drug Administration’s (FDA) rules when it comes to administering drugs in practice. While not comprehensive, here are some good ways to ensure that you are following the FDA’s rules:

1. Select FDA-approved drugs for use in your practice whenever possible. Look for an “NADA” or “ANADA” number, which is one good way to recognize if the drug has been approved by the FDA. You can also refer to FDA’s Green Book of approved animal drugs and Orange Book of approved human-label drugs.

2. Use AVMA’s algorithm to help you decide on an extra-label drug use. Remember that certain drugs are prohibited for extra-label use in food animals.

3. Maintain complete records of the drugs you’ve administered or provided, particularly when it comes to food-animal medicine.

4. Maintain a Veterinarian-Client-Patient Relationship, especially when using drugs (see FDA’s Extralabel Drug Use Rules) in an extra-label manner and when ordering Veterinary Feed Directive drugs.

5. Establish an appropriate withdrawal interval when using drugs extra-label in food animals. Check with FARAD if needed.

6. Recognize that only a veterinarian (not a client) can make the decision to use a drug in an extra-label fashion.

7. Maintain identity of animals treated with drugs extra-label, especially in food-animal practice.

8. Avoid unintended “extra-label” uses, like use of a product outside the labeled expiration date or outside the manufacturer’s storage directions.

9. Prior to using or recommending wellness or therapeutic pet foods, assess relevant product information through principles of evidence-based medicine.

10. Include complete labels on all drugs being dispensed. See AVMA’s Guidelines for Veterinary Prescription Drugs for guidance.

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