Drug Regulations

Question 1

Define Extralabel Drug Use (ELDU)

Answer 1

• ANY change to the label directions
  
  • dose
  • route
  • frequency
  • duration
  • class of animal (beef, dairy, veal, etc)
  • disease indication
  • drug handling - diluents, etc

Question 2

When is ELDU permitted?

Answer 2

• Only under the direction of a veterinarian within a VCPR

Question 3

When is ELDU illegal?

Answer 3

• When it results in unsafe residues
• When it results in unsafe risk
  
  • drugs prohibited for ELDU in nonfood-producing animals
• ELDU in feed

Question 4

What Drugs are prohibited for ELDU in food producing animals?

Answer 4

• Chloramphenicol
• Clenbuterol
• Diethylstilbestrol
• Dimetridazole
• Ipronidazole
• Nitroimidazoles
• Furazolidone
• Nitrofurazone
• Sulfonamides (Lactating Dairy)
• Fluoroquinolones
• Glycopeptides
• Phenylbutazone (Dairy ≥20mo)
• Cephalosporines (Cattle, Swine, chicken, Turkey)
  
  • For disease prevention
  • At unapproved doses, frequencies, durations or routes of administrations
  • For use in other species or productions classes

Question 5

What is a VFD

Answer 5

• Written statement issued by a licensed vet in the state in which the animals reside
• authorizes the use of a VFD drug or combination VFD in or on animal feed
• Can ONLY be in accordance with VFD drug’s approved labeling

Question 6

What elements are required in a VFD?

Answer 6

• Vet - name, address, telephone
• Client - name, address, telephone
• Premises at which the specified group of animals are located
• VFD issue date
• VFD Expiration date (max 6 months or as specified by the label)
• Name of VFD drug
• Species and production class of animals
• Approximate # of animals to be fed by the expiration date
• Which VFD feed is issued
• Level of drug in VFD feed
• Duration of use
• Withdrawal time
• Cautionary statements
• Number of refills
  
  • (if permitted by drug label - default is zero)
• The Statement: Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use), is not permitted”
• Affirmation of intent for use of combination VFD drugs
• Vet Signature

Question 7

What elements are required in a VFD?

Answer 7

• Vet - name, address, telephone
• Client - name, address, telephone
• Premises at which the specified group of animals are located
• VFD issue date
• VFD Expiration date (max 6 months or as specified by the label)
• Name of VFD drug
• Species and production class of animals
• Approximate # of animals to be fed by the expiration date
• Which VFD feed is issued
• Level of drug in VFD feed
• Duration of use
• Withdrawal time
• Cautionary statements
• Number of refills
  
  • (if permitted by drug label - default is zero)
• The Statement: Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use), is not permitted”
• Affirmation of intent for use of combination VFD drugs
• Vet Signature