Exam 2: Extra-Label Drug Use and Compounding

Question 1

What constitutes a valid veterinarian-patient-client relationship?

Answer 1

Vet has assumed responsibility for the care of the animal and the owner has agreed to follow his guidance
The vet is knowledgeable enough of the situation to at least make a preliminary diagnosis
The vet has personally seen the animal recently or has made regular visits to herds to be knowledgeable of the situation
The vet is available for follow-up of adverse reactions or assessment of treatment failure

Question 2

What drugs are banned from ELDU?

Answer 2

Pesticides
Medicated feed
Chloramphenicol
Clenbuterol
Diethylstilbestrol
Dimetridazole, ipronidazole, or other nitoimidazoles (metronidazole)
Nitrofurans
Sulfonamide drugs in lactating dairy cattle
Phenylbutazone in lactating dairy cattle
Fluorquinolones
Cephalosporin
Glycopeptides
Adamantane and Neuraminidase inhibitor influenza drugs

Question 3

Why are pesticides banned from ELDU?

Answer 3

They are not governed by the FDA

Question 4

Why is medicated feed banned from ELDU?

Answer 4

Concerns with antimicrobial resistance, so must follow the label that is preestablished by FDA

Question 5

Why is chloramphenicol banned from ELDU?

Answer 5

Causes aplastic anemia in humans

Question 6

Why is clenbuterol banned from ELDU?

Answer 6

If cattle are treated with this, it has long term residue in liver
People were hospitalized after eating cow liver due to clenbuterol toxicity

Question 7

Why is diethylstilbestrol (DES) banned from ELDU?

Answer 7

Carcinogenic in humans

Woman who took DES while pregnant had daughter that were prone to ovarian and uterine cancer

Question 8

Why are Dimetridazole, ipronidazole, or other nitroimidazoles banned from ELDU?

Answer 8

Carcinogenic to humans

Question 9

Why are nitrofurans banned from ELDU?

Answer 9

Carcinogenic to humans

Question 10

What are sulfonamide drugs in lactating dairy cattle banned from ELDU?

Answer 10

Can cause thyroid hyperplasia in humans

Potential carcinogen

Question 11

Why is phenylbutazone in lactating dairy cattle banned from ELDU?

Answer 11

Causes aplastic anemia in humans

Question 12

Why are fluoroquinolones banned from ELDU?

Answer 12

Used in human septicemic salmonella infections
Baytril use in cattle had started the approval process before the human salmonella infection crisis, so it is till used in cattle but it must be used by the label (no ELDU)

Question 13

Why is cephalosporin banned from ELDU?

Answer 13

Used in children so it can’t be used in food animals ELDU

Question 14

Why are glycopeptides banned from ELDU?

Answer 14

This is a drug of last resort for MRSA

Due to its importance in human health, it cant be used in food animal so that resistance does not occur

Question 15

Why are adamantane and neuraminidase inhibitor influenza drugs banned from ELDU?

Answer 15

We do not want to use anti-virals in food animals because there is concern of viruses maturing to become infective to humans

Question 16

What are the labeling requirements for ELDU?

Answer 16

1. The name and address of vet and pharmacy (if applicable)
2. The established name(s) of the ingredients and their strengths
3. Directions for use, including:
   a. The class/species/identification of the animal or herd
   b. The dosage, frequency, and route of the animal or herd being treated
   c. The duration of therapy
4. Precautions if applicable
5. Withdrawal times

Question 17

What are the record requirements for ELDU?

Answer 17

1. Animal identification either individually or by herd
2. The name(s) of the drug and active ingredients(s)
3. The condition treated
4. The species of the treated animals
5. The dosage administered
6. The duration of treatment
7. The number of animals treated
8. The specified withdrawal or discard times

Question 18

What reasons are valid to allow for ELDU and which ones are not: pain, suffering, production, and performance enhancement?

Answer 18

ELDU cannot be used to enhance production and performance

ELDU can be used if the animal will have pain or will suffer if not treated

Question 19

What is FARAD and what is its role relative to AMDUCA?

Answer 19

Food animal residue avoidance and depletion program

Establishes an appropriate withdrawal period based on scientific evidence

Question 20

Describe the antemortem screening tests for detection of antimicrobial residues using milk or urine.

Answer 20

Live Animal Swab Test (LAST), Pre-Harvest Antibiotic Screening Test (PHAST), and Calf antibiotic and sulfonamide test (CAST) are all urine tests used to screen for antibiotics
Delvo-P and Charm Cowside are milk tests that can be used to screen for antibiotics.

Question 21

When is cost allowed as a reason for ELDU?

Answer 21

In small animals, a veterinarian can use a human drug extra label, even when animal drug exists if economic reasons are valid.

Question 22

Identify the hierarchy of ELDU choices relative to: veterinary approved drugs versus human drugs versus compounded drugs.

Answer 22

If a veterinary approved drug is available, it must be used. If not, a human drug must be used before a compounded drug option.

Question 23

Identify the conditions compounding is allowed

Answer 23

When no formulation exists to meet the demands of the patient, a pharmacist is allowed to create a new formulation from an existing approved drug.
Compounded drugs have not undergone premarket FDA review of safety, effectiveness, or manufacturing quality, making them a concern.

Question 24

What is the FDA’s view on compounding in anticipation of needs?

Answer 24

No patient yet
Basis of they will need it eventually
This is technically not allowed as you need a patient to distribute it

Question 25

What is the FDA’s view on knock-offs?

Answer 25

Not legal to sell

Question 26

What is the FDA’s view on large scale compounding?

Answer 26

Approved drug is turned into a new formulation in a different strength, form, etc.
Abuse put this category under the radar of the FDA

Question 27

What are methods whereby animals may be identified to make sure they do not enter the human food chain until after the proper withdrawal time has passed?

Answer 27

If no scientific evidence exists on which to base a withdrawal time, the animal must not enter the human food chain. Readily retrievable records must be kept for 2 years or as mandated by state law, whichever is greater.

Question 28

Identify who assume the liability associated with ELDU and compounded products

Answer 28

Pharmacists assumes liability for the quality of the product
The vet assumes the liability for safety and efficacy
The degree of liability will vary depending on whether the use is “generally accepted practice”

Question 29

What are the 10 condition for ELDU according to AMDUC guidelines?

Answer 29

1. There is no approved animal drug that contains the same active ingredient in the required dosage form and concentration is labeled for such use OR all approved animal drugs are clinically ineffective for its intended use
2. The use must occur within the context of a valid veterinarian-client-patient relationship
3. Prior to prescribing or dispensing animal of human drug for an extra-label use in food, the vet must:
   i. Make a diagnosis that warrants the extra-label use
   ii. The diagnosis and treatment are within limits of accepted medical practice
   iii. Make sure animals are identified to prevent accidental entry into the food chain
   iv. Make sure other measures are in place to adhere to recommended withdrawal times
   v. Establish an appropriate withdrawal period base on scientific evidence
4. Labeling must accompany the extra-label product
5. If no scientific evidence exists on which to base a withdrawal time, the animal must not enter the food chain
6. A human drug can only be used if there is no approved veterinary drug that could be used instead, even if an extra-label manner
7. The use must not be banned. Medicated feed, whether OTC or VFD, cannot be used extra-labely
8. The drug must not be banned by the FDA
9. Extra-label use to enhance production is prohibited
10. Readily retrievable records must be kept for 2 years or as mandated by state law, whichever is greater

Question 30

Explain the roles USDA versus the FDA play in the detection of drug residues in meat and the enforcement when a violation has occurred.

Answer 30

Meat is regulated by the USDA (FSIS). If any drug use results in a residue in a food animal, the FDA has regulatory authority to intervene
US National Residue program performs continuous baseline monitoring and targeted sampling
Public Health vets also perform routine inspector generated sampling

Question 31

What agency(ies) typically monitor and enforce drug residue violations for milk?

Answer 31

Milk is monitored by the Pasteurized Milk Ordinance and the State Department of Health.

Question 32

What is the disposition of a food animal that receives a drug for which adequate withdrawal information cannot be found?

Answer 32

That animal cannot be used for human consumption

Question 33

What does the term “enforcement discretion” mean relative to the “COMPLIANCE POLICY GUIDE (CPG) FOR EXTRA-LABEL USE OF MEDICATED FEEDS FOR MINOR SPECIES”?

Answer 33

This guide directs FDA field personnel to make the use of medicated feeds for minor species a low enforcement priority under the stated conditions