CFR Part 530

Question 1

How long must records of extralabel drug use be kept?

Answer 1

2 years

Question 2

In what form is extralabel drug use not allowed?

Answer 2

In or on an animal feed

Question 3

When is extralabel use from compounding of approved human or animal drugs permitted?

Answer 3

No approved drug, that when used as labeled, is available in the dosage form and concentration needed. Compounding from a human drug for use in food-producing animals will not be permitted if an approved animal drug can be used for compounding.

Question 4

How is withdrawal times handled for extralabel use of drugs in food-producing animals?

Answer 4

Vet must establish a substantially extended withdrawal period prior to the marketing of milk, meat, eggs, or other edible products, supported by appropriate scientific information.

Question 5

How is withdrawal time in food-producing animals handled when the drug is only approved for use in animals not intended for human consumption?

Answer 5

If scientific information on the human food safety aspect of the drug is not available, the vet must take appropriate measures to ensure that the animal and its food products will not enter the human food supply.

Question 6

Under what two circumstances may the FDA ban the extralabel use of certain drugs?

Answer 6

1. An acceptable analytical method has not been developed, submitted, and found to be acceptable by FDA
2. Extralabel use in animals presents a risk to public health

Question 7

Once the FDA prohibits extralabel use of a drug, how long until the order comes into effect?

Answer 7

90 days

Question 8

When is extralabel use in nonfood animals permitted?

Answer 8

In all situations except those where the public health is threatened.

Question 9

What drugs are prohibited for use in food producing animals? (13)

Answer 9

1. Chloramphenicol
2. Clenbuterol
3. Diethylstilbestrol
4. Dimetridazole
5. Ipronidazole
6. Other nitroimidazoles
7. Furazolidone
8. Nitrofurazone
9. Sulfonamides in lactating diary cattle (Excepts sulfadimethoxine, sulfabromomethazine, and sulfaethoxypuridazine)
10. Fluoroquinolones
11. Glycopeptides
12. Phenylbutazone in female dairy cattle 20 months or older
13. Cephalosporins (not cephapirin) in cattle, swine, chickens, or turkeys for disease prevention, at unapproved doses, frequencies, durations, or routes of administration, or if the drug is not approved for that species and production class.

Question 10

Extralabel use of what drugs used for treating/preventing influenza A are prohibited from extralabel use in chickens, turkeys, and ducks?

Answer 10

Adamantanes and neuraminidase inhibitors.