Vet Drug Labels

Question 1

which of the following are NOT veterinary drugs

a) non-systemic ectoparasiticides
b) teat dips
c) vaccines
d) vitamins

Answer 1

TRICK QUESTION!! all of them are NOT veterinary drugs

Question 2

veterinary drug

Answer 2

products that are used to diagnose, cure, mitigate, treat or prevent diseases

Question 3

product

Answer 3

specific formulation of an active substance(s) and has a claim for efficacy and safety at a certain dose

Question 4

what does the FDA ensure?

Answer 4

that products are safe and effective for their intended use

Question 5

efficacy

Answer 5

definition/level is DISEASE DEPENDENT, each indication product at planned label dose must be shown to be effective in the target species (i.e. parasites -decreased worms, decreased eggs in feces)

Question 6

what is the level of efficacy required for parasiticides?

Answer 6

> 90%

Question 7

why might a product w/ lower efficacy be registered?

Answer 7

• side effects
• resistance
• only drug available
• MOA different

Question 8

who creates the label and leaflet of a drug?

Answer 8

FDA and product registration holder (negotiate wording)

Question 9

T/F: too much data can cause people to be scared of a product

Answer 9

TRUE!! even though more data = better warnings

Question 10

1 kg = how many lbs

Answer 10

2.2!