Approved and Unapproved Drug Use

Question 1

What does the FDA regulate?

Answer 1

• food (wholesomeness)
• drugs
• medical devices
• nutraceuticals
• therapeutic diets

Question 2

What does the USDA regulate?

Answer 2

• patient-side diagnostic tests

- biologics: vaccines, immunomodulators, antiserum, monoclonal antibody treatments

Question 3

What does the EPA regulate?

Answer 3

• disinfectants

- pesticides: insecticides (topical), rodenticides

Question 4

VFD

Answer 4

Veterinary feed directive (requires authorization by vet)

- applies to feeds, top-dressings, milk replacers

Question 5

Medicated feeds that are not VFD

Answer 5

OTC antibiotics that have no human health implication

Question 6

Category 1

Answer 6

Animal drugs which require no withdrawal period

- made by both licensed and unlicensed feed mills (includes some VFDs)

Question 7

Category 2

Answer 7

Animal drugs which require a withdrawal period, and/or have a zero tolerance residue limit
- made only by licensed feed mills

Question 8

Type A

Answer 8

Basic, raw medicated article and carrier that is used in manufacturing medicated feeds
- concentrated premixes

Question 9

Type B

Answer 9

Animal remedy containing an animal feed produced from a Type A drug

• intermediate pre-blend containing at least 25% animal feed
• used to make other Type B feeds or Type C feed

Question 10

Type C

Answer 10

Contains an animal drug and may be offered as complete feed, either free-choice or top-dressed on another feed

• ex: medicated mineral, vitamin-enriched crumbles top-dressed on another feed
• complete feed!

Question 11

implications of the 2015 amendment to the VFD regulations as it relates to over the counter
antimicrobial use.

Answer 11

Eliminates use of medically important antimicrobials for growth promotion and feed efficiency
- brings therapeutic use in feed and water under supervision of vets (disease prevention and control still allowed)

Question 12

Approved drugs have a ____

Answer 12

New animal drug approval number (NADA)

Question 13

Approved biologics have a ______

Answer 13

USDA license number

Question 14

Approved pesticides have an _______

Answer 14

EPA registration number

Question 15

By what means may an unapproved veterinary drug be legally marketed in the USA?

Answer 15

• nutraceuticals and therapeutic diets

- MUMS, indexed drug

Question 16

Prior to 2002, only ____ required duration of immunity challenge studies

Answer 16

Rabies

Question 17

Duration of immunity

Answer 17

Required for new agents

• only done by a few companies
• west nile virus - yes
• canine distemper - no

Question 18

MUMS

Answer 18

Major use in minor species, or minor use in major species

- modifies provisions of Federal Food, Drug, and Cosmetic Act with conditional approval, designation, and indexing

Question 19

Conditional approval

Answer 19

Allows company to make the drug available before collecting all necessary effectiveness data, but after proving drug is safe
- can keep drug on market for up to 5 years, with annual renewal while collecting data

Question 20

Designation

Answer 20

Similar to “Orphan Drug Act” for humans

• provides incentives for approval
• grants to support safety and effectiveness testing available
• company given 7 years of marketing exclusivity

Question 21

Indexing

Answer 21

When the potential market for a minor species drug is too small to ever support the costs of the drug approval process, even under conditional approval
- indexed drug allows it to be a legally marketed unapproved new animal drugs

Question 22

Medically necessary veterinary product

Answer 22

Used to treat or prevent a serious animal disease or condition, or is needed to assure the availability of safe food products of animal origin and no other available source of that product or adequate alternative drug substitute exists
- owner inconvenience and non-therapeutic uses are inappropriate reasons for classification as an MNVP

Question 23

Nutraceutical

Answer 23

Foodstuff (fortified food or a dietary supplement) that is held to provide health or medical benefits in addition to its basic nutritional value

Question 24

Other things categorized as nutraceuticals

Answer 24

• probiotic: live bacteria intended to colonize the GIT
• prebiotic: food or dietary supplement that modulates the GI microflora
• synbiotic: prebiotic + probiotic

Question 25

In what area does the FDA use “enforcement discretion” and does not approve efficacy or assure safety?

Answer 25

Nutraceuticals and therapeutic diets

- company does not have to prove efficacy in order to be on market, only have to be wholesome

Question 26

Therapeutic diets

Answer 26

Do not have to disclose studies that did not work, are safe but there is a question of efficacy

Question 27

Holistic medicine

Answer 27

Infers treatment of the entire individual

- represents alternatives to traditional medicine

Question 28

Homeopathy

Answer 28

System of medical practice that treats a disease by the administration of minute doses of a remedy that would in healthy persons produce symptoms similar to those of the disease
- is a form of pseudo-science