Drug Legality

Question 1

Who has the hardest approval standard and is responsible for labeling medications and supplements, and regulating new prescription drugs before they can be sold?

Answer 1

FDA

Question 2

Which FDA center is responsible for overseeing the animal and veterinary program, and regulates animal drugs, animal feed, and veterinary devices?

Answer 2

Center for Veterinary Medicine (CVM)

Question 3

Who oversees drugs with potential for human abuse?

Answer 3

DEA

Question 4

Who oversees animal biologics (vaccines, anti-toxins, diagnostics) and things like x-ray exposure to veterinary professionals?

Answer 4

USDA

Question 5

Who oversees pesticides and has a pretty easy approval standard?

Answer 5

EPA

Question 6

T/F: DEA regulation of controlled substances is at the Federal level only.

Answer 6

FALSE

Federal and State regulations. State regulations can be more strict.

Question 7

Practitioners have to registered with the DEA every 2 years in order to prescribe what kind of drugs?

Answer 7

Controlled substances

Question 8

How long do records of any controlled substance administration have to be retained?

Answer 8

3 years

Question 9

As part of their goal to protect human health and the environment, the ___ and FDA work together to decide what will be regulated as a drug vs pesticide.

Answer 9

EPA

Question 10

What is a major challenge for the athletic commission and AEI in control of doping at athletic events?

Answer 10

Control doping without interfering with legitimate use of veterinary medications

Question 11

Who regulates how prescriptions must be written?

Answer 11

Each state’s veterinary medical board

Question 12

If prescription drugs are being sold or used without a prescription, it should be reported to:

Answer 12

State authority and FDA

Question 13

How long do treatment/dispensing records need to be kept for uncontrolled substances?

Answer 13

2 years

Question 14

What did the Animal Medicinal Drug Use Clarification Act in 1994 do?

Answer 14

Enabled veterinarians to use human or animal drugs extra-label under certain conditions.

Question 15

What is the stipulation for using drugs extra-label in food animals?

Answer 15

Must not result in volatile residues

Question 16

What are some drugs that are prohibited for extra-label use in food animals?

Answer 16

Chloramphenicol
Clenbuterol
DES

Question 17

T/F: Individual treatment records have to be kept for every animal, including for herd treatment.

Answer 17

FALSE

Individual records are not necessary for herd treatment

Question 18

What kind of tests are done to see if a new product is safe and effective for people to use?

Answer 18

Clinical trials

Question 19

What was the purpose of the act for Animal Drugs Intended for Minor Use/Minor Species (MUMS) in 2004?

Answer 19

Provide FDA authorized drugs for less common species and indications

Question 20

What are the stipulations for a new drug being brought to market?

Answer 20

Safe
Effective
Good quality
Proper labeling

Question 21

How long does it take to bring a new drug to market?

Answer 21

7-10 years

*and MILLIONS of dollars

Question 22

Who monitors new drugs after they’ve been brought to market, including reports of adverse events and marketing materials?

Answer 22

FDA

Question 23

What did the Federal Food, Drug, and Cosmetic Act do?

Answer 23

Provided 5 years of market exclusivity to new animal drugs before generics can be made.

Question 24

Who should adverse drug reactions be reported to?

Answer 24

Drug manufacturer

FDA

Question 25

What is a VFD drug?

Answer 25

Veterinary Feed Directive drugs are intended to be used in feed or water

Question 26

For generics to be approved, the manufacturer must provide evidence of what?

Answer 26

Same active ingredients in the same concentration, and that it is bioequivalent to the approved animal drug product.

Question 27

Why are generic drugs important?

Answer 27

Help keep treatment more affordable, and encourage competition and lower drug prices.

Question 28

What’s up with the Animal Drug Availability Act?

Answer 28

Meant to increase the amount of animal drugs on the market and reduce regulatory burdens on the animal health industry. More flexible FDA regulation of new animal drugs and medicated feeds.

*Gave CVM the ability to modify requirements for “effectiveness” on a case by case basis.

Broader ranges of acceptable doses

Question 29

What is compassionate use?

Answer 29

Expanded access and use of investigational drugs to treat certain conditions and serious, life threatening diseases, or when there is no alternative.

Question 30

Who regulates compliance in compounding drugs?

Answer 30

Pharmacy Compounding Accreditation Board (PCAB)

Question 31

What drugs were labeled for the same dose for horses and dogs, so vets were illegally prescribing the dog tablets to horses because they were so much cheaper?

Answer 31

Equioxx and Previcox

Question 32

If your client is traveling to Florida and they run out of their pet’s medication, can you legally call in a prescription to Walgreens in Florida even though you are not licensed in that state?

Answer 32

Yes, as long as the pharmacy is licensed in that state you can have them dispense drugs to your client.