Regulations 2

Question 1

DEA

Answer 1

Drug Enforcement Administration

Question 2

Each Veterinarian has his/her own DEA number and registration with the DEA occurs ______________

Answer 2

Triennially (every 3 years)

Question 3

DEA Prescribing Regulations (4)

Answer 3

1. Veterinarian Registration
2. Locked Cabinet or Safe
3. Controlled Substance Log
4. Biannual Inventory (twice a year)

Question 4

The DEA requires a Controlled Substance Log with Records for ____ years. The log must include what 5 things?

Answer 4

Two Years worth of:
1. Orders
2. Receipts
3. Use
4. Discard
5. Theft

Question 5

What are the 4 Stages/Steps of Drug Development

Answer 5

Stage 1 - Synthesis/Discovery
Stage 2 - Safety/Effectiveness
Stage 3 - New animal drug application
Stage 4 - Post market surveillance

Question 6

Stage 1 of drug development (synthesis/ discovery) includes preliminary studies on _____________ and _____________

Answer 6

Effects and Toxicity

Question 7

Stage 2 (safety/ effectiveness) of drug development includes pre clinical studies, and _____________ _____________

Answer 7

Clinical trials (phases 1-3)

Question 8

When determining safety and effectiveness of a drug, what four factors are important to consider

Answer 8

1. Therapeutic doses
2. Human safety in food producing animals
3. Short term tests (adverse reactions)
4. Long term tests (toxicity damage)

Question 9

Special testing for safety and effectiveness for drugs in both the short and long term focus on what three factors

Answer 9

1. Carcinogenicity (cancer)
2. Teratogenicity (birth defects)
3. Reproduction

Question 10

ED50
LD50
TI

Answer 10

Effective Dose (50%)
Lethal Dose (lethal in 50%)
Therapeutic index