Pharm Regs

Question 1

adulteration

Answer 1

refers to composition of the drug

Question 2

misbranding

Answer 2

refers to labeling and marketing of the drug

Question 3

Pure Food Act of 1906

Answer 3

product must contain what label says it contains

Question 4

Food, Drug, Cosmetic Act of 1938

Answer 4

establish SAFETY for human medications

Question 5

Sulfanilamide Disaster of 1937

Answer 5

diethylene glycol for raspberry flavor to treat strep throat in children –> kidney failure

Question 6

Kefauver Harris Amendment of 1962

Answer 6

drugs have to be safe AND effective

Question 7

Green Book

Answer 7

lists animal drug products that have been approved for safety and effectiveness

Question 8

AMDUCA 1994

Answer 8

Animal Medicinal Drug Use Clarification Act allowed extra-label drug use again!!! and compounding.

Question 9

Major Species

Answer 9

cats, dogs, cattle, horses, pigs, chickens, turkeys

Question 10

Controlled Substances Schedule I to IV

Answer 10

I (one) has the highest abuse potential, no accepted medical use
V (five) has the lowest abuse potential

Question 11

Do weight, dosage, and length of therapy have to be included on a drug prescription?

Answer 11

No, but it’s recommended