3 - Drug Regulations & Control

Question 1

status of medications that are classified as both prescription and OTC drugs

Answer 1

dual marketing

Question 2

medications with habit-forming ingredients that can be dispensed without a prescription by a pharmacist to persons of at least 18 years of age

Answer 2

exempt narcotics

Question 3

a court order preventing a specific action, such as the distribution of a potentially dangerous drug

Answer 3

injunction

Question 4

drug products that contain identical amounts of the same active ingredients in the same dosage form

Answer 4

pharmaceutical equivalent

Question 5

pharmaceutical equivalents that produce the same effects in patients

Answer 5

therapeutic equivalent

Question 6

this prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs

Answer 6

Food and Drug Act of 1906

Question 7

this required new drugs be shown to be safe before marketing because of fatal poisoning from liquid sulfanilamide

Answer 7

Food, Drug, and Cosmetic Act of 1938

Question 8

this required child-proof packaging for most prescription drugs

Answer 8

Poison Prevention Packaging Act

Question 9

this allowed quicker introduction of drugs and extension of drug patent terms

Answer 9

Hatch-Watchman Act of 1984

Question 10

this allowed quicker introduction of drugs and extension of drug patent terms

Answer 10

Hatch-Watchman Act of 1984

Question 11

the purpose of phase 2 clinical trials

Answer 11

effectiveness

Question 12

the form used to order Schedule II controlled substances

Answer 12

DEA Form 222

Question 13

drug recall that is issued by manufacturers when there is a strong likelihood that the product will cause serious adverse effects or death

Answer 13

Class I

Question 14

drugs with a high potential for abuse and no accepted medical use in the US

Answer 14

Schedule I

Question 15

drugs with a high potential for abuse which may lead to addiction but have accepted medical uses like amphetamines, opium, cocaine, methadone and various opiates

Answer 15

Schedule II

Question 16

drugs with a potential for abuse that may lead to moderate to low dependencies or high psychological dependence. (i.e., anabolic steroids and various compounds containing limited quantities of narcotic substances such as codeine)

Answer 16

Schedule III

Question 17

drugs with low potential for abuse that may lead to limited physical and psychological dependence (i.e., phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital)

Answer 17

Schedule IV

Question 18

drugs with the lowest potential for abuse that may lead to very limited physical or psychological dependences (i.e., compounds containing limited amounts of narcotic such as codeine)

Answer 18

Schedule V