Test 1 Part 1

Question 1

Any substance that, when administered to living organisms , produces a change in function.

Answer 1

drug

Question 2

the study of adverse effects of chemical, physical or biological agents on living organisms and the ecosystem

Answer 2

toxicology

Question 3

the study of the uses, effects, and modes of actions of drugs

Answer 3

pharmacology

Question 4

What law/act was the first attempt to protect consumers in manufacture of drugs and foods, requiring all drugs to meet minimal standards of strength, purity, and quality?

Answer 4

1906 Pure Food and Drug Act

Question 5

What was the first law/act that required the label to state if the drug contained dangerous ingredients and also established two references of officially approved drugs (USP and NF)?

Answer 5

1906 Pure Food and Drug Act

Question 6

Following the sulfa drug that was distributed to pediatric patients and was very similar to antifreeze, what law/act authorized the FDA to demand evidence of the safety for new drugs as well as issue standards for food, and conduct factory inspections?

Answer 6

1938 Federal Food, Drug, and Cosmetic Act (FD&C)

Question 7

What 1951 amendment defined drugs that could only be purchased if the patient had a prescription from a license practitioner?

Answer 7

FD&C Durham-Humphrey Amendment

Question 8

What 1958 amendment made approval of new food additives required?

Answer 8

FD&C Food Additives Amendment

Question 9

What does the Food Additives Amendment Exemption GRAS stand for?

Answer 9

Generally recognized as safe

Question 10

What 1960 Amendment stated that all colors (natural or synthetic) must be approved making it unlawful to use colors to mask blemishes or inferior products?

Answer 10

1960 FD&C Color Additives Amendment

Question 11

What 1962 amendment made it required for drug manufacturers to use standard labeling, listing adverse reactions and contraindications?

Answer 11

1962 FD&C Kefauver-Harris Amendment

Question 12

What amendment required drug companies to prove their drugs’ safety and effectiveness?

Answer 12

1962 FD&C Kefauver-Harris Amendment

Question 13

What Act is designed to regulate the dispensing of drugs that have the potential for abuse (controlled substances), assigned drugs to one of five SCHEDULES, and is commonly referred to as the Controlled Substances Act?

Answer 13

1970 Comprehensive Drug Abuse Prevent and Control Act

Question 14

Is Heroin Schedule I or Schedule V? Marijuana?

Answer 14

Schedule I for both

Question 15

What 1994 Act made the FDA responsible for taking action against any unsafe dietary supplement product after it reaches the market?

Answer 15

1994 Dietary Supplements Health & Education Act

Question 16

T/F: Generally, manufacturers need to register their products with the FDA and get FDA approval before producing or selling dietary supplements and are required to determine efficacy.

Answer 16

False; they don’t have to do any of that.

Question 17

What 1996 Act reinvestigated pesticide tolerance levels, developing stricter pesticide safety standards, especially for children?

Answer 17

1996 Food Quality Protection Act

Question 18

What is the regulatory agency for food distribution and school lunch programs?

Answer 18

USDA (US Dept of Agriculture)

Question 19

What is the regulatory agency for food labeling/nutrition, food ingredients/packaging, pharmaceuticals, animal foods, cosmetics, and other things?

Answer 19

FDA (Food and Drug Admin)

Question 20

What is the regulatory agency for controlled substances, enforcing laws against drug activity, and changing schedules of abused drugs?

Answer 20

DEA (Drug Enforcement Admin)

Question 21

What is the regulatory agency for agricultural and industrial chemicals as well as water?

Answer 21

EPA (Environmental Protection Agency)

Question 22

What regulatory Agency recalls unsafe consumer products?

Answer 22

Consumer Products Safety Commission (CPSC)

Question 23

What is the regulatory agency for workplace chemical exposure?

Answer 23

Occupational Safety and Health Admin (OSHA)

Question 24

What plant are drugs like codeine and morphine made from?

Answer 24

Poppy (opium)

Question 25

Cholesterol medications like Lipitor, Crestor, and Zocor fall into what common drug classification?

Answer 25

Hypolipidemics

Question 26

What kind of nomenclature is N-acetyl-p-aminophenol?

Answer 26

chemical name

Question 27

What kind of nomenclature is Acetaminophen?

Answer 27

Generic name

Question 28

What is the brand or trade name for acetaminophen?

Answer 28

Tylenol

Question 29

What is the term for the intended physiological effect of a drug?

Answer 29

therapeutic effect

Question 30

What is the term for the medical conditions or diseases for which a drug is meant to be used?

Answer 30

indication

Question 31

What is the term for the conditions/circumstance for which a drug should not be used?

Answer 31

contraindication

Question 32

What is the term for the conditions or types of patients that warrant closer observation for specific side effects?

Answer 32

Caution

Question 33

What is the term for unintended effects, other than therapeutic effect, which may or may not be negative?

Answer 33

Side effect