Exam 2 - Law

Question 1

Homeopathy

Answer 1

A system of alternative medicine based on treating symptoms of disease w/ substances that produce symptoms of disease in health subjects

Question 2

Do homeopathic drugs go through an FDA approval process

Answer 2

No

Question 2

Homeopathic drugs are regulated by the _____ as _____

Answer 2

FDA
Drugs

Question 3

Homeopathic drugs must have a

Answer 3

Therapeutic indication for self limiting, self diagnosable condition

Question 4

OTC labeling of homeopathic drugs must have what

Answer 4

Drug facts box

Question 5

What word must be included in the labeling of homeopathic drugs

Answer 5

Homeopathic

Question 6

How are ingredients in homeopathic drugs listed

Answer 6

In terms of dilution

Question 6

Advertising is regulated by

Answer 6

FTC

Question 7

Homeopathic drugs have never been required to show what before marketing

Answer 7

Safety or efficacy

Question 8

What does the FDA system operate on

Answer 8

Honor code

Question 9

USP seal does not ensure ____

Answer 9

Safety or efficacy

Question 10

Who determines if a homeopathic product can be OTC

Answer 10

FDA

Question 10

Dietary supplements are regulated by the FDA as what

Answer 10

Food

Question 11

Amount of calcium that requires electrolyte per dosage on label

Answer 11

20 mg

Question 12

Amount of magnesium that requires electrolyte per dosage on label

Answer 12

8 mg

Question 13

Amount of potassium that requires electrolyte per dosage on label

Answer 13

5 mg

Question 14

Ask a dr before use of calcium if you have

Answer 14

Kidney stones
Calcium reduced diet

Question 14

Amount of sodium that requires electrolyte per dosage on label

Answer 14

5 mg

Question 15

Ask a dr before use of magnesium if you have

Answer 15

Kidney disease
Magnesium reduced diet

Question 16

Threshold amount of calcium

Answer 16

> 3.2 g

Question 16

Ask a dr before use of potassium if you have

Answer 16

Kidney disease
Potassium reduced diet

Question 17

Ask a dr before use of sodium if you have

Answer 17

Kidney stones
Sodium reduced diet

Question 18

Threshold amount of magnesium

Answer 18

> 600 mg

Question 19

Threshold amount of LOW sodium

Answer 19

< 140 mg

Question 19

Threshold amount of potassium

Answer 19

> 975 mg

Question 19

Threshold amount of VERY LOW sodium

Answer 19

< 35 mg

Question 19

Threshold amount of sodium

Answer 19

> 140 mg

Question 20

Threshold amount of sodium FREE

Answer 20

< 5 mg

Question 20

Effect/use of PSE product abuse

Answer 20

Precursor to meth

Question 20

Effect/use of dextromethorphan product abuse

Answer 20

Intoxication Altered mental status

Question 20

Effect/use of class V controlled substances (cough syrup) product abuse

Answer 20

Opioid abuse

Question 21

Effect/use of OTC antihistamines (dimenhydrate) product abuse

Answer 21

Intoxication Stimulant like effects Euphoria Hallucinations

Question 22

Requirement for selling codeine OTC

Answer 22

Limited to 200 mg/100 mL OR 100 g

Question 22

Requirement for selling dihydrocodeine, ethylmorphine, opium OTC

Answer 22

Limited to 100 mg/100 mL OR 100 g

Question 23

Requirement for selling diphenoxylate OTC

Answer 23

Limited to 25 mg/25 mcg atropine sulfate

Question 23

Requirement for selling diphenoxin OTC

Answer 23

Limited 0.5 mg/25 mcg atropine sulfate

Question 24

Not more than _____ mL of anything containing opium

Answer 24

240 mL

Question 24

Not more than ____ dosage units of anything containing opium

Answer 24

48

Question 25

Not more than ___ mL of any other controlled substance

Answer 25

120 mL

Question 26

Not more than ____ dosage units of any other controlled substance

Answer 26

24

Question 27

Record keeping requirements of PSE

Answer 27

ID # Name of purchaser Total PSE weight in grams Name of product purchased Qty purchased Type of ID shown Signature of purchaser Address of purchaser Date and time of purchase (I Need To Not Quit Talking Shit All Day)