Exam 2 - Law Flashcards

1
Q

Homeopathy

A

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

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2
Q

Do homeopathic drugs go through an FDA approval process

A

No

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2
Q

Homeopathic drugs are regulated by the _____ as _____

A

FDA
Drugs

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3
Q

Homeopathic drugs must have a

A

Therapeutic indication for self limiting, self diagnosable condition

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4
Q

OTC labeling of homeopathic drugs must have what

A

Drug facts box

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5
Q

What word must be included in the labeling of homeopathic drugs

A

Homeopathic

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6
Q

How are ingredients in homeopathic drugs listed

A

In terms of dilution

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6
Q

Advertising is regulated by

A

FTC

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7
Q

Homeopathic drugs have never been required to show what before marketing

A

Safety or efficacy

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8
Q

What does the FDA system operate on

A

Honor code

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9
Q

USP seal does not ensure ____

A

Safety or efficacy

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10
Q

Who determines if a homeopathic product can be OTC

A

FDA

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10
Q

Dietary supplements are regulated by the FDA as what

A

Food

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11
Q

Amount of calcium that requires electrolyte per dosage on label

A

20 mg

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12
Q

Amount of magnesium that requires electrolyte per dosage on label

A

8 mg

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13
Q

Amount of potassium that requires electrolyte per dosage on label

A

5 mg

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14
Q

Ask a dr before use of calcium if you have

A

Kidney stones
Calcium reduced diet

14
Q

Amount of sodium that requires electrolyte per dosage on label

A

5 mg

15
Q

Ask a dr before use of magnesium if you have

A

Kidney disease
Magnesium reduced diet

16
Q

Threshold amount of calcium

A

> 3.2 g

16
Q

Ask a dr before use of potassium if you have

A

Kidney disease
Potassium reduced diet

17
Q

Ask a dr before use of sodium if you have

A

Kidney stones
Sodium reduced diet

18
Q

Threshold amount of magnesium

A

> 600 mg

19
Q

Threshold amount of LOW sodium

A

< 140 mg

19
Q

Threshold amount of potassium

A

> 975 mg

19
Q

Threshold amount of VERY LOW sodium

A

< 35 mg

19
Q

Threshold amount of sodium

A

> 140 mg

20
Q

Threshold amount of sodium FREE

A

< 5 mg

20
Q

Effect/use of PSE product abuse

A

Precursor to meth

20
Q

Effect/use of dextromethorphan product abuse

A

Intoxication
Altered mental status

20
Q

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

A

Opioid abuse

21
Q

Effect/use of OTC antihistamines (dimenhydrate) product abuse

A

Intoxication
Stimulant like effects
Euphoria
Hallucinations

22
Q

Requirement for selling codeine OTC

A

Limited to 200 mg/100 mL OR 100 g

22
Q

Requirement for selling dihydrocodeine, ethylmorphine, opium OTC

A

Limited to 100 mg/100 mL OR 100 g

23
Q

Requirement for selling diphenoxylate OTC

A

Limited to 25 mg/25 mcg atropine sulfate

23
Q

Requirement for selling diphenoxin OTC

A

Limited 0.5 mg/25 mcg atropine sulfate

24
Q

Not more than _____ mL of anything containing opium

A

240 mL

24
Q

Not more than ____ dosage units of anything containing opium

A

48

25
Q

Not more than ___ mL of any other controlled substance

A

120 mL

26
Q

Not more than ____ dosage units of any other controlled substance

A

24

27
Q

Record keeping requirements of PSE

A

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)