Exam 2 - Law Flashcards
Homeopathy
A system of alternative medicine based on treating symptoms of disease w/ substances that produce symptoms of disease in health subjects
Do homeopathic drugs go through an FDA approval process
No
Homeopathic drugs are regulated by the _____ as _____
FDA
Drugs
Homeopathic drugs must have a
Therapeutic indication for self limiting, self diagnosable condition
OTC labeling of homeopathic drugs must have what
Drug facts box
What word must be included in the labeling of homeopathic drugs
Homeopathic
How are ingredients in homeopathic drugs listed
In terms of dilution
Advertising is regulated by
FTC
Homeopathic drugs have never been required to show what before marketing
Safety or efficacy
What does the FDA system operate on
Honor code
USP seal does not ensure ____
Safety or efficacy
Who determines if a homeopathic product can be OTC
FDA
Dietary supplements are regulated by the FDA as what
Food
Amount of calcium that requires electrolyte per dosage on label
20 mg
Amount of magnesium that requires electrolyte per dosage on label
8 mg
Amount of potassium that requires electrolyte per dosage on label
5 mg
Ask a dr before use of calcium if you have
Kidney stones
Calcium reduced diet
Amount of sodium that requires electrolyte per dosage on label
5 mg
Ask a dr before use of magnesium if you have
Kidney disease
Magnesium reduced diet
Threshold amount of calcium
> 3.2 g
Ask a dr before use of potassium if you have
Kidney disease
Potassium reduced diet
Ask a dr before use of sodium if you have
Kidney stones
Sodium reduced diet
Threshold amount of magnesium
> 600 mg
Threshold amount of LOW sodium
< 140 mg
Threshold amount of potassium
> 975 mg
Threshold amount of VERY LOW sodium
< 35 mg
Threshold amount of sodium
> 140 mg
Threshold amount of sodium FREE
< 5 mg
Effect/use of PSE product abuse
Precursor to meth
Effect/use of dextromethorphan product abuse
Intoxication
Altered mental status
Effect/use of class V controlled substances (cough syrup) product abuse
Opioid abuse
Effect/use of OTC antihistamines (dimenhydrate) product abuse
Intoxication
Stimulant like effects
Euphoria
Hallucinations
Requirement for selling codeine OTC
Limited to 200 mg/100 mL OR 100 g
Requirement for selling dihydrocodeine, ethylmorphine, opium OTC
Limited to 100 mg/100 mL OR 100 g
Requirement for selling diphenoxylate OTC
Limited to 25 mg/25 mcg atropine sulfate
Requirement for selling diphenoxin OTC
Limited 0.5 mg/25 mcg atropine sulfate
Not more than _____ mL of anything containing opium
240 mL
Not more than ____ dosage units of anything containing opium
48
Not more than ___ mL of any other controlled substance
120 mL
Not more than ____ dosage units of any other controlled substance
24
Record keeping requirements of PSE
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)
