Drug Classifications

Question 1

Prescription/legend

Answer 1

require a prescription by a qualified licensed professional

Question 2

Controlled substances

Answer 2

have abuse potential, 5 schedules (Schedule I = high abuse potential - Schedule V = low abuse potential), enforced by DEA & Dept. of Justice

Question 3

Over the Counter (OTC)

Answer 3

available w/o a prescription (often prescribed for higher doses)

Question 4

Orphan

Answer 4

treat, diagnoses or prevent rare disease (affects 200,000 or fewer people in US or the cost of development & marketing will not likely be recovered by sales in the US)

Question 5

Investigational

Answer 5

only available under IND protocol & not yet approved by FDA, often when under evaluation for new indication

Question 6

Dietary Supplements

Answer 6

intended to supplement the diet & contains vitamins, mineral, herbs, botanicals, amino acid, substance used to increase total daily intake, or a concentrate, metabolite, constituent, extract or combination of these ingredients
Cannot be represented as a food or make claims to diagnose, prevent, mitigate, treat or cure a specific disease unless approved by the FDA