Regulatory Issues for OTCs

Question 1

What is a Drug? (3)

Answer 1

1. ) listed in official compendia
2. ) DCMT
3. ) affect structure or function

Question 2

Explain the role of the 1906 Pure Food and Drug Act

Answer 2

established the FDA

labels must be truthful

Question 3

Role of 1938 Food, Drug, & Cosmetic Act

Answer 3

cosmetics added
drugs must provide adequate direction for use and warnings
Elixir of Sulfanilamide tragedy

Question 4

Elixir of Sulfanilamide Tragedy

Answer 4

wanted to make antibiotic as liquid so they dissolved it in antifreeze

Question 5

Role of 1951 Durham-Humphrey Amendment

Answer 5

Label on vial dispensed to patient

legend (Rx) & non-legend (OTC)

Question 6

Role of 1962 Kefauver Harris Amendment

Answer 6

Tested drugs for safety & effectiveness

Thalidomide disaster - used as sedative but caused birth defects

Question 7

Implications or being classified as a drug

Answer 7

Drug approval process by FDA
-clinical testing
-time to market
Label requirements
Tamper evident Packaging

Question 8

3 ways Rx become OTC

Answer 8

• manufacturer requests via application
• manufacturer petitions
• switched to OTC through drug review process

Question 9

Benefits of Rx to OTC

Answer 9

1. usage increase allows 2. people to live longer

lowers cost

Question 10

Active Ingredients/ purpose

Answer 10

tells you about what is in the medication that is doing the work

Question 11

Uses

Answer 11

tells you what the drug treats

Question 12

Warnings

Answer 12

• when you should talk to a doctor
• how medicine will make you feel
• when you should stop
• when you shouldn’t use it

Question 13

Directions

Answer 13

• how much
• how to
• how often
• how long

Question 14

other info

Answer 14

how to store

Question 15

inactive ingredients

Answer 15

• flavor
• color
• preservatives