Pharmacy part 2: FDA

FDA

100

What is the largest and most impactful federal agency?

1. FDA (Federal Drug Administration) 

200

What does MedWatch do?

Allows healthcare providers to report defects or any errors related to medication and medical products. 

300

What act established the two classifications of medications? 

Federal Food, Drug, and Cosmetic Act of 1938- (previously Pure Food and Drug Act of 1906)

400

The FDA provides a reporting program. What is it called?

MedWatch 

500

What does the Kefauver-Harris amendment of 1962 require?

1. Required drug manufacturers to prove the safety and effectiveness of the drug before the FDA approves it for commercial use. 

MISCELLANEOUS

100

Which act regulates the manufacture, importation, possession, use, and distribution of medications and substances that have the potential for abuse and/or psychological dependence?

Controlled Substances Act (under the DEA)

200

Which of the following is a responsibility of the Food and Drug Administration (FDA)?

Approving drugs for safety and effectiveness before marketing