FDA rules and Regulations

Question 1

For medications like Estrogens, DES, oral contraceptives, and IUDs what are the requirements pharmacies must follow

Answer 1

1) Must provide a leaflet at INITIAL FILL and REFILLS
2) Manufacturers must notify pharmacist to insert leaflet in EACH PERSCRIPTION DISPENSED
3) Provide general information regarding risks with use and adverse effects

Question 2

What must generic drugs fill out to be approved

Answer 2

Abbreviated New Drug Application

Question 3

What ACT requires drug manufacturers completion of ANDA for generics

Answer 3

Hatch-Waxman Act

Question 4

What is the name of the Adverse Event Reporting System used by the FDA in phase 4 post-marketing surveillance studies

Answer 4

Medwatch

Question 5

What is the orange book, who publishes it

Answer 5

Therapeutic Equivalence Evlauations, Center for Drug Evaluation and Research (CDER)

Question 6

T/F: Recalled drugs are segregated, documented, and labeled true

Answer 6

True

Question 7

Who are required to follow current Good Manufacturing Practices (cGMP)

Answer 7

Manufacturers, repackagers, and Outsourcing pharmacies

Question 8

T/F: Prescription drug samples should never be distributed from any retail pharmacy

Answer 8

True

Question 9

Who appoints the Collaborative Pharmaceutical Task Force representative for retailers

Answer 9

Speaker of the house