Acts

Question 1

Required purity and strength standards

Answer 1

pure food and drug act 1906

not efficacy

Question 2

Created NDA process and FDA as we know it

Answer 2

federal food drug and cosmetic act (FDCA) 1938

Question 3

Established OTC and Rx drug classes

Answer 3

Durham-Humphrey 1951

Question 4

Established efficacy requirement

Answer 4

Kefauver-Harris Amendments 1962

Question 5

Incentives to develop drugs to treat rare diseases

Answer 5

Orphan Drug Act 1983

Question 6

created ANDA process for generic drug approval

Answer 6

Drug Price Competition and Patent term Restoration act (Hatch-Waxman) 1984

Question 7

Bans reimportation of drugs

Answer 7

prescription drug marketing act (PDMA) 1987

Question 8

3 things omnibus budget reconciliation act (OBRA-90) of 1990 mandated?

Answer 8

pt profiles
DUR
counseling

Question 9

Places burden on FDA to provide dietary supplement is unsafe before removing from market

Answer 9

dietary supplement and health education act (DSHEA) 1994

Question 10

Who administers/enforces federal hazardous substances act of 1996?

Answer 10

OSHA

Question 11

HIPPA requires compliance within __ days generally but TSBP requires compliance within __ days

Answer 11

30, 15

Question 12

If patient wants to amend PHI pharmacies must comply within __ days of request

Answer 12

60

Question 13

attempted to clarify compounding vs. manufacturing; legend “Rx only” on label

Answer 13

FDA modernization act (FDAMA) 1997`

Question 14

Established REMS

Answer 14

food and drug administration amendments act (FDAAA) 2007

Question 15

Cannot send compounded products out of state in excess of 5% of total prescriptions

Answer 15

drug quality and security act 2013 (DQSA)