Federal Requirements Flashcards
1
Q
Pure Food and Drug Act
A
Prohibits Misbranded and Adulterated drugs
2
Q
Federal Food, Drug, and Cosmetic Act
A
- FDA began
- requires drug man. to submit a New Drug Application before marketing drug
3
Q
Durham-Humphrey Amendment
A
two categories are created: OTC and legend drugs
4
Q
Kefauver-Harris Amendment
A
requires drug company to prove that the drug is both safe AND effective
5
Q
How many refills can a CIII and CIV have?
A
five refills or refills for up to six months
6
Q
DEA Form 41
A
reporting destruction of CS
7
Q
DEA Form 104
A
pharmacy closure or surrender of a pharmacy permit
8
Q
DEA Form 106
A
reporting the loss or theft of a CS
9
Q
DEA Form 222a
A
ordering more of Form DEA 222
10
Q
DEA Form 224
A
for applying for a DEA registration number
11
Q
DEA form 224a
A
DEA registration renewal (every 3 years)