Federal Requirements Flashcards

1
Q

Pure Food and Drug Act

A

Prohibits Misbranded and Adulterated drugs

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2
Q

Federal Food, Drug, and Cosmetic Act

A
  • FDA began
  • requires drug man. to submit a New Drug Application before marketing drug
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3
Q

Durham-Humphrey Amendment

A

two categories are created: OTC and legend drugs

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4
Q

Kefauver-Harris Amendment

A

requires drug company to prove that the drug is both safe AND effective

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5
Q

How many refills can a CIII and CIV have?

A

five refills or refills for up to six months

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6
Q

DEA Form 41

A

reporting destruction of CS

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7
Q

DEA Form 104

A

pharmacy closure or surrender of a pharmacy permit

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8
Q

DEA Form 106

A

reporting the loss or theft of a CS

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9
Q

DEA Form 222a

A

ordering more of Form DEA 222

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10
Q

DEA Form 224

A

for applying for a DEA registration number

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11
Q

DEA form 224a

A

DEA registration renewal (every 3 years)

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