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Spring 2022: Pharmacy Law > Reading 7 > Flashcards

Reading 7 Flashcards

Covers pregnancy categories, inspections, generic equivalency, the NDA process, and REMS.

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1
Q

What does pregnancy category A mean?

A

Adequate number of studies in pregnant women have been conduct and no demonstrated risk seen

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2
Q

What does pregnancy category B mean?

A

No adequate students in pregnant woman conducted, but animal studies show no demonstrated risk

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3
Q

What does pregnancy category C mean?

A

No adequate studies in pregnant woman, animal studies show risk or have not been conducted. Used if potential benefits outweigh the risks

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4
Q

What does pregnancy category D mean?

A

Evidence of risk. Used if potential benefits outweigh risks. Must contain a statement of fetal harm and patient should be aware

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5
Q

What does pregnancy category X mean?

A

Contraindicated for use during pregnancy. Risk outweighs any potential benefits

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6
Q

When would an FDA inspection at a pharmacy be warranted?

A

to verify that the pharmacy is not manufacturing/compounding appropriately

MUST BRING A NOTICE OF INSPECTION (NOI) AND SHOW THEIR CREDENTIALS

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7
Q

When would a DEA inspection be warranted?

A

any location where controlled substances are kept

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8
Q

Can the DEA review financial/sales/pricing data without a warrant or permission?

A

No

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9
Q

What must a DEA agent provide in order to enter a pharmacy for inspection?

A

NOI, credentials, and purpose of visit

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10
Q

True or false: the FDA must tell you whether or not the inspection is routine or complaint-based.

A

false

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11
Q

What is included in the statement of rights that accompanies a Notice of Inspection (NOI)?

A
  • right to require the DEA to get an AIW
  • right to refuse inspection; will trigger AIW
  • anything incriminating can be used against you
  • you’ll get a copy of the notice
  • you can withdraw consent at any time; will trigger AIW
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12
Q

In which 3 scenarios are warrants not required?

A
  1. owners or PIC consents
  2. imminent danger to public health/safety
  3. emergencies
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13
Q

Which warrant has the higher threshold for probable cause?

A

Search warrant

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14
Q

Which warrant can be served at any time of day?

A

Search warrant

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15
Q

When must an Administrative Inspection Warrant (AIW) be served?

A

regular business hours

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16
Q

Which pharmacy inspection can you NOT refuse, even if there isn’t a warrant?

A

Board of Pharmacy

17
Q

What is the source for generic equivalency ratings?

A

Orange Book

18
Q

What is the source for interchangeable biological products?

A

Purple Book

19
Q

What source lists whether drug products are bioequivalent to the Reference Listed Drug (RLD)?

A

Orange Book

20
Q

True or false: there can be more than one RLD for a drug product.

A

true

21
Q

Drug products must be both ____________ and ___________ to be interchangeable or substitutable.

A

therapeutic equivalents; pharmaceutical equivalents

22
Q

In the Orange Book ratings, what does the first letter indicate?

A

bioequivalence information

23
Q

In the Orange Book ratings, what does the second letter indicate?

A

additional bioequivalence information or dosage form information

24
Q

What happens during Phase 1 of an IND clinical trial?

A

first introduction into human subjects; healthy volunteers and designed to understand the profile of the drug; involve less than 100 patients

25
Q

What happens during Phase 2 of an IND clinical trial?

A

first introduction to patients with the disease; evaluate the effectiveness of the drug; involve less than 1000 patients

26
Q

What happens during Phase 3 of an IND clinical trial?

A

introduction into a large number of patients with the disease; continue to expand safety and efficacy data; involve several thousand patients

27
Q

Generally, how long does the FDA have to respond with a decision after the NDA has been submitted?

A

180 days (although they often need more time based on the information shared)

28
Q

When is an NDA form completed and submitted?

A

after all trial phases are complete; details all the information obtained during the IND process

29
Q

ANDAs are used for the approval of what drugs?

A

generics

30
Q

True or false: in an ANDA, a manufacturer must redo all trial phases to demonstrate bioequivalence.

A

false

31
Q

True or false: REMS are designed to stop all issues with drugs.

A

false

32
Q

What are the 4 parts of REMS?

A
  1. patient-friendly labeling
  2. communication plans
  3. Elements to Assure Safe Use (ETASU)
  4. implementation system
33
Q

What is ETASU?

A

required activities or clinical interventions done prior to prescribing, dispensing or receiving a product (iPLEDGE system with isotretinoin)

Spring 2022: Pharmacy Law (20 decks)

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