Reading 7

Question 1

What does pregnancy category A mean?

Answer 1

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

Question 2

What does pregnancy category B mean?

Answer 2

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

Question 3

What does pregnancy category C mean?

Answer 3

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

Question 4

What does pregnancy category D mean?

Answer 4

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

Question 5

What does pregnancy category X mean?

Answer 5

Contraindicated for use during pregnancy. Risk outweighs any potential benefits

Question 6

When would an FDA inspection at a pharmacy be warranted?

Answer 6

to verify that the pharmacy is not manufacturing/compounding appropriately

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

Question 7

When would a DEA inspection be warranted?

Answer 7

any location where controlled substances are kept

Question 8

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

Answer 8

No

Question 9

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

Answer 9

NOI, credentials, and purpose of visit

Question 10

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

Answer 10

false

Question 11

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

Answer 11

• 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

Question 12

In which 3 scenarios are warrants not required?

Answer 12

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

Question 13

Which warrant has the higher threshold for probable cause?

Answer 13

Search warrant

Question 14

Which warrant can be served at any time of day?

Answer 14

Search warrant

Question 15

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

Answer 15

regular business hours

Question 16

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

Answer 16

Board of Pharmacy

Question 17

What is the source for generic equivalency ratings?

Answer 17

Orange Book

Question 18

What is the source for interchangeable biological products?

Answer 18

Purple Book

Question 19

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

Answer 19

Orange Book

Question 20

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

Answer 20

true

Question 21

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

Answer 21

therapeutic equivalents; pharmaceutical equivalents

Question 22

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

Answer 22

bioequivalence information

Question 23

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

Answer 23

additional bioequivalence information or dosage form information

Question 24

What happens during Phase 1 of an IND clinical trial?

Answer 24

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

Question 25

What happens during Phase 2 of an IND clinical trial?

Answer 25

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

Question 26

What happens during Phase 3 of an IND clinical trial?

Answer 26

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

Question 27

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

Answer 27

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

Question 28

When is an NDA form completed and submitted?

Answer 28

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

Question 29

ANDAs are used for the approval of what drugs?

Answer 29

generics

Question 30

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

Answer 30

false

Question 31

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

Answer 31

false

Question 32

What are the 4 parts of REMS?

Answer 32

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

Question 33

What is ETASU?

Answer 33

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