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PHRM 871: Law > Reading 7 > Flashcards

Reading 7 Flashcards

1
Q

What is an Inspection?

A
  • “Check Up” that happens for two reason:
  • Routine Inspection OR
  • Suspicion

Inspected by FDA, DEA, BoP

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2
Q

What inspection does the FDA do?

A
  • Really only look at the places that make the drugs or devices
  • Could refuse them but thats a little sus
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3
Q

What inspection does the DEA do?

A
  • Inspect anywhere controlls are kept
  • MUST state why, show credentials, & notice of inspection
  • Could be refuse but WILL come back with a warrent
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4
Q

What are the rights that the pharmacist has during Notice of Inspection?

A
  • Require a Warrent
  • Refuseal [will trigger to get a warrent]
  • Anything incriminating will be used againts you
  • Get a Copy of the notice
  • Withdrawl consent [will trigger to get a warrent]
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5
Q

What are the two types of warrents that can be obtained?

A
  • Administrative Inspection Warrent
  • Search Warrent
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6
Q

What is important to know about an Administrative Inspection Warrent?

A
  • Anything of interset could lead to one [VERY broad]
  • During business hours
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7
Q

What is important to know about a Search Warrent?

A
  • Must convince a judge that a crime has been committed
  • Anytime, even closed
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8
Q

What inspections does the Borad of Pharmacy do?

A
  • CANT BE REFUSED and DONT NEED NO WARRENT
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9
Q

What is the Orange Book?

A
  • Provides equivalency rating for different products
  • Helps determine Generic Equivalency
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10
Q

What is the Purple Book?

A
  • Helps with Biological Interchange
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11
Q

What information does the Orange and Purple books provide?

A
  • Shows equivalent Generic/Biologic compared to Prescribed
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12
Q

What products can be substiuted and how are they noted in the Orange Book/

A
  • Must be both Pharmacutical & Therapeutic equivant
  • Noted by a RLD rating system
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13
Q

What is the Reference Listed Drug [RLD]?

A
  • Listed drug by the FDA that is seeking approval from the ANDA
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14
Q

What is the two letter rating system that the FDA has for therapeutic equivalence?

A
  • A: ARE bioequivalant
  • B: NOT bioequivalant
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15
Q

What are Preclinical Investigations?

A
  • Seeing how good the drug is
  • IN INVITRO: not testing on living
  • IN VIVO testing on animals
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16
Q

What is a new drug application used for, and what are the components of the approval?

A
  • IND: Company applies for marketing new drug
  • Must submit to FDA and wait 30 days then they can do their clinical trials
17
Q

What is important to know about the Phase 0 or Early Phase 1 Clincial Trails?

A
  • Basically are low doses to help adjust the drug for the main test
18
Q

What is important to know about Phase 1 Clinical Trails?

A
  • REAL test in Healthy Volunteers
  • Shows MOA, Metabolism, Safety
  • <100 Patients
19
Q

What is important to know about Phase 2 Clinical Trials?

A
  • Test with diseases
  • Shows side effects, safety, risks
20
Q

What is important to know about Phase 3 Clinical Trials?

A
  • Basically the same as Phase 2, just more indepth effectiveness data
21
Q

What is a New Drug Application/

A
  • Application sent to FDA to approve for marketing
  • FDA has 6 to 10 months to approve
22
Q

What is imporant to know about Phase 4 Trials?

A
  • “Post-market Surveillance”
23
Q

How do supplemental and abbreviated new drug application differ from new drug applications?

A
  • Supplemental: Manufacturer CANNOT change anything about the drug
  • Abbreviated: Want to approve therapeutic equivance
24
Q

What are the requirements for Nonprescription drug approval?

A
  • Direct-to-Nonprescription: NDA to make it OTC
  • Prescription-to-Nonprescription: Decide what to make it; then give NDA
25
Q

What happens if the FDA does not meet the required timelinfe for approval?

A
  • Company can sue the FDA, but that could further the approval
  • Most of the time the company will just try to give the FDA more info
26
Q

What are REMS?

A
  • Risk Evalution and Mitigation Strategy
  • Manage serious risk with the drug
27
Q

Why are REMS used, who makes them, and who approves them?

A
  • FDA MAKES manufacturer make REMS
  • REMS show benefits outwieghts risks
  • FDA APPROVES REMS
28
Q

What is important to know about Patient Friendly Labeling in REMS?

A
  • Shows information about the drug or drug class
29
Q

What is important to know about Communication Plans in REMS?

A
  • Information giving To doctors about the risks
30
Q

What is important to know about Elements to Assure Safe Use in REMS?

A
  • Done before giving, dispensing, receiving meds
  • REQUIRED by doctors [labs, evals, pharmacies [Lab values], patients [Tests, Surveys]
31
Q

What is important to know about the Implementation System in REMS?

A
  • Measures quality assurance
32
Q

What are the general requirement of Advertising to Professionals?

A
  • Must have generic name, ingredents, ADRs, contraindications, effectiveness
  • CANNOT be misleading

PHRM 871: Law (19 decks)

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