Law Exam 1 - Lecture 8 (Inspections, Generic Equivalency) Flashcards

1
Q

part of USP that is considered to have the force of law

A

drug monographs, not following them leaves a drug adulterated or misbranded

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

part of USP that is not considered to have the force of law

A

information on appropriate means for drug preparation and drug storage

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

USP 795 covers what

A

nonsterile compounding

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

USP 797 covers what

A

sterile compounding

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

USP 800 covers what

A

hazardous drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

USP 795 - nonsterile compounding covers what

A

quality and safety
BUDs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

USP 797 - sterile compounding covers what

A

numerous sterile compounding requirements, including personnel, training, facilities, environmental monitoring, and storage and testing of finished products

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

USP 800 - hazardous substances covers what

A

handling of hazardous materials in healthcare setting

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

hazardous means what 6 things

A

carcinogenic
teratogenic
reproductive tox.
organ tox. at low doses
genotox.
new drugs that mimic existing hazardous drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

expiration date definition

A

last date when the product will meet the requirements of the USP monograph for strength or stability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

BUDs definition

A

date after which a product should not be used. Cannot be later than an expiration date.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

exemptions to repackaging guidelines (4)

A
  1. a prescription drug on the drug shortage list
  2. a drug product repackaged under direct supervision of a licensed pharmacist
  3. if repackaged by a pharmacy, only distributed upon receipt of a valid prescription for an individual patient
  4. repackaged product is assigned a BUD as described in the repackaging guidance
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

BUD for non aqueous formulation

A

no more than 6 months or the expiration date, whichever is sooner

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

BUD for water containing oral formulations

A

no more than 14 days or the expiration date, whichever is sooner

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

BUD for water containing topical, mucosal, and semisolid formulations

A

no more than 30 days or the product expiration date, whichever is sooner

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

2 types of inspections

A

routine
triggered by suspicion or formal complaint

17
Q

who can do inspections

A

FDA, DEA, State board of pharmacy

18
Q

FDA inspectors must show what 2 things to request entry into a pharmacy for an inspection

A

their credentials
notice of inspections

19
Q

When requesting inspection, a DEA inspector must: (3)

A
  1. state the purpose of their inspection
  2. show their credentials
  3. provide written notice of inspection to the pharmacy owner or pharmacist in charge
20
Q

DEA notice of inspection (NOI) lists out what 5 rights?

A
  1. right to require the DEA to get an administrative inspection warrant (AIW)
  2. the right to refuse an inspection (at which point they will acquire a AIW)
  3. anything incriminating found can be seized and used against you in prosecution
  4. you will get a copy of the NOI
  5. you may withdraw your consent to inspection at any time
21
Q

what is the bar for AIW?

A

provided for anything considered a valid public interest (low bar)

22
Q

what is the bar for search warrants?

A

a reasonable person would believe that a crime has been or will be committed (higher bar)

23
Q

_____ can only be served during regular business hours, _____ can be served anytime

A

AIW, search warrants

24
Q

can you deny a Board of Pharmacy (BoP) inspection?

A

no, they can inspect without a warrant

25
Q

the _____ _____ provides info on equivalency ratings

A

orange book

26
Q

the _____ _____ provides info on interchangeable biological product information

A

purple book

27
Q

pharmaceutical equivalence includes what 5 things?

A

active ingredient
dosage form
strength
route
labeling

28
Q

bio-equivalence includes what 2 things?

A

in vivo (human) results
in vitro (lab) results

29
Q

first letter of TE indicates what

A

the relevant therpeutic equivalence code

30
Q

second letter of TE indicates what

A

dosage form

31
Q

drugs with a 3 character codes are considered therapeutically equivalent only to other drugs with what

A

the same 3 letter code

32
Q

TE code A means

A

therapeutically equivalent, no concerns with TE or biological equivalence

33
Q

TE code B means

A

Not therapeutically equivalent