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Compounding Exam 1 > Lecture 4 - USP chapters > Flashcards

Lecture 4 - USP chapters Flashcards

1
Q

true or false

USP is a governmental, not for profit public health organization

A

false - non government

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2
Q

the USP provides drug standards that are enforced by….

A

the FDA under the FDCA act

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3
Q

what organization provides the reference standards for tests and methods to measure quality assurance, among other things

A

USP

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4
Q

*** explain the general trend of USP chapter numbers

A

the ones numbered UNDER 1000 are required and enforceable

the ones greater than 1000 are informational and not required. they work in concert with the mandatory chapters - describe the theory and analytical considerations

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5
Q

true or false

USP800 - hazardous drugs - is mandatory

A

true - under 1000

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6
Q

USP chapters that are numbered greater than 2000 are what?

A

specific for DIETARY SUPPLEMENTS

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7
Q

how is the USP involved in compounding

A

they have compounded preparation MONOGRAPHS

contains formulations and quality assurance standards. helps practicioners to compound formulations where there is NO SUITABLE COMMERCIAL PRODUCT

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8
Q

name 3 specific patient populations that may require compounding

A

pediatrics
geriatrics
veterinary (pets)

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9
Q

** USP 71

A

sterility testing of products

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10
Q

which USP chapter contains packaging and storage requirements***

A

USP 659

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11
Q

nonsterile/sterile/hazardous USP chapters

A

nonsterile - USP 795
sterile - USP 797
hazardous - USP 800

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12
Q

true or false

the sterility test USP chapter is required and enforceable

A

TRUE

its ch 71 – below 1000

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13
Q

which USP chapter is QUALITY ASSURANCE in pharmaceutical compounding***

IS IT REQUIRED

A

USP1163

NO

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14
Q

Which 2 USP chapters are about containers and container-performance testing

A

USP661 and 671

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15
Q

true or false

USP chapters numbered greater than 1000 are considered informational

A

true

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16
Q

what USP chapter is good compounding practices

A

USP 1075

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17
Q

what USP chapter is pharmaceutical calculations in pharmacy practice

A

1160

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18
Q

what USP chapter is prescription balances and volumetric apparatus used in compounding

A

1176

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19
Q

what USP chapter is determining the BUD of compounded preparation and/or use stability info

A

1191

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20
Q

when is it possible that the BUD may be longer than the standard 14, 35, 90, and 180 days rules??

A

if sterility tests are done according to USP 71 and they’re all passed – BUD may be longer

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21
Q

what is CNSP and what USP chapter provides standards for it

A

USP 795 provides standard for COMPOUNDING NONTERILE PREPARATIONS

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22
Q

USP 795 describes the requirements for quality controls for nonsterile preparations

give an example of this

A

labeled potency must be within 10% (above or below)

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23
Q

**** name the 3 general categories of non-sterile compounding

A

simple, moderate, and complex

24
Q

differentiate between simple, moderate, and complex compounding**

A

simple - reconstituting or manipulating a commercial product. may require adding 1 or more ingredients - AS DIRECTED BY THE MANUFACTURER

moderate - preparation requires special calc or procedures to determine the qty of components needed. OR making a preparation in which the stability data for the specific formulation is NOT AVAILABLE

complex - requires SPECIAL TRAINING, environment, facilities, equipment, or procedures

25
Q

preparing hormone vaginal suppositories is considered what category of compounding and why

A

COMPLEX

need special facility and ingredients

26
Q

is preparing capsules simple, moderate, or complex compounding***

A

COMPLEX - need special training and equipment

27
Q

**compounding an oral suspension with water

what water do we use?

A

purified — nonsterile compounding

28
Q

an example of moderate compounding is if stability data for that formulation is not available

what must be done?

A

contact the manufacturer for stability info or run own stability tests

may need to be conservative with assigning BUD

29
Q

*oral antibiotic comes as a powder and we have to add water

what kind of compounding

A

simple

30
Q

*oral antibiotic has been reconstituted with water and the patient wants you to add FLAVOR

what kind of compounding is this

A

still simple

31
Q

*preparing an ointment and stability info is missing. what kind of compounding is this

A

moderate

32
Q
  • all ingredients in compounding should be purchased from where?
A

A RELIABLE SOURCE - for both active and inactive ingredients

33
Q

*who is allowed in the vicinity of compounding operations

A

ONLY authorized personnel

34
Q

*the processes used in compounding must be carried out how?

A

exactly as specified, so much so that they can be replicated and reproduced without an issue

35
Q

*all aspects of compounding procedures must be ____ in ____

A

documented in the compounding record

36
Q

***what is the written record before/after the compounding is done

A

before - master formulation record

after - compounding record

37
Q

TRUE OR FALSE

there should only be ONE preparation compounded at a time

A

TRUE

38
Q

what is “compendial quality” and is it required****

A

USP/NF grade ingredients

these must be tried to obtain 1st

HOWEVER, if not possible - can use:
-chemically pure
-analytical reagent grade
-ACS certified (american chemical society)
HOWEVER - caution should be used in these cases bc impurities may have side effects

39
Q

name 3 sources in which ingredients can be obtained when it’s not possible to get compendial quality

A

chemically pure
analytical reagent grade
american chemical society (ACS) certfied

40
Q
  1. USP/NF grade

3.

A
    • LAB GRADE
  2. Technical or commercial grade
41
Q

differentiate between if something as “USP” at the end or “NF” at the end

A

both are compendial grade

USP is for active ingredients and NF is for inactive

42
Q

**CONTAINERS WITH NO EXPIRATION DATE

how must the compounder label the container?

A

must put date of receipt (when pt received) and assign an expiration themselves, no later than 3 years after the date of receipt

the date chose must be based on 4 things

-nature of component
-degradation mechanism
-container
-storage conditions

43
Q

containers WITH expiration dates can be used before that expiration date when…

A

material stays in original container under conditions to avoid chemical dedcomposition

minimal exposure of the material when some is withdrawn

44
Q

true or false

it is okay to put something back into the container after taking it out

A

false

it is now contaminated and should be discarded

45
Q

aqueous solution has preservative, but 1 excipient expires in 20 days

what should BUD be

A

20 days

46
Q

which compounding documentation must include sources, lot numbers, and expiration dates of the components

A

the compounding record

47
Q

which compounding documentation must include a description of all the ingredients and their quantities

A

master formulation record

48
Q

results of quality control procedures must go in what compounding documentation??

give 2 examples of quality control procedures*******

A

compounding record

weight range of filled capsules
pH of aqueous liquids

49
Q

a drug adhered to the bottle it was dispensed in when compounding

what must be done

A

document it in compounding record and recall the product. this is going to be an underdose since drug is sticking to the container and not being delivered

50
Q

***what USP chapter is involved with quality control

A

USP1163

51
Q

true or false

under USP 1163, the compounder must have written procedures to describe the tests performed on the compounded preparation to ensure its integrity

A

TRUE — involved with USP 1163 which is QUALITY CONTROL**

52
Q

Aside from quality control tests to ensure the integrity of the compounded product, name another important quality control aspect of USP1163

A

determining when recalls must be initiated

if a recall must be done - need to notify prescriber and identify the patients who have received the CNSP (compounded nonsterile preparation), dispose of it, and DOCUMENT

53
Q

quality control of CNSP’s are a combination of what 2 USPs

A

USP 795 and USP 1163

54
Q

name some patient counseling considerations when dispensing a compounded preparation

A

they must be told how to use, store, and dispose of it

also be instructed to let pharmacist know of any adverse events or changes in the compound’s physical appearance

55
Q
A

Compounding Exam 1 (9 decks)

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