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VA MPJE Prep > Compounding > Flashcards

Compounding Flashcards

1
Q

Compounds you cannot make:

A

-drug removed from market by FDA because component unsafe
-large amounts of drug that are copies of commercial products (but can be for individual patient if there is change to it slightly or if product temp unavail)
-large amounts of drug in cases where there is no historical pattern (would constitute as manufacturing)

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2
Q

A pharmacy must have a person designated to be responsible for implementation of compounding procedures (non-sterile, sterile, or hazardous). True or false

A

True-could be the same person for all 3 if necessary; does not have to be a pharmacist

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3
Q

Opthalmic and inhalation suspensions do not need to be sterile. True or false

A

False!

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4
Q

Hazardous drug compounding can be sterile or non sterile. True or false

A

True

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5
Q

Compounded drugs are subject to GMP?

A

No-they are not FDA approved drugs

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6
Q

Non-sterile compounding frequency of competency?

A

Initially and then every 12 months

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7
Q

What garb is required for non-sterile compounding?

A

Gloves. Change or wipe gloves when starting new procedure. Gowns not required but can be reused

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8
Q

For non sterile products-how often does temp need to be monitored?

A

Daily

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9
Q

Does non sterile compounding require its own room?

A

No-should have its own designated area.

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10
Q

What is required before something is compounded for the first time?

A

Master Formulation record; then a compounding record must be completed each time it occurs

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11
Q

What must be included in a master formulation?

A

-name/strength/dosage form
-calculations needed
-compatibility/stability
-mixing
-sample labeling with BUD guidance
-container for dispensing

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12
Q

Every non sterile compound requires a label saying what

A

“This is a compounded preparation”

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13
Q

What must be included in a master record?

A

name/strength/dosage
MFR used
info of components (source/lot/exp)
total quantity prepared
name of person who prepared
name of person with quality control
date of prep
Rx number
BUD

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14
Q

Who often do you need to undergo media fill tests for category 1 and 2 preparations?

A

every 6 months

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15
Q

Who often do you need to undergo media fill/garbing tests for category 3 preparations?

A

every 3 months

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16
Q

What must be applied to gloves before sterile compounding?

A

70% IPA

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17
Q

What circumstances may be gown be reworn in sterile compounding?

A

-gown maintained in classified area to prevent contamination
-class 1 and 2 compounding
remember everything else must be discarded

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18
Q

Category 3 compounding garb rules”

A

-no exposed skin; face or neck must be covered
-all low lint outer garb must be sterile
-disposable garb can’t be reused

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19
Q

A drug infusion can finish after BUD date. True or false

A

True-it must just be started before BUD date

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20
Q

When must a single use container be used in ISO5 air?

A

12 hours

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21
Q

How long is BUD for multi dose vial?

A

28 days

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22
Q

Category 1 CSP

A

-can be prepped in unclassified segregated compounding area
-BUD </= 12 hrs room temp and </= 24 hours refrigerated

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23
Q

Immediate use CSPs are exempt from garbing and ISO5 as long as:

A

-no more than 3 different sterile products
-administration is within 4 hours of start of prep
-cannot be stored/prepped in advance

24
Q

Category 2 CSP

A

-must be in a cleanroom suite
-BUD >12 hrs room temp and >24 hrs refrigerated

25
Q

Category 3

A

-BUDs up to 180 days

26
Q

ISO Class air in ante room?

A

7/8

27
Q

ISO Class air in hood?

A

5

28
Q

How often must Primary Engineering Control (Hood?) be cleaned?

A

-beginning of each shift
-before each batch
-not longer than every 30 minutes when compounding is ongoing
-floors and countertops: daily
-walls/ceilings/storage: monthly

29
Q

Master formulation records must be created for any CSP prepared for more than 1 patient. True or false.

A

True

30
Q

What is limit for field units for CSP sterility testing (??)

A

250 final yield units

31
Q

How quickly must single dose vial be used?

A

12 hrs

32
Q

Hazardous PPE expectations

A

-cannot reuse disposable PPE
-gowns, head, hair, shoe covers, and two pairs of chemo gloves required for preparation and administration

33
Q

How often must chemotherapy gloves be changed?

A

every 30 minutes

34
Q

How often must HD gowns be changed?

A

-every 2 to 3 hours or immediately after splash

35
Q

2nd pair of shoe covers must be donned before entering HD areas. True or false

A

True

36
Q

What type of mask needed for HD prep?

A

N95

37
Q

Sterile and nonsterile HD can be stored together. True or false

A

true-but HD used for nonsterile compounding should not be stored in areas designated for sterile compounding to minimize traffic to that area

38
Q

Pharmacy can compound drugs w/o Rx if its an anticipation of typical Rx. What is required for documentation?

A

-name/strength vs list of active ingredients
-pharmacy assigned control number
-BUD
-quantity

39
Q

Who must obtain outsourcing license?

A

-Sterile compounding of drugs to be dispensed without a prescription
-reminder: must have PIC
-records are for 5 years

40
Q

What is required for 795 training?

A

-every 12 months competency
-understand 795
-understand/interpret safety data sheets
-understand procedures related to compounding duties

41
Q

How often does NSCP vent need to be recertified?

A

Every 12 months

42
Q

How often must NSCP be sanitized and cleaned?

A

-sanitized: daily and if compounding not performed daily, before initiating compounding
-cleaning: beginning and end of each shift

43
Q

How often does biosafety cabinet need to cleaned/sanitized for NSCP?

A

-beginning of each shift when compounding occurs, after spills, surface contamination
-between compounds w different components
-under the work surface monthly

44
Q

What must be done if CSP is not going to be dispensed on the day that it was prepared?

A

A visual inspection must be done prior to dispensing to make sure no precipitation
**This excludes dispensing to Pyxis (by law this is the same as dispensing to patient, RN should inspect)

45
Q

When can distilled water be used for compounding ?

A

-non sterile
-rinsing equipment
-IF the water meets the requirement of purified water you can use it to compound

46
Q

When making hazardous drugs when do gown and outer pair of shoe covers need to be removed?

A

Doffing area PRIOR to leaving negative pressure room

47
Q

When making hazardous drugs when must gloves be removed?

A

Inside the C-PEC. All other items besides gown and shoe covers can be removed in anteroom

48
Q

How soon must water containing CSPs that are nonsterile during any phase of compounding procedure be sterilized?

A

within 6 hours after completing the preparation in order to minimize the generation of bacterial endotoxins.

49
Q

Manufacturers must comply with 797. True or false

A

False-they must comply with CGMP

50
Q

A master formulation record is required for repackaging conventionally manufactured components. True or false

A

True-MFR is required if you are making CSP for more than 1 patient or for CSPs that are prepped from nonsterile ingredients

51
Q

Pharmacists can distribute compounded drug products for subsequent distribution/sale to other persons or commercial entities. True or false?

A

False-this can only happen to vets (vet cannot dispense more than 7 day supply)
-another scenario is if there is a critical need/emergency condition (remember bc this is not in context of patient/prescriber relationship)

52
Q

Pharmacists may compound without RX to vet. True or false

A

True-limit to drugs necessary to treat an emergent condition

53
Q

When must you have individual hazardous drug equipment?

A

Mortars and pestles, anything disposable, equipment that comes in direct contact with HD.

Anything that doesn’t come in direct contact can be multipurpose but must be deactivated/decontaminated

54
Q

Who is not required to do media fill tests with CSP?

A

People who only do immediate use CSP

55
Q

When do you NOT need to test nonpreservative topical opthalmic CSP for anti microbial effectiveness ?

A

-prepped as cat 2 or 3
-for single patient use
-must be discarded within 24 hr of opening room temp or 72 hr room temp

56
Q

Does pharmacist need to recheck compounded product visual inspection if in ‘pick up area’?

A

No-not if only awaiting pick up or delivery

VA MPJE Prep (10 decks)

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