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NYS MPJE 2024 > Compounding: USP 797 > Flashcards

Compounding: USP 797 Flashcards

1
Q

Compounding facilities: 503A facilities- what do they do?

A

Traditional compounding

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2
Q

What do 503A facilities do?

A

Pharmacies perform the compounding pursuant to a script and are allowed to compound items when there’s a shortage of a commercially available drugs

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3
Q

Compounding facilities: 503B facilities- what do they do?

A

Outsourcing facilites

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4
Q

What do 503B facilities do?

A

Allows compounders to manufacture products without a script

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5
Q

What do 503B facilities have to follow?

A

GMPs as prescribed by the FDA and have to volunteer to inspections by the FDA

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6
Q

Examples of preparations that are CSPs

A

Infusions
Injections
Aqueous preparations for pulmonary inhalations
Irrigation for internal body categories
Anything that goes into the eye
Implants
Baths and soaks for live organs

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7
Q

Do USP 797 standards apply to manufacturing?

A

No

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8
Q

Do USP standards apply to preparing sterile products following a manufacturer’s approved labeling?

A

No, this is only for a single patient and won’t be stored

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9
Q

Immediate use CSP: is it considered compounding?

A

No

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10
Q

How are immediate use CSPs prepared?

A

Using the manufacturer’s labeling instructions

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11
Q

Who can use an immediate use CSP? (Who is it for?)

A

A single patient

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12
Q

When to administer an immediate use CSP

A

Within 4 hours of making it

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13
Q

Can hazardous drugs be made as immediate use products?

A

No

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14
Q

Do personnel need to use aseptic technique when making an immediate use compound?

A

YES, they need to be trained and demonstrate competency

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15
Q

Who needs to comply with 797?

A

All pharmacies that perform sterile compounding

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16
Q

Nursing home compliance with 797: who is preparing the CSPs?

A

The pharmacy (duhhhhh)

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17
Q

If products are made according to the manufacturer’s approved label, does it need to follow USP standards?

A

No. It needs to be for a single patient, can’t be stored for future use, and limited to nonhazardous drugs

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18
Q

What does prepackaging and repackaging fall under?

A

USP 797

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19
Q

Why does prepacking and repackaging fall under 797?

A

It involves sterility and stability

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20
Q

USP 797 products need assessments of what?

A

Change of container and closure

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21
Q

Responsibilities of the designated person overseeing USP 797 compounding

A

Developing and implementing policies and procedures
Establishing a training program
Overseeing compliance
Selecting components
Ensuring environmental controls for compounding and storing products

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22
Q

Does a designated person have to be a pharmacist?

A

No, but it’s most likely going to be one. Some states may select a tech and some practices may not have a pharmacist to serve in this role

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23
Q

Can one person be the designated person for multiple sites?

A

Yes

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24
Q

Where does a designated person receive their training?

A

Via ASHP with didactic and hands-on experience; they have certificate programs in sterile compounding

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25
Q

Activities a designated person must do: USP 797

A

Compliance with 797, applicable federal and state laws and regulations, accreditation statements

Oversight of personnel training, competency documentation, and monitoring

Oversight of facility use and monitoring

Establish SOPs

Develop master formulation records

Monitor BUDs

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26
Q

Personnel competency requirements for USP 797: what should they be trained in?

A

Organizational policies and procedures
Use of garb
Use of equipment
Selection of components
Spill management

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27
Q

Personnel competency requirements: what should happen BEFORE they can compound?

A

They have to show competency and it has to be documented

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28
Q

Personnel competency requirements: how do personnel requalify?

A

Showing competency in garbing and gloved fingertip testing
Media fill and post medial fill gloved fingertip testing
Surface sampling

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29
Q

How often do personnel have to requalify in competency if they’re compounding Category 1 and 2 CSPs? (797)

A

q6 months

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30
Q

How often do personnel have to requalify in competency if they’re compounding Category 3 CSPs? (797)

A

q3 months

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31
Q

How often do personnel who oversee 797 compounding but don’t directly compound have to recertify? (Also includes designated person)

A

Once a year

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32
Q

Requirements for a Category 1 CSP (4 things)

A

ISO 5 PEC
Unclassified SCA
Sterile ingredients
No additional testing

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33
Q

Requirements for a Category 2 CSP (3 things)

A

Cleanroom suite
Sterile or nonsterile ingredients
Aseptic processing

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34
Q

Requirements for a Category 3 CSP (3 things)

A

Cleanroom suite
Sterile or nonsterile ingredients
Additional garbing, cleaning, etc. requirements

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35
Q

Initial testing for personnel, designated person, and personnel with direct oversight of compounders: what do they have to do?

A

Pass these 3 times sequentially:

Media fill test
Gloved fingertip and thumb test
Have to complete hand hygiene and full garbing procedure after each attempt

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36
Q

Key competency areas for personnel

A

Hand hygiene
Garbing
Knowledge of compounding technique
Proper movement of materials
Cleaning and disinfecting
Calculations
Measuring and mixing
Aseptic technique
Achieving and maintaining sterility
Proper use of equipment
Documentation

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37
Q

Gloved fingertip and thumb test: initial training

A

Must be done and passed 3 times before beginning to compound- if one is failed, you have to start over and perform 3 again

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38
Q

Purpose of the gloved fingertip and thumb test

A

Involves checking to ensure personnel maintain aseptic technique during the process

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39
Q

When is the gloved fingertip and thumb test done?

A

After handwashing and garbing

40
Q

What is used for the gloved fingertip and thumb test?

A

Agar plates, they get incubated after the test

41
Q

When is the media fill test done?

A

After sterile compounding

42
Q

What’s tested in a media fill test?

A

Aseptic technique, sterility of the environment, transfer of components, equipment handling

43
Q

What’s used in a media fill test?

A

Triptic soy broth (TSB), and then it’s incubated for 14 days

44
Q

Passing the fingertip test

A

No growth from both hands (no CFUs)

45
Q

Passing the media fill test

A

The TSB is clear, no turbidity

46
Q

Definitions: PEC

A

Primary engineering control, aka the IV hood

47
Q

Definitions: SEC

A

Secondary engineering control, aka the room the hood is in

48
Q

Examples of SECs

A

Buffer room, anteroom, SCAs

49
Q

ISOs

A

International organization for standardization, classifies the air cleanliness for cleanrooms

50
Q

ISO for a PEC

A

ISO 5 or lower

51
Q

ISO for a buffer room

A

ISO 7 or lower

52
Q

What kind of pressure has to be in the anteroom?

A

Positive pressure, to reduce contamination

53
Q

ISO for an anteroom if it opens up to a negative pressure room

A

ISO 7

54
Q

ISO for an anteroom if it opens up to a positive pressure room

A

ISO 8 or lower

55
Q

ACPH for an anteroom that opens up ONLY into a positive pressure buffer room

A

20

56
Q

ACPH for an anteroom that opens into ANY negative buffer room

A

30

57
Q

ACPH for a positive pressure buffer room

A

30

58
Q

ACPH for a negative pressure buffer room

A

30

59
Q

Up to 15 ACPH can come from where?

A

A PEC that’s vented back into the room

60
Q

Generally speaking, do you want to use the same area to compound nonhazardous and hazardous drugs?

A

No, there needs to be separate areas for compounding each product

61
Q

Environmental testing for Category 1 and 2 compounds: air sampling should be done how often?

A

Every 6 months

62
Q

Environmental testing for Category 1 and 2 compounds: surface sampling should be done how often?

A

Every month

63
Q

Environmental testing for Category 3 compounds: air sampling should be done how often?

A

Monthly

64
Q

Environmental testing for Category 3 compounds: surface sampling should be done how often?

A

Weekly

65
Q

Expiration date definition

A

Official date of expiry set by the manufacturer of a product

66
Q

BUD definition

A

Day of expiry set by the compounder for drug preparation

67
Q

In-use time definition

A

Timeframe from when a product or preparation is punctured or opened until the point it can no longer be used

68
Q

Infusion time definition

A

Time a product or preparation is being administered to a patient

69
Q

BUD dating for Category 1 CSPs: at room temp

A

≤12 hours

70
Q

BUD dating for Category 1 CSPs: in the fridge

A

≤24 hours

71
Q

BUD for Category 2 CSPs: NOT aseptically processed and prepared with at least one non-sterile component at ROOM TEMP

A

1 day

72
Q

BUD for Category 2 CSPs: NOT aseptically processed and prepared with at least one non-sterile component in THE FRIDGE

A

4 days

73
Q

BUD for Category 2 CSPs: NOT aseptically processed and prepared with at least one non-sterile component in THE FREEZER

A

45 days

74
Q

BUD for Category 2 CSPs: NOT aseptically processed and prepared with ONLY STERILE components at ROOM TEMP

A

4 days

75
Q

BUD for Category 2 CSPs: NOT aseptically processed and prepared with ONLY STERILE components in THE FRIDGE

A

10 days

76
Q

BUD for Category 2 CSPs: NOT aseptically processed and prepared with ONLY STERILE components in THE FREEZER

A

45 days

77
Q

BUD for Category 2 CSPs: ASEPTICALLY processed at ROOM TEMP

A

30 days

78
Q

BUD for Category 2 CSPs: ASEPTICALLY PROCESSED in THE FRIDGE

A

45 days

79
Q

BUD for Category 2 CSPs: ASEPTICALLY PROCESSED in THE FREEZER

A

60 days

80
Q

BUD for Category 2 CSPs: NOT TERMINALLY STERILIZED at ROOM TEMP

A

14 days

81
Q

BUD for Category 2 CSPs: NOT TERMINALLY STERILIZED in THE FRIDGE

A

28 days

82
Q

BUD for Category 2 CSPs: NOT TERMINALLY STERILIZED in THE FREEZER

A

45 days

83
Q

BUD for Category 2 CSPs: TERMINALLY STERILIZED at ROOM TEMP

A

45 days

84
Q

BUD for Category 2 CSPs: TERMINALLY STERILIZED in THE FRIDGE

A

60 days

85
Q

BUD for Category 2 CSPs: TERMINALLY STERILIZED in THE FREEZER

A

90 days

86
Q

BUD for Category 3 CSPs: aseptically prepared, sterility tested, and passed all required tests AT ROOM TEMP

A

60 days

87
Q

BUD for Category 3 CSPs: aseptically prepared, sterility tested, and passed all required tests IN THE FRIDGE

A

90 days

88
Q

BUD for Category 3 CSPs: aseptically prepared, sterility tested, and passed all required tests IN THE FREEZER

A

120 days

89
Q

BUD for Category 3 CSPs: terminally sterilized, sterility tested, passed all required tests IN ROOM TEMP

A

90 days

90
Q

BUD for Category 3 CSPs: terminally sterilized, sterility tested, passed all required tests IN THE FRIDGE

A

120 days

91
Q

BUD for Category 3 CSPs: terminally sterilized, sterility tested, passed all required tests IN THE FREEZER

A

180 days

92
Q

BUD for a single-dose container OUTSIDE of an ISO 5 environment

A

1 hour from the time of puncture or opening

93
Q

BUD for a single-dose container INSIDE of an ISO 5 environment

A

Up to 6 hours from the time of puncture or opening

94
Q

BUD for a single-dose container (specifically an AMPULE) inside OR outside of an ISO 5 environment

A

Any leftover contents have to be discarded and can’t be stored

95
Q

BUD for a multi-dose container inside OR outside of an ISO 5 environment

A

Up to 28 days from the time of puncture or opening unless otherwise stated by the manufacturer

NYS MPJE 2024 (27 decks)

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