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USP Flashcards

(91 cards)

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1
Q

Who is the person in charge of implementing compounding procedures of USP 795, 797, 800?

A

The “designated person”

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2
Q

Does the designated person have to be a pharmacist?

A

No

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3
Q

T/F: reconstituting/mixing a drug per the manufacturer’s supplemental materials is compounding

A

FALSE: that’s just prepping the physical drug

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4
Q

What compounded drugs DO NOT need to be sterile? (4)

A

Otic (ear) preparations
Any meds in the mouth
Rectal meds
Sinus cavity/nasal preparations

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5
Q

Pharmacies are prohibited from compounding products that are commercially available; what are reasons that drugs CAN be compounded?

A

Change in dosage form
Strength not available commercially
Omit components with allergies
Add flavoring other than directed by drug package insert

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6
Q

What kind of ingredients can be used in compounding? (Like, approved by what orgs?)

A

USP approved components
National Formulary monograph components
FDA-approved drugs (as ingredients)
FDA bulk drug substances

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7
Q

T/F: drugs compounded with product NOT approved by the FDA are NOT subject to CGMP requirements

A

True (like supplements)

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8
Q

What classes of drugs/materials require special equipment dedicated specifically for the one product (ie. Mortar/pestle only for rifampin) [3]

A

Antibiotics
Cytotoxic drugs
Hazardous materials

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9
Q

USP 795 knowledge/competence check - how often?

A

Every 12 months

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10
Q

What garb is required for ALL USP 795 products?

A

Gloves

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11
Q

What garb may be reused within one shift (except for hazardous)?

A

Gown

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12
Q

How often is temperature recorded in non-hazardous compounding areas?

A

Once daily

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13
Q

What is a master formulation record?

A

Recipe for any compounded drug, must have one for each compound

Must include: name/strength/dosage form, required calculations, stability/compatibility, mixing instructions, labeling info [BUD, storage], required container

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14
Q

What is a compounding record?

A

Record of a SPECIFIC compounded product; written every time a compound is made.

Must include: name/strength/dose, Master Record referenced, component info [source, lot#, expirations], total quantity compounded, name of compounder, date of compounding, Rx#, assigned BUD, any issues reported by patient.

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15
Q

When compounding with water, ____ or _____ may be used. What water is NOT allowed?

A

Purified water
Sterile water for irrigation
(Distilled NOT allowed unless meets requirements of purified water)

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16
Q

What water activity level (Aw) is the cutoff between aqueous and non-aqueous non-sterile preparations?

A

Aw 0.6

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17
Q

Non-preservative, aqueous non-sterile product BUD (refrigerated)

A

14 days

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18
Q

Preservative, aqueous non-sterile product BUD

A

35 days

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19
Q

Oral liquid, non-aqueous non-sterile product BUD

A

90 days

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20
Q

Non-oral liquid, non-aqueous non-sterile product BUD

A

180 days

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21
Q

What are SOPs?

A

Standard Operating Procedures
Addresses training requirements of compounders, selection of components, BUD and labeling, initial and ongoing training requirements

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22
Q

Media fill is required every _______ for Category 1 and 2 compounders

A

Every 6 months

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23
Q

Media fill is required every _______ for Category 3 compounders

A

3 months

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24
Q

Media fill is required every _______ for those who have direct oversight over compounders (but not compounding)

A

Every 12 months

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25
Personnel who ONLY compound immediate-use drugs only need to demonstrate competency in ____
Aseptic technique (no need for media fill)
26
How many *initial* garbing competencies are required?
3 times in a row
27
Ongoing garbing and aseptic manipulation competency evaluations are required HOW OFTEN for **Category 1 and 2** compounders?
Every 6 months (same as media fill)
28
Ongoing garbing and aseptic manipulation competency evaluations are required HOW OFTEN for **Category 3** compounders?
Every 3 months (same as media fill)
29
Ongoing garbing and aseptic manipulation competency evaluations are required HOW OFTEN for **people who have oversight over compounders only**?
Every 12 months (same as media fill)
30
What are special considerations of Category 3 garbing?
NO exposed skin (cover face and neck) terminally sterilized low-lint outer garb Disposable garb (including gown) cannot be reused
31
T/F: non-sterile products are NEVER allowed in USP 797 compounds
False, can use non-sterile ingredients so long as terminal sterilization is done of the FINAL product
32
If a drug infusion begins before the BUD, but is scheduled to run over the BUD time should it be discarded?
No, it is okay to run through BUD as long as STARTED before BUD
33
What is the BUD of an immediate-use compound per USP 797?
4 hours
34
After initially opening a multi-dose vial, what is its BUD?
28 days (Unless specified by manufacturer)
35
What is the acceptable variability of active ingredient in a sterile compound? (Monograph available & no monograph)
*Monograph* - Acceptable range is listed in monograph No monograph - ±10% of the labeled strength
36
Immediate-use CSPs should not consist of more than ___ different sterile products
No more than 3 different sterile ingredients
37
Category 1 CSPs compounding environment requirements
Must be prepared in a PEC that may be located in an **unclassified SCA**
38
BUD of Class 1 CPS compounds (room temp and fridge?)
Room temp: ≤ 12 hours Refrigerator: ≤ 24 hours
39
Category 2 CSPs compounding environment requirements
Must be prepared in a **cleanroom suite** In a sterile hood (PEC + SEC)
40
Category 3 CSPs compounding environment requirements
Like category 2 but with extra requirements (PEC + SEC +) Need to meet additional quality assurance requirements (sterility testing, endotoxin testing when applicable) More rigorous personnel competency assessments, sterile garbing practices, and environmental monitoring
41
BUD of Class 2 CPS compounds (room temp, fridge, freezer?)
Room temp: 45 days Refrigerator: 60 days Freezer: 90 days
42
BUD of Class 3 CPS compounds (room temp, fridge, freezer?)
Room temp: 90 days Refrigerator: 120 days Freezer: 180 days *DOUBLE Category 2 BUDs*
43
Where and how often should temperature/humidity be recorded (USP 797)?
SEC and drug storage **DAILY**
44
Where and how often should *air sampling [ISO]* be recorded (Category 1 & 2)?
Classified areas (ISO 8, 7, 5) **Every 6 months**
45
Where and how often should *surface sampling* be recorded (Category 1 & 2)?
Classified areas, frequently touched areas **Every 30 days at the end of the compounding shift**
46
Where and how often should *air pressure* be recorded (USP 797)?
Between classified areas **Continuously**
47
How often should *air sampling [ISO]* be recorded (Category 3)?
**Every 3 months**
48
Where and how often should *surface sampling* be recorded (Category 3)?
**every 7 days (weekly)**
49
A Primary Engineering Control (PEC) has WHAT class ISO air? What devices are usually used in USP 797/800?
ISO class **5** air Laminar airflow workstation (LAFW) Compounding Aseptic Containment Isolator (CACI) Biological safety cabinet (BSC) Compounding Aseptic Isolator (CAI)
50
What is a CAI?
Compounding Aseptic Isolator For *sterile, non-hazardous* compounding Positive pressure ISOLATOR, so has glove attachment
51
What is a CACI?
Compounding Aseptic *Containment* Isolator For **sterile hazardous drugs** ISOLATOR, has glove attachment
52
What is a BSC?
Biological Safety Cabinets (BSCs) Designed to protect personnel and product from biohazards Has Class 1, 2, 3
53
What area has ISO 7 air? What area has ISO 8 air?
Buffer room = ISO 7 Ante room = ISO 8
54
What are requirements for compounding non-preservative topical ophthalmic CSPs?
Anitmicrobial effectiveness UNLESS… - Prepared as a Category 2 or 3 CSP - For use by a single patient - labeled that BUD is 24 hrs (room temp) or 72 hrs (fridge) once opened
55
BUD of opened multidose and single dose CSPs for compounding?
Multi-dose CSP BUD once opened: 28 days Single dose CSP BUD once opened: 12 hours
56
How often is HD training for handling/garbing/risk competency/spill management/disposal completed? (USP 800)
Every 12 months
57
T/F: If a person is of reproductive capability, they must sign that they understand the risks of handling HD products
True
58
TWO PAIRS of what PPE must be used when compounding hazardous drugs?
Two pairs of chemotherapy gloves Two pairs of shoe covers
59
What PPE should nurses wear when administering chemo/HD drugs?
Two pairs of chemotherapy gloves
60
How often should chemotherapy gloves be changed?
Every 30 mins or if torn/contaminated
61
How often should HD gowns be changed?
Every 2-3 hours or immediately after a spill
62
What kind of mask should be used in an HD room if at risk of inhaling splashes/droplets/sprays?
Surgical N95 mask (with fit test) Respirator mask with attached gas canisters Powered Air-Purifying Respirator (PPAR)
63
What must be placed in YELLOW vs BLACK waste bins? (USP 800)
Yellow = trace HD Black = Bulk HD
64
HDs must be stored in what environmental conditions?
Must be stored in an externally ventilated *negative pressure* room
65
What is the difference between cleaning, disinfecting and sporicidal agents?
Cleaning - removes *organic and inorganic contaminants* Disinfecting - destroys *microbes* Sporicidal - destroys *vegetative spores*
66
What areas of a compounding area are cleaned and disinfected DAILY?
PEC (hoods) Pass-through chamber Work surfaces outside of PEC Floors
67
What areas of a compounding area are cleaned and disinfected MONTHLY?
Walls Doors Ceilings Shelves and bins Equipment outside PEC
68
How often does sporicidal need to be used (same for all compounding areas)?
Monthly
69
What is the garbing order?
1. Hair net 2. Beard cover 3. Face mask 4. Shoe covers 5. Gown 6. Sterile gloves (HD) [7. 2nd shoe covers 8. HD gown 9. 2nd gloves]
70
What is terminal sterilization and what techniques are there?
Eliminates microorganisms REQUIRED if non-sterile ingredients were used **Techniques:** Steam (Autoclave)* Dry heat* Filtration (usually w 0.22 micron filter) * = do not use with heat sensitive drugs
71
What is pyrogen testing?
Tests for endotoxins (may cause fever/shock if given IV) REQUIRED if non-sterile ingredients were used Used to extend BUD & is required for some Category 3 CSPs
72
What is sterility testing?
Tests for viable organisms (confirms a product is NOT sterile) Used to extend BUD & is required for some Category 3 CSPs
73
Which compounding document is crucial when there is a recall??
Compounding record (can track who received recalled ingredient)
74
What is NIOSH?
Determines if drugs are hazardous Refer to list - *NIOSH List of Antineoplastics and Other Hazardous Drugs in Healthcare*
75
A drug is considered hazardous if: (per NIOSH)
Carcinogenic Teratogenic Toxic to reproduction Genotoxic Toxic to organs Similar in structure/toxicity to another HD drug
76
What is a Safety Data Sheet (SDS)?
Drug-specific safety documents created by the manufacturer - what PPE to wear, what to do in case of a spill
77
What is a Hazard Communication Plan?
Facility-specific SOP for hazardous drugs - How personnel handling HDs will be trained, where USP compliance documentation will be stored, list of HDs in the facility
78
What is an EXCEPTION to USP 800?
Assessment of Risk is conducted for lower risk formulations (ie. Tabs, capsules) SOPs require: - Distinctive shelf bins - Chemotherapy gloves - Dedicated counting tray and spatula
79
C-PECs have what kind of airflow?
Vertical (C=containment, for hazardous!)
80
How many air changes per hour are required in a C-SEC for sterile compounding?
30 air changes per hour (same as any sterile SEC)
81
How many air changes per hour are required in a C-SEC for non-sterile compounding?
12 air changes over hour (whereas not specified in non-HD non-sterile compounding)
82
How many air changes per hour are required in a C-SCA?
12 air changes per hour (same as C-SEC for non-sterile)
83
If a non-sterile HD compounding space does NOT have external ventilation, what else can be used to clear the space of hazardous particles?
A redundant HEPA filter
84
How should chemo gloves be disposed of in a CACI?
Dispose of outer chemo gloves while hands inside hood (in trace bin)
85
What are RED disposal bins for (not sharps bins)
Red = NOT for hazardous drugs For non-hazardous infectious waste (ie. Blood and body fluid)
86
When cleaning after HD compounding, what 2 extra steps are required before Cleaning & Disinfecting?
Deactivation (make HDs inert/inactive) Decontamination (removes HD residue)
87
Why should wetted wipes be used over spraying disinfectant in vertical hoods?
Wetted wipes clean the vertical hood without spraying hazardous contaminant everywhere
88
What is contained in an HD spill kit? (6)
Warning signs to put up in the area Garb Absorbent pads Decontamination solution Waste bags Hazardous drug spill report form
89
If a staff member thinks more than 2 spill kits, what should they do?
Call for outside help
90
Steps to clean an HD spill:
1. Obtain spill kit 2. Don garb 3. Remove large glass fragments 4. Absorb with spill pads 5. Decontaminate 6. Dispose of waste 7. Doff garb and wash hands 8. Complete HD spill report form
91
What steps should be taken in case of a drug exposure?
1. Immediately remove garb 2. Cleanse with soap and water 3. Flood eyes at eyewash station for ≥ 15 mins 4. Obtain medical attention 5. Document exposure

NY MPJE (4 decks)

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