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Compounding Flashcards

1
Q

Which compounded meds are FDA-approved?

A

none dumbass it’s compounded

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2
Q

What is the USP and who enforces them?

A

nongovermental and non profit org

state boards of pharmacy and FDA

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3
Q

BUD:

Aqueous oral
Aqueous topical with no perservative
Aqueous topical with preservative
Non-aqeuous topical
Solid forms

A
  1. 14 days fridge
  2. 14 days fridge
  3. 35d room temp/fridge
  4. 90day room temp/fridge
  5. 180 days room temp/fridge
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4
Q

When to clean non-sterile areas:

Work surfaces
Floors
Walls
Storage shelves

A
  1. Beginning and end of each shit, after spills, and in between compounds if using different ingredients
  2. Daily and after spills
  3. Every 3 months
  4. Every 3 months
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5
Q

How long to keep non-sterile compounding records?

A

3 years

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6
Q

What is considered..

  1. Cold temp
  2. Controlled room temp
A
  1. <8C or 46.2F
  2. 20-25C or 68-77F
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7
Q

What should you never mix with a stainless steel spatula?

A

iodine products

use plastic instead

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8
Q

Definitions

  1. Tituration
  2. Levigation
  3. Fusion
A
  1. Grinding to a dry fine powder
  2. “wet grinding”
  3. Mixing in their melting state
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9
Q

What are two examples of wetting agents and why is it used?

A

alcohol and glycerin

To displace air from particles

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10
Q

What are some aqueous and oily levigating agents?

A

Aqueous: water, glycerin, propylene glycol, PEG 400, purified water

Oily- mineral/caster/cottonseed oil

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11
Q

What are suspending agents used for and what are some examples?

A

To thicken agents and help insoluble solids ot become evenly dispersed

Natural- acacia, alginic acid, xanthan gum, gelatin, tragacanth

Semisythetic - methycellulose

Synthetic - polaxamers (pluronic)

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12
Q

What are diluents used for?

A

AKA fillers are inactive substances

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13
Q

What are 4 soluble diluents?

A

Lactose
sucrose
mannitol
sorbitol

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14
Q

What are 5 insoluble diluents?

A

Starch
cellulose
microcrystalline cellulose
calcium phosphase
magensium stearate

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15
Q

What are emulsyfying agents used for and how to scale it?

A

They are both soluble in oil and water to help them mix

Lower hydrophile-lipophile balance (HLB) = more oil soluble = <10

High HLB = more water soluble = >10

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16
Q

What is the smallest and largest cap size?

What are they made of?

A

000 = LARGEST

5 = smallest

Made of gelatin

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17
Q

How to mix with methycellulose?

A

Initially mix with hot water

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18
Q

What are some major preservatives for compounding?

A

Benzoic acid (anything “benz)

Sorbic acid (anything acid)

Methylparaben (anything “parabens)

Thiomerosal

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19
Q

What is ora-blend made of?

A

Suspending agent and vehicle

1:1 of ora plus (suspending agent) +ora sweet (vehicle)

20
Q

What is ISO?

What are the requirements for sterile preparations?

A

Number of particles in air

The lower the number, the less particle in the air

Hood = ISO 5
Buffer room = ISO 7
Ante room = ISO 8

21
Q

How often does your good need to be on? And how often is it certfied?

A

It should be on continuously or at least 30 minutes prior to compounding

Certified every 6 months

22
Q

What does HEPA stand form? How does it work?

A

High efficiency partical air filter

airflow is unidirectional horizontally or vertically

23
Q

What are three PEC devices?

A

Laminar benches (horizontal flow)

Biological safety cabinets (vertical flow)

Compounding aseptic isolators (non-haz) or CACI (hazardous)

24
Q

What is the recommended temperature for the buffer area?

A

20C or 68F

25
What are the 4 risk levels of CSP's?
1. Immediate use 2. Category 1 3. Category 2 4. Cateogry 3
26
How soon must immediate use CSP's be used? What are the limitations? What is the ISO requirement?
4 hours No more than three different sterile products ISO class 5 is NOT required
27
How are category 1 CSP's made? What is the ISO requirement?
Prepared in PEC that is in ISO 5 but not required to be placed in an ISO 7 room
28
What constitutes as a category 2 CSP?
multi-dose CSP's and require a clean room environment
29
What is a category 3 CSP? What are the requirements?
Used for longer BUD's Must undergo sterility and endotoxin testing
30
What is USP 71? USP 85?
USP 71 = sterility testing USP 85 = endotoxin testing
31
What is the BUD of a single dose CSP vial?
12 hours
32
How often must compounding personal: 1. Complete written or electronic testing 2. Gloved fingertip 3. Media fill test 4. Visually obserbed
1. 12 months 2. 6 months 3. 6 months 4. 6 months
33
How is a media fill test conducted?
Incubated for 7 days in tryptic soy broth at 20-25C Then for 7 days at 30-35C
34
How are glove-fingertip tests performed?
3 sets of fingertip tests inside ISO 5 PEC on agar plates Incubate at 30-35C for 2 days then at 20-25C for at least 5 more days
35
What is the bubble test?
Use to ensure the integrity of filters for sterilizing compounded solutions
36
When would you need two pairs of gloves when compounding?
Chemo drugs
37
Do otic solutions need to be sterile?
fuck no
38
What is the maximum BUD if multi-dose vials?
28 days after first puncture
39
Waste containers: What goes in them? 1. Red 2. Blue 3. Yellow 4. Black
1. Sharps - needles, blood products, glass vials 2. Non-bio-hazardous - IV bags (empty or not), tablets, large glass vials , CONTROLLED substances 3. Trace Chemo - and anything involved in making the chemo (masks, gloves, empty syringes, zip lock bags, etc) even the diapers that chemo patients wear bro 4. Hazardous - BULK CHEMO , warfarin, nicotine products, heavy metal agents
40
What are three medications that need to be flushed down the toilet?
Duragesic patches Daytrana patches Diastat rectal gel
41
Definition 1. Efflorescent 2. Deliquescent
1. Contains water which can be released when powder is manipulated 2. Like hygroscopic powder but it can absorb so much water from the air that it becomes water like a selfish little hoe
42
What is the formula for HLB?
HLB = ( (amount of surfactant x it's HLB ) + (amount of other surfactants x it's HLB )) / total surfactant amount
43
What are 5 classes of ointment bases and what are some examples?
1. Oleaginous /hydrocarbon - greasy/occlusive - white petrolatum 2. Absorption - Slightly hydrophillic / occlusive - Aquaphor 3. Water in oil - Hydrophillic - Lanolin, eucerin, rose water 4. Oil in water - Washable / nonocclusive - dermabase 5. Water soluble - Washable / nonocclusive- PEG ointment
44
What are 3 examples of binders ?
Hypromellose Povidone StarchWh
45
What is an example of a gildant? Why is it used?
Added to powder to improve flowability Colloidal silicon dioxide
46

NAPLEX (42 decks)

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