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NAPLEX Content > Compounding Requirements And Terminology > Flashcards

Compounding Requirements And Terminology Flashcards

1
Q

What’s the relationship btw FDA-approved and regulated drugs and NDA, GML NDC number and expiration date?

A

They must have:
An approved NDA

Must be produced under Good Manufacturing Practices (GMP)

Have NDC numbers

And carry a set of expiration date (provided by pharmacy)

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2
Q

List gen non-sterile compounding rules

A

Compounding space should be separate and away from dispensing section

Ideally, use only USP or NF chemicals from FDA-inspected manufacturers

Req logs

Info for each compounded product

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3
Q

What expiration date should be on labels of Pharmacy-Compounded pdts wrt solids (non-aqueous) preparation?

A

Up to 6-months

OR

Date that’s no later than 25% of time left on manufacturers date

Use whichever is soonest

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4
Q

What expiration date should be on labels of Pharmacy-Compounded pdts wrt aqueous preparation?

A

No more than 14 days (if stored in refrigerator)

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5
Q

If compounding a rx that calls for alcohol and the type is not specified, what should u use?

A

USP 95% ethyl alcohol

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6
Q

List the pdts that must be compounded in a sterile environment

A

Injections

Inhalations

Wound and cavity irrigation baths

Eye drops and ointments

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7
Q

What type of water should be used in sterile compounding?

A

Sterile water for injection

OR

Bacteriostatic water for injection

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8
Q

Sterile compounding req personnel trained and evaluated ANNUALLY for competency in what areas?

A

Aseptic techniques

Environmental control

Quality assurance testing

End-pdt evaluation

Sterility testing

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9
Q

What’s the req of preparing an injectable?

A

Certified sterile compounding environment must be either:

ISO class 5 (class 100) laminar air flow hood

Within ISO class 7 (class 10,000) clean room with positive pressure differential relative to adjacent areas

OR a barrier isolator that provides a ISO class 5 (class 100) environment for compounding

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10
Q

Whats req to enter the clean room - ISO class 5 (class 100)?

A

Clean room garb (low-shedding coverall, head cover, face mask and shoe covers)

Hand, finger and wrist jewelry is NOT allowed

Head and facial hair have to be out of the way (tied up) and covered

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11
Q

Should u separate the sterile and non-sterile areas?

A

Yes

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12
Q

T/F? When measuring, select a deveined equal to or slightly larger than the amount to be measured

A

True

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13
Q

What should be used if the vol to be measured is viscous?

A

Syringe

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14
Q

What are pipettes used for?

A

Liquid that 1.5mL or less of liquids

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15
Q

Which is the most commonly used mortars and pestle?

A

Wedgewood or porcelain

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16
Q

What’s Wedgewood or porcelain best for?

A

Best for reducing particle size of dry powders and crystals

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17
Q

What mortar and pestle is preferred for blending powders or pulverizing soft material? Why?

A

Porcelain

Bcuz it has a Smoother surface than wedgewood

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18
Q

What type of mortar and pestle is used for liquids and chemicals that are oily or that may stain porcelain, including many chemo agents?

A

Glass mortar & pestle

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19
Q

What’s glass mortar & pestle preferred for?

A

For mixing liquids and semi-soft dosage forms

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20
Q

What’s glassine weighing paper used for?

A

Weighing ointments and some dry chemicals

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21
Q

What type and size of spatula blades are used?

A

Large metal (stainless steel) spatula blades

Small spatula (< 6 inches) blades are used for transferring pdt from large spatula to jars

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22
Q

What’s plastic spatulas used for?

A

Used for chemicals e.g. Potassium, iodine, that can react with stainless steel blades

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23
Q

What are compounding slabs also called? Use? Xtic?

A

Compounding slabs are also called Ointment slabs

They are gen glass

And have nonabsorbent surfaces

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24
Q

What’s levigation?

A

Process of reducing the size of a particle of solid by triturating it

25
Q

What’s a wetting agent?

A

Small amt of liquid used during levigation in which the soiplid is NOT soluble

26
Q

List the levigation agents used for aqueous systems (o/w dispersions)

A

Glycerin

Propylene glycol

Polyethylene glycol 80

27
Q

List the levigation agents used for oleaginous systems (w/o dispersions)

A

Mineral oil (light & heavy)

Castor oil

Cottonseed oil

Tween 80

28
Q

What’s trituration!

A

Process of REDUCING fracturable POWDER substances into FINE PARTICLES by rubbing (or grinding) them with a mortar & pestle or on an ointment slab

29
Q

What’s extemporaneous compounding?

A

Extemporaneous compounding refers to a comp prepared WITHOUTa specific formula from an official compendium and made especially to fill the needs of a specific pt

30
Q

What’s an emollient?

A

A SINGLE agent that’s used to soften and smooth the skin.

31
Q

What’s an emulsion?

A

Emulsions are 2-phase system of 2 immiscible liquids, one of which is dispersed through the other as small droplets.

An emulsion could be oil in water or water in oil

32
Q

What’s an emulsifier?

A

Emulsifiers (or emulgent) is used to stabilize the emulsion

33
Q

Role of emulsifiers?

A

Emulsifiers are gen surfactants (used to reduce surface tension so that the 2 subst can move closer to each other)

34
Q

Do emulsions from a suspension?

A

No! They are 2 immiscible liquids

35
Q

List the most common emulsifiers

A

Lipophilic esters of sorbitan:

Arlacel

Span

36
Q

List hydrophilic esters

A

Myrj

Tween

37
Q

List other commonly used emulsifiers

A

Polyethylene glycol (PEG)

Acacia

Glyceryl monostearate

Sodium laurel sulfate

38
Q

What’s the hydrophilic-lipophilic balance (HLB) number?

A

HLB determines how much surfactant will be req to form the mixture together

39
Q

What’s the implication of a low HLB number?

A

Agents with low HLB number are more oil soluble

40
Q

What’s the implication of a high HLB number?

A

Agents with high HLB number are more water soluble

41
Q

Whats the HLB scale range? Midpoint?

A

0 - 20

10 (breakpt btw water and oil solubility)

42
Q

T/F? A medication packaged in an ointment will have a higher potency than the same med packaged in a cream or lotion?

A

True

Mometasone (Elocon) ointment is high-potency and Mometasone (Elocon) cream is low-medium potency

43
Q

What are lotions?

A

Lotions have the MOST water and are most often o/w (small amt of oil)

E.g.

Keri

Cetaphil

44
Q

What are creams?

A

Emulsions of about half oil and half water

E.g. Terbinafine (Lamisil AT) antifungal cream,
Docosanol (Abreva) antiviral cream

45
Q

What are ointments?

A

Ointments are ~ 80% oil and 20% water

46
Q

What are ointments used for?

A

Occlusive benefit - they block (trap in) moisture (preferred for dry or dry/cracked skin)

E.g. 
Mupirocin (Bactroban) ointment
NTG ointment
Aquaphor
Aquabase
47
Q

What are pastes?

A

Thickest ointments and also used as protective barriers

E.g.
Triple paste medicated diaper rash ointment

48
Q

List examples of gels

A

Benzoyl peroxide

Erythromycin topical acne gel (Benzamycin)

49
Q

Uses of gels?

A

Used as thickeners

50
Q

What are solutions?

A

Liquid preparations of soluble chemicals dissolved in solvents such as water, alcohol or propylene alcohol

51
Q

Whats a suspension?

A

2- phased of finely divided solid in liquid medium

52
Q

A suspension must be deflocculated. What does this mean?

A

This means that the repulsive forces btw particles predominate so that the particles in the suspension repel each other and remain as discrete, single particles

53
Q

Xtics of a suspension?

A

Suspensions should;

Settle quickly
Re-dispense by gentle shaking
Have uniform particles that are of small size

54
Q

What are suppositories?

A

Suppositories are solid dosage forms used to deliver medicine into rectum, vagina or urethra

55
Q

What tablet formulation is the most common dispensed in everyday practice (often the least the expensive)?

A

Compressed tablets

56
Q

What may tablets also contain?

A

Excipients (also called binders)

57
Q

What’s the concern with using lactose as a binder (excipient)?

A

May present a problem for pts with lactose- intolerance

58
Q

What should be applied to each compded pdt to determine expiry?

A

Beyond use dates

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