Chapter 3: Non-sterile Compounding

Question 1

What organization regulates pharmaceutical compounding?

Answer 1

State boards of pharmacy

Question 2

How is compounding different than manufacturing?

Answer 2

Compounding is a medication made specifically for an individual patient; not regulated by the FDA, and no NDC number

Question 3

Which USP guidelines dictate beyond use dates for non-sterile compounded products?

Answer 3

USP 795

USP 797 is for sterile preparations

Question 4

Explain “outsourcing” compounding?

Answer 4

Outsourcing compounding is when an exceptional circumstance (i.e. drug shortage) requires bulk products to be made by a compounding pharmacist (when it would normally be done by a manufacturer). The compounding pharmacist must use a CGMP lab, product labeled with a batch control number, and expiration date.

Question 5

Define simple compounding.

Answer 5

Simple compounding is something like reconsituting an amoxicillin suspension or adding benzoyl peroxide to clindamycin to make benzamycin gel

Question 6

Define moderate compounding.

Answer 6

Requires calculations for final product + no data on stability of final product

Question 7

Define complex compounding.

Answer 7

Complex compounding requires special training and special environment

Question 8

Typically, ingredients for non-sterile compounding come from FDA-registered facilities that follow USP 795. What document must be obtained if ingredients come from a non-FDA-registered facility?

Answer 8

Certificate of Analysis

Question 9

T/F:

Compounding facilities must be separate from other pharmacy activities?

Answer 9

True

Question 10

How often must personnel’s non-sterile compounding skills (verbal and functional) be reviewed?

Answer 10

At least annually

Question 11

Which record is the “recipe” for the compounded product, Compounding Record or Master Formulation Record?

Answer 11

Master Formulation Record is the “recipe” with mixing instructions, calculations/doses, etc.

Compounding Record is the log book of what products have been made

Question 12

What sensitivity (ex mg) must a class III torsion balance (class A balance) have?

Answer 12

6mg

Although the class III torsion balance is rarely utilized, they are required according to USP 795 for all compounding facilities

Question 13

What measuring device yields the most accurate way of measuring liquid?

Answer 13

graduate cylinder (cylindrical graduate)

Question 14

Compounding requires two different mortar and pestles: 1 glass and 1 wedgwood (or porcelain or ceramic). Which one is preferred for mixing liquids and semi-soft dosage forms and which one is best for reducing particle size of dry powders and crystals?

Answer 14

Glass mortar and pestle is best for mixing liquids

Wedgwood is best for reducing particle size of dry powders

Question 15

Generally stainless steel spatulas are used for compounding. What type of spatula should be used for chemicals such as potassium or iodine?

Answer 15

Plastic spatulas since these chemicals can react with stainless steel spatulas

Question 16

If a compound does not specify what type of alcohol to be used for the preparation, what type should be assumed?

Answer 16

USP 95% ethyl alcohol

Remember, 70% isopropyl alcohol is used for cleaning

Question 17

What is the margin of error as far as contained product (i.e. +/- %) according the the USP monograph?

Answer 17

The USP monographs require that the product must contain +/-10% of the labeled content

Question 18

Rank of the following waters from least pure to most pure:

purified water, sterile water for injection, sink water

Answer 18

1. Sink water
2. Purified water
3. Sterile water for injection

Question 19

Ruminant animal components can contain BLANK, which cause severe muscle-wasting disease

Answer 19

prions

Question 20

This process reduces particle size of a solid by triturating in a mortar with a small amount of liquid

Answer 20

levigation

Question 21

Which of the following levigating agents should be used with an oleaginous system (w/o)? (Select all that apply)

A. Glycerin
B. Mineral oil
C. Tween 80
D. Castor oil
E. Polyethylene glycol 80

Answer 21

A. Glycerin NO (used for aqueous system (o/w)
B. Mineral oil YES
C. Tween 80 YES
D. Castor oil YES
E. Polyethylene glycol 80 NO (used for aqueous system (o/w)

Question 22

What is the name of the mixture with two or more components that melt at a temperature lower than the melting temperature for the individual components

Answer 22

Eutectic mixture

Question 23

What is the role of glycerol and sorbitol in capsules?

Answer 23

glycerol and sorbitol are used as plasticizers to soften the capsule

Question 24

Which capsule size is larger: 5 or 000

Answer 24

5 is the smallest capsule size, while 000 is the largest

Question 25

Which tablet ingredient that can act as a sweetener, plasticizer, or thickening agent (in liquids), can cause considerable GI distress due to its laxative properties?

Answer 25

Sorbitol

Question 26

Describe a suspension

Answer 26

A solid in a liquid medium; a two-phased system

Question 27

T/F:

A suspension should be deflocculated?

Answer 27

True. What is deflocculated?

This means that the repulsive forces between particles predominate so that the particles in a suspension repel each other and remain as discreet, single particles.

Question 28

What drug formulation would use an emulsifier?

Answer 28

Suspensions contain suspending agents or emulsifiers which can originate from plant (pectin) or animal (lanolin) products

Question 29

Which of the following are common emulsifying agents? (Select all that apply)

A. Gelatin
B. Tween
C. PEG
D. Sodium  laurel sulfate
E. Span

Answer 29

A. Gelatin NO
B. Tween YES
C. PEG YES
D. Sodium laurel sulfate YES
E. Span YES

Question 30

Define an emulsion?

Answer 30

An emulsion is comprised of two immiscible liquids that typically require an emulsifying agent (i.e. surfactant) to reduce the surface tension to stabilize it

Question 31

Explain the “Continental” or dry gum method

Answer 31

This is a method of preparing an emulsion using oil purified water and gum in a specific ratio

Question 32

Explain the “English” or wet gum method

Answer 32

This is essentially the same thing as the dry gum method (preparing an emulsion) and it uses the same ingredients, except the order that they’re combined is different

Question 33

The HLB scale ranges from 0-20. Interpret a surfactant with an HLB of 2?

Answer 33

This means the surfactant is very oil-soluble and would be good for an w/o emulsion.

HYdrophilc = HIGH number (o/w)
Lipophilic - LOW number (w/o)

Question 34

What is the beyond use date for water-containing oral formulations?

Answer 34

14 days when stored at controlled cold temperatures

Question 35

What is the beyond use date for water-containing topical/dermal and mucosal liquid and semisolid formulations?

Answer 35

30 days

Question 36

What is the beyond use date for non-aqueous formulations?

Answer 36

6 months OR not later than the time remaining until the earliest expiration date of any API, whichever is earlier

Question 37

T/F:

A statement that the product has been compounded by the pharmacy must be placed on the label of the container

Answer 37

True

Question 38

What expiration date should you assign a component that arrived at your facility without an expiration date written?

Answer 38

No more than 3 years from date of receipt