Study Notes
Nonsterile Pharmaceutical Compounding
Chapter Outline
The Need for Compounding
Key Terms
compounding
sterile compounding
nonsterile compounding
Study Questions
Why is there a need for
compounding? There is still a
need for a prescribed med made
from a bulk product for a
specific medical disease,
product is not commercially
available
Sterile Compounding
Where is most sterile
compounding performed?
Sterile is aseptic for parenteral
or ophthalmic preparations
performed in the “clean room
environment” CSPcompounded sterile
preparations
Nonsterile Compounding
Where does most nonsterile
compounding occur?
Pharmacy area
Solutions
Gives examples of when
nonsterile compounding might
be required. Smaller dose than
commercially available, topical
formulation when oral had
adverse effect, customization
• Define solution- liquid
dosage form
Suspensions
, solvent- dissolved in a solution,
and solute- Active ingredient.
• What is the difference
between a solution and a
suspension? Suspension
– active ingredient not
dissolved but dispersed
Ointments and Creams
What is the purpose of a
suspending agent? Prevents
settling
Distinguish between ointmentswater/oil, creams-oil/water
Page 1 of 6
Chapter Outline
Powders
Key Terms
Suppositories
Capsules
Bio-Identical Hormones
Laws, Regulations, and
Standards for Compounding
hormone replacement therapy
(HRT)
estrogen replacement therapy
(ERT)
good compounding practices
(GCP)
anticipatory compounding
USP Chapter 795
manufactured products
compounded preparations
Product Inventory
Material Safety Data Sheet
(MSDS)
Beyond-Use Dating
beyond-use dating
stability
Accreditation of Compounding
Pharmacies
Pharmacy Compounding
Accrediting Board (PCAB)
continuous quality improvement
(CQI)
Certification of Pharmacy
Technicians
Study Questions
Why are powders no longer
dispensed in bulk forminaccurate dosing
How do pharmacists describe
powders? Finely divided
combination, or a mixture, of
drugs and or chemicals ranging
in size from extremely fine to
very coarse
How are suppositories prepared?
Melting base material, adding
active ingredient and pouring
the resultant liquid into a mold
What are reasons for
compounding capsules?
Unusual doses maybe less of an
active ingredient
What is the advantage of
compounded bio-identical
hormones? Cream, it is safer
than the oral medication
Who or what regulates
compounding pharmacies?
USP, FDA Modernization Act of
1997
What is USP Chapter 795?
US Pharmacopeia, the develop
standards for CGMP
How do pharmacists in a
compounding pharmacy assure
the quality of the ingredients
they use? USP
How is beyond-use dating
calculated? Aqueous solutions
14-30 days; solids 6months or
less
Under what circumstances might
the beyond-use dating be
extended? Depends on the
stability- extent to which a
product retains the same
properties and characteristics
possessed at the time of
preparation
Why do compounding pharmacies
seek accreditation?
Marketing/reimbursement
What requirements must a
pharmacy technician meet in
order to work in a compounding
pharmacy? Additional
training/certification
Page 2 of 6
Chapter Outline
Documentation of Nonsterile
Compounding
Key Terms
The Master Control Record
master control record
The Compounding Log
compounding log
prescription record
Calculations in the Compounding
Pharmacy
Equipment for Weighing,
Measuring, and
Compounding
Weights and Balances
Pharmaceutical Weights
Class III prescription balance
counterbalance
weighing paper
digital electronic analytical
balance
pharmaceutical weights
Forceps and Spatulas
forceps
spatula
Compounding Slab
compounding slab
Mortar and Pestle
mortar and pestle
Study Questions
What must be documented in a
compounding pharmacy?
Master Control Recordformula/recipe for the drug
How is a master control record
like a recipe used in cooking?
Record and prepare quality
preparation for a legal
prescription
How is a compounding log like a
master control record? How is it
different? MCR is about drug
only, CL has info on drug and
the patient
Describe procedures for C-II
compounds.
Give an example of how a
technician uses calculations in a
compounding practice.
Which type of balance is required
equipment in every pharmacy?
Counterbalance
Describe a typical weight set. 1-2
pans, polished brass metric and
apothecary weights
Why is it important to use forceps
to pick up weights? Medicine
cant be touched with bare skin
because moisture /oil affect
their accuracy
How are spatulas used in the
pharmacy? Transfer solid
pharmaceutical ingredients to
and from weighing pans
What can be used in place of a
compounding or ointment slab?
Special disposable
nonabsorbent parchment paper
What are different types of mortar
and pestle and how is each
used? Electric-used in high
volume compounding; glass/
porcelain - triturating or
pulverizing;
Page 3 of 6
Chapter Outline
Graduate Cylinders, Pipettes, and
Beakers
Key Terms
graduate cylinder
pipette
Other Equipment
Describe equipment used to make
tablets and capsules.
Convection oven, autoclave,
balance, graduated cylinders,
pipettes, mortar, pestle, beakers,
flasks, slabs, molds
Technique for Weighing,
Measuring, and
Compounding
Attire and Preparation
Requirements
What are minimum attire
standards for nonsterile
compounding? Lab coat;
gloves; and hairnet
Technique for Weighing
Pharmaceutical Ingredients
Calculating Percentage of Error
percentage of error
Technique for Measuring Liquid
Volumes
meniscus
Techniques for Mixing
Compounded Drugs
Comminution and Blending
Study Questions
How do conical-wide tops narrow
base and cylindrical- uniform
column graduates differ in
appearance?
comminution
blending
trituration
levigation
pulverization
spatulation
sifting
tumbling
Which type of balance is preferred
in the compounding pharmacy?
Why is using a Class III balance
more difficult?
How is percentage of error
calculated? Amount of
error/quantity desired x 100 =
% of error ( range should be
less than 5%)
What is a general rule of thumb
for selecting a container for
volumetric measurement?
Always select the device that
yields the most accurate volume
How does the technician know
which technique to use for
mixing compounded drugs?
Master control record or the
pharmacist
When performing trituration what
technique produces the best
results? Minimal pressure rotate
pestle rapidly
When mixing solids and liquids,
how can you make the solid
dissolve more quickly and
uniformly? Gently heating the
liquid to reduce particle size
What is a levigating agent? Castor
oil; glycerin, mineral oil
Page 4 of 6
Chapter Outline
Compounding Ointments and
Creams
Key Terms
Compounding Powders
diluent powder
Filling Capsules
punch method
Geometric Dilution Method
geometric dilution method
Why is it important to follow the
USP Chapter 795 steps in
compounding prescriptions?
What is the appropriate container
for each of these products:
tablets and capsules-ambercolored prescription vials,
ointments and creams-white
ointment jar, suppositoriescardboard box?
The Compounding Process
Selecting Medication Containers
Labeling and Cleanup
Final Check by the Pharmacist
Patient Counseling by the
Pharmacist
Study Questions
When compounding ointments
and creams, how can you
achieve a smooth end product?
Use a spatula press against slab
to provide a shearing force
How are oral solid pediatric doses
prepared? Pulverize, or triturate
tablet mix resultant powder
with diluent and use that
powder to fill capsule
What are three ways to fill
capsules? Punch method;
capsule machine, hand fill
What is the procedure for
combining drugs using the
geometric dilution method? Use
mortar/pestle to gradually
combine several drugs and
inactive ingredients
pharmaceutical elegance
What information should be on
the medication container label?
Ingredients and amounts;
beyond use date; lot number
and date of compounding
What is correct cleanup procedure
for ingredients containing
hazardous chemicals? Discard
in sealed bag then place in bio
bag; verified and signed off by
pharmacist; outside vendor
takes and discards
What does the final check by the
pharmacist include? Final
product; master control and
calculations
What information should the
pharmacist communicate to the
patient? Individually prepared
and compounded and make sure
they understand information
Page 5 of 6
Chapter Outline
Reimbursement
Key Terms
Study Questions
Why is the number of specialized
compounding pharmacies
growing? More need for
specialized meds
Page 6 of 6