Dispensing Part 1

Question 1

Preparation, mixing, assembling, packaging, or labeling of a
drug or device
* Result of a practitioner’s prescription drug order or initiative
based on pharmacist/patient/prescriber relationship in the
course of professional practice or the purpose of, as in incident
to research, teaching or chemical analysis and not for sale
dispensing

Answer 1

COMPOUNDING

Question 2

the art or practice of preparing & preserving the drugs. Important role of RPh (ASIDE DISPENSING):
compounding of drugs prescribed by the physician

Answer 2

PHARMACY

Question 3

preparation of parenteral

Answer 3

STERILE COMPOUDING

Question 4

the process of compounding when the meds in Rx is not available

Answer 4

extemporaneous compounding

Question 5

extemporaneous compounding

Answer 5

EXTEMPORANEOUS COMPOUNDING

Question 6

Production, preparation, propagation (can be more
than thousands depending on the manufacturing
order), conversion or processing of a drug or device,
either directly or indirectly, by extraction from
substances of natural origin or independently by
means of chemical or biological synthesis, and
includes any packaging or repackaging of the
substance(s) or labeling or relabeling of its container,
and the promotion and marketing of such drugs or
devices

Answer 6

MANUFACTURING

Question 7

purpose of manufacturing

Answer 7

SELLING the final product

Question 8

FUNDAMENTAL DIF BETWEEN COMPOUNDING &
MANUFACTURING:

Answer 8

pharmacist/prescriber/patient relationship

Question 9

USP uses the term __________ to refer to
compounded prescriptions

Answer 9

preparation

Question 10

USP uses the term __________ to refer to
manufactured pharmaceuticals

Answer 10

products

Question 11

a prescription with two or more components,
requiring compounding or mixing the components

Answer 11

COMPOUNDED PRESCRIPTION

Question 12

one that the pharmacist is
not expecting to receive nor expecting to receive
again (ONE TIME PREPARATION ONLY)

Answer 12

Isolated prescription

Question 13

one that the pharmacist
may expect to receive in the future on a routine
basis, and there may be some benefit to products
quality to standardize preparations like this
(preparation protocols on file) → REPEATING
ORDER/HAVE PATTERN

Answer 13

Routine prescription

Question 14

one of which multiple identical units are prepared as a single operation in anticipation of a receipt of
prescription

Answer 14

Batch prepared prescription

Question 15

FACTORS TO CONSIDER IN COMPOUNDING

Answer 15

• Stability
• Compounding support
• Training & experience of pharmacist → skillrelated examination like in the States to know
  the incompatibilities in mixing, & practices in
  compounding
• Environmental/compounding facility
• Equipments
• Formulas
• Chemical supplies

Question 16

the time and date after
which the compounded product should not be
stored nor transported (not usable anymore)

Answer 16

beyond-use-date

Question 17

beyond-use date for non-aqueous liquids and solids formulation e.g. tablets (manufactured drug
product/commercially drug product is the
source of the active ingredients)

Answer 17

not later than 25% of the time remaining
until the product expiration date or 6 months,
whichever is earlier

Question 18

beyond-use date for product with the a USP or NF substance (coming from scratch not from commercially
produced products)

Answer 18

lesser than or equal to 6 months

Question 19

BUD for non-aqueous formation e.g. capsule w/o
water in it

Answer 19

6 months max

Question 20

BUD for oral formulation with water e.g. suspension

Answer 20

(14 days under refrigeration
max)

Question 21

BUD for topical containing water e.g. ointment

Answer 21

(30 days max)

Question 22

Freezer between

Answer 22

(-) 25 degrees C & (-) 10 degrees C

Question 23

Cold temperature:

Answer 23

not exceeding 8 degrees C

Question 24

o Refrigerator:

Answer 24

thermostatically controlled
between 2 degrees C & 8 degrees C

Question 25

o Cool temperature:

Answer 25

between 8 degrees C & 15 degrees C

Question 26

o Controlled room temperature:

Answer 26

thermostatically
controlled between 20 degrees C & 25 degrees
C with allowed excursions between 15 to 30
degrees C

Question 27

Equipment surfaces that come in contact with
ingredients or compounded preparations should
not be ________,_______, and _________

Answer 27

reactive, additive, or sorptive

Question 28

equipment for aseptic compounding of
sterile solutions (low particulate matter → so there
are areas like clean room before entering to
control/limit the no. of particulate matter)

Answer 28

Laminar flow hood

Question 29

Equipment to maintain temperatures as
specified in the USP; used in storage

Answer 29

refrigerator

Question 30

an instrument for determining the
relative weights of substances (weighing balances in
manufacturing are more enormous as to compare
with compounding balances e.g. analytical balances

Answer 30

BALANCEs

Question 31

ALL BALANCES MUST HAVE A CERTAIN
_______________THAT CAN BE TOLERATED
TO PRESCRIPTION, COMPOUNDING, & in the
PHARMACEUTICAL MANUF

Answer 31

DEGREE OF ERROR

Question 32

Maximum amount of error accdg. to USP on a single weighing
operation

Answer 32

5%

Question 33

_____________ of the balance represent the
absolute error in using that balance

Answer 33

SR (sensitivity requirement)