Dispensing & Incompatibilities Flashcards
(265 cards)
Small scale of production
Preparation, mixing, assembling, packaging or labeling of a drug
or device
COMPOUNDING
Large scale production
Production, preparation, propagation, 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
MANUFACTURING
to refer to compounded prescriptions
PREPARATION
refer to manufactured pharmaceuticals
PRODUCTS
ne that the pharmacist is not expecting to receive nor expecting to receive again
ISOLATED PRESCRIPTION
→ 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)
ROUTINE PRESCRIPTION
one of which multiple identical units are prepared as a single
operation in anticipation of a receipt of prescription
BATCH PREPARED PRESCRIPTION
Factors to Consider in Compounding (7)
Stability
Compounding support
Training and experience of pharmacist
Equipment
Environmental/compounding facility
Formulas
Chemical supplies
extent to which a preparation retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that is possessed at the time of compounding
STABILITY
is the time and date after which the
compounded product should not be stored nor transported
beyond-use date
is the term for manufactured
products (date assigned)
Expiration date
For non-sterile compounded drug product packaged in tight,
light, resistant containers and stored at controlled room
temperature:
For non-aqueous liquids and solid formulations (manufactured drug product is the source of active
ingredient)
The beyond-use date is _____
The beyond-use date is not later than 25%
of the time remaining until the product’s expiration
date or 6 months, whichever is earlier
For product with A USP or NF substance as the
source of active ingredients → The beyond-use date is _____
The beyond-use date ≤ 6 months
For water-containing formulations (prepared from ingredients in solid form) → The beyond-use date is ____
The beyond-use date is not later than 14 days when stored at cold temp
For all other formulations → The beyond-use date is ______
The beyond-use date is not later than intended duration of therapy or 30 days, whichever is earlier unless there is a supporting valid scientific
stability information applicable to the specific prep
<795> BUD
A non-aqueous formulation (eg, a
capsule without water in it)
6 months maximum BUD
<795> BUD
An oral formulation containing water
14 days under refrigeration maximum BUD
<795> BUD
A topical containing water (eg, ointment)
30 days maximum BUD
(Usually if it contains water, it is
shorter beyond-use date because
of possible microbial contamination)
*Storage Temp
Freezer
between -25C and -10C
*Storage Temp
Cold Temp
not exceeding 8C
*Storage Temp
Refrigerator
thermostatically controlled between 2 and 8C
*Storage Temp
Cool Temp
between 8 and 15C