Ch 4: Non-Sterile Compounding Flashcards
compounding practices
exempt from FDA drug approval process and current good manu practices (CGMPs). best practices set by USP
simple compounding
reconstituting powder suspensions or solutions (may not be considered compounding in all states)
moderate compounding
calculations or procedures required to determine quantities of each dose
complex compounding
special training, env, facilities, equip and procedures required.
personnel training
personnel (staff) training for compounding must be completed and documented for the type of compounding they will perform
space/area
compounding space must be separate from rest of pharmacy. sterile compounding area must be separate from nonsterile compounding area. all areas need adequate heating, AC, and ventilation. as well as washing facilities for washing hands (hot AND cold water)
conical graduate
wider the mouth, lower the accuracy
pipettes
volumetric pipette draws up a set volume. mohr pipette is graduated to measure different volumes.
class A balance
class III torsion balance
analytical balance
electronic balance. weighs small amounts accurately.
BUD nonaqueous formulation
not later than earliest exp of ingredients or 6 mo, whichever sooner. room temp
BUD water containing PO formulation
not later than 14 days when stored at controlled cold temp. store in fridge.
BUD water containing topical/dermal and mucosal liquid and semisolid forms (cream/lotion)
not later than 30 days. store at room temp.
label of compounded products
include BUD, storage/handling info, and aux laels.
glass mortar
liquids or compounds that are oily or can stain
wedgwood motars
rougher surface than porcelain, used for grinding dry crystals and hard powders
porcelain mortars
smoother surface, preferred for blending powders and pulverizing gummy consistencies
spatulas
stainless steel and plastic used commonly. do not use steel if mixture has metallic ions. use rubber if material is corrosive.
ointment mill
draws ointment or other semi-solid preparation between rollers to homogenize the ingredients, smoothes the ointment and removes grittiness
electric mortar/pestle
homogenizer, popular brand is the unguator.
master formulation record
recipe for ingred and instructions to prepare compounded product
compounding record
log book of all products made at pharmacy, in reference to the master formula. includes components with source, lot number, expiration dates, compounder, rph, etc, BUD, rx label, description of product. ADRs reported by pt are written here.
quality assurance
steps and mx of proper standards of compounded preps. includes the SOPs (standard operating procedures), how to perform routine and expected tasks.
comminution
reduce to a smaller average particle size by trituration (grinding with mortar and pestle/other) or levigation (wetting or levigating agent helps - mineral oil if oil based or glycerin if aqueous to turn compound into paste for ointment or susp)
geometric dilution
smooth and uniform mixture making. small amt of powder mixed into equal amt of other ingred. repeat adding equal amts and mixing together until all ingred are added.
certificate of analysis
for non-FDA registered facilities to confirm specification and quality requirements.
if component without exp date
be cautious and choose date no more than 3 yrs from date of receipt of the item, label should contain the date of receipt and the chosen esp date
Mg stearate
used in powder forms as glidant/lubricant and improve the flowability of a powder
