Compounding pt 1 Flashcards
True or false: If a prescription you receive is for a commercially available product, or it was withdrawn from the market for safety reasons, it should not be made.
True
True or false: Compounding is exempt from the FDA’s drug approval process and Current Good Manufacturing Practices (CGMPs)
True
What is simple compounding?
Involves reconstituting (manipulating) a commercial product by adding one or more ingredients such as water or alcohol as directed by the manufacutrer
What is moderate compounding?
Requires calculations or procedures to determine the quantities of components for each dose
What is complex compounding?
Requires special training, environment, facilities, equipment, and procedures
When measuring, select a device that has a measuring capacity equal to or slightly _______ than the amount in order to get the most accurate measurement
Larger
Where do you read the meniscus for liquid measurements?
At the bottom of the meniscus at the center
How do conical graduates differ from graduated cylinders?
Graduated cylinders have the same diameter throughout, and are more accurate
Conical graduates are wider at the top. The wider the “mouth”, the lower the measuring accuracy
Syringes are most accurate for measuring…
small volumes, and also useful for measuring viscous liquids
Difference between a Mohr pipette and a volumetric pipette?
Volumetric pipette draws up a set volume only
Mohr pipette, or a graduated pipette, can draw up small (different) volumes
Types of balances
Electronic balance (or analytical balance) - simple to use, higher sensitivity, can weigh small amounts accurately
class III torsion balance (or class A balance) use internal weights. They have a sensitivity requirement of 6 mg, which means 6 mg can be added or removed before the dial moves 1 division
Types of mortar and pestles
Compounding pharmacy needs at least one glass and one Wedgewood or porcelain mortar and pestle
Glass = liquids, such as suspensions or solutions, or for mixing compounds that are oily or can stain
Wedgewood = rougher surface, so they’re preferred for grinding dry crystals and hard powders
Porcelain = smoother surface, preferred for blending powders and pulverizing gummy consistencies
When would you not use a steel spatula?
When making a mixture containing metallic ions
What material do you mix ointments on?
Compounding (or ointment) slabs
or
disposable parchment ointment pads, if the water content of the mixture will not cause the paper to tear
What is a homogenizer?
Electric mortar and pestle
Can be used to mix ointments, creams, or other semi solid preparations
Like a smoothie blender
What is an ointment mill
Machine that draws ointment or other semi solid preparation between rollers that grind and homogenize the ingredients
What records must each compounded preparation have?
Master formulation record and compounding record
Master formulation record = recipe, with ingredients and instructions
Compounding record = info about all of the ingredients used in the preparation including source, lot number, expiration dates, BUD, description of preparation, etc and is kept in a compounding log
What is a QA plan? And what must it include?
Quality assurance plan
Standard operating procedures (SOPs), which are itemized steps on how to perform routine and expected tasks in the pharmacy
Should include periodic testing of the finished compounded preparations, such as confirming weight and consistency. Can do them in-house or outsource.
What should the pharmacist do if an ADR is reported from a compounded preparation?
Record it in the compounding record
Comminution
Reduce solids from an average particle size to a smaller average particle size b crushing, grinding, or a similar process
Includes both trituration and levigation
Trituration
Grinding powder into smaller, finer particles
Levigation
Trituration adding a wetting agent (or “levigating” agent)
Turns a solid into a smooth uniform paste
Glycerin is what kind of excipient
Levigating agent
Also used in lozenges as a base for chewable lozenges
Where should ingredients come from, ideally? And if they don’t come from here, what should be done to ensure quality requirements?
FDA-registered facility
If it comes from a non-FDA registered facility, a Certificate of Analysis (CoA) should be obtained to confirm the specification and quality requirements
