Practice Questions and Answers with Complete A+
Solutions 100% Correct!!!
What are the required 11 elements of an MFR? - Correct Answer -Name/strength of the medication
Dosage Form
Date it was prepared "Release date"
Internal ID
Ingredients + Quantity (include vendor, lot #)
Equipment/container close systems
Compounding instructions
BUD and storage
Reference source for BUD and storage
Quality Control Procedure
Physical description of final CSP
What may serve as a compounding record? - Correct Answer -A prescription or medication order or label
may serve as the compounding record
What are the 10 required elements of a CR? - Correct Answer -1. name, strength, and dose of the CSP
2. Date AND time the CSP was prepared
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, 3. Internal identification number (order #)
4. All individuals involved in the compounding process must be identified
5. The name of each component of the CR
6. The weights and volumes of each component
--- 5 and 6 may require an ancillary compounding log... think of reconning a vial.. this isnt on the label
7. Strength and activity of each component
8. "Total quantity compounded" - number of units compounded
9. BUD and storage conditions
10. Results of QC procedures - the most common being visual inspection... don't always have to be on the
label itself
What form of QC is required for all compounds? - Correct Answer -visual inspection
What are 4 additional elements that must be include when a CR is derived from an MFR? - Correct Answer
-1. A reference to the MFR the CR was made from
2. Calculations to derive quantities or concentrations
3. Results of QC procedures and additional QC procedures which might include results from bacterial
endotoxin testing, sterility testing, and autoclave methodology
4. information on the vendor, lot#, and expiration date of each ingredient
An ancillary compound log may include what kind of info? - Correct Answer -number of units compounded
amount and type of each component
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