BCSCP - MFR AND CRS QUESTIONS
& ANSWERS(RATED A+)
What are the 4 main reasons for compounding documentation - ANSWER1.
*Communication* (be able to tell story of a CSP just from looking at compounding doc) -
include environmental samplingd ata, inventory/billing docs, staff signature/initial logs
2. Accountability - who did which steps
3. Regulatory requirements
4. Quality Improvement
All CSPs are required by USP797 to have a ___ - ANSWERCompounding Record
can be in paper or electronic format as long as they are reproducible after the fact
(record remains after CSP is administered)
Create for batches for more than one patient or any CSP made from nonsterile
ingredients - ANSWERMFR
More complex of the two - ANSWERMFR
The major cause of harm to patients is
_______________________________________________ - ANSWERvariation in how
procedures are carried out
An ____ is a detailed record of all the steps to make a particular CSP, similar to a recipe
in cooking - ANSWERMFR
MFRs are recommended for all CSPs.... but USP requires them for which 2 types of
CSPs? - ANSWER1. Those created in a batch for more than one patient
2. Any CSP prepared from nonsterile ingredients
What are the required 11 elements of an MFR? - ANSWERName/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
& ANSWERS(RATED A+)
What are the 4 main reasons for compounding documentation - ANSWER1.
*Communication* (be able to tell story of a CSP just from looking at compounding doc) -
include environmental samplingd ata, inventory/billing docs, staff signature/initial logs
2. Accountability - who did which steps
3. Regulatory requirements
4. Quality Improvement
All CSPs are required by USP797 to have a ___ - ANSWERCompounding Record
can be in paper or electronic format as long as they are reproducible after the fact
(record remains after CSP is administered)
Create for batches for more than one patient or any CSP made from nonsterile
ingredients - ANSWERMFR
More complex of the two - ANSWERMFR
The major cause of harm to patients is
_______________________________________________ - ANSWERvariation in how
procedures are carried out
An ____ is a detailed record of all the steps to make a particular CSP, similar to a recipe
in cooking - ANSWERMFR
MFRs are recommended for all CSPs.... but USP requires them for which 2 types of
CSPs? - ANSWER1. Those created in a batch for more than one patient
2. Any CSP prepared from nonsterile ingredients
What are the required 11 elements of an MFR? - ANSWERName/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
