Colorado Rules Flashcards
Immediate Use Compounding
a. Where low-risk compounding would add risk due to delays
b. No storage or batch compounding
c. Continuous compounding process lasting NO MORE than 1 hour
d. Administer less than 1 hour after preparation begins
e. Simple transfer or sterile non-hazardous drugs
Low-Risk Compounding
a. Using only sterile ingredients, components
b. Simple volume transfers of sterile dosage forms (Ampules, bottles, bags and vials using sterile syringes and needles)
c. Simple aseptic measuring and transferring with NOT more than 3 packages of manufactured sterile products
Low-Risk with < 12 hour BUD Compounding
a. Usually used in rural sites
b. Used in facilities that don’t need longer beyond use dating (Infusion centers, operating room pharmacies)
Medium-Risk Compounding
a. Using only sterile ingredients
b. Batch preparations
c. Complex manipulations (TPN)
d. Preparation for use over several days
e. Making or using preservative free components
High-Risk Compounding
a. Using non-sterile (bulk powders) ingredients
b. Open system transfers
c. Sterile products must be terminally sterilized (Filtered or autoclaved)
Notify the SBOP if disciplined in another state
30 days
Retain CDTM records
7 years
Maximum expiration of emergency kits
1 year
Pharmacy manager must notify SBOP of his employment termination
Immediately
After starting, new manager must take CS inventory within
72 hours
Retain initial interpretation and final evaluation records
2 years
