|
Risk Level
|
Risk to Patients
|
|
1
|
low
|
|
2
|
intermediate
|
|
3
|
high
|
|
Room Temperature Storage (15-30°C)
|
Refrigerator
(2-8°C)
|
Freezer
(-20 to –10°C)
|
Risk Level Storage
|
|
completely administered <= 28 hours
|
<= 7 days
|
<= 30 days
|
1
|
|
storage and administration > 28 hours
|
> 7 days
|
> 30 days
|
2
|
Risk Level 1 – all of the following:
(1) risk level 1 storage conditions
(2) either (a) unpreserved sterile products prepared for administration to 1 patient, or (b) batch-prepared products containing suitable preservatives prepared for administration to more than 1 patient
(3) Products are prepared by closed-system aseptic transfer of sterile, nonpyrogenic finished pharmaceuticals obtained from licensed manufacturers into sterile final containers obtained from licensed manufacturers.
where:
• The final sterile container may be a syringe, minibag, or portable infusion-device cassette.
• Batch prepared products for multiple patients carry a greater risk than products prepared for a single patient since a product problem would affect a larger number of patients.
Risk Level 2:
(1) risk level 2 storage conditions
(2) Batch-prepared products without preservatives that are intended for use by more than 1 patient.
(3) Products compounded by combining multiple sterile ingredients obtained from licensed manufacturers in sterile reservoir obtained from a licensed manufacturer, by using closed-system aseptic transfer before subdivision into multiple units to be dispensed to patient.
Risk Level 3 - one of the following:
(1) Products are compounded from nonsterile ingredients.
(2) Products are compounded using nonsterile components, containers or equipment.
(3) Products prepared by combining multiple ingredients (may be sterile or nonsterile) using an open resevoir or open-system transfer before terminal sterilization or division into multiple units to be dispensed.
