USP 797 QUESTIONS WITH ANSWERS RATED A+
Medium Risk Quality Assurance Procedures - -more stringent media fill
-bare hand and nonsterile gloves with only initial disinfection w/70% IPA
High Risk CSPs - CSPs prepared from non-sterile ingredients or with non-sterile devices.
Prepared with sterile ingreidents, but exposed to poorer air quality than ISO Class 5 for >1 hr.
Storage Requirements for High Risk CSPs - Controlled Room Temp: 24 hours max
Cold Temp: 3 days max
Solid Frozen State: 45 days max
High Risk Examples - -nonsterile bulk and nutrient powders that will be sterilized (morphine,
glutamine)
-sterile ingredients in nonsterile containers
-bladder irrigations made from bulk powder
-with low and medium risk, start out sterile and maintain sterility
-with high risk a nonsterile component needs to be made sterile
High risk quality assurance procedure - -semi-annual media fill testing
-sterilization procedures must be validated
-sterility tests for autoclaved CSPs are not required unless prepared in batches of more than 25
units
Immediate Use CSPs - -patient bedside
-ambulance
-ER
-combat zone
-code
-exempt from all 797 requirements
-only simple aseptic manipulations
-NMT 3 sterile non-hazardous drugs
-no chemotherapy
-NMT 2 entries in one container
-no delays/interruptions
-no contact contamination
-dose must be labeled if not administered by the preparer
-administration must begin within 1 hour of the start of preparation
-dose must be discarded if administration has not begun within 1 hour after the start of
preparation
Reqs for Low Risk Level CSPs with 12 hour BUD - -Low risk, non-hazardous, prepared in ISO
class 5 without ISO class 7 buffer area.
-pursuant to a physician order for a specific patient
, -administration must commence within 12 hours of preparation or as recommended by the
manufacturer (whichever is less)
-primary engineering control must be in a segregated compunding area
-all personnel cleansing and garbing procedures apply
-no hazardous drugs
Beyond Use Dating - -BUD
-microbiologic as well as chemical data
-valid scientific data
-differs from the expiration date which applies to manufactured drug products
ISO Class 5 - Classification of particulate matter: ISO 5 = Class 100 (100/ft^3 or 3520/m^3).
Limits are in particles of 0.5 microns or greater.
Preparation of Operators - Didactic review, written test of skills. Media fill testing (annually for
low & medium risk, 2x year for high risk). Demonstrate proficiency of proper
hygiene/garbing/cleaning procedures (eg: Glove fingertip sampling).
Media-Fill Test Procedure - Performed annually by each person authorized to compound in a
low-risk level environment. Soybean-casein Digest Medium (TSB or TSA), media transferred
via sterile syringe into clear vials, incubated at 20-35 degrees for at least 14 days.
ASHP - American Society of Health-System Pharmacists
ASHP recommendations in the 80's and 90s - -issued practice recommendations in an effort to
provide a professional mandate and practice assistance to pharmacists and technicians who
compounded sterile preparations
-did not impact practice (cost and perceived lack of value)
Revised USP 797 - -effective June 1, 2008
-30 month revision
-MINIMUM practice and quality standards for compounding sterile preparations of drugs and
nutrients based on current scientific information and best sterile compounding practices
Sterile Compounding Requires - -cleaner facilities
-specific personnel training and testing in aseptic technique
-sterility tests
-air quality standards
-knowledge of solutions sterilization and stability
Main Sections of 797 - -intro
-definitions
-immediate-use category
-low-risk level with 12-hr or less BUD
-single and multiple dose containers
-proprietary vial/bag systems
Medium Risk Quality Assurance Procedures - -more stringent media fill
-bare hand and nonsterile gloves with only initial disinfection w/70% IPA
High Risk CSPs - CSPs prepared from non-sterile ingredients or with non-sterile devices.
Prepared with sterile ingreidents, but exposed to poorer air quality than ISO Class 5 for >1 hr.
Storage Requirements for High Risk CSPs - Controlled Room Temp: 24 hours max
Cold Temp: 3 days max
Solid Frozen State: 45 days max
High Risk Examples - -nonsterile bulk and nutrient powders that will be sterilized (morphine,
glutamine)
-sterile ingredients in nonsterile containers
-bladder irrigations made from bulk powder
-with low and medium risk, start out sterile and maintain sterility
-with high risk a nonsterile component needs to be made sterile
High risk quality assurance procedure - -semi-annual media fill testing
-sterilization procedures must be validated
-sterility tests for autoclaved CSPs are not required unless prepared in batches of more than 25
units
Immediate Use CSPs - -patient bedside
-ambulance
-ER
-combat zone
-code
-exempt from all 797 requirements
-only simple aseptic manipulations
-NMT 3 sterile non-hazardous drugs
-no chemotherapy
-NMT 2 entries in one container
-no delays/interruptions
-no contact contamination
-dose must be labeled if not administered by the preparer
-administration must begin within 1 hour of the start of preparation
-dose must be discarded if administration has not begun within 1 hour after the start of
preparation
Reqs for Low Risk Level CSPs with 12 hour BUD - -Low risk, non-hazardous, prepared in ISO
class 5 without ISO class 7 buffer area.
-pursuant to a physician order for a specific patient
, -administration must commence within 12 hours of preparation or as recommended by the
manufacturer (whichever is less)
-primary engineering control must be in a segregated compunding area
-all personnel cleansing and garbing procedures apply
-no hazardous drugs
Beyond Use Dating - -BUD
-microbiologic as well as chemical data
-valid scientific data
-differs from the expiration date which applies to manufactured drug products
ISO Class 5 - Classification of particulate matter: ISO 5 = Class 100 (100/ft^3 or 3520/m^3).
Limits are in particles of 0.5 microns or greater.
Preparation of Operators - Didactic review, written test of skills. Media fill testing (annually for
low & medium risk, 2x year for high risk). Demonstrate proficiency of proper
hygiene/garbing/cleaning procedures (eg: Glove fingertip sampling).
Media-Fill Test Procedure - Performed annually by each person authorized to compound in a
low-risk level environment. Soybean-casein Digest Medium (TSB or TSA), media transferred
via sterile syringe into clear vials, incubated at 20-35 degrees for at least 14 days.
ASHP - American Society of Health-System Pharmacists
ASHP recommendations in the 80's and 90s - -issued practice recommendations in an effort to
provide a professional mandate and practice assistance to pharmacists and technicians who
compounded sterile preparations
-did not impact practice (cost and perceived lack of value)
Revised USP 797 - -effective June 1, 2008
-30 month revision
-MINIMUM practice and quality standards for compounding sterile preparations of drugs and
nutrients based on current scientific information and best sterile compounding practices
Sterile Compounding Requires - -cleaner facilities
-specific personnel training and testing in aseptic technique
-sterility tests
-air quality standards
-knowledge of solutions sterilization and stability
Main Sections of 797 - -intro
-definitions
-immediate-use category
-low-risk level with 12-hr or less BUD
-single and multiple dose containers
-proprietary vial/bag systems
