USP 797 Questions and Answers | Updated
True
True/False
USP 797 standards apply to human and
animal drug compounding
Which of the following drug manipulations ANY manipulation of a drug to make a STERILE
is/are not considered sterile compounding medication is considered compounding
-Combining
-Reconstituting Clearly smoking crack is not considered sterile
-Admixing medication compounding
-Repackaging
-Diluting *See "preparing per approved labeling" flash card
-Smoking crack in a pipe for exemptions
-Pooling
1) Microbial contamination
2)Bacterial endotoxins
The requirements in USP 797 must be 3)Variability of strength of ingredients
followed to prevent what 6 types of harm 4) Physical/chemical incompatibilities
5)Physical/chemical contaminants
6) Inappropriate ingredient quality
They don't!!!!
How often may representatives of USP USP has no role in enforcement
inspect compounding facilities
It is the responsibility of regulating bodies
, Which of the following medications need Any body space that does not normally communicate with outside environment
to be sterile requires sterile preparation.
-Soaks for tissue graft -Soaks for tissue graft
-Enemas -Solution for nebulizer
-Solution for nebulizer -Peritoneal dialysis solution
-Nasal Spray -Bladder irrigation
-Peritoneal dialysis solution
-Bladder irrigation
When are allergenic extracts exempt from -When the compounding is limited to transferring or drawing up a manufactured
most CSPs regulations in USP 797 allergenic product
What regulations should be followed -There is a specific section just for allergenic extracts
Sterile radiopharmaceuticals are required Neither
to meet the standards of
-Category 1 CSP They are subject to USP 825
-Category 2 CSP
-Neither
Immediate use CSPs (T/F) Immediate use CSPs (T/F)
1) Do not required evidenced- 1) Do not required evidenced-based chemical/physical stability
based chemical/physical stability documentation if administered within 1 hour (F)
documentation if administered within 1 2)Is limited to not more than 3 involved sterile products (T)
hour 3)Single use containers may be used on multiple patients within 6 hours (F)
2)Is limited to not more than 3 ONE PATIENT ONLY
involved sterile products 4)Administration must begin within 4 hours of the start of CSP preparation (T)
3)Single use containers may be used 5)Label must contain initials of compounder (T)
on multiple patients within 6 hours
4)Administration must begin within 4
hours of the start of CSP preparation
5)Label must contain initials
of compounder
Proprietary Bag and Vial Systems Preparation Per Approved Labeling
1) When is use of ADD-vantage 1) When for IMMEDIATE use
system not considered compounding
2) When prepared for FUTURE activation
2) When must Mini-bag system be
prepared in and ISO 5 environment 3)Refer to specific manufacturer's labeling
3)What is the BUD for systems
connected in an ISO 5 environment
Preparation Per Approved Labeling Preparation Per Approved Labeling
Compounding does not include mixing, 1) Single dose for individual patient
reconstituting, or by following manufacturer 2)Label includes diluent, strength, container, and BUD
directions under what 2 conditions
CSP Categories
CSP Categories
1) Conditions they are made
What are the 3 main considerations
differentiating a category 1 and category 2 2)Probability of microbial growth
CSP
3)BUD
True
True/False
USP 797 standards apply to human and
animal drug compounding
Which of the following drug manipulations ANY manipulation of a drug to make a STERILE
is/are not considered sterile compounding medication is considered compounding
-Combining
-Reconstituting Clearly smoking crack is not considered sterile
-Admixing medication compounding
-Repackaging
-Diluting *See "preparing per approved labeling" flash card
-Smoking crack in a pipe for exemptions
-Pooling
1) Microbial contamination
2)Bacterial endotoxins
The requirements in USP 797 must be 3)Variability of strength of ingredients
followed to prevent what 6 types of harm 4) Physical/chemical incompatibilities
5)Physical/chemical contaminants
6) Inappropriate ingredient quality
They don't!!!!
How often may representatives of USP USP has no role in enforcement
inspect compounding facilities
It is the responsibility of regulating bodies
, Which of the following medications need Any body space that does not normally communicate with outside environment
to be sterile requires sterile preparation.
-Soaks for tissue graft -Soaks for tissue graft
-Enemas -Solution for nebulizer
-Solution for nebulizer -Peritoneal dialysis solution
-Nasal Spray -Bladder irrigation
-Peritoneal dialysis solution
-Bladder irrigation
When are allergenic extracts exempt from -When the compounding is limited to transferring or drawing up a manufactured
most CSPs regulations in USP 797 allergenic product
What regulations should be followed -There is a specific section just for allergenic extracts
Sterile radiopharmaceuticals are required Neither
to meet the standards of
-Category 1 CSP They are subject to USP 825
-Category 2 CSP
-Neither
Immediate use CSPs (T/F) Immediate use CSPs (T/F)
1) Do not required evidenced- 1) Do not required evidenced-based chemical/physical stability
based chemical/physical stability documentation if administered within 1 hour (F)
documentation if administered within 1 2)Is limited to not more than 3 involved sterile products (T)
hour 3)Single use containers may be used on multiple patients within 6 hours (F)
2)Is limited to not more than 3 ONE PATIENT ONLY
involved sterile products 4)Administration must begin within 4 hours of the start of CSP preparation (T)
3)Single use containers may be used 5)Label must contain initials of compounder (T)
on multiple patients within 6 hours
4)Administration must begin within 4
hours of the start of CSP preparation
5)Label must contain initials
of compounder
Proprietary Bag and Vial Systems Preparation Per Approved Labeling
1) When is use of ADD-vantage 1) When for IMMEDIATE use
system not considered compounding
2) When prepared for FUTURE activation
2) When must Mini-bag system be
prepared in and ISO 5 environment 3)Refer to specific manufacturer's labeling
3)What is the BUD for systems
connected in an ISO 5 environment
Preparation Per Approved Labeling Preparation Per Approved Labeling
Compounding does not include mixing, 1) Single dose for individual patient
reconstituting, or by following manufacturer 2)Label includes diluent, strength, container, and BUD
directions under what 2 conditions
CSP Categories
CSP Categories
1) Conditions they are made
What are the 3 main considerations
differentiating a category 1 and category 2 2)Probability of microbial growth
CSP
3)BUD
