FLORIDA MPJE 2024
ANSWER ALL QUESTIONS IN THIS SECTION
QUESTION 1
When must the Probable Cause Panel receive its final recommendation after
receipt of a complaint? - ANSWERS-6 months
QUESTION 2
If probable cause is found and a complaint is officially filed, how long does the
subject have to respond? - ANSWERS-21 days
QUESTION 3
Does USP enforce their standards? - ANSWERS-No, they are
recommendations. The states and other governing boards do the actual
enforcing.
ie the FDCA mandates following USP guidelines
END OF
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, FLORIDA MPJE 2024
QUESTION 4
503a pharmacies are governed by. .... 503b pharmacies are governed by... -
ANSWERS-USP
QUESTION 5
FDA and cGMP standards
USP 795 - ANSWERS-Non-sterile compounding
NOT OFFICIALLY ADOPTED IN FLORIDA
QUESTION 6
USP 797 - ANSWERS-Sterile preparations
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, FLORIDA MPJE 2024
QUESTION 7
USP 800 - ANSWERS-Hazardous Drugs - Compounding in Healthcare Settings
NOT OFFICIALLY ADOPTED IN FLORIDA
QUESTION 8
USP 825 - ANSWERS-Radiopharmaceutical
NOT OFFICIALLY ADOPTED IN FLORIDA
QUESTION 9
Low risk csp - ANSWERS-Mixed in USP 797 compliant area as a single dose
for apatient
ex: Reconstituting a vial of cefazolin and putting in an IV piggyback
QUESTION 10
Medium risk CSP - ANSWERS-Multiple individual or small doses of sterile
products combined, more complex manipulation, with medium risk storage
Ex: batching syringes and TPN
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, FLORIDA MPJE 2024
QUESTION 11
High risk CSP - ANSWERS-Use of a non-sterile product, product without
preservatives or exposure to environment for over 1 hour, non-sterile water or
bulk products, with high risk storage
QUESTION 12
Ex: Not garbing to make something or starting with a non-sterile API
Immediate use CSP - ANSWERS-are compounded in emergency situations or where
immediate patient administration is mandated to avoid harm that may result from
delays in treatment
QUESTION 13
What is the allowable percent error for compounding? - ANSWERS-10%
END OF
PAGE 4
ANSWER ALL QUESTIONS IN THIS SECTION
QUESTION 1
When must the Probable Cause Panel receive its final recommendation after
receipt of a complaint? - ANSWERS-6 months
QUESTION 2
If probable cause is found and a complaint is officially filed, how long does the
subject have to respond? - ANSWERS-21 days
QUESTION 3
Does USP enforce their standards? - ANSWERS-No, they are
recommendations. The states and other governing boards do the actual
enforcing.
ie the FDCA mandates following USP guidelines
END OF
PAGE 1
, FLORIDA MPJE 2024
QUESTION 4
503a pharmacies are governed by. .... 503b pharmacies are governed by... -
ANSWERS-USP
QUESTION 5
FDA and cGMP standards
USP 795 - ANSWERS-Non-sterile compounding
NOT OFFICIALLY ADOPTED IN FLORIDA
QUESTION 6
USP 797 - ANSWERS-Sterile preparations
END OF
PAGE 2
, FLORIDA MPJE 2024
QUESTION 7
USP 800 - ANSWERS-Hazardous Drugs - Compounding in Healthcare Settings
NOT OFFICIALLY ADOPTED IN FLORIDA
QUESTION 8
USP 825 - ANSWERS-Radiopharmaceutical
NOT OFFICIALLY ADOPTED IN FLORIDA
QUESTION 9
Low risk csp - ANSWERS-Mixed in USP 797 compliant area as a single dose
for apatient
ex: Reconstituting a vial of cefazolin and putting in an IV piggyback
QUESTION 10
Medium risk CSP - ANSWERS-Multiple individual or small doses of sterile
products combined, more complex manipulation, with medium risk storage
Ex: batching syringes and TPN
END OF
PAGE 3
, FLORIDA MPJE 2024
QUESTION 11
High risk CSP - ANSWERS-Use of a non-sterile product, product without
preservatives or exposure to environment for over 1 hour, non-sterile water or
bulk products, with high risk storage
QUESTION 12
Ex: Not garbing to make something or starting with a non-sterile API
Immediate use CSP - ANSWERS-are compounded in emergency situations or where
immediate patient administration is mandated to avoid harm that may result from
delays in treatment
QUESTION 13
What is the allowable percent error for compounding? - ANSWERS-10%
END OF
PAGE 4
