FLORIDA MPJE
When must the Probable Cause Panel receive its final recommendation after
receipt of a complaint? - ANSWERS-6 months
If probable cause is found and a complaint is officially filed, how long does the
subject have to respond? - ANSWERS-21 days
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
503a pharmacies are governed by.... 503b pharmacies are governed by... -
ANSWERS-USP
FDA and cGMP standards
USP 795 - ANSWERS-Non-sterile compounding
NOT OFFICIALLY ADOPTED IN FLORIDA
USP 797 - ANSWERS-Sterile preparations
,USP 800 - ANSWERS-Hazardous Drugs - Compounding in Healthcare Settings
NOT OFFICIALLY ADOPTED IN FLORIDA
USP 825 - ANSWERS-Radiopharmaceutical
NOT OFFICIALLY ADOPTED IN FLORIDA
Low risk csp - ANSWERS-Mixed in USP 797 compliant area as a single dose for a
patient
ex: Reconstituting a vial of cefazolin and putting in an IV piggyback
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
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
,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
What is the allowable percent error for compounding? - ANSWERS-10%
ISO classification for an anteroom that opens into positive pressure buffer rooms -
ANSWERS-ISO 8
ISO classification for an anteroom that opens into negative pressure rooms -
ANSWERS-ISO 7
ISO classification for a positive pressure buffer room - ANSWERS-ISO 7
ISO classification for a negative pressure buffer room - ANSWERS-ISO 7
How often must PECs and SECs be certified? - ANSWERS-Every 6 months
Expiration for an opened ampule - ANSWERS-Use and discard remainder
regardless of ISO class
, Expiration for a single dose vial - ANSWERS-6 hours in ISO 5
1 hour outside of ISO 5
Expiration for multi-dose vial - ANSWERS-28 days in/out of ISO 5
BUD for immediate use CSP - ANSWERS-1 hour
BUD for low risk CSP in an SCA - ANSWERS-12 hours room temp or fridge
BUD for low risk CSP in ISO - ANSWERS-48 hours room temp
14 days fridge
45 days freezer
BUD for medium risk CSP - ANSWERS-30 hours room temp
9 days fridge
45 days freezer
When must the Probable Cause Panel receive its final recommendation after
receipt of a complaint? - ANSWERS-6 months
If probable cause is found and a complaint is officially filed, how long does the
subject have to respond? - ANSWERS-21 days
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
503a pharmacies are governed by.... 503b pharmacies are governed by... -
ANSWERS-USP
FDA and cGMP standards
USP 795 - ANSWERS-Non-sterile compounding
NOT OFFICIALLY ADOPTED IN FLORIDA
USP 797 - ANSWERS-Sterile preparations
,USP 800 - ANSWERS-Hazardous Drugs - Compounding in Healthcare Settings
NOT OFFICIALLY ADOPTED IN FLORIDA
USP 825 - ANSWERS-Radiopharmaceutical
NOT OFFICIALLY ADOPTED IN FLORIDA
Low risk csp - ANSWERS-Mixed in USP 797 compliant area as a single dose for a
patient
ex: Reconstituting a vial of cefazolin and putting in an IV piggyback
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
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
,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
What is the allowable percent error for compounding? - ANSWERS-10%
ISO classification for an anteroom that opens into positive pressure buffer rooms -
ANSWERS-ISO 8
ISO classification for an anteroom that opens into negative pressure rooms -
ANSWERS-ISO 7
ISO classification for a positive pressure buffer room - ANSWERS-ISO 7
ISO classification for a negative pressure buffer room - ANSWERS-ISO 7
How often must PECs and SECs be certified? - ANSWERS-Every 6 months
Expiration for an opened ampule - ANSWERS-Use and discard remainder
regardless of ISO class
, Expiration for a single dose vial - ANSWERS-6 hours in ISO 5
1 hour outside of ISO 5
Expiration for multi-dose vial - ANSWERS-28 days in/out of ISO 5
BUD for immediate use CSP - ANSWERS-1 hour
BUD for low risk CSP in an SCA - ANSWERS-12 hours room temp or fridge
BUD for low risk CSP in ISO - ANSWERS-48 hours room temp
14 days fridge
45 days freezer
BUD for medium risk CSP - ANSWERS-30 hours room temp
9 days fridge
45 days freezer
