PA MPJE USP and Compounding
questions with verified answers passed
The FDA exempts _______ from the rigorous requirements for a new drug application.
Compounding
What are 3 procedures that are not compounding but are sometimes confused for
compounding?
Reconstitution, Repackaging, Splitting (tablets)
Which United States Pharmacopeia (USP) chapter handles nonsterile compounding?
(USP) 795
Which United States Pharmacopeia (USP) chapter handles sterile compounding?
(USP) 797
Which United States Pharmacopeia (USP) chapter handles hazardous drugs?
(USP) 800
Which United States Pharmacopeia (USP) chapter handles radiopharmaceuticals?
,(USP) 825
In USP 795, 797, and 800, core competencies must be demonstrated initially and every ______.
12 months
Under USP 795, temperature of storage areas must be monitored at least every ______.
1 day
Under USP 795, temperature monitoring equipment must be calibrated at least every ______.
12 months
What is the "recipe" for the CNSP (compounded nonsterile preparations)?
MFR (Master Formulation Record)
What includes the details of a specific CNSP (compounded nonsterile preparations)?
CR (Compounding Record)
Ingredients must be stored appropriately and cannot be stored ____________________.
on the floor
, Is the BUD assigned for a component without a manufacturer's expiry be based on the date the
component was opened or the date it was received?
received
Are ointments aqueous or nonaqueous?
nonaqueous
Are creams aqueous or nonaqueous?
aqueous
Under USP 795, what is the maximum BUD for a non-preserved aqueous dosage form when
refrigerated?
14 days
Under USP 795, what is the maximum BUD for a preserved aqueous dosage form when
refrigerated or stored at controlled room temperature?
35 days
questions with verified answers passed
The FDA exempts _______ from the rigorous requirements for a new drug application.
Compounding
What are 3 procedures that are not compounding but are sometimes confused for
compounding?
Reconstitution, Repackaging, Splitting (tablets)
Which United States Pharmacopeia (USP) chapter handles nonsterile compounding?
(USP) 795
Which United States Pharmacopeia (USP) chapter handles sterile compounding?
(USP) 797
Which United States Pharmacopeia (USP) chapter handles hazardous drugs?
(USP) 800
Which United States Pharmacopeia (USP) chapter handles radiopharmaceuticals?
,(USP) 825
In USP 795, 797, and 800, core competencies must be demonstrated initially and every ______.
12 months
Under USP 795, temperature of storage areas must be monitored at least every ______.
1 day
Under USP 795, temperature monitoring equipment must be calibrated at least every ______.
12 months
What is the "recipe" for the CNSP (compounded nonsterile preparations)?
MFR (Master Formulation Record)
What includes the details of a specific CNSP (compounded nonsterile preparations)?
CR (Compounding Record)
Ingredients must be stored appropriately and cannot be stored ____________________.
on the floor
, Is the BUD assigned for a component without a manufacturer's expiry be based on the date the
component was opened or the date it was received?
received
Are ointments aqueous or nonaqueous?
nonaqueous
Are creams aqueous or nonaqueous?
aqueous
Under USP 795, what is the maximum BUD for a non-preserved aqueous dosage form when
refrigerated?
14 days
Under USP 795, what is the maximum BUD for a preserved aqueous dosage form when
refrigerated or stored at controlled room temperature?
35 days
