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Days' supply limit: drugs dispensed by a hospital to an inpatient or ER patient on
discharge if the prescriber believes the drug is warranted a community pharmacy
service is not readily accessible. - ✔✔ANSWER✔✔>>The greater of 48 hours supply or
amount until next business day (Page 207)
Can an automated pharmacy system at a nursing home, long-term care, hospice, or
correctional facility contain controlled substances? - ✔✔ANSWER✔✔>>yes (and this
facility would require a DEA registration)
If a nursing home is using the automated dispensing system as an Emergency
Medication Kit, does it require a DEA registration? - ✔✔ANSWER✔✔>>Yes
Nuclear pharmacist requirements:
____ hours of formal didactic training
____ hours of internship training
____hours of CE on nuclear pharmacy topics - ✔✔ANSWER✔✔>>200 didactic
500 internship
24 CE
T/F A nuclear pharmacy technician can take an order for a diagnostic
radiopharmaceutical product, but not a blood product or products for therapy/treatment -
✔✔ANSWER✔✔>>True
Which of these facilities makes only patient-specific compounds? (503A/503B)
503A pharmacies are governed by the (state BOP/FDA) and must comply with
(USP/cGMP) standards, whereas 503B pharmacies are governed by the (state
BOP/FDA) and must comply with (USP/cGMP) - ✔✔ANSWER✔✔>>503A (503B is an
outsourcing facility)
,503A pharmacies are governed by the *state BOP* and must comply with *USP*
standards, whereas 503B pharmacies are governed by the *FDA* and must comply with
*cGMP* standards.
Immediate use CSPs are limited to a simple transfer of not more than ____ sterile
manufactured ingredients and not more than ___ entries into any one container -
✔✔ANSWER✔✔>>3; 2
Low risk CSPs are defined as: - ✔✔ANSWER✔✔>>A single dose of a CSP made the
one patient
Medium risk CSPs are defined as: - ✔✔ANSWER✔✔>>Any CSP made in a batch for
multiple patients or complex mixtures (TPNs)
High risk CSPs are defined as: - ✔✔ANSWER✔✔>>Any CSP made with a nonsterile
starting ingredient, or any CSP made without complete garb/PPE.
For someone who only compounds low/medium risk CSPs, how often do they need to
perform the media fill test and fingertip test? - ✔✔ANSWER✔✔>>Annually (12 months)
For someone who compounds high risk CSPs, how often do they need to perform the
media fill test and fingertip test? - ✔✔ANSWER✔✔>>Every 6 months
The buffer room must be at least ISO _____ - ✔✔ANSWER✔✔>>7
The anteroom that opens into a negative pressure buffer room must be at least ISO
______ - ✔✔ANSWER✔✔>>7
The anteroom that opens into a positive pressure buffer room must be at least ISO
______ - ✔✔ANSWER✔✔>>8
The PEC for sterile compounds (both hazardous and non-hazardous) must be at least
ISO _____ - ✔✔ANSWER✔✔>>5
PECs/SECs must be certified every _________ - ✔✔ANSWER✔✔>>6 months
High risk CSPs that are made in groups of more than ____ units must pass a
____________________ test. - ✔✔ANSWER✔✔>>25 units; bacterial endotoxin
(pyrogen) test
A opened single dose vial is able to be used for up to ___ hours when maintained in an
ISO 5 environment and _____ hour(s) if opened outside of an ISO 5 -
✔✔ANSWER✔✔>>6 hours; 1 hour
, A opened multi-dose vial is able to be used for up to ___ days when maintained in an
ISO 5 environment and _____ day(s) if opened outside of an ISO 5 -
✔✔ANSWER✔✔>>28 days; 28 days
Immediate use CSPs must be used within _______ hour(s) - ✔✔ANSWER✔✔>>1 hour
Low risk CSPs have a BUD of ____ hours if stored at room temperature or _____ days
when stored in a refrigerator and ____ days when frozen - ✔✔ANSWER✔✔>>48 hours;
14 days; 45 days
Medium risk CSPs have a BUD of ____ hours if stored at room temperature or _____
days when stored in a refrigerator and ____ days when frozen - ✔✔ANSWER✔✔>>30
hours; 9 days; 45 days
High risk CSPs have a BUD of ____ hours if stored at room temperature or _____ days
when stored in a refrigerator and ____ days when frozen - ✔✔ANSWER✔✔>>24 hours;
3 days; 45 days
The storage room and C-SEC for sterile HDs must have _______ or more air changes
per hour (ACPH) - ✔✔ANSWER✔✔>>30
The storage room and C-SEC for nonsterile HDs must have _______ or more air
changes per hour (ACPH) - ✔✔ANSWER✔✔>>12
Any sink or water source that is outside of the buffer room must be at least how many
meters away from the C-PEC? - ✔✔ANSWER✔✔>>1 meter
T/F A C-PEC used for compounding non-sterile hazardous drugs must have an ISO of 5
or better and have unidirectional airflow. - ✔✔ANSWER✔✔>>False. There is no ISO
requirement for *non*sterile hazardous drugs, and no airflow requirement. The only
requirement is that the *air pressure must be negative*
What are two examples of a C-PEC that may be used for sterile HD compounding? -
✔✔ANSWER✔✔>>Class II Biological Safety Cabinet (BSC)
Compounding Aseptic Containment Isolator (CACI)
How often should chemotherapy gloves be changed? - ✔✔ANSWER✔✔>>Q30min
At a minimum, chemotherapy gowns should be changed every: - ✔✔ANSWER✔✔>>2-3
hours
If a person is compounding HDs and following all USP 800 rules, how many pairs of
gloves and shoe covers would that person be wearing? - ✔✔ANSWER✔✔>>2