CPJE LAW COMPREHENSIVE ANSWERS AND
QUESTIONS SET A+
✔✔Class III Recall - ✔✔Use or exposure of drug is not likely to cause adverse health
consequences
Ex: coloring on tablets may have been applied inconsistently.
✔✔A pharmacy or outsourcing facility that issues a recall notice about its
COMPOUNDED drug preparation must contact....
The recipient pharmacy, prescriber, or patient within _____ (time)
AND
The BOP within _____ (time)
..... of the recall notice if BOTH of the following apply:
* Use/ exposure to the recalled compounded preparation can cause serious adverse
effects or death
* The recalled compounded preparation was dispensed, or is intended for use in
California - ✔✔12 hours
24 hours
✔✔If the PHARMACY is made aware that a patient has been harmed by using a
compounded product prepared by the pharmacy, the pharmacy must report the event to
the federal FDA MedWatch within _____ (time). - ✔✔72 hours
✔✔If the OUTSOURCING FACILITY is made aware that a patient has been harmed by
using a compounded product prepared by the facility, the facility must report the event
to the federal FDA MedWatch within _____ (time). - ✔✔15 calendar days
✔✔Returning Drugs to Supplier
Non-controlled medications: FDA permits pharmacies to return drugs to wholesalers
and manufacturers as long as there is proper recordkeeping.
Schedule III-V: Pharmacist must maintain a _____ (thing) showing:
1. Date of transaction
, 2. Name, strength, dosage form, and quantity of the controlled substance.
3. The supplier or manufacturer's name, address, and registration number.
Schedule II: A DEA Form _____ (#) or its electronic equivalent must accompany the
transfer of schedule II drugs. Wholesaler will keep Copy _____ (#) and send Copies
_____ & _____ (#s) to the pharmacy, which is acting as the "supplier".
Pharmacy will forward Copy _____ (#) to the DEA - ✔✔Written record
3
1, 2
2
✔✔When a pharmacy transfers Scheduled II drugs to a reverse distributor for
DESTRUCTION, the reverse distributor MUST issue an official order form (DEA Form
_____ (#)) or the electronic equivalent to the pharmacy. The reverse distributor will keep
Copy _____ (#) and send Copies _____ & _____ (#s) to the pharmacy, which is acting
as the "supplier". Pharmacy will forward Copy _____ (#) to the DEA
When a pharmacy transfers Scheduled III- V drugs to a reverse distributor for
DESTRUCTION, the pharmacy must maintain a RECORD OF DESTRIBUTION that
lists the drug name, dosage form, strength, quantity, and date transferred.
DEA registered reverse distributor who will destroy the controlled substances is
responsible for completing DEA Form _____(#) - ✔✔222
3
1, 2
2
41
✔✔Drugs that are donated CANNOT be already used or _____. - ✔✔Expired
✔✔Can controlled substances be accepted as donations? - ✔✔Never
✔✔Can pharmacies accept returned prescription drugs from patients? (Ex: the wrong
drug was dispensed) - ✔✔Yes but only in certain conditions like the example provided
✔✔Can a returned drug (from pt) be returned to stock and dispensed to another pt? -
✔✔No, pharmacy must dispose of the returned drug
✔✔Pharmacy Take Back Program: Drugs that have been placed in the bin cannot be
removed by anyone win the pharmacy. Only the _____ (title name) is able to REMOVE
the liner that contains the drugs. _____ (#) pharmacy staff must WATCH the removal
and sign that they witnessed the disposal. - ✔✔reverse distributor
2
QUESTIONS SET A+
✔✔Class III Recall - ✔✔Use or exposure of drug is not likely to cause adverse health
consequences
Ex: coloring on tablets may have been applied inconsistently.
✔✔A pharmacy or outsourcing facility that issues a recall notice about its
COMPOUNDED drug preparation must contact....
The recipient pharmacy, prescriber, or patient within _____ (time)
AND
The BOP within _____ (time)
..... of the recall notice if BOTH of the following apply:
* Use/ exposure to the recalled compounded preparation can cause serious adverse
effects or death
* The recalled compounded preparation was dispensed, or is intended for use in
California - ✔✔12 hours
24 hours
✔✔If the PHARMACY is made aware that a patient has been harmed by using a
compounded product prepared by the pharmacy, the pharmacy must report the event to
the federal FDA MedWatch within _____ (time). - ✔✔72 hours
✔✔If the OUTSOURCING FACILITY is made aware that a patient has been harmed by
using a compounded product prepared by the facility, the facility must report the event
to the federal FDA MedWatch within _____ (time). - ✔✔15 calendar days
✔✔Returning Drugs to Supplier
Non-controlled medications: FDA permits pharmacies to return drugs to wholesalers
and manufacturers as long as there is proper recordkeeping.
Schedule III-V: Pharmacist must maintain a _____ (thing) showing:
1. Date of transaction
, 2. Name, strength, dosage form, and quantity of the controlled substance.
3. The supplier or manufacturer's name, address, and registration number.
Schedule II: A DEA Form _____ (#) or its electronic equivalent must accompany the
transfer of schedule II drugs. Wholesaler will keep Copy _____ (#) and send Copies
_____ & _____ (#s) to the pharmacy, which is acting as the "supplier".
Pharmacy will forward Copy _____ (#) to the DEA - ✔✔Written record
3
1, 2
2
✔✔When a pharmacy transfers Scheduled II drugs to a reverse distributor for
DESTRUCTION, the reverse distributor MUST issue an official order form (DEA Form
_____ (#)) or the electronic equivalent to the pharmacy. The reverse distributor will keep
Copy _____ (#) and send Copies _____ & _____ (#s) to the pharmacy, which is acting
as the "supplier". Pharmacy will forward Copy _____ (#) to the DEA
When a pharmacy transfers Scheduled III- V drugs to a reverse distributor for
DESTRUCTION, the pharmacy must maintain a RECORD OF DESTRIBUTION that
lists the drug name, dosage form, strength, quantity, and date transferred.
DEA registered reverse distributor who will destroy the controlled substances is
responsible for completing DEA Form _____(#) - ✔✔222
3
1, 2
2
41
✔✔Drugs that are donated CANNOT be already used or _____. - ✔✔Expired
✔✔Can controlled substances be accepted as donations? - ✔✔Never
✔✔Can pharmacies accept returned prescription drugs from patients? (Ex: the wrong
drug was dispensed) - ✔✔Yes but only in certain conditions like the example provided
✔✔Can a returned drug (from pt) be returned to stock and dispensed to another pt? -
✔✔No, pharmacy must dispose of the returned drug
✔✔Pharmacy Take Back Program: Drugs that have been placed in the bin cannot be
removed by anyone win the pharmacy. Only the _____ (title name) is able to REMOVE
the liner that contains the drugs. _____ (#) pharmacy staff must WATCH the removal
and sign that they witnessed the disposal. - ✔✔reverse distributor
2
