Alabama MPJE Questions and Answers (2022/2023) Already Graded A
Pure Food and Drug Act (1906) aka Wiley Law -Ans>>Prohibits adulteration and misbranding
Food, Drug and Cosmetic Act (1938) -Ans>>-New drug could not be marketed unless safe
-Required manufacturer label to have directions for use and warnings about habit forming drugs
Durham-Humphrey Amendment (1951) -Ans>>-Established prescription and OTC drug categories
-Allowed for oral prescriptions
-Allowed for refills
Manufacturer label on Rx drugs after Durham-Humphrey Amendment -Ans>>-Not required to have
directions for use
-"Caution: Federal law prohibits dispensing w/o a prescription"
Kefauver-Harris Amendment (1962) -Ans>>-New drug could not be marketed unless effective
-Informed consent
-FDA allowed to regulate prescription drug advertising
-Reporting of ADRs
-GMPs
Who regulates OTC drug advertising? -Ans>>FTC
Hatch-Waxman Amendment -Ans>>-Generics only have to submit abbreviated NDA (ANDA):
bioequivalence, not safety and efficacy
-Gives incentives to brand manufacturers by giving 5 more years of patent protection (up to 22 years)
Reverse distributor -Ans>>Distributor registered with the DEA to destroy drugs
# of DEA registrations: owner of two pharmacies -Ans>>2
# of DEA registrations: hospital with inpatient satellites -Ans>>1
# of DEA registrations: hospital with outpatient pharmacy down the street -Ans>>2
# of DEA registrations: pharmacy with nursing home business -Ans>>2
# of DEA registrations: consultant pharmacist -Ans>>0
# of DEA registrations: pharmacy that does coop buying -Ans>>2
# of DEA registrations: pharmacy that provides methadone -Ans>>1
Explain DEA number -Ans>>First letter: A,B,F for providers; M for midlevel; R for distributor
Second letter: Last name or 9
Number: 6 digits plus check digit
Who can use the hospital DEA number and internal code to prescribe? -Ans>>Any employee
authorized to prescribe
Explain the check digit in the DEA number? -Ans>>a) Add 1,3,5
b) Add 2,4,6 and multiply by 2
c) Add (a) and (b)
d) Last digit in the sum is the check digit
,What two things should a pharmacist look for when deciding whether or not to fill a prescription? -
Ans>>Physician-patient relationship and scope of practice
What information must be on a prescription for a controlled substance? -Ans>>1. Patient name
2. Patient address
3. Date written
4. Drug, quantity, directions
5. Physician signature
6. Physician address
7. Physician DEA number
What act developed office based narcotic maintenance programs (buprenorphine rather than
methadone)? -Ans>>Drug Addiction Treatment Act (DATA)
T/F: Methadone prescriptions not written in multiple daily doses should be assumed for maintenance
of addiction and only dispensed by MMPs -Ans>>True
T/F: A pharmacy may use a computer to store records of C3-5 -Ans>>True
Computerized refill history must include -Ans>>-Drug name
-Date of refill
-Quantity dispensed
-Total number of refills (pills) dispensed to date
-Pharmacist identifier
Computer generated prescription/refill information must be maintained for ___ -Ans>>2 years after
the dispensing date
What must the pharmacist write on the printout of the day's CS refills? -Ans>>Signature and date (by
each pharmacist that dispensed)
Refill printout must be provided to each pharmacy that uses the computer system within ___ of the
refill being dispensed -Ans>>72 hours
Printout of refill data must include -Ans>>-Patient name and address
-Prescriber name
-Pharmacist ID
-Prescription number
-Date dispensed
-Quantity dispensed
A centralized pharmacy must be capable of giving refill printouts to a requesting pharmacy within
____ -Ans>>48 hours
T/F: C2 prescriptions must be written and manually signed -Ans>>True
When do C2 prescriptions expire? -Ans>>Never
T/F: Oral orders for C2 prescriptions are allowed in emergency situations -Ans>>if it is for long term
care facility, hospice, patient receiving home health services and the amount is only for 72 hours AND
physician furnishes written rx for the amount given within 7 days.
Can a pharmacist fill a faxed C2 prescription? -Ans>>Yes, they may fill it but they may not dispense it
until a hard copy is presented.
Under what circumstances can a faxed C2 serve as an original? -Ans>>-Home infusion for pain (direct
parenteral administration of a narcotic)
, -LTCF
-Medicare certified hospice (must note hospice on Rx)
What additional information is required for a faxed C2? -Ans>>-Signature of sender (nurse)
-Pharmacist verifies sender
T/F: Signed C3-5 can be faxed -Ans>>True
Where must the fax machine be in the pharmacy? -Ans>>Pharmacy department
How many times can a C3-4 be refilled? -Ans>>Up to 5 refills in 6 months after the date of ISSUE
How are controlled substances received by the pharmacy? -Ans>>Pharmacist must sign the invoice of
the controlled substance
How many times can a C3-5 be transferred? -Ans>>Once
CS prescription label requirements -Ans>>-Name and address of pharmacy
-Prescription number
-Date of dispensing
-Name of patient
-Name of prescriber
-Directions
-Cautionary statements
"Federal law prohibits the transfer of this drug to any person other than the patient for whom it was
prescribed" must be on which prescriptions? -Ans>>C2-4
What are the rules for partial dispensing of C2s? (Not LTCF or terminal illness) -Ans>>1. May only
partial if the pharmacy doesn't have adequate supply
2. Remainder may be dispensed within 72 hours
3. If the remainder is not dispensed within 72 hours the prescriber must be notified
What are the rules for partial dispensing of C2s in a LTCF or terminal illness? -Ans>>1. Must note
"LTCF patient" or "terminally ill"
2. Note date filled, quantity dispensed, quantity remaining and ID of pharmacist
3. Valid for 60 days from the date of issue
What are the requirements for partially dispensing a C3-5? -Ans>>1. Must write quantity and initials
on prescription
2. Rx still expires after 6 months from issue
Important aspects of electronic prescribing -Ans>>Authentication (are who they say they are),
Nonrepudiation (cannot deny signing), Integrity (not changed following signature)
T/F: A C2 can be prescribed electronically -Ans>>True
What is two factor credentialing used for? -Ans>>Electronic signing of prescriptions and approval of
control access
What are three things that may be used in two factor credentialing? -Ans>>-Something you know
-Something you have
-Something you are
Can an electronic prescription be faxed or printed? -Ans>>-May NOT be faxed
-May be printed if
(a) for copy only (b) if transmission failed (must indicate attempt)
Pure Food and Drug Act (1906) aka Wiley Law -Ans>>Prohibits adulteration and misbranding
Food, Drug and Cosmetic Act (1938) -Ans>>-New drug could not be marketed unless safe
-Required manufacturer label to have directions for use and warnings about habit forming drugs
Durham-Humphrey Amendment (1951) -Ans>>-Established prescription and OTC drug categories
-Allowed for oral prescriptions
-Allowed for refills
Manufacturer label on Rx drugs after Durham-Humphrey Amendment -Ans>>-Not required to have
directions for use
-"Caution: Federal law prohibits dispensing w/o a prescription"
Kefauver-Harris Amendment (1962) -Ans>>-New drug could not be marketed unless effective
-Informed consent
-FDA allowed to regulate prescription drug advertising
-Reporting of ADRs
-GMPs
Who regulates OTC drug advertising? -Ans>>FTC
Hatch-Waxman Amendment -Ans>>-Generics only have to submit abbreviated NDA (ANDA):
bioequivalence, not safety and efficacy
-Gives incentives to brand manufacturers by giving 5 more years of patent protection (up to 22 years)
Reverse distributor -Ans>>Distributor registered with the DEA to destroy drugs
# of DEA registrations: owner of two pharmacies -Ans>>2
# of DEA registrations: hospital with inpatient satellites -Ans>>1
# of DEA registrations: hospital with outpatient pharmacy down the street -Ans>>2
# of DEA registrations: pharmacy with nursing home business -Ans>>2
# of DEA registrations: consultant pharmacist -Ans>>0
# of DEA registrations: pharmacy that does coop buying -Ans>>2
# of DEA registrations: pharmacy that provides methadone -Ans>>1
Explain DEA number -Ans>>First letter: A,B,F for providers; M for midlevel; R for distributor
Second letter: Last name or 9
Number: 6 digits plus check digit
Who can use the hospital DEA number and internal code to prescribe? -Ans>>Any employee
authorized to prescribe
Explain the check digit in the DEA number? -Ans>>a) Add 1,3,5
b) Add 2,4,6 and multiply by 2
c) Add (a) and (b)
d) Last digit in the sum is the check digit
,What two things should a pharmacist look for when deciding whether or not to fill a prescription? -
Ans>>Physician-patient relationship and scope of practice
What information must be on a prescription for a controlled substance? -Ans>>1. Patient name
2. Patient address
3. Date written
4. Drug, quantity, directions
5. Physician signature
6. Physician address
7. Physician DEA number
What act developed office based narcotic maintenance programs (buprenorphine rather than
methadone)? -Ans>>Drug Addiction Treatment Act (DATA)
T/F: Methadone prescriptions not written in multiple daily doses should be assumed for maintenance
of addiction and only dispensed by MMPs -Ans>>True
T/F: A pharmacy may use a computer to store records of C3-5 -Ans>>True
Computerized refill history must include -Ans>>-Drug name
-Date of refill
-Quantity dispensed
-Total number of refills (pills) dispensed to date
-Pharmacist identifier
Computer generated prescription/refill information must be maintained for ___ -Ans>>2 years after
the dispensing date
What must the pharmacist write on the printout of the day's CS refills? -Ans>>Signature and date (by
each pharmacist that dispensed)
Refill printout must be provided to each pharmacy that uses the computer system within ___ of the
refill being dispensed -Ans>>72 hours
Printout of refill data must include -Ans>>-Patient name and address
-Prescriber name
-Pharmacist ID
-Prescription number
-Date dispensed
-Quantity dispensed
A centralized pharmacy must be capable of giving refill printouts to a requesting pharmacy within
____ -Ans>>48 hours
T/F: C2 prescriptions must be written and manually signed -Ans>>True
When do C2 prescriptions expire? -Ans>>Never
T/F: Oral orders for C2 prescriptions are allowed in emergency situations -Ans>>if it is for long term
care facility, hospice, patient receiving home health services and the amount is only for 72 hours AND
physician furnishes written rx for the amount given within 7 days.
Can a pharmacist fill a faxed C2 prescription? -Ans>>Yes, they may fill it but they may not dispense it
until a hard copy is presented.
Under what circumstances can a faxed C2 serve as an original? -Ans>>-Home infusion for pain (direct
parenteral administration of a narcotic)
, -LTCF
-Medicare certified hospice (must note hospice on Rx)
What additional information is required for a faxed C2? -Ans>>-Signature of sender (nurse)
-Pharmacist verifies sender
T/F: Signed C3-5 can be faxed -Ans>>True
Where must the fax machine be in the pharmacy? -Ans>>Pharmacy department
How many times can a C3-4 be refilled? -Ans>>Up to 5 refills in 6 months after the date of ISSUE
How are controlled substances received by the pharmacy? -Ans>>Pharmacist must sign the invoice of
the controlled substance
How many times can a C3-5 be transferred? -Ans>>Once
CS prescription label requirements -Ans>>-Name and address of pharmacy
-Prescription number
-Date of dispensing
-Name of patient
-Name of prescriber
-Directions
-Cautionary statements
"Federal law prohibits the transfer of this drug to any person other than the patient for whom it was
prescribed" must be on which prescriptions? -Ans>>C2-4
What are the rules for partial dispensing of C2s? (Not LTCF or terminal illness) -Ans>>1. May only
partial if the pharmacy doesn't have adequate supply
2. Remainder may be dispensed within 72 hours
3. If the remainder is not dispensed within 72 hours the prescriber must be notified
What are the rules for partial dispensing of C2s in a LTCF or terminal illness? -Ans>>1. Must note
"LTCF patient" or "terminally ill"
2. Note date filled, quantity dispensed, quantity remaining and ID of pharmacist
3. Valid for 60 days from the date of issue
What are the requirements for partially dispensing a C3-5? -Ans>>1. Must write quantity and initials
on prescription
2. Rx still expires after 6 months from issue
Important aspects of electronic prescribing -Ans>>Authentication (are who they say they are),
Nonrepudiation (cannot deny signing), Integrity (not changed following signature)
T/F: A C2 can be prescribed electronically -Ans>>True
What is two factor credentialing used for? -Ans>>Electronic signing of prescriptions and approval of
control access
What are three things that may be used in two factor credentialing? -Ans>>-Something you know
-Something you have
-Something you are
Can an electronic prescription be faxed or printed? -Ans>>-May NOT be faxed
-May be printed if
(a) for copy only (b) if transmission failed (must indicate attempt)
