Alabama MPJE | Pharmacy Law Practice Questions, Answers & Exam Review 2026-2027
Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding
Food, Drug and Cosmetic Act (1938) -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) -Established prescription and OTC drug categories
-Allowed for oral prescriptions
-Allowed for refills
Manufacturer label on Rx drugs after Durham-Humphrey -Not required to have directions for use
Amendment -"Caution: Federal law prohibits dispensing w/o a prescription"
Kefauver-Harris Amendment (1962) -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? FTC
Hatch-Waxman Amendment -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 Distributor registered with the DEA to destroy drugs
# of DEA registrations: owner of two pharmacies 2
# of DEA registrations: hospital with inpatient satellites 1
# of DEA registrations: hospital with outpatient pharmacy 2
down the street
# of DEA registrations: pharmacy with nursing home 2
business
# of DEA registrations: consultant pharmacist 0
# of DEA registrations: pharmacy that does coop buying 2
, Alabama MPJE | Pharmacy Law Practice Questions, Answers & Exam Review 2026-2027
# of DEA registrations: pharmacy that provides methadone 1
Explain DEA number 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 Any employee authorized to prescribe
to prescribe?
Explain the check digit in the DEA number? 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 Physician-patient relationship and scope of practice
deciding whether or not to fill a prescription?
What information must be on a prescription for a controlled 1. Patient name
substance? 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 Drug Addiction Treatment Act (DATA)
programs (buprenorphine rather than methadone)?
T/F: Methadone prescriptions not written in multiple daily True
doses should be assumed for maintenance of addiction
and only dispensed by MMPs
T/F: A pharmacy may use a computer to store records of True
C3-5
Computerized refill history must include -Drug name
-Date of refill
-Quantity dispensed
-Total number of refills (pills) dispensed to date
-Pharmacist identifier
Computer generated prescription/refill information must be 2 years after the dispensing date
maintained for ___
What must the pharmacist write on the printout of the day's Signature and date (by each pharmacist that dispensed)
CS refills?
Refill printout must be provided to each pharmacy that 72 hours
uses the computer system within ___ of the refill being
dispensed
, Alabama MPJE | Pharmacy Law Practice Questions, Answers & Exam Review 2026-2027
Printout of refill data must include -Patient name and address
-Prescriber name
-Pharmacist ID
-Prescription number
-Date dispensed
-Quantity dispensed
A centralized pharmacy must be capable of giving refill 48 hours
printouts to a requesting pharmacy within ____
T/F: C2 prescriptions must be written and manually signed True
When do C2 prescriptions expire? Never
T/F: Oral orders for C2 prescriptions are allowed in if it is for long term care facility, hospice, patient receiving home health services and
emergency situations 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? 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 -Home infusion for pain (direct parenteral administration of a narcotic)
original? -LTCF
-Medicare certified hospice (must note hospice on Rx)
What additional information is required for a faxed C2? -Signature of sender (nurse)
-Pharmacist verifies sender
T/F: Signed C3-5 can be faxed True
Where must the fax machine be in the pharmacy? Pharmacy department
How many times can a C3-4 be refilled? Up to 5 refills in 6 months after the date of ISSUE
How are controlled substances received by the pharmacy? Pharmacist must sign the invoice of the controlled substance
How many times can a C3-5 be transferred? Once
CS prescription label requirements -Name and address of pharmacy
-Prescription number
-Date of dispensing
-Name of patient
-Name of prescriber
-Directions
-Cautionary statements
Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding
Food, Drug and Cosmetic Act (1938) -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) -Established prescription and OTC drug categories
-Allowed for oral prescriptions
-Allowed for refills
Manufacturer label on Rx drugs after Durham-Humphrey -Not required to have directions for use
Amendment -"Caution: Federal law prohibits dispensing w/o a prescription"
Kefauver-Harris Amendment (1962) -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? FTC
Hatch-Waxman Amendment -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 Distributor registered with the DEA to destroy drugs
# of DEA registrations: owner of two pharmacies 2
# of DEA registrations: hospital with inpatient satellites 1
# of DEA registrations: hospital with outpatient pharmacy 2
down the street
# of DEA registrations: pharmacy with nursing home 2
business
# of DEA registrations: consultant pharmacist 0
# of DEA registrations: pharmacy that does coop buying 2
, Alabama MPJE | Pharmacy Law Practice Questions, Answers & Exam Review 2026-2027
# of DEA registrations: pharmacy that provides methadone 1
Explain DEA number 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 Any employee authorized to prescribe
to prescribe?
Explain the check digit in the DEA number? 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 Physician-patient relationship and scope of practice
deciding whether or not to fill a prescription?
What information must be on a prescription for a controlled 1. Patient name
substance? 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 Drug Addiction Treatment Act (DATA)
programs (buprenorphine rather than methadone)?
T/F: Methadone prescriptions not written in multiple daily True
doses should be assumed for maintenance of addiction
and only dispensed by MMPs
T/F: A pharmacy may use a computer to store records of True
C3-5
Computerized refill history must include -Drug name
-Date of refill
-Quantity dispensed
-Total number of refills (pills) dispensed to date
-Pharmacist identifier
Computer generated prescription/refill information must be 2 years after the dispensing date
maintained for ___
What must the pharmacist write on the printout of the day's Signature and date (by each pharmacist that dispensed)
CS refills?
Refill printout must be provided to each pharmacy that 72 hours
uses the computer system within ___ of the refill being
dispensed
, Alabama MPJE | Pharmacy Law Practice Questions, Answers & Exam Review 2026-2027
Printout of refill data must include -Patient name and address
-Prescriber name
-Pharmacist ID
-Prescription number
-Date dispensed
-Quantity dispensed
A centralized pharmacy must be capable of giving refill 48 hours
printouts to a requesting pharmacy within ____
T/F: C2 prescriptions must be written and manually signed True
When do C2 prescriptions expire? Never
T/F: Oral orders for C2 prescriptions are allowed in if it is for long term care facility, hospice, patient receiving home health services and
emergency situations 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? 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 -Home infusion for pain (direct parenteral administration of a narcotic)
original? -LTCF
-Medicare certified hospice (must note hospice on Rx)
What additional information is required for a faxed C2? -Signature of sender (nurse)
-Pharmacist verifies sender
T/F: Signed C3-5 can be faxed True
Where must the fax machine be in the pharmacy? Pharmacy department
How many times can a C3-4 be refilled? Up to 5 refills in 6 months after the date of ISSUE
How are controlled substances received by the pharmacy? Pharmacist must sign the invoice of the controlled substance
How many times can a C3-5 be transferred? Once
CS prescription label requirements -Name and address of pharmacy
-Prescription number
-Date of dispensing
-Name of patient
-Name of prescriber
-Directions
-Cautionary statements
