Alabama MPJE Exam Practice Pack — Actual Questions
& 100% Correct Verified Answers | Updated 2025/2026
Edition | Pharmacy Law | Graded A+
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 Amendment ✔✔-Not required to have
directions for use
-"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 down the street ✔✔2
# of DEA registrations: pharmacy with nursing home business ✔✔2
# of DEA registrations: consultant pharmacist ✔✔0
# of DEA registrations: pharmacy that does coop buying ✔✔2
# 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 to prescribe? ✔✔Any employee authorized 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 deciding whether or not to fill a prescription?
✔✔Physician-patient relationship and scope of practice
What information must be on a prescription for a controlled substance? ✔✔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)? ✔✔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 ✔✔True
T/F: A pharmacy may use a computer to store records of C3-5 ✔✔True
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 maintained for ✔✔2 years after the
dispensing date
What must the pharmacist write on the printout of the day's CS refills? ✔✔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 ✔✔72 hours
Printout of refill data must include ✔✔-Patient name and address
-Prescriber name
-Pharmacist ID
-Prescription number
& 100% Correct Verified Answers | Updated 2025/2026
Edition | Pharmacy Law | Graded A+
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 Amendment ✔✔-Not required to have
directions for use
-"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 down the street ✔✔2
# of DEA registrations: pharmacy with nursing home business ✔✔2
# of DEA registrations: consultant pharmacist ✔✔0
# of DEA registrations: pharmacy that does coop buying ✔✔2
# 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 to prescribe? ✔✔Any employee authorized 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 deciding whether or not to fill a prescription?
✔✔Physician-patient relationship and scope of practice
What information must be on a prescription for a controlled substance? ✔✔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)? ✔✔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 ✔✔True
T/F: A pharmacy may use a computer to store records of C3-5 ✔✔True
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 maintained for ✔✔2 years after the
dispensing date
What must the pharmacist write on the printout of the day's CS refills? ✔✔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 ✔✔72 hours
Printout of refill data must include ✔✔-Patient name and address
-Prescriber name
-Pharmacist ID
-Prescription number
