Update!!!
1. Pure Food and Drug Act (1906) aka Prohibits adulteration and misbranding
Wiley Law
2. 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
3. Durham-Humphrey Amendment -Established prescription and OTC drug categories
(1951) -Allowed for oral prescriptions
-Allowed for refills
4. Manufacturer label on Rx drugs -Not required to have directions for use
after Durham-Humphrey Amend- -"Caution: Federal law prohibits dispensing w/o a
ment prescription"
5. Kefauver-Harris Amendment (1962) -New drug could not be marketed unless ettective
-Informed consent
-FDA allowed to regulate prescription drug advertis-
ing
-Reporting of ADRs
-GMPs
6. Who regulates OTC drug advertis- FTC
ing?
7. Hatch-Waxman Amendment -Generics only have to submit abbreviated NDA
(ANDA): bioequivalence, not safety and eflcacy
-Gives incentives to brand manufacturers by giving 5
more years of patent protection (up to 22 years)
8. Reverse distributor Distributor registered with the DEA to destroy drugs
9. 2
, Alabama MPJE Exam Questions And Answers Verified 100% Correct 2026
Update!!!
# of DEA registrations: owner of two
pharmacies
10. # of DEA registrations: hospital with 1
inpatient satellites
11. # of DEA registrations: hospital 2
with outpatient pharmacy down the
street
12. # of DEA registrations: pharmacy 2
with nursing home business
13. # of DEA registrations: consultant 0
pharmacist
14. # of DEA registrations: pharmacy 2
that does coop buying
15. # of DEA registrations: pharmacy 1
that provides methadone
16. 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
17. Who can use the hospital DEA num- Any employee authorized to prescribe
ber and internal code to prescribe?
18. Explain the check digit in the DEA a) Add 1,3,5
number? b) Add 2,4,6 and multiply by 2
, Alabama MPJE Exam Questions And Answers Verified 100% Correct 2026
Update!!!
c) Add (a) and (b)
d) Last digit in the sum is the check digit
19. What two things should a pharma- Physician-patient relationship and scope of practice
cist look for when deciding whether
or not to fill a prescription?
20. What information must be on a 1. Patient name
prescription for a controlled sub- 2. Patient address
stance? 3. Date written
4. Drug, quantity, directions
5. Physician signature
6. Physician address
7. Physician DEA number
21. What act developed office Drug Addiction Treatment Act (DATA)
based narcotic maintenance pro-
grams (buprenorphine rather than
methadone)?
22. T/F: Methadone prescriptions not True
written in multiple daily doses
should be assumed for mainte-
nance of addiction and only dis-
pensed by MMPs
23. T/F: A pharmacy may use a comput- True
er to store records of C3-5
24. Computerized refill history must in- -Drug name
clude -Date of refill
-Quantity dispensed
, Alabama MPJE Exam Questions And Answers Verified 100% Correct 2026
Update!!!
-Total number of refills (pills) dispensed to date
-Pharmacist identifier
25. Computer generated prescrip- 2 years after the dispensing date
tion/refill information must be
maintained for
26. What must the pharmacist write on Signature and date (by each pharmacist that dis-
the printout of the day's CS refills? pensed)
27. Refill printout must be provided to 72 hours
each pharmacy that uses the com-
puter system within of the refill
being dispensed
28. Printout of refill data must include -Patient name and address
-Prescriber name
-Pharmacist ID
-Prescription number
-Date dispensed
-Quantity dispensed
29. A centralized pharmacy must be ca- 48 hours
pable of giving refill printouts to a
requesting pharmacy within
30. T/F: C2 prescriptions must be writ- True
ten and manually signed
31. When do C2 prescriptions expire? Never
32. if it is for long term care facility, hospice, patient re-
ceiving home health services and the amount is only