Nebraska_MPJE_Exam_396_Questions_
Verified_Answers_2025-2026
1. What legistation was created for the provi- Food and Drug Administration (FDA) Mod-
sions for the fast track review of some NDA ernization Act 1997
submissions to expedite approval of new
drugs used to treat life-threatening condi-
tions?
2. What legistation encouraged manufactur- FDA modernization act 1997
ers to conduct research for new uses of
drugs and to submit SNDAs for these uses?
3. What act reduced the cose of orphan Orphan drug act 1983
drugs?
4. What act prohibited the adulteration or Pure Food and Drug Act 1906
misbranding of food and drugs?
5. What act required tha active ingredients be Pure food and drug act 1906
placed on the label of a drug's packaging
and that drugs couldn't fall below purity
levels established by the USP or National
Formulary?
6. What amendment de�ned two categories - Durham-humphrey 1951
legend and OTC
7. What amendment mandated there must Durham-Humphrey 1951
be "adequate directions for use" on the
manufacturer's label for OTC's
8. What amendment declared that all new Kefauver-Harris 1962
drugs marketed in the U.S. had to be
shown to be safe and e ective
,9. What act was passed to correct the prob- Prescription Drug Marketing Act 1987
lem of diversion from the normal distri-
bution channels. Prohibits drug from be-
ing re-imported into the U.S. Except by the
manufacturer of said drugs.
10. What act requires proper storage of drugs Prescription Drug Marketing Act 1987
and maintenance of appropriate distribu-
tion records?
11. What act prohibits sale, purchase, or trade Prescription Drug Marketing Act 1987
of any drug which was purchased by a pub-
lic or private hospital or other health care
entity?
12. What act prohibits the sale, purchase, or Prescription Drug Marketing Act 1987
trade of any drug sample or drug coupon
redeemable for a drug product?
13. To be PIC what are the hourly requirements majority of the hours per week that the
they must physically work in a pharmacy? pharmacy is open averaged over a 12 -
month period or 30 hours per week
14. Who must submit the Pharmacy Quality As- PIC and Annually
surance Report and when?
15. Who submits the Parkinson's Disease Reg- PIC
istry Act to the Department semiannually?
16. Who needs to be noti�ed if there's a Department of Health and Human Services
change in pharmacy ownersip, address,
PIC, or pharmacy closes?
, 17. Within how many days should the depart- 30 days prior
ment be noti�ed that a pharmacy is clos-
ing?
18. Within how many days should the depart- 15 days
ment be noti�ed of the disposition/sale of
inventory, prescription records, etc due to
pharmacy closing?
19. When shold the department be noti�ed of Immediately
a change in PIC?
20. What information is reported under the Report shall include the name, address,
Parkinson's disease registry and socical security number of the person
for whom the drugs were prescribed and
the name and address of the prescribing
physician
21. How long must a pharmacy maintain in- 5 years
ventory records
22. Within how many days should a copy of Within 30 days after completion
the initial CS inventory, annual invento-
ry, and/or CS inventory take pursuant to
change in PIC be forwarded to the Depart-
ment?
23. In the event of a pharmacy closing what Pharmacy license, pharmacy's DEA regis-
documents must be returned to the De- tration, all unused DEA 222 Forms
partment
24. 2 years
Verified_Answers_2025-2026
1. What legistation was created for the provi- Food and Drug Administration (FDA) Mod-
sions for the fast track review of some NDA ernization Act 1997
submissions to expedite approval of new
drugs used to treat life-threatening condi-
tions?
2. What legistation encouraged manufactur- FDA modernization act 1997
ers to conduct research for new uses of
drugs and to submit SNDAs for these uses?
3. What act reduced the cose of orphan Orphan drug act 1983
drugs?
4. What act prohibited the adulteration or Pure Food and Drug Act 1906
misbranding of food and drugs?
5. What act required tha active ingredients be Pure food and drug act 1906
placed on the label of a drug's packaging
and that drugs couldn't fall below purity
levels established by the USP or National
Formulary?
6. What amendment de�ned two categories - Durham-humphrey 1951
legend and OTC
7. What amendment mandated there must Durham-Humphrey 1951
be "adequate directions for use" on the
manufacturer's label for OTC's
8. What amendment declared that all new Kefauver-Harris 1962
drugs marketed in the U.S. had to be
shown to be safe and e ective
,9. What act was passed to correct the prob- Prescription Drug Marketing Act 1987
lem of diversion from the normal distri-
bution channels. Prohibits drug from be-
ing re-imported into the U.S. Except by the
manufacturer of said drugs.
10. What act requires proper storage of drugs Prescription Drug Marketing Act 1987
and maintenance of appropriate distribu-
tion records?
11. What act prohibits sale, purchase, or trade Prescription Drug Marketing Act 1987
of any drug which was purchased by a pub-
lic or private hospital or other health care
entity?
12. What act prohibits the sale, purchase, or Prescription Drug Marketing Act 1987
trade of any drug sample or drug coupon
redeemable for a drug product?
13. To be PIC what are the hourly requirements majority of the hours per week that the
they must physically work in a pharmacy? pharmacy is open averaged over a 12 -
month period or 30 hours per week
14. Who must submit the Pharmacy Quality As- PIC and Annually
surance Report and when?
15. Who submits the Parkinson's Disease Reg- PIC
istry Act to the Department semiannually?
16. Who needs to be noti�ed if there's a Department of Health and Human Services
change in pharmacy ownersip, address,
PIC, or pharmacy closes?
, 17. Within how many days should the depart- 30 days prior
ment be noti�ed that a pharmacy is clos-
ing?
18. Within how many days should the depart- 15 days
ment be noti�ed of the disposition/sale of
inventory, prescription records, etc due to
pharmacy closing?
19. When shold the department be noti�ed of Immediately
a change in PIC?
20. What information is reported under the Report shall include the name, address,
Parkinson's disease registry and socical security number of the person
for whom the drugs were prescribed and
the name and address of the prescribing
physician
21. How long must a pharmacy maintain in- 5 years
ventory records
22. Within how many days should a copy of Within 30 days after completion
the initial CS inventory, annual invento-
ry, and/or CS inventory take pursuant to
change in PIC be forwarded to the Depart-
ment?
23. In the event of a pharmacy closing what Pharmacy license, pharmacy's DEA regis-
documents must be returned to the De- tration, all unused DEA 222 Forms
partment
24. 2 years
