LOUISIANA MPJE REVIEW EXAM 2025
QUESTIONS AND ANSWERS
Food, Drug, and Cosmetic Act (FDCA) notes that certain products requires a ___ and with ___. -
ANS a batch process with instructions for use and warnings for abuse.
FDCA requires ___ documentation for drugs. - ANS SAFETY
The FDCA is the the FDA's ______. - ANS primary federal law
Three major Limitations to the FDCA? - ANS 1. Need to document safety only
2. Created an Rx only class of medications
3. Application to INTRASTATE commerce
also, created a loophole for current products (i.e., levothyroxine)
Durham-Humfrey Amendment of 1951 , which served as an update to the FDCA, clarified the
role of ____ and ____. - ANS prescription and pharmacist
Durham-Humfrey classified drugs into two different categories ___ vs ___. Prescriptions were
allowed in both ____ forms by authorized personnel. - ANS Rx (prescription) vs OTC
oral and written (must write immediately)
Kefauver-Harris Amendement of 1962 required ____. Drugs must be proven ____, in
accordance to safety. - ANS 1. Extensive animal testing prior to use in humans
1 Copyright ©2025 BRAINBARTER ALL RIGHTS RESERVED
,2. EFFECTIVE
____ requires submission of an IND followed by a NDA. - ANS Kefauver-Harris
IND (Investigational New Drug)
NDA (New Drug Application)
According to Kefauver-Harris Amendment:
OTC medications are regulated by the ___.
Prescription Medications are regulated by the ____,
FDA trials require _________________ - ANS FTC (Federal Trade Commission)
FDA
(1) informed consent (2) reporting of SE (3) GMPs*
According to the FDCA prescriptions need to be stored for a minimum of ___. - ANS 5 years
According to the Medicare Modernization Act of 2003 prescriptions need to be stored for a
minimum of ___. - ANS 10 years
Who is authorized to Prescribe in LA? - ANS MD
DO (Osteopathic Medicine)
PA
NP
TO (therapeutic Optometrist)
T or F? Self prescribing in LA is okay? if so, why? - ANS True, you *must* document the note,
exam, or test.
Avoid Filling a prescription if ___.
2 Copyright ©2025 BRAINBARTER ALL RIGHTS RESERVED
,NOTE: *LA does not have CONSCIENTIOUS OBJECTION* - ANS 1. Forgery (signature, written,
voice w/o permission)
2. Fictitious (Fake patient or MD)
3. Violation of the law
4. Harmful to a patient
Original Prescription, prior to filling, belongs to the ___. After filling, it belongs to ____. Patients
can only receive a ___ of the prescription after it is filled. *NEVER GIVE BACK THE ORIGINAL.* -
ANS patient
pharmacy
copy
Louisiana Rx Labeling Requirements - ANS 1. Prescriber's name, licensure designation,
address, telephone number, and if for a controlled
substance, the Drug Enforcement Administration (DEA) registration number;
2. Patient's name, and if for a controlled substance, address;
3. Date prescription issued by the prescriber;
4. Name of drug or device, and if applicable, strength, and quantity to be dispensed;
5. Directions for use;
6. Signature of prescriber; and
7. Refill instructions, if any. In the absence of refill instructions on the original prescription, the
prescription shall not be refilled.
Information NOT required by Federal Law on a prescription - ANS Exp. Date (BUD for
compounding)
Lot #
Manufacturer Data
3 Copyright ©2025 BRAINBARTER ALL RIGHTS RESERVED
, Poison Prevention Act of 1970 requires _____ for children < ___. Less than ___% of children can
get in, and about ____% or more of adults CAN get in. - ANS child resistant containers for
children less than 5 years old.
less than 20% (1/5) of children can get in
90% adults can get in
Only the ___ can request both single scripts and blanket of Scripts to be in an easy open
containers.
___ can only request a "single script" at a time.
Pharmacists cannot request easy opens at all. - ANS Patients
Prescribers
Plastic vials cannot be recycled; however ___ can be recycled INDEFINITELY! - ANS glass
Medications excluded from the Poison Prevention Act: - ANS Nitroglycerin SL
Isosorbide dinitrate 10mg or less
EES granules not more than 8 g
EES suspension not more than 16 g
Cholestyramine PWD
Colestipol less than 5g)
K+ Supp. not more than 50 mEq and packs
Sodium Fluoride NTE 264
Betamethasone NTE 12.6 mg/pack
Prednisone (less than 105mg)
Mebendazole (not more than 600mg)
Methylprednisolone (less than 84 mg)
Conjugates Estrogen (less than 32mg)
Pancrealipase Preps.
Oral Contraceptives
4 Copyright ©2025 BRAINBARTER ALL RIGHTS RESERVED
QUESTIONS AND ANSWERS
Food, Drug, and Cosmetic Act (FDCA) notes that certain products requires a ___ and with ___. -
ANS a batch process with instructions for use and warnings for abuse.
FDCA requires ___ documentation for drugs. - ANS SAFETY
The FDCA is the the FDA's ______. - ANS primary federal law
Three major Limitations to the FDCA? - ANS 1. Need to document safety only
2. Created an Rx only class of medications
3. Application to INTRASTATE commerce
also, created a loophole for current products (i.e., levothyroxine)
Durham-Humfrey Amendment of 1951 , which served as an update to the FDCA, clarified the
role of ____ and ____. - ANS prescription and pharmacist
Durham-Humfrey classified drugs into two different categories ___ vs ___. Prescriptions were
allowed in both ____ forms by authorized personnel. - ANS Rx (prescription) vs OTC
oral and written (must write immediately)
Kefauver-Harris Amendement of 1962 required ____. Drugs must be proven ____, in
accordance to safety. - ANS 1. Extensive animal testing prior to use in humans
1 Copyright ©2025 BRAINBARTER ALL RIGHTS RESERVED
,2. EFFECTIVE
____ requires submission of an IND followed by a NDA. - ANS Kefauver-Harris
IND (Investigational New Drug)
NDA (New Drug Application)
According to Kefauver-Harris Amendment:
OTC medications are regulated by the ___.
Prescription Medications are regulated by the ____,
FDA trials require _________________ - ANS FTC (Federal Trade Commission)
FDA
(1) informed consent (2) reporting of SE (3) GMPs*
According to the FDCA prescriptions need to be stored for a minimum of ___. - ANS 5 years
According to the Medicare Modernization Act of 2003 prescriptions need to be stored for a
minimum of ___. - ANS 10 years
Who is authorized to Prescribe in LA? - ANS MD
DO (Osteopathic Medicine)
PA
NP
TO (therapeutic Optometrist)
T or F? Self prescribing in LA is okay? if so, why? - ANS True, you *must* document the note,
exam, or test.
Avoid Filling a prescription if ___.
2 Copyright ©2025 BRAINBARTER ALL RIGHTS RESERVED
,NOTE: *LA does not have CONSCIENTIOUS OBJECTION* - ANS 1. Forgery (signature, written,
voice w/o permission)
2. Fictitious (Fake patient or MD)
3. Violation of the law
4. Harmful to a patient
Original Prescription, prior to filling, belongs to the ___. After filling, it belongs to ____. Patients
can only receive a ___ of the prescription after it is filled. *NEVER GIVE BACK THE ORIGINAL.* -
ANS patient
pharmacy
copy
Louisiana Rx Labeling Requirements - ANS 1. Prescriber's name, licensure designation,
address, telephone number, and if for a controlled
substance, the Drug Enforcement Administration (DEA) registration number;
2. Patient's name, and if for a controlled substance, address;
3. Date prescription issued by the prescriber;
4. Name of drug or device, and if applicable, strength, and quantity to be dispensed;
5. Directions for use;
6. Signature of prescriber; and
7. Refill instructions, if any. In the absence of refill instructions on the original prescription, the
prescription shall not be refilled.
Information NOT required by Federal Law on a prescription - ANS Exp. Date (BUD for
compounding)
Lot #
Manufacturer Data
3 Copyright ©2025 BRAINBARTER ALL RIGHTS RESERVED
, Poison Prevention Act of 1970 requires _____ for children < ___. Less than ___% of children can
get in, and about ____% or more of adults CAN get in. - ANS child resistant containers for
children less than 5 years old.
less than 20% (1/5) of children can get in
90% adults can get in
Only the ___ can request both single scripts and blanket of Scripts to be in an easy open
containers.
___ can only request a "single script" at a time.
Pharmacists cannot request easy opens at all. - ANS Patients
Prescribers
Plastic vials cannot be recycled; however ___ can be recycled INDEFINITELY! - ANS glass
Medications excluded from the Poison Prevention Act: - ANS Nitroglycerin SL
Isosorbide dinitrate 10mg or less
EES granules not more than 8 g
EES suspension not more than 16 g
Cholestyramine PWD
Colestipol less than 5g)
K+ Supp. not more than 50 mEq and packs
Sodium Fluoride NTE 264
Betamethasone NTE 12.6 mg/pack
Prednisone (less than 105mg)
Mebendazole (not more than 600mg)
Methylprednisolone (less than 84 mg)
Conjugates Estrogen (less than 32mg)
Pancrealipase Preps.
Oral Contraceptives
4 Copyright ©2025 BRAINBARTER ALL RIGHTS RESERVED
