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Louisiana MPJE Review Questions and Answers
(100% Correct Answers) Already Graded A+
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
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The FDCA is the the FDA's ______. Ans: primary federal law
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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)
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Kefauver-Harris Amendement of 1962 required ____. Drugs must be
proven ____, in accordance to safety. Ans: 1. Extensive animal testing
prior to use in humans
2. EFFECTIVE
____ requires submission of an IND followed by a NDA. Ans: Kefauver-
Harris
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IND (Investigational New Drug)
NDA (New Drug Application)
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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
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Who is authorized to Prescribe in LA? Ans: MD
DO (Osteopathic Medicine)
PA
NP
TO (therapeutic Optometrist)
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T or F? Self prescribing in LA is okay? if so, why? Ans: True, you must
document the note, exam, or test.
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Avoid Filling a prescription if ___.
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
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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;
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3. Date prescription issued by the prescriber;
4. Name of drug or device, and if applicable, strength, and quantity to
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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
1
Louisiana MPJE Review Questions and Answers
(100% Correct Answers) Already Graded A+
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
© 2026 Assignment Expert
The FDCA is the the FDA's ______. Ans: primary federal law
Guru01 - Stuvia
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)
,For Expert help and assignment handling,
2
Kefauver-Harris Amendement of 1962 required ____. Drugs must be
proven ____, in accordance to safety. Ans: 1. Extensive animal testing
prior to use in humans
2. EFFECTIVE
____ requires submission of an IND followed by a NDA. Ans: Kefauver-
Harris
© 2026 Assignment Expert
IND (Investigational New Drug)
NDA (New Drug Application)
Guru01 - Stuvia
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
,For Expert help and assignment handling,
3
Who is authorized to Prescribe in LA? Ans: MD
DO (Osteopathic Medicine)
PA
NP
TO (therapeutic Optometrist)
© 2026 Assignment Expert
T or F? Self prescribing in LA is okay? if so, why? Ans: True, you must
document the note, exam, or test.
Guru01 - Stuvia
Avoid Filling a prescription if ___.
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
, For Expert help and assignment handling,
4
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;
© 2026 Assignment Expert
3. Date prescription issued by the prescriber;
4. Name of drug or device, and if applicable, strength, and quantity to
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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
