TENNESSEE MPJE | COMPREHENSIVE
EXAM PREP, PRACTICE QUESTIONS,
CORRECT ANSWERS AND STUDY GUIDE
| GRADED A+ | GUARANTEED SUCCESS
Updated 2026 Questions and Answers
100% Verified Exam Prep
,DEFINITIONS
Drug Intended for use in diagnosis, treatment or prevention of disease
Food Intended for use as a food or drink
Device Intended to affect the structure or function of the body
Cosmetic Intended to be applied to the body for cleansing, beautifying, or promoting
attractiveness
Label Actual written/printed information placed upon the container (commercial container)
Labeling Federal definition: Written/printed information placed upon the container PLUS any other
written/printed information packaged with the container
Tennessee definition: The act of placing a label on the prescription bottle
Promotional Labeling Information such as advertising that does not accompany the container (e.g.,
advertisements)
*Must give fair balance of risk vs benefit
Prescription/Legend/Non-Proprietary Drug Product that CANNOT be taken safely without medical supervision
Manufacturer must provide adequate INFORMATION for use to prescribers and
dispensers
The Rx label must provide adequate DIRECTIONS for use to the patient
Advertising is regulated by the FDA
Non-Prescription/OTC/Proprietary/Patent Drugs Manufacturers are able to provide adequate DIRECTIONS for use so a patient can take
safely without medical supervision
Labeling must provide complete information ("Drug Facts Panel," directions for use,
warnings, active and inactive ingredients, telephone number for questions)
Advertising is regulated by the FTC
,Pregnancy Category A Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the
first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Ex. Folic Acid, Levothyroxine, Magnesium Sulfate
Pregnancy Category B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are
no adequate and well-controlled studies in pregnant women.
Ex. Metformin, HCTZ, Amoxicillin, Pantoprazole
Pregnancy Category C Animal reproduction studies have shown an adverse effect on the fetus and there are no
adequate and well-controlled studies in humans, but potential benefits may warrant use
of the drug in pregnant women despite potential risks.
Ex. Tramadol, Trazodone, Prednisone, Amlodipine, Gabapentin
Pregnancy Category D There is positive evidence of human fetal risk based on adverse reaction data from
investigational or marketing experience or studies in humans, but potential benefits may
warrant use of the drug in pregnant women despite potential risks.
Ex. Lisinopril, Alprazolam (BZDs), Losartan
Pregnancy Category X Studies in animals or humans have demonstrated fetal abnormalities and/or there is
positive evidence of human fetal risk based on adverse reaction data from investigational
or marketing experience, and the risks involved in use of the drug in pregnant women
clearly outweigh potential benefits.
Ex. Warfarin, Atorvastatin (Statins), Methotrexate, Finasteride
National Drug Code Number (NDC) Unique 11 digit number assigned to a drug product
First 5 - manufacturer/distributor
Next 4 - strength, dosage form, and formulation
Last 2 - package size
*NDC does NOT indicate FDA approval
, New Drug A drug that is not generally accepted by experts as safe and effective for the intended
use
- New package material (e.g., glass to plastic)
- New dosage form or method of administration
- New combination of approved drugs
- New intended use/indication
- New dosage or strength
- New patient population
- New chemical entity
Investigational New Drug A drug that has been tested on animals, and has shown it is safe and effective for the
intended treatment
Investigational New Drug Application (INDA) Filed with the FDA BEFORE testing the drug on humans
*If FDA does NOT reject the INDA within 30 DAYS, trials in humans can begin
Phase I Clinical Trial Drug is tested in a SMALL number of HEALTHY people to establish SAFETY
Phase II Clinical Trial Drug is tested in a LIMITED number of SICK people to establish its EFFICACY and
SAFETY
Phase III Clinical Trial Drug is tested on a LARGE number of SICK people to establish EFFICACY and SAFETY
Phase IV Clinical Trial AFTER drug is approved the manufacturer will do post-market surveillance
Informed Consent WRITTEN consent REQUIRED in Phase I and II
ORAL consent PERMITTED in Phase III
Compassionate Use/Treatment INDA Allows investigational drugs to be used to treat patients who are not enrolled in the
clinical trial
*Condition must be serious/life-threatening
*No other effective treatment options available
*Can use drugs in Phases I, II or III
EXAM PREP, PRACTICE QUESTIONS,
CORRECT ANSWERS AND STUDY GUIDE
| GRADED A+ | GUARANTEED SUCCESS
Updated 2026 Questions and Answers
100% Verified Exam Prep
,DEFINITIONS
Drug Intended for use in diagnosis, treatment or prevention of disease
Food Intended for use as a food or drink
Device Intended to affect the structure or function of the body
Cosmetic Intended to be applied to the body for cleansing, beautifying, or promoting
attractiveness
Label Actual written/printed information placed upon the container (commercial container)
Labeling Federal definition: Written/printed information placed upon the container PLUS any other
written/printed information packaged with the container
Tennessee definition: The act of placing a label on the prescription bottle
Promotional Labeling Information such as advertising that does not accompany the container (e.g.,
advertisements)
*Must give fair balance of risk vs benefit
Prescription/Legend/Non-Proprietary Drug Product that CANNOT be taken safely without medical supervision
Manufacturer must provide adequate INFORMATION for use to prescribers and
dispensers
The Rx label must provide adequate DIRECTIONS for use to the patient
Advertising is regulated by the FDA
Non-Prescription/OTC/Proprietary/Patent Drugs Manufacturers are able to provide adequate DIRECTIONS for use so a patient can take
safely without medical supervision
Labeling must provide complete information ("Drug Facts Panel," directions for use,
warnings, active and inactive ingredients, telephone number for questions)
Advertising is regulated by the FTC
,Pregnancy Category A Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the
first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Ex. Folic Acid, Levothyroxine, Magnesium Sulfate
Pregnancy Category B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are
no adequate and well-controlled studies in pregnant women.
Ex. Metformin, HCTZ, Amoxicillin, Pantoprazole
Pregnancy Category C Animal reproduction studies have shown an adverse effect on the fetus and there are no
adequate and well-controlled studies in humans, but potential benefits may warrant use
of the drug in pregnant women despite potential risks.
Ex. Tramadol, Trazodone, Prednisone, Amlodipine, Gabapentin
Pregnancy Category D There is positive evidence of human fetal risk based on adverse reaction data from
investigational or marketing experience or studies in humans, but potential benefits may
warrant use of the drug in pregnant women despite potential risks.
Ex. Lisinopril, Alprazolam (BZDs), Losartan
Pregnancy Category X Studies in animals or humans have demonstrated fetal abnormalities and/or there is
positive evidence of human fetal risk based on adverse reaction data from investigational
or marketing experience, and the risks involved in use of the drug in pregnant women
clearly outweigh potential benefits.
Ex. Warfarin, Atorvastatin (Statins), Methotrexate, Finasteride
National Drug Code Number (NDC) Unique 11 digit number assigned to a drug product
First 5 - manufacturer/distributor
Next 4 - strength, dosage form, and formulation
Last 2 - package size
*NDC does NOT indicate FDA approval
, New Drug A drug that is not generally accepted by experts as safe and effective for the intended
use
- New package material (e.g., glass to plastic)
- New dosage form or method of administration
- New combination of approved drugs
- New intended use/indication
- New dosage or strength
- New patient population
- New chemical entity
Investigational New Drug A drug that has been tested on animals, and has shown it is safe and effective for the
intended treatment
Investigational New Drug Application (INDA) Filed with the FDA BEFORE testing the drug on humans
*If FDA does NOT reject the INDA within 30 DAYS, trials in humans can begin
Phase I Clinical Trial Drug is tested in a SMALL number of HEALTHY people to establish SAFETY
Phase II Clinical Trial Drug is tested in a LIMITED number of SICK people to establish its EFFICACY and
SAFETY
Phase III Clinical Trial Drug is tested on a LARGE number of SICK people to establish EFFICACY and SAFETY
Phase IV Clinical Trial AFTER drug is approved the manufacturer will do post-market surveillance
Informed Consent WRITTEN consent REQUIRED in Phase I and II
ORAL consent PERMITTED in Phase III
Compassionate Use/Treatment INDA Allows investigational drugs to be used to treat patients who are not enrolled in the
clinical trial
*Condition must be serious/life-threatening
*No other effective treatment options available
*Can use drugs in Phases I, II or III
