FLORIDA MPJE BUNDLED EXAMS ACTUAL
EXAMS 2026 COMPLETE QUESTIONS AND
ANSWERS GRADED A+
⩥ Federal Food Drug and Cosmetic Act. Answer: This act states:
No adulterated or misbranded drugs in interstate commerce
⩥ Adulteration. Answer: Gross - Think inside the capsule
⩥ Misbranded. Answer: Improperly labeled - think outside the bottle
⩥ FDCA. Answer: This act requires:
ingredients are disclosed on bottle
drug must be proven safe before marketing
authorizes FDA inspection of manufactures and distributors
⩥ Public Health Service Act. Answer: This act:
- biologic drugs approved under BLA not NDA
- reviewed for purity, potency, and safety
⩥ Durham- Humphrey Labeling Amendments to FDCA. Answer: This
act:
,- allows for refills
- establishes Rx and OTC
⩥ OTC requirements of Durham-Humphrey. Answer: This act states:
- must be labeled with adequate directions for use (drug facts label)
- pregnancy/ breast feeding warning
- domestic contact information to receive ADR report
- OTC drugs approved under OTC monograph or NDA
⩥ Rx requirements of Durham-Humphrey. Answer: This act states:
- Rx must be labeled with adequate info for use (package insert)
- Rx approved under NDA - grandfathered pre 1938
⩥ Durham-Humphrey Act established Pregnancy Categories
What are they?. Answer: A - safe in humans
B - safe in animals - no data in humans
C - Unknown safety in humans
D - unsafe in humans - benefits may outweigh risks
X - unsafe in humans - risks always outweighs benefits
⩥ Unit Dose Drugs - Labeling requirements. Answer: These items are
required on which labels?
,- generic name or brand - not both
- strength
- dosage form
- exp date (1 yr or earlier if manufacturer is sooner)
- Lot number
- business name of packager
- qty
-Rx only + Cautionary statement (if applies)
** directions for use are not required on dose but should be stored where
can be accessed easily
⩥ Kefauver-Harris Drug Efficacy Amendments to FDCA. Answer: This
act states:
- drugs must be proven effective before marketing
- creates NDA and SNDA
Phase I, II, and III research - studies require informed
consent and IRB approval
- IND required to test new drugs in humans (FDA has 30 days to issues
"clinical hold" or else study can proceed
- mandates informed consent in clinical research
- ADRs must be reported to FDA on Med Watch Form
Manufacturers are required to report ADRs
Healthcare professionals and patients are voluntary
, - All drug labels must have brand and generic name
- Advertising FDA for Rx FTC for OTC
- Establishes cGMP - current good manufacturing practices
- Manufacturers must register facility and be inspected every 2 years
- If not registered - drugs are Misbranded
- If a facility produces substandards of strength, quality or purity drugs
are adulterated
⩥ Advertising of Rx drugs is by. Answer: FDA
⩥ Advertising of OTC drugs is by. Answer: FTC
⩥ ADRs must be reported on which form. Answer: Med Watch Form
⩥ If a Manufacturer is not registered the drugs are considered. Answer:
Misbranded
⩥ If a facility produces substandards of strength, quality, or purity drugs
are considered _________?. Answer: Adulterated
⩥ Pharmacies that compound large amounts of drug not based on an
individual's Rx must register with the FDA as a _____________?.
Answer: Manufacturer and meet cGMP
EXAMS 2026 COMPLETE QUESTIONS AND
ANSWERS GRADED A+
⩥ Federal Food Drug and Cosmetic Act. Answer: This act states:
No adulterated or misbranded drugs in interstate commerce
⩥ Adulteration. Answer: Gross - Think inside the capsule
⩥ Misbranded. Answer: Improperly labeled - think outside the bottle
⩥ FDCA. Answer: This act requires:
ingredients are disclosed on bottle
drug must be proven safe before marketing
authorizes FDA inspection of manufactures and distributors
⩥ Public Health Service Act. Answer: This act:
- biologic drugs approved under BLA not NDA
- reviewed for purity, potency, and safety
⩥ Durham- Humphrey Labeling Amendments to FDCA. Answer: This
act:
,- allows for refills
- establishes Rx and OTC
⩥ OTC requirements of Durham-Humphrey. Answer: This act states:
- must be labeled with adequate directions for use (drug facts label)
- pregnancy/ breast feeding warning
- domestic contact information to receive ADR report
- OTC drugs approved under OTC monograph or NDA
⩥ Rx requirements of Durham-Humphrey. Answer: This act states:
- Rx must be labeled with adequate info for use (package insert)
- Rx approved under NDA - grandfathered pre 1938
⩥ Durham-Humphrey Act established Pregnancy Categories
What are they?. Answer: A - safe in humans
B - safe in animals - no data in humans
C - Unknown safety in humans
D - unsafe in humans - benefits may outweigh risks
X - unsafe in humans - risks always outweighs benefits
⩥ Unit Dose Drugs - Labeling requirements. Answer: These items are
required on which labels?
,- generic name or brand - not both
- strength
- dosage form
- exp date (1 yr or earlier if manufacturer is sooner)
- Lot number
- business name of packager
- qty
-Rx only + Cautionary statement (if applies)
** directions for use are not required on dose but should be stored where
can be accessed easily
⩥ Kefauver-Harris Drug Efficacy Amendments to FDCA. Answer: This
act states:
- drugs must be proven effective before marketing
- creates NDA and SNDA
Phase I, II, and III research - studies require informed
consent and IRB approval
- IND required to test new drugs in humans (FDA has 30 days to issues
"clinical hold" or else study can proceed
- mandates informed consent in clinical research
- ADRs must be reported to FDA on Med Watch Form
Manufacturers are required to report ADRs
Healthcare professionals and patients are voluntary
, - All drug labels must have brand and generic name
- Advertising FDA for Rx FTC for OTC
- Establishes cGMP - current good manufacturing practices
- Manufacturers must register facility and be inspected every 2 years
- If not registered - drugs are Misbranded
- If a facility produces substandards of strength, quality or purity drugs
are adulterated
⩥ Advertising of Rx drugs is by. Answer: FDA
⩥ Advertising of OTC drugs is by. Answer: FTC
⩥ ADRs must be reported on which form. Answer: Med Watch Form
⩥ If a Manufacturer is not registered the drugs are considered. Answer:
Misbranded
⩥ If a facility produces substandards of strength, quality, or purity drugs
are considered _________?. Answer: Adulterated
⩥ Pharmacies that compound large amounts of drug not based on an
individual's Rx must register with the FDA as a _____________?.
Answer: Manufacturer and meet cGMP
