FLORIDA MPJE
REVIEWED QUESTIONS
AND CORRECT ANSWERS
GRADED A+ 2025-2026
Food, Drug, and Cosmetic Act - 1938 - ANS-- New drugs must be proven safe before
marketing
- Established the FDA
Durham-Humphrey Amendments - 1951 - ANS-- Established prescription vs OTC
- Authorized verbal prescriptions and refills
Kefauver-Harris Amendment - 1962 - ANS-- Drugs must be safe and effective for the
listed use
- Established good manufacturing practices
- FDA can regulate drug advertising
Prescription Drug Marketing Act - 1987 - ANS-- Bans the reimportation of prescription
drugs
- Bans the sale of drug samples
- Regulates the storage of samples
The Drug Quality and Security Act - 2013 - ANS-Drug Compounding Quality Act
- 503A = individual prescription compounding
- 503B = mass compounding (outsourcing facilities)
,Drug Supply Chain Security Act
- Created the track and trace program
Track and Trace Records - ANS-Transaction data must be maintained for 6 years
Illegitimate Product - ANS-- Submit FDA Form 3911
- Notify trading partners within 24 hrs
Adulteration - ANS-A contaminated or subpar product
- Unsanitary conditions, unsafe additives, different strength/quality/purity, or the
facility is denying inspections
- Ex. misfill with the wrong strength, expired drug, not temp controlled, or residue
from another drug
Misbranded - ANS-The labeling is false, misleading, or missing required information
- Ex. dispensing Rx without authorization, misfill with the wrong
drug/strength/information, or does not meet REMS criteria
Drug Approval Process - ANS-- Investigational New Drug (IND) = applied for after
animal studies
- Phase 1 Clinical Trial = healthy volunteers to look for safety (20-80 people)
- Phase 2 Clinical Trial = drug/placebo groups to determine if it is effective for the
disease state (36-300 people)
- Phase 3 Clinical Trial = large-scale safety and effectiveness in different populations
with different doses (300-3,000 people)
- New Drug Application (NDA) = approval to market the drug
- Post Market Studies (Phase 4) = long-term use data
OTC Special Warning Requirements - ANS-- Yellow No. 5 (tartrazine) and 6
- Aspartame
- Sulfites
- Mineral Oil
, - Wintergreen Oil
- Sodium Phosphate
- Isoproterenol
- Potassium salts (oral)
- Ipecac syrup
- Phenacetin
- Salicylates
- Anything with alcohol content
- Contraception with spermicide (does not prevent STDs)
- Acetaminophen (liver)
- Ibuprofen (bleeding)
- Iron (oral)
FDA Drug and Device Recall - ANS-- Class 1 = reasonably could cause death or serious
harm
- Class 2 = temporary or reversible side effects
- Class 3 = not likely to cause harm
Drug Regulation - ANS-- Prescription = FDA
- OTC = Federal Trade Commission (FTC)
Patient Package Inserts in Hospitals - ANS-Must be provided to the patient before the
first administration and every 30 days after
MedGuides - ANS-Provided in the community setting for drugs that are high risk and
where adherence is crucial
- Ex. Accutane, antidepressants (minors only), warfarin, NSAIDs, BZD, opioids, etc
REMS - ANS-Safety and adherence programs for high-risk medications
- Ex. Accutane, thalidomide, opioids, etc
REVIEWED QUESTIONS
AND CORRECT ANSWERS
GRADED A+ 2025-2026
Food, Drug, and Cosmetic Act - 1938 - ANS-- New drugs must be proven safe before
marketing
- Established the FDA
Durham-Humphrey Amendments - 1951 - ANS-- Established prescription vs OTC
- Authorized verbal prescriptions and refills
Kefauver-Harris Amendment - 1962 - ANS-- Drugs must be safe and effective for the
listed use
- Established good manufacturing practices
- FDA can regulate drug advertising
Prescription Drug Marketing Act - 1987 - ANS-- Bans the reimportation of prescription
drugs
- Bans the sale of drug samples
- Regulates the storage of samples
The Drug Quality and Security Act - 2013 - ANS-Drug Compounding Quality Act
- 503A = individual prescription compounding
- 503B = mass compounding (outsourcing facilities)
,Drug Supply Chain Security Act
- Created the track and trace program
Track and Trace Records - ANS-Transaction data must be maintained for 6 years
Illegitimate Product - ANS-- Submit FDA Form 3911
- Notify trading partners within 24 hrs
Adulteration - ANS-A contaminated or subpar product
- Unsanitary conditions, unsafe additives, different strength/quality/purity, or the
facility is denying inspections
- Ex. misfill with the wrong strength, expired drug, not temp controlled, or residue
from another drug
Misbranded - ANS-The labeling is false, misleading, or missing required information
- Ex. dispensing Rx without authorization, misfill with the wrong
drug/strength/information, or does not meet REMS criteria
Drug Approval Process - ANS-- Investigational New Drug (IND) = applied for after
animal studies
- Phase 1 Clinical Trial = healthy volunteers to look for safety (20-80 people)
- Phase 2 Clinical Trial = drug/placebo groups to determine if it is effective for the
disease state (36-300 people)
- Phase 3 Clinical Trial = large-scale safety and effectiveness in different populations
with different doses (300-3,000 people)
- New Drug Application (NDA) = approval to market the drug
- Post Market Studies (Phase 4) = long-term use data
OTC Special Warning Requirements - ANS-- Yellow No. 5 (tartrazine) and 6
- Aspartame
- Sulfites
- Mineral Oil
, - Wintergreen Oil
- Sodium Phosphate
- Isoproterenol
- Potassium salts (oral)
- Ipecac syrup
- Phenacetin
- Salicylates
- Anything with alcohol content
- Contraception with spermicide (does not prevent STDs)
- Acetaminophen (liver)
- Ibuprofen (bleeding)
- Iron (oral)
FDA Drug and Device Recall - ANS-- Class 1 = reasonably could cause death or serious
harm
- Class 2 = temporary or reversible side effects
- Class 3 = not likely to cause harm
Drug Regulation - ANS-- Prescription = FDA
- OTC = Federal Trade Commission (FTC)
Patient Package Inserts in Hospitals - ANS-Must be provided to the patient before the
first administration and every 30 days after
MedGuides - ANS-Provided in the community setting for drugs that are high risk and
where adherence is crucial
- Ex. Accutane, antidepressants (minors only), warfarin, NSAIDs, BZD, opioids, etc
REMS - ANS-Safety and adherence programs for high-risk medications
- Ex. Accutane, thalidomide, opioids, etc
