FLORIDA MPJE BUNDLED EXAMS
CERTIFICATION EVALUATION EXAMS 2026
UPDATED QUESTIONS WITH CORRECT
ANSWERS GRADED A+
⩥ Durham-Humphrey Amendments - 1951. Answer: - Established
prescription vs OTC
- Authorized verbal prescriptions and refills
⩥ Kefauver-Harris Amendment - 1962. Answer: - Drugs must be safe
and effective for the listed use
- Established good manufacturing practices
- FDA can regulate drug advertising
⩥ Prescription Drug Marketing Act - 1987. Answer: - Bans the
reimportation of prescription drugs
- Bans the sale of drug samples
- Regulates the storage of samples
⩥ The Drug Quality and Security Act - 2013. Answer: 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. Answer: Transaction data must be
maintained for 6 years
⩥ Illegitimate Product. Answer: - Submit FDA Form 3911
- Notify trading partners within 24 hrs
⩥ Adulteration. Answer: 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. Answer: 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. Answer: - 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. Answer: - 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. Answer: - 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. Answer: - Prescription = FDA
- OTC = Federal Trade Commission (FTC)
⩥ Patient Package Inserts in Hospitals. Answer: Must be provided to the
patient before the first administration and every 30 days after
⩥ MedGuides. Answer: 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. Answer: Safety and adherence programs for high-risk
medications
- Ex. Accutane, thalidomide, opioids, etc
CERTIFICATION EVALUATION EXAMS 2026
UPDATED QUESTIONS WITH CORRECT
ANSWERS GRADED A+
⩥ Durham-Humphrey Amendments - 1951. Answer: - Established
prescription vs OTC
- Authorized verbal prescriptions and refills
⩥ Kefauver-Harris Amendment - 1962. Answer: - Drugs must be safe
and effective for the listed use
- Established good manufacturing practices
- FDA can regulate drug advertising
⩥ Prescription Drug Marketing Act - 1987. Answer: - Bans the
reimportation of prescription drugs
- Bans the sale of drug samples
- Regulates the storage of samples
⩥ The Drug Quality and Security Act - 2013. Answer: 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. Answer: Transaction data must be
maintained for 6 years
⩥ Illegitimate Product. Answer: - Submit FDA Form 3911
- Notify trading partners within 24 hrs
⩥ Adulteration. Answer: 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. Answer: 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. Answer: - 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. Answer: - 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. Answer: - 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. Answer: - Prescription = FDA
- OTC = Federal Trade Commission (FTC)
⩥ Patient Package Inserts in Hospitals. Answer: Must be provided to the
patient before the first administration and every 30 days after
⩥ MedGuides. Answer: 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. Answer: Safety and adherence programs for high-risk
medications
- Ex. Accutane, thalidomide, opioids, etc
