MPJE Florida 2026/2027 Expert
Verifed Ace the Test
Durham-Humphrey Amendment - ANSWER ✔✔Created 2 classes of
drugs: OTC and Rx
Kefauver-Harris Amendment - ANSWER ✔✔This requires drug
manufacturers to provide proof of safety and efficacy.
Drug Importation - ANSWER ✔✔Florida allows drug importation from
Canada, but no plan has been approved yet by the HHS
Drug Quality and Security Act - DSQA - ANSWER ✔✔distinguishes
compounding from manufacturing
,503A vs 503B facilities - ANSWER ✔✔503A: may only compound
persuant to a prescription and are regulated by states
503B: outsourcing facilities; permitted to compound sterile products
without patient specific prescriptions. Exempt from the new drug
provisions, adequate directions, and track -and-trace. regulated by FDA
How soon do pharmacists have to notify the authorities of an illegitimate
product? - ANSWER ✔✔24 hours
Adulteration vs Misbranding - ANSWER ✔✔If a drug's strength is less
than the label says, it's both
adulteration: impure/unsanitary product, non-CGMP manufacturing
methods, unsafe/deleterious additives or containers
misbranding: label is false/misleading, does not have required
manufacturer labeling (OTC and Rx), is an imitation of another product
Products that Require Special Labeling - ANSWER ✔✔Yellow N5 &
N6
Aspartame
,Sulfites
Mineral oil
Wintergreen oil (methyl salicylate)
sodium phosphate
isoproterenol
potassium salts or oral ingestion
ipecac syrup
phenacetin
salicylates
APAP
NSAIDs
FDA Recall Classifications - ANSWER ✔✔Class III: not likely to
cause adverse events
Class II: may cause temporary or reversible adverse events
Class I: will cause either SAEs or death
PPIs vs MedGuides vs REMs - ANSWER ✔✔PPIs are currently
required for hormone products (OCP and Estrogen). MedGuides are a
step up and are required if patient labeling could prevent SAEs. REMs
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2026. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY
STATEMENT. ALL RIGHTS RESERVED
3
, are required if the FDA finds it necessary to ensure benefits outweigh
the risks
Orange Book - ANSWER ✔✔generic equivalents
Purple Book - ANSWER ✔✔Biological products and biosimilar
biosimilar does not = interchangeable
Exemptions to Poison Prevention Packaging Act - ANSWER ✔✔-by
request from patient/physician
-bulk containers (non-household)
-instutionalized patients
-OTC designed for elderly
-OCPs, conjugate estrogens, norethindrone, and medroxyprogesterone,
HRTs
-SL nitroglycerin and chewable isosorbide
-effervescent ASA or APAP
-unit dose potassium supplements
-sodium fluoride (<264mg)
-anhydrous cholestyramine
Verifed Ace the Test
Durham-Humphrey Amendment - ANSWER ✔✔Created 2 classes of
drugs: OTC and Rx
Kefauver-Harris Amendment - ANSWER ✔✔This requires drug
manufacturers to provide proof of safety and efficacy.
Drug Importation - ANSWER ✔✔Florida allows drug importation from
Canada, but no plan has been approved yet by the HHS
Drug Quality and Security Act - DSQA - ANSWER ✔✔distinguishes
compounding from manufacturing
,503A vs 503B facilities - ANSWER ✔✔503A: may only compound
persuant to a prescription and are regulated by states
503B: outsourcing facilities; permitted to compound sterile products
without patient specific prescriptions. Exempt from the new drug
provisions, adequate directions, and track -and-trace. regulated by FDA
How soon do pharmacists have to notify the authorities of an illegitimate
product? - ANSWER ✔✔24 hours
Adulteration vs Misbranding - ANSWER ✔✔If a drug's strength is less
than the label says, it's both
adulteration: impure/unsanitary product, non-CGMP manufacturing
methods, unsafe/deleterious additives or containers
misbranding: label is false/misleading, does not have required
manufacturer labeling (OTC and Rx), is an imitation of another product
Products that Require Special Labeling - ANSWER ✔✔Yellow N5 &
N6
Aspartame
,Sulfites
Mineral oil
Wintergreen oil (methyl salicylate)
sodium phosphate
isoproterenol
potassium salts or oral ingestion
ipecac syrup
phenacetin
salicylates
APAP
NSAIDs
FDA Recall Classifications - ANSWER ✔✔Class III: not likely to
cause adverse events
Class II: may cause temporary or reversible adverse events
Class I: will cause either SAEs or death
PPIs vs MedGuides vs REMs - ANSWER ✔✔PPIs are currently
required for hormone products (OCP and Estrogen). MedGuides are a
step up and are required if patient labeling could prevent SAEs. REMs
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2026. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY
STATEMENT. ALL RIGHTS RESERVED
3
, are required if the FDA finds it necessary to ensure benefits outweigh
the risks
Orange Book - ANSWER ✔✔generic equivalents
Purple Book - ANSWER ✔✔Biological products and biosimilar
biosimilar does not = interchangeable
Exemptions to Poison Prevention Packaging Act - ANSWER ✔✔-by
request from patient/physician
-bulk containers (non-household)
-instutionalized patients
-OTC designed for elderly
-OCPs, conjugate estrogens, norethindrone, and medroxyprogesterone,
HRTs
-SL nitroglycerin and chewable isosorbide
-effervescent ASA or APAP
-unit dose potassium supplements
-sodium fluoride (<264mg)
-anhydrous cholestyramine
