MPJE – Florida Exam Questions with 100% Correct Answers

Durham-Humphrey Amendment Correct Answer Created 2 classes of drugs: OTC and Rx Kefauver-Harris Amendment Correct Answer This requires drug manufacturers to provide proof of safety and efficacy. Drug Importation Correct Answer Florida allows drug importation from Canada, but no plan has been approved yet by the HHS Drug Quality and Security Act - DSQA Correct Answer distinguishes compounding from manufacturing 503A vs 503B facilities Correct 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? Correct Answer 24 hours Adulteration vs Misbranding Correct 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 Correct Answer Yellow N5 & N6 Aspartame Sulfites Mineral oil Wintergreen oil (methyl salicylate) sodium phosphate isoproterenol potassium salts or oral ingestion ipecac syrup phenacetin