Florida MPJE Latest Version Already Passed

Florida MPJE Latest Version Already Passed Durham-Humphrey Amendment Created 2 classes of drugs: OTC and Rx Kefauver-Harris Amendment This requires drug manufacturers to provide proof of safety and efficacy. Drug Importation Florida allows drug importation from Canada, but no plan has been approved yet by the HHS Drug Quality and Security Act - DSQA distinguishes compounding from manufacturing 503A vs 503B facilities 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? 24 hours Adulteration vs Misbranding 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 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 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 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 are required if the FDA finds it necessary to ensure benefits outweigh the risks Orange Book generic equivalents Purple Book Biological products and biosimilar biosimilar does not = interchangeable Exemptions to Poison Prevention Packaging Act -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