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Florida MPJE Questions and Answers with Verified Solutions

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Sherman Antitrust Act ✔✔This act: Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition Federal Food Drug and Cosmetic Act ✔✔This act states: No... adulterated or misbranded drugs in interstate commerce Adulteration ✔✔Gross - Think inside the capsule Misbranded ✔✔Improperly labeled - think outside the bottle FDCA ✔✔This act requires: ingredients are disclosed on bottle drug must be proven safe before marketing authorizes FDA inspection of manufactures and distributors Public Health Service Act ✔✔This act: - biologic drugs approved under BLA not NDA - reviewed for purity, potency, and safety Durham- Humphrey Labeling Amendments to FDCA ✔✔This act: - allows for refills - establishes Rx and OTC OTC requirements of Durham-Humphrey ✔✔This act states: - must be labeled with adequate directions for use (drug facts label) - pregnancy/ breast feeding warning - domestic contact information to receive ADR report - OTC drugs approved under OTC monograph or NDA Rx requirements of Durham-Humphrey ✔✔This act states: - Rx must be labeled with adequate info for use (package insert) - Rx approved under NDA - grandfathered pre 1938 [Show More]

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