BioChemistry > QUESTIONS & ANSWERS > Federal MPJE 2022 Study Guide(questions&answers) (All)
Federal MPJE 2022 Study Guide(questions&answers)
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What did the FDCA of 1938 accomplish? - ✔✔Food, Drug, and Cosmetic Act 1) Drugs must be safe prior to marketing 2) Established the FDA - Food, Drug, Cosmetic, Medical device safety Durham-Humph ... rey Amendment of 1951 - ✔✔• Created a distinction between "OTC" and "Legend Drugs/Prescription". • Authorized verbal prescriptions/refills • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". Kefauver-Harris Amendment of 1962 - ✔✔1) Requires all medications in US to be pure safe and effective. 2) Established the Good Manufacturing Practices (currentGMPs) Prescription Drug Marketing Act of 1987 (PDMA) - ✔✔1) Prevents re-importation of a drug into US. 2) Prohibited hospital and healthcare entities from reselling their pharamaceuticals. 3) Prohibits sale, trade, or purchase of Rx samples 4) "Samples Act" [Show More]
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