Wisconsin MPJE (Pharmacy Jurisprudence) Practice Exam

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The Durham-Humphrey Amendment of 1951 is significant because it...

Created the FDA

The Durham-Humphrey Amendment of 1951 is significant because it determined the distinction between prescription and over-the-counter (OTC) drugs. This amendment established that certain drugs can only be dispensed with a prescription from a licensed healthcare provider, while others can be obtained without a prescription. This differentiation helped in regulating access to medications based on their safety and complexity, ensuring that prescription drugs are dispensed safely and appropriately under the supervision of a healthcare provider.

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Established guidelines for Good Manufacturing Practices (GMP)

Determined prescription versus over-the-counter (OTC) drug status

Required efficacy for drugs

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