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BIOS267 Pathopharmacology New Drug Approval System DeVry University

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DeVry University

BIOS267 Pathopharmacology New Drug Approval System DeVry University

Why are some drugs only available with a doctor’s prescription whereas other drugs can be
bought over the counter?
Over the counter (OTC) medicine are bought off the shelf and do not require a prescription.
However, the FDA regulates OTC drugs through OTC drug monographs. Which is sort of like a
regularly updating “recipe book” covering allowable ingredients, doses, formulations and
labeling. One’s conforming to a monograph could be marketed without needing more FDA
approvals, while those that don’t are required to undergo a separate review and approval
through the “New Drug Approval System.”
Prescription drugs are intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease. Regulated by FDA through the New Drug Application (NDA) process. Sold
at pharmacies and is prescribed by a doctor for and intended to be used by one person.
What is one of the 3 medical uses for drugs….be sure to give examples

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BIOS267 Pathopharmacology New Drug Approval System DeVry University

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