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Која е разликата помеѓу лековите на рецепт и ОТЦ лековите?

Време: 2020-05-20 Посети: 569

A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Here are the main differences between OTC drugs and prescription drugs.

Prescription drugs are:Hand holding prescription drug bottle

Prescribed by a doctor
Bought at a pharmacy
Prescribed for and intended to be used by one person
Regulated by FDA through the New Drug Application (NDA) process. This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured. For more information on the NDA process, please see "The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective."
OTC drugs are:Photograph of several medicine bottles

Drugs that do NOT require a doctor's prescription
Bought off-the-shelf in stores
Regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System."