PEDIATRICS Vol. 59 No. 2 February 1977, pp. 309-311
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Safety and effectiveness of over-the-counter drugs: The FDA's OTC drug review

Food and Drug Administration

Nonprescription (Over-The-Counter Or Otc) Drugs Permit Patients To Treat A Wide Range Of Minor, Usually Self-Limiting, Problems And May Be Helpful Before Professional Medical Assistance Is Sought Or When It Is Not Immediately Available. While Their Misuse May At Times Create Or Compound Medical Problems, Most People Perceive Otc Drugs As Safe And Effective In Their Limited Role. In Fact, However, The Evidence Supporting Safety And Effectiveness Of Most Otc Products Has Never Been Subjected To Critical Review. The Principal Reason For This Is That Most Otc Products Are Made Of Ingredients Marketed Long Before The Modern Requirements Of The Food, Drug And Cosmetic Act Were Promulgated.