For those who yearn to break their cigarette addiction but don't fancy a trip to the doctor's office, the ability to get the nicotine patch without a physician's prescription may be just what the doctor ordered. The patch and gum join more than 600 other OTC drugs that, according to the Nonprescription Drug Manufacturers Association, would have required a prescription only 20 years ago. The 600-plus products are now available without a prescription because FDA, in cooperation with panels of outside experts, determined they could be used safely and effectively without a doctor's supervision. It's part of our mission to keep up with the consumers' wish to be more involved.
Switches have a huge impact on the health-care economy.
The original Federal Food, Drug, and Cosmetic Act of 1938 made no clear-cut distinction between Rx and OTC drugs. The 1951 Durham-Humphrey amendments to the act set up specific standards for classification. The amendment requires that drugs that cannot be used safely without professional supervision be dispensed only by prescription. A drug must be made available without a prescription if, by following the labeling, consumers can use it safely and effectively without professional guidance. Some drugs are approved initially as OTC drugs.