Over The Counter Drugs - Drugs that are safe and effective for use by the general public is defined as over the counter drugs. Includes legal marketing requirements and FDA review process of OTC.

Over The Counter Drugs - Information

Over the counter (OTC) drugs are defined as drugs that are safe and effective for use by the general public without seeking treatment by a professional. Unlike prescription drugs, they must bear adequate directions for safe and effective use and warnings against misuse. The distributor of OTC drugs is required by law to label the product appropriately. A 7 point label containing the following is required for the legal marketing of OTC drugs:

1. The name of the product;
2. The name and address of the manufacturer, packer, or distributor;
3. The net contents of the packages;
4. The established name of all active ingredients, and the quantity of certain other ingredients whether active or not;
5. The name of any habit-forming drug contained in the preparation;
6. Cautions and warnings needed for the protection of the user; and
7. Adequate directions fo rsafe and effective use.

Any drug that does not bear the Rx Legend can be sold without a prescription, and the consumer has the responsibility for reading and heeding the directions and warnings.

FDA OTC Categories

In 1972, FDA began a review of over the counter (OTC) drug products as part of the 1962 congressional mandate to review drugs approved between 1938 and 1962. Because there are over 300,000 marketed OTC drug products, FDA is reviewing the active ingredients and the labeling of over 80 therapeutic classes of drugs instead of individual drug products, as in the prescription Drug Effeficay Study Implementation review. Ingredients reviewed are classified in on of three ways:

1. Category I - generally recognized as safe and effective and not misbranded;
2. Category II - not generally recognized as safe and effective or misbranded, and
3. Category III - insufficient data available to premit classification. Misbranded products will be those whose labeling is false or misleading.

(Added: 4-Feb-2008 Rating: 0 Votes: 0) Rate It
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