Non-prescription Medications
Over-the-counter (OTC) drugs and dietary and herbal supplements are not formally approved by the Food and Drug Administration (FDA). The active ingredients of these medications and supplements are, however, reviewed by the FDA to ensure that they are safe.
Drug companies must conform to the requirements in the relevant medication and supplement class. The companies do NOT need formal FDA approval to make and sell these products, although many times they do seek approval. The labels will indicate whether a drug or supplement has been FDA approved.
Generic Prescription Drugs
All prescription drugs must be approved by the FDA.
Generic prescription drugs contain the same active pharmaceutical ingredient as brand-name drugs but are re-sold under a different brand name. Generic prescription drugs must be approved by the FDA, and meet the same strict standards for safety, effectiveness and quality as brand-name drugs.
While generic drugs are usually available for much lower prices than brand-name products, generics are not available for every brand-name product, and some brand-name drugs do not have approved generic equivalents.
New drugs are protected by patents that are commonly in effect for twenty years. During the time that a drug is patent-protected, no other company is allowed to make or sell it. Following the expiration of a drug’s patent, generic versions can be developed by any company. Once the drug is approved by the FDA it can be marketed and sold as a generic.