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What is a legend drug?
A legend drug is a drug approved by the U.S. Food and Drug Administration that can be dispensed to the public only with a prescription from a medical doctor or other licensed practitioner.
Federal and state laws require that all prescription drugs bear a “legend” prohibiting their sale without a prescription. The legend may say: “Caution: Federal law prohibits dispensing without a prescription” or “Rx only.” Legend drugs must be stored and maintained according to law. Federal and state laws also govern the disposal of legend drugs.
Non-legend drugs are over-the-counter (OTC) medicines, such as Tylenol, Nyquil or aspirin, which can be bought at any store without the supervision of a medical practitioner.
Legend drugs are highly controlled because many of them, such as pain medications or antidepressants, are habit-forming. Physicians are required to record all medications, legend and non-legend, that they give to patients. Patients who cannot obtain the legend drugs they want from their doctors sometimes try to buy the medicines online. This is illegal in the U.S.
Many legend drugs are also classified into schedules. For example, morphine is a legend drug that is Schedule II, a classification for narcotics and stimulants with a high potential for abuse. Schedule III and IV drugs have less potential for abuse; Schedule V drugs are preparations with limited quantities of narcotics, such as cough syrups that contain codeine.
Schedule I drugs are not legend drugs and are illegal. They include heroin, LSD and other substances that have no accepted medical use, are unsafe and have a high potential for abuse.
Legend drug example
Jack had been taking an over-the-counter medicine that he bought at the drugstore to relieve heartburn. The medicine, however, was not very effective. Jack visited his doctor, who prescribed a legend drug that was similar to what Jack had been taking, but in a higher dose that was not available over the counter. Jack took his doctor’s prescription to the drugstore, where the pharmacist filled it and gave it to Jack. The drug came with instructions on how Jack was to take the drug, its potential side effects, and what Jack was to do if he experienced any side effects.
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