Understanding Legend Drugs: Criteria for Prescription and Distribution in the United States

what two criteria are required for a drug to be a legend drug?

1. the drug is unsafe for the use except under the supervision of a practitioner with prescribing authority due to toxicity, method of use, or collateral measures needed to use drug 2. drug is a new drug and subject to the new drug application (NDA) approval process *note: drug is habit forming – no longer a requirement

In the United States, a drug must meet two criteria to be considered a legend drug:

1. Drug classification: The drug must be classified as a prescription drug by the Food and Drug Administration (FDA). This means that the drug is not safe for use without medical supervision and intervention by a licensed healthcare professional.

2. Restricted distribution: The drug must be available only by prescription from a licensed healthcare professional, such as a physician, dentist, or nurse practitioner. It cannot be sold over-the-counter or through other unrestricted means of distribution. This is to ensure that patients receive appropriate medical guidance and supervision in the use of the drug and to prevent misuse or abuse of the medication.

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