What is meant by "off-label" drug use?

"Off-label" drug use refers to the practice of prescribing medications for conditions or in dosages that have not been specifically approved by regulatory bodies, such as the FDA. This means that a healthcare provider may use their clinical judgment to prescribe a drug for a patient based on the drug's pharmacological properties or existing clinical evidence, even if that particular use is not included in the drug's approved labeling.

This practice is common in medicine, as healthcare professionals may find that a medication can be useful for treating conditions that fall outside of the established indications. Such use is supported by clinical research, experience, and the understanding of the drug's mechanism of action. While off-label prescribing is legal and often important for patient care, it does require a thorough assessment from the prescribing physician to ensure that the potential benefits outweigh the risks, since the evidence supporting off-label uses may not be as robust as that for approved indications.

The remaining options do not accurately capture the concept of off-label use: using a drug exclusively for FDA-approved indications represents standard use, administering drugs only in clinical trials does not pertain to everyday clinical practice, and dispensing drugs solely in non-liquid forms is unrelated to the concept of off-label use.