Off-label use

Definition

The practice of prescribing an FDA-approved medication for a purpose, age group, or dosage other than those specifically approved by the FDA. This is legal and extremely common in medicine, especially in pediatrics.

Examples

• •Tennessee noted that using puberty blockers and hormones for gender dysphoria in minors is an off-label use not specifically approved by the FDA, while the petitioner responded that off-label use is extremely common in pediatrics and the same medications are used off-label for many other conditions without restriction.

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