Off-Label
The use of an FDA-approved drug for a purpose, population, dose, or route of administration not included in its official approved labeling.
Off-label prescribing is entirely legal and widely practiced in medicine — it is estimated that 20% of all prescriptions in the United States are off-label. When a drug is approved for one condition, physicians may legally prescribe it for other conditions based on clinical judgment and the available evidence base, even without FDA approval for that specific use.
In the peptide context, compounds like BPC-157 and TB-500 are not FDA-approved for any indication, so their use in humans falls outside the off-label framework entirely — they are research chemicals, not approved drugs. Understanding the distinction between off-label use of approved drugs and use of unapproved research compounds is important for accurately characterizing the regulatory and safety landscape of peptide research.