Turkish Medical Law Glossary

Off-Label Drug Use

Turkish: Endikasyon Dışı İlaç Kullanımı

Off-label use means using a medicine outside aspects of its authorised product information. It is not automatically improper, but may raise regulatory, clinical and consent questions.

Written by Att. Başak ÇavuşoğullarıUpdated 2 October 2026

What Off-Label Drug Use means in a Turkish medical case

The review examines the clinical reason, evidence base, applicable Ministry or medicines-authority process, dosage, monitoring and information provided to the patient.

The legal analysis must distinguish authorised product status from professional judgment and from unauthorised or unsafe practice.

Professional case review illustrating off-label drug use in Turkish medical law

Evidence that usually deserves early attention

Keep the relevant records in their original form, with dates and the issuing provider identified. This checklist helps organise an initial review.

  • Medicine name, dose and indication
  • Prescription and administration record
  • Clinical rationale and monitoring plan
  • Information and consent documentation
Records and evidence relevant to off-label drug use

Official primary sources

Read the official text relevant to the treatment date and legal question. These sources explain the framework; they do not determine disputed facts in an individual case.

Related glossary concepts

Informed Consent Standard of Care Medical Malpractice

Questions patients often ask

Is use outside a medicine's authorised indication automatically unlawful?

The indication, applicable rules, clinical justification, approvals where required, information and monitoring need assessment. Record the exact medicine, dose, purpose and prescribing professional rather than relying on the label alone.