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Legal protection · 08

Using a drug outside its indication.

The law allows it in individual cases, under the doctor's responsibility, with information and consent from the patient and with a documentable scientific basis.

Information, not legal advice. Read on 12 October 2026.

Off-label use

The rule

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Decree-Law 23 of 1998, Article 3, paragraph 2

"In individual cases the doctor may, under his or her direct responsibility and after informing the patient and obtaining the patient's consent, use an industrially produced medicinal product for an indication or route of administration" different from the authorised one, if he or she considers "on the basis of documentable data" that the patient cannot be usefully treated with authorised medicinal products, and "provided that such use is known and consistent with work published in internationally accredited scientific publications".

Read the textNormattiva

Off-label use

The precedents

Filed on 9 June 2025

Court of Cassation, Labour Division, order 15327 of 2025

The facts
An anaesthetist doctor at a private clinic is dismissed. Among the charges: having used a drug off-label without specifically informing some patients. It is a labour case, not an aesthetic medicine case.
What was decided
The private clinic's appeal was rejected: the objection was late and the conduct was considered mild negligence. The off-label use appears among the charges, in the summary of facts.
Read the textItalgiureWeb, SentenzeWeb: search by number and year

Off-label use

What protects the physician

  • A note in the medical record: the authorised indication, the one used and the reason.
  • The reference publications.
  • A specific written consent for off-label use.
  • The reference linking the prescription to the archive.

In Fibonacci

  • In the session, off-label use is noted together with its justification.
  • Consent is generated for that treatment, and remains in the medical record with the session.

Off-label use

What these sources do not say

The law speaks of medicinal products. For devices, such as fillers used outside the intended purpose indicated by the manufacturer, we have not found an equivalent rule or case law. We have not found civil judgments on damage from off-label use in aesthetic medicine.

Documentation must be done while you work, not when the lawyer's letter arrives.

In half an hour we show you how Fibonacci records consents, sessions, batches, and photos during the visit.

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