Expired Drug and Criminal Offense: The Court of Cassation Clarifies with Ruling No. 22658 of 2025

In the realm of criminal law, the protection of public health is a fundamental pillar, and the Penal Code provides specific rules aimed at sanctioning conduct that may jeopardize this primary asset. Among these, Article 443 of the Penal Code, which punishes the administration of medicines in a manner dangerous to public health, is often subject to interpretation and debate. The recent Ruling of the Court of Cassation No. 22658 of 03/06/2025 (filed on 17/06/2025) intervenes with a clarification of considerable importance, clarifying a crucial point regarding the configurability of this offense: the mere expiration of a drug is not, in itself, sufficient to determine its "dangerousness" or "ineffectiveness" for criminal purposes.

The Offense of Administering Spoiled or Imperfect Medicines (Art. 443 c.p.)

Article 443 of the Penal Code sanctions anyone who possesses for trade, places on the market, or administers spoiled or imperfect medicines, or spoiled or imperfect medicinal substances. The rationale of the rule is clearly to prevent the dissemination of pharmaceutical products that, due to alterations or defects, may harm consumer health or, at least, not achieve the expected therapeutic effect. However, the wording "spoiled or imperfect" opens up various interpretations, especially when it comes to defining what makes a drug so. The issue becomes particularly delicate in relation to the expiration date, an objective parameter that, as we will see, does not always coincide with the actual alteration of the product.

Ruling of the Court of Cassation No. 22658/2025: Beyond the Expiration Date

The case examined by the Court of Cassation concerned the defendant C. V., for whom the Court of Appeal of L'Aquila had issued a ruling that was annulled with referral by the Supreme Court. The core of the dispute revolved precisely around the interpretation of the concept of "spoiled or imperfect drug" in relation to exceeding the expiration date. The Court of Cassation, with the ruling by President D. M. G. and Rapporteur P. G., reiterated a principle already expressed in previous case law, but which always deserves to be clarified forcefully due to its practical and legal implications.

For the purpose of configuring the offense referred to in Art. 443 of the Penal Code, the quality of a "spoiled or imperfect" drug cannot be inferred from the mere exceeding of the expiration date, as the efficacy of the active ingredients may persist for some time after the expiry of the term indicated on the packaging. Therefore, it is necessary to verify in concreto whether the expired drug has actually undergone an alteration process, becoming dangerous to health or otherwise lacking therapeutic efficacy.

This maxim is of fundamental importance. The Court emphasizes that the mere fact that a drug has exceeded its expiration date is not sufficient to automatically qualify it as "spoiled or imperfect" for criminal purposes. The reason is simple: the efficacy of a medicine's active ingredients can persist for a certain period even after the term indicated on the packaging. This means that the expiration date is a precautionary indication from the manufacturer, but not an insurmountable threshold beyond which the product becomes ipso facto harmful or useless. The Court of Cassation therefore requires a "concrete verification": it is essential to ascertain whether the expired drug has actually undergone an alteration process such as to make it dangerous to health or devoid of therapeutic efficacy. This principle aligns perfectly with the principle of offensiveness, the cornerstone of criminal law, according to which there can be no crime without an offense (or a concrete danger of offense) to a protected legal interest.

Practical Implications and Legal Protection

The ruling in question has several practical repercussions, both for operators in the pharmaceutical sector and for jurisprudence:

• Need for Technical Expertise: In case of contestation of the offense, it will not be sufficient to produce the drug packaging with the expired date. Technical assessment (expert report) demonstrating the actual alteration of the product and its concrete dangerousness or ineffectiveness will be indispensable.
• Overcoming Formalism: The ruling invites a move beyond a purely formalistic approach, based on the expiration date as the sole parameter, in favor of a substantive evaluation of the medicine's actual condition.
• Protection of the Professional: This interpretation offers greater protection to those operating in the sector (pharmacists, doctors, distributors), who cannot be held criminally liable for the mere handling of an expired drug, in the absence of concrete proof of its harmfulness or uselessness. Naturally, responsibilities of an administrative or deontological nature remain unaffected.

It is important to note that this approach is in line with previous case law cited by the Court of Cassation itself (such as Section 6, No. 725 of 1994, Rv. 197239-01; Section 1, No. 6926 of 1992, Rv. 190580-01; Section 4, No. 1104 of 1987, Rv. 176869-01), which have already highlighted the need for concrete verification.

Conclusions

Ruling No. 22658 of 2025 by the Court of Cassation represents an important clarification on offenses against public health. By reiterating that the mere expiration of a drug does not automatically constitute the offense referred to in Art. 443 of the Penal Code, the Supreme Court reinforces the principle of offensiveness, always requiring a concrete assessment of the medicine's dangerousness or ineffectiveness. This orientation ensures a fairer and more proportionate application of criminal law, balancing the need to protect collective health with the necessity of grounding criminal liability on an actual harm or danger, and not on a mere formal datum.