The legal status of Sustanon 250 in Ukraine and the EU

Sustanon 250 is a medicinal product, and its legal status is determined primarily by pharmaceutical legislation. But for athletes there are also anti-doping rules, and in a number of European countries the circulation of anabolic steroids outside medicine is directly criminalized. The editorial team explains the general principles of regulation in Ukraine and the EU. This material is not legal advice: legislation changes, so in a specific situation you should consult a lawyer.

Sustanon 250 as a medicinal product

Sustanon 250 is an injectable testosterone preparation developed by Organon. It contains four testosterone esters in an oil solution and is intended for replacement therapy in male hypogonadism and for certain other indications. In different countries the drug has been registered under different marketing authorization holders.

From a legal standpoint the key characteristic is its prescription status. In all countries where Sustanon 250 is registered, it is dispensed only on a doctor's prescription. This means the lawful route to obtaining the drug is a doctor's prescription, a written prescription and a licensed pharmacy.

Testosterone and its esters also belong to the anabolic androgenic steroids — a group of substances regulated separately by anti-doping legislation and, in some countries, by controlled-substances legislation. So the same drug can fall under several legal regimes at once.

The legal status of a specific drug should be checked against primary sources: in the State Register of Medicinal Products of Ukraine, on the websites of national regulators of EU countries and the European Medicines Agency, and, for athletes, in the current WADA Prohibited List.

Ukraine: prescription status and liability

In Ukraine the circulation of medicinal products is regulated by the Law "On Medicinal Products" and Ministry of Health by-laws. Medicinal products may be dispensed only after state registration, and prescription ones only on a prescription. Trade in medicinal products is permitted only to entities holding the appropriate license.

Selling a prescription drug without a prescription or without a license is a violation of the law and entails administrative or other liability for the seller. Separately, the Criminal Code of Ukraine provides for liability for the falsification of medicinal products and the circulation of falsified medicinal products (Article 321-1) — this directly concerns the counterfeits we wrote about in a separate article.

The Criminal Code also contains Article 323, "Inducing minors to use doping". It shows that the legislator specifically singles out the protection of minors from doping substances, which include anabolic steroids.

Whether a specific action involving testosterone falls under other articles — for example, those on potent substances — depends on the current lists and the classification in each case. The editorial team does not give legal assessments of individual situations and advises turning to primary sources and lawyers.

For patients the main practical conclusion is simple: if a doctor has prescribed Sustanon 250 for medical indications, the drug is obtained from a pharmacy on a prescription. Any other channels mean stepping outside the legal framework and having no guarantees of quality.

The European Union: common rules and national differences

In the EU the basic rules for the circulation of medicinal products are set by Directive 2001/83/EC. It defines the criteria by which drugs are classified as prescription-only and requires that medicinal products be sold only after obtaining a marketing authorization. Testosterone is prescription-only in all member states.

However, the criminal-law treatment of the non-medical circulation of anabolic steroids differs. Some countries have gone considerably further than general pharmaceutical norms and adopted special laws.

The United Kingdom, which is no longer in the EU, classifies anabolic steroids as Class C under the Misuse of Drugs Act 1971. There, possession for personal use is usually not prosecuted, but manufacture, importation for supply and sale are crimes.

An important point for travelers: bringing prescription drugs into EU countries for personal treatment is usually possible only in a limited quantity and with documents confirming the prescription. The rules differ, so they should be checked for the specific country before traveling.

Sport: anti-doping rules

For athletes who compete under the rules of the World Anti-Doping Code, testosterone and its esters are included in section S1 "Anabolic Agents" of the WADA Prohibited List. They are prohibited at all times — both in and out of competition.

Ukraine is a party to the UNESCO International Convention against Doping in Sport and the Council of Europe Anti-Doping Convention. Enforcement of anti-doping rules at the national level is provided by the relevant national anti-doping organization.

An athlete with a confirmed medical diagnosis requiring treatment with testosterone may apply for a therapeutic use exemption (TUE). For testosterone such exemptions are granted under strict criteria, in particular in the presence of laboratory-confirmed organic hypogonadism.

Anti-doping rules apply independently of criminal legislation: even in a country where possession of steroids is not a crime, a positive sample entails sporting sanctions — disqualification, annulment of results.

Practical consequences for patients and athletes

Let us summarize what these legal regimes mean in practice for different groups of people:

• A patient with hypogonadism:obtains the drug on a doctor's prescription at a pharmacy; there are no legal risks if the medical chain is followed.
• An athlete under anti-doping control:even medical use without an approved TUE is a violation of anti-doping rules.
• A person traveling in Europe:must take into account the strict national laws of individual countries, where even storage without a prescription is an offense.
• Sellers outside the pharmacy network:violate pharmaceutical legislation and may bear criminal liability, in particular for trafficking in counterfeits.

Legal risks are closely linked to medical ones. Drugs outside the legal chain do not undergo quality control, and the person using them usually receives no medical supervision. In this case the legal framework and safety coincide.

Legislation on medicinal products and doping changes regularly, and the lists of controlled substances are updated. So any decisions should be made on the basis of current official sources, not forums and hearsay.

Editorial conclusions

In all countries where it is registered, Sustanon 250 is a prescription medicinal product. The only legal route to obtaining it is a doctor's prescription and a licensed pharmacy.

In Ukraine, selling it without a prescription and a license violates pharmaceutical legislation, and falsification and trafficking in counterfeits are punishable under criminal law. In the EU, the general rules are supplemented by strict national laws, such as in Sweden, Germany and Italy.

For athletes, testosterone is prohibited by WADA at all times, and medical use is possible only with a therapeutic use exemption.

We also recommend reading our materials on how to recognize a counterfeit Sustanon 250, on the drug's metabolites and on the body's recovery after its use.

References

1. World Anti-Doping Agency. The World Anti-Doping Code International Standard: Prohibited List. Montreal: WADA (чинна редакція).
2. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal of the European Communities. 2001;L 311:67–128.
3. UNESCO. International Convention against Doping in Sport. Paris: UNESCO; 2005.
4. Council of Europe. Anti-Doping Convention (ETS No. 135). Strasbourg; 1989.
5. Закон України «Про лікарські засоби» від 04.04.1996 № 123/96-ВР (зі змінами).
6. Кримінальний кодекс України від 05.04.2001 № 2341-III (зі змінами).
7. Kanayama G, Pope HG Jr. History and epidemiology of anabolic androgens in athletes and non-athletes. Mol Cell Endocrinol. 2018;464:4–13.