The United States Food and Drug Administration (FDA) describes compounding generally as a practice in which a licensed pharmacist, a licensed physician or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes or alters ingredients to create a medicine tailored to the needs of an individual patient.
In the European Union, Directive 2001/83 defines it as "any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient.” Other jurisdictions define compounded medicines similarly. While compounded medicines may be necessary in rare circumstances to address unique, individual patient needs that could not be satisfied by the products approved by health authorities, they nonetheless are not approved by health agencies and their safety, effectiveness, and quality have not been verified.
Illicit semaglutide compounding refers to the unauthorised and unlawful manufacturing, preparation, distribution, promotion and sales of illicit semaglutide. This encompasses a spectrum of unlawful activities, such as product imitations; non-licensed entities acquiring APIs to illegally sell them to patients for individual use; unlawfully manufactured compounded medicines violating existing patents and other laws; and the production, marketing and sale of compounded products that do not meet the approved standards and bypass regulatory frameworks.
Attempts by compounders to evade compounding laws by making manipulated, unnecessary and pretextual changes to ingredients, routes of administration or dosages are also unlawful.
Unauthorized semaglutide products pose significant safety risks. In many jurisdictions, including Australia, it's illegal to compound semaglutide outside of rare exceptions. In 2024, the Therapeutics Goods Administration prohibited pharmacists in Australia from compounding GLP-1 RAs, including semaglutide. Novo Nordisk's testing shows that compounding semaglutide often involves synthetic processes that can compromise safety. Compounded samples may contain lower-than-indicated strengths or no semaglutide at all. Moreover, these samples often introduce new impurities or higher levels of impurities compared to Novo Nordisk's products, which have not been safety tested in clinical studies, risking serious adverse reactions. This underscores the need to obtain medications from authorized providers and the importance of educating patients and healthcare professionals about the dangers of compounded medicines.
Additionally, semaglutide from compounding pharmacies frequently lacks Good Manufacturing Practice (GMP) standards. A Brookings Institute report indicates that suppliers are creating their own manufacturing standards, leaving patients unaware of product quality. Novo Nordisk is the sole manufacturer of approved semaglutide medications: Wegovy®, Ozempic®, and Rybelsus®.
Novo Nordisk has implemented a clear strategy to protect patients and our products from the complex threat posed by illicit compounding. Our efforts follow a defined strategy of Prevent, Detect, and Respond, aligned with our initiatives to combat falsified medicines.
To prevent illicit compounding, we educate global communities by actively providing information about the risks associated with unauthorised semaglutide and by countering misinformation. We emphasise collaborating with external stakeholders through educational initiatives and awareness campaigns while supporting law enforcement and health authorities with capacity-building activities and information sharing. Furthermore, because of our commitment to high-quality medicines and legitimate distribution, promotion and sales activities, we report issues for enhanced regulatory oversight to ensure that semaglutide is produced solely in authorised facilities.
In our commitment to maintaining patient safety, we work persistently to detect illicit compounding. This includes identifying unauthorised semaglutide through online and field monitoring, as well as collecting and analysing data to map associated risks. We also perform comprehensive testing of product samples globally to identify and understand the safety risks associated with illicit compounding.
Novo Nordisk responds to illicit compounding through the implementation of our Anti-Illicit Trade programme, which aims to disrupt of illicit compounding activity by taking legal action where necessary to fight misinformation and uphold patient safety standards, as well as by enforcing our patents and trademarks and other laws whenever it is effective in mitigating illicit compounding. We further advocate for meaningful regulatory engagement and, as necessary, regulatory and legislative reform to ensure that patients are protected from illicit compounding activity on a lasting basis.
Protecting patients from unlawful sales of unapproved semaglutide medicines is a key aspect of Novo Nordisk’s commitment to patient safety. Safe, clinically tested, approved semaglutide medicines are available, and no one should be misled into compromising their health. Novo Nordisk will continue taking proactive measures to combat illicit compounding activity.
If you suspect an unapproved semaglutide medicine, please report this immediately through one of the contact channels below: