The journey of falsified or substandard cancer medicines often begins long before they reach hospitals or pharmacies. Weak oversight, fragmented supply chains, and cost pressures create openings for poor manufacturing practices, illegal production, and other vulnerabilities. From the earliest stages of drug formulation to distribution and repackaging, each link in the chain presents opportunities for counterfeit or unsafe products to enter legitimate markets.
Production of APIs or finished products in facilities that do not follow GMPs (Good Manufacturing Practices)
Falsified drugs are often produced in substandard facilities lacking proper equipment and adherence to GMPs leading to contamination and errors. This is especially a problem in countries where regulation and legal oversight to enforce GMPs is weak.
Compounding pharmacies
Compounding pharmacies are not directly implicated in SF oncology medicines, but they are an important consideration for other SF medicines. Unregulated compounding pharmacies can proliferate substandard or falsified drugs due to dosing errors, contamination or improper ingredients. In some countries like the U.S., compounding pharmacies are regulated and can be an important source of legitimate medicines in certain contexts.
Example: In the U.S., the 2012 New England Compounding Center fungal meningitis outbreak illustrates one of the worst case scenarios of unregulated compounding. 64 people died after receiving contaminated steroid injections from the compounding center, which was in violation of its state license.
Repackaging
Compounding pharmacies are not directly implicated in SF oncology medicines, but they are an important consideration for other SF medicines. Unregulated compounding pharmacies can proliferate substandard or falsified drugs due to dosing errors, contamination or improper ingredients. In some countries like the U.S., compounding pharmacies are regulated and can be an important source of legitimate medicines in certain contexts.
Example: In the U.S., the 2012 New England Compounding Center fungal meningitis outbreak illustrates one of the worst case scenarios of unregulated compounding. 64 people died after receiving contaminated steroid injections from the compounding center, which was in violation of its state license.
Cold chain lapses
Cancer medications contain active ingredients which require storage in temperature-controlled conditions during transportation. Unregulated producers or counterfeiters may disrupt sensitive temperature conditions at any point due to lack of resources or malicious intent, resulting in an ineffective or dangerous product.
Example: An individual illegally shipped foreign cold chain cancer chemotherapy drugs to U.S. doctors, who received the medicines in a “gooey mess” due to cold chain lapses. The individual did not have the temperature-controlled shipping to ship Rituxan, Herceptin, and Neupogen.
Diversion or use of repurposed drugs
A medicine designed for a specific market or function is re-marketed in violation of the producer’s instructions. According to the United States Department of Justice, “Most pharmaceuticals abused in the United States are diverted by doctor shopping, forged prescriptions, theft and, increasingly, via the Internet.”
Parallel trade and gray markets
The practice of purchasing items in one country at a lower price and importing them into a country in which they are available at a higher price. While there are regulations around parallel trade in some regions (such as Europe), the system is still subject to risks since parallel traders don’t need to verify the origin of products they buy, creating a “gray market” of pharmaceuticals. They can undergo 20–30 intermediary transactions, introducing the potential for counterfeiting. Key regions where parallel importation is legal and regulated include the EU, Australia, Japan, and some parts of Africa and Southeast Asia.
Example: A common misconception is that medicines imported from countries like Canada and the U.K. are under strict regulatory oversight and are safe. With parallel trade, a medicine sold in one of those countries may actually originate from a country notorious for ineffective or lethal SF medicines. Additionally, regulations in Canada do not always apply for exported drugs. Exporters may operate out of Canada, but if the drugs are primarily for export, Canadian safety regulations do not apply.
Free trade zones
Low regulatory oversight makes free trade zones attractive for criminals falsifying medicines.
Example: In a 2006 case, U.K. customs seized several pharmaceutical products in transit from Dubai to the Bahamas free trade zone. The seizure uncovered that the drugs were destined for the U.S. and marketed as originating from a Canadian online pharmacy.
Foreign labeled drugs without verified pedigree
Medicines imported from another country that carry foreign packaging or labeling but lack a documented supply chain tracing them from the original manufacturer to the distributor. The U.S. FDA requires all drugs to contain a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the dates of those transactions and the names and addresses of all parties to them.
Street vendors and informal markets
In some developing countries, street markets are often used to sell medicines, but this process is not regulated.
Example: In Ghana, drug inspectors found tablets purporting to be antimalarial medicines in a rural dispensary. The tablets contained less than 2% of the expected active ingredients.
Online pharmacies
Most online pharmacies operate illegally and without a license. Ninety-five percent of sites selling prescription drugs operate unlawfully, and 50–90% of medicines sold online are SF. Frequently, in the U.S., pills purchased online have been found to contain fentanyl. They target vulnerable patients directly through search ads, social media, and “no-prescription” offers, luring people with low prices and convenience.
Example: According to the Institute of Human Data Science, oncology medicines are the #1 product sold in illegal online pharmacies in the U.S.
Medical tourism
Medical tourism is often driven by lower costs, faster access, or treatments unavailable at home, but it carries significant risks. Patients may encounter weaker regulation, gray-market supply chains, and language barriers, making it easier for substandard or falsified medicines to slip into care. These drugs may contain the wrong ingredients, be stored improperly, or be entirely fake, leaving patients vulnerable to treatment failure or harm.