FDA Stops 500 International Shipments

US and India work together to stop illicit and unapproved drug shipments

(RxWiki News) The US Food and Drug Administration (FDA) recently stopped 500 shipments from India.

The FDA stopped these shipments because they were potentially dangerous to consumers in the US. They included illicit and unapproved medications and certain medical devices, the agency noted.

This action is a result of the FDA's first bilateral enforcement operation with the Government of India.

“With standards and regulations varying in each country, U.S. consumers face hazards when they order drugs and other FDA-regulated products from unauthorized foreign sources and receive them through the international mail system," said FDA Commissioner Dr. Stephen M. Hahn in a press release. "Consumers and physicians purchasing medicines cannot be assured the products they are receiving are legitimate, safe or effective if they are obtained from outside of the FDA-regulated pharmaceutical supply chain."

From Jan. 28 through Jan. 30, investigators targeted packages entering the US through one International Mail Facility (IMF). During the operation, people from both the US and India evaluated more than 800 shipments.

They found around 50 different FDA-regulated products. These included medications to treat cancer and HIV, as well as strong painkillers (opioids). Many of these medications were sent through other countries (transshipped) in order to hide the country of origin and avoid detection. The process of trying to conceal the shipments' origin actually makes the health risks even greater, the FDA noted. This is because the medications are no longer going through the regulated pharmaceutical supply chains and processes.

Nine IMFs receive mail from more than 180 countries. One of the FDA's missions is to inspect, find and intercept illegal products before they enter the US.

The FDA said it is concerned with products that are:

  • Unapproved
  • Counterfeit
  • Potentially dangerous

These products may include illicit opioid products and medical devices. And they are not limited to prescription medications. The FDA is also concerned with dietary supplements that may contain harmful ingredients.

In 2019, the agency screened approximately 25,200 parcels (more than 41,000 products). The FDA held up more than 38,000 of those products and plans to destroy more than 17,000.

The FDA strongly advised against buying prescription medicines from illegal online pharmacies. These companies may be placing consumers at risk.

These illegal online pharmacies look legitimate and trustworthy, and their products are marketed as authentic. But the medications they sell may be counterfeit, contaminated, expired and unsafe. Other risks include credit card fraud and identity theft.

Your local pharmacy's website is not the same as these unverified websites. If you have a relationship with your pharmacist, you can assume their website is a safe way to refill and order your prescriptions.

Speak with your health care provider if you have any questions.

Written by Digital Pharmacist Staff