Basics

More than 60% of adults in the United States use prescription drugs to address health issues. With chronic conditions rising and a reliance on pharmaceutical options to treat them, ensuring drug quality and safety is paramount to protecting more than 130 million adults. While the Food and Drug Administration (FDA) has strict standards in place to ensure pharmaceutical quality and safety, bad actors can often find loopholes and ways to circumvent regulations. 

Recently, counterfeit drug production and distribution have increased. This trend has led to serious issues for patients who may unknowingly consume unregulated dosages, illicit ingredients, and non-sterile pharmaceutical products. Counterfeit pharmaceuticals are untested and often take advantage of the gray area of reselling. Recent reports suggest the problem is particularly prevalent in the obesity and diabetes medication markets, with illegal actors selling more than 730,000 counterfeit medications a month.

Some suggest compounded drugs are at a higher risk of counterfeit production. These drugs are custom-made for patients with specific clinical needs by mixing or altering ingredients to meet specific patient needs. While compounded medicines help fill a needed gap, they are not FDA-approved and not held to the same safety and efficacy standards as FDA-approved pharmaceuticals.