In the U.S. health care supply chain, before a medical device or drug can be shipped -- state and county licenses must be secured, FDA Quality Systems regulations must be complied with, and accreditations must be earned. The health care supply chain plays a key role in patient safety by ensuring the integrity of products from the time they are manufactured to the time they are delivered to a health care provider or patient.
Instances of theft, diversion and counterfeiting in the supply chain are on the rise. They have heightened public awareness and concern over the quality and integrity of prescription drugs and medical devices. As Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration stated in 2010, "We have seen that the threat from economically motivated adulteration, counterfeiting and cargo theft is real." Counterfeiters and thieves have demonstrated tremendous creativity and boldness in pirating and diverting product for black and gray market sales. They find buyers for any type of product or drug. All drugs and devices are at risk.