Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Monday, April 8, 2019
FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin
Today, the U.S. Food and Drug Administration warned against using test strips from a previous owner (pre-owned) or test strips not authorized for sale in the U.S. because they may potentially cause infection or lead to inaccurate test results, which can cause serious harm, including death. The FDA issued a safety communication alerting patients and health care professionals about the risks of using these kinds of test strips.
“Millions of Americans use test strips at home to monitor serious diseases or conditions. We recognize that some people may be choosing to purchase pre-owned or unauthorized test strips because they believe there is a cost savings. However, by doing so they may be putting themselves at risk for serious injury or even death,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s warning is part of our ongoing public health commitment to