TMA reminds physicians and providers that buying medical devices and drugs from illegal or unlicensed sources not only puts patients in danger but also can result in criminal charges, fines, and jail time.
"Since 2012, the U.S. Food and Drug Administration (FDA) has notified nearly 3,500 physicians that their drug purchasing practices might be illegal," the FDA said in a statement. "The U.S. Department of Justice has successfully prosecuted more than 95 corporations and individuals, including physicians, for criminal charges related to selling unapproved drug products, or receiving and administering unapproved drug products to patients."
Texas examples have included physicians purchasing misbranded products or medical devices from outside the United States not approved by the FDA. Other physicians have unknowingly bought products from a distributor not licensed and not authorized to do business in Texas or the United States.
The Texas Attorney General's Office generally says receiving and using unapproved drugs or devices violates the Texas Deceptive Trade Practices Act, which is punishable by a fine of up to $20,000 per violation, plus an added penalty of up to $250,000 if the affected consumer is older than 65. Physicians also can find themselves facing violations of the Texas Food, Drug, and Cosmetic Act, which carries a civil penalty of up to $25,000 a day for each violation.
Physicians can verify all drug distributor and in-state medical device distributor licenses online through the Public License Search feature provided by the Texas Department of State Health Services (DSHS) Division of Regulatory Services.
DSHS recommends physicians verify that distributors of medical devices located outside Texas are lawfully engaged in the wholesale or retail distribution of such devices in their resident state.
The FDA provides online services for physicians to verify a wholesale distributor or report suspicious activity.
Physicians may contact the TMA Knowledge Center with any questions and concerns about buying and prescribing wholesale devices and drugs. The knowledge center can be reached at (800) 880-7955 or by email.
Action, May 1, 2017
Last Updated On
May 01, 2017