ZEPHYRHILLS, Fla. - FDA agents walked into several Tampa Bay Area drug stores last week and told employees that it is no longer legal to sell medications from Canada and from elsewhere outside the United States, even if those medications are considered safe.
Up until now, the Food and Drug Administration has allowed, since 2003, the sale of medications from Canada and elsewhere in the United States as long as the medications are for personal use, and as long as only a 90-day supply is purchased.
The new warning from FDA agents to local drug stores that provide medications from Canada signals that this policy could be over, even though no such warning was issued publicly.
The owner of The Canadian Medstore, who operates 6 of 9 independently-owned businesses in Florida recently confronted by the FDA, tells ABC Action News he plans to continue operating and selling medications, for now, although he has reached out to the office of U.S. Senator Bill Nelson of Florida, and has been warning his customers that their source of cheaper medications could be in jeopardy.
Bill Hepscher says he spoke with the owners of the other three Florida drug stores with similar business models, and expressed doubt they would continue to operate in the face of the FDA threat.
"The really sad part is these folks are either going to be forced to go without their medication or they're going to be forced to go to some shady website somewhere and hope they're getting a real medication," Hepscher says.
Hepscher’s business model is valuable to a lot of people who otherwise would not be able to afford certain medications, like people with Diabetes, or EpiPens, where a generic version is not readily available, without getting the drugs through Canada, which negotiates lower prices with drug makers before they hit the market.
Hepscher tells ABC Action News that Senator Bill Nelson’s office told him they’d received several calls from people concerned about this change in policy.
ABC Action News has reached out to Nelson’s office to confirm the concern and if his office had been made aware of any policy change.
Recently, the new FDA Commissioner, Scott Gottlieb, announced that the FDA will recognize certain international regulatory authorities — other countries — as capable of conducting inspections of drugs that meet FDA requirements, a sign that the FDA is changing several policies regarding the sale of drugs in the United States.