DALLAS — Lawmakers are on the attack: They say compounding pharmacies, like the one in Massachusetts that has allegedly sickened more than 100, operate in a "regulatory black hole" with very little federal oversight by the FDA.
And that discussion is calling attention to a compounding pharmacy in Dallas that recently pleaded guilty to shipping mislabeled medication that led to three deaths.
When three patients died in Portland, Washington after taking the same gout medication in 2007, it was no coincidence. A federal investigation quickly pointed back to Dallas and a compounding pharmacy called ApothéCure.
The FDA found ApothéCure's drug mixture was 640 percent stronger than prescribed. Last April, owner Gary Osborn pleaded guilty on misdemeanor charges.
"Once these medications start crossing state lines, logistically it's just more difficult," said Mike Jacobson, Dean of the University of North Texas System’s College of Pharmacy.
There are 7,500 compounding pharmacies in the U.S., many of them mom-and-pop operations that serve local customers.
The Framingham, Massachusetts-based New England Compounding Center had to recall 17,675 single dose vials of steroids that were contaminated with a fungus. Nationwide, 105 people have been sickened with meningitis as a result, health officials say.
These compound pharmacies are regulated at the state level — not under the more rigorous federal standards of the FDA.
But now that some companies — like the one under investigation in Massachusetts — ship large quantities of medicine all across the country, critics in Congress think the FDA needs more oversight.
"When we see an instance like this, this is a wake-up call to revisit this question of balance," Jacobson said.
In ApothéCure’s case, in Dallas, the FDA did have the authority to prosecute because the deadly medicine was inaccurately labeled. That's a federal offense.
In a statement, the government wrote:
"The drugs mixed by Mr. Osborn's company were not merely misbranded, but lethal. Drug makers of all sizes, from large corporations to small compounding pharmacies, have a duty to ensure their products are safe."
ApothéCure's attorney did not respond to News 8's request for comment.