But while Congress is considering legislation, there is no guarantee a bill will pass. So states are moving ahead on their own.
“Rather than wait for the decision on whether it’s going to be FDA or the states, in order for the [state pharmacy] license to have meaning, we’re going to make sure we do our best to protect you,” said Carmen Catizone, executive director of the National Association of Boards of Pharmacy, which represents the state regulators.
Iowa has been one of the most aggressive states in scrutinizing out-of-state pharmacies, including compounders. Agents for the Iowa pharmacy board have inspected about 50 facilities in Florida, New Jersey, Texas and Utah.
Those inspections led the Iowa board to charge five pharmacies, including Pharmedium. Iowa inspected Pharmedium’s Sugarland, Tex., facility in December. The board is accusing the company of shipping medications to hospitals without the required individual prescriptions and engaging in manufacturing, a violation of its pharmacy license.
In a statement, Pharmedium said it does not manufacture drugs. It also said “no inspection should have applied” because the company discontinued operations under its pharmacy license a month before the Texas inspection. The company continues to make and ship drugs under a wholesale license at the same facility, it said. The board’s inspection of that operation found no negative or deficient findings related to quality or patient safety, the company said.
But Pharmedium, which has four plants, acknowledged that its operations, like those of other large compounders, aren’t a perfect “fit” for regulation solely as a pharmacy, wholesaler or drug manufacturer. The company supports federal oversight of a new hybrid category — between a pharmacy and a manufacturer — and one set of standards.
Otherwise, proliferating — and possibly conflicting — state regulations could be a nightmare, company officials said.
“Who are we supposed to be in compliance with? The state we’re in or the state we’re shipping to?” Pharmedium President Rich Kruzynski said at a recent industry conference. “People are nervous because there is no one set of standards. . . . You may pass Iowa but fail California.”
The company is continuing to ship medications into Iowa while its case is pending.
Pharmedium declined to comment on the New York ban. In a cease-and-desist letter sent last year from New York’s pharmacy board to Pharmedium, authorities said New York permits compounded products to “be prepared and dispensed pursuant only to patient-specific prescriptions.”
Pharmedium was one of several companies highlighted in a Washington Post investigation about problems at manufacturing-style compounding pharmacies years before last fall’s outbreak. The Post reported that unsanitary conditions and human errors at Pharmedium plants had caused illnesses in at least 19 people.