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Pharmakon's Woes Point To Shifting Trends In Pharmacy Regulations

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The inspection of a special type of pharmacy in Hamilton County has Indiana experts examining licensing rules for the industry.

When mass-produced drugs don’t work for some people—they might be allergic to a dye in a pill or need a special dosage, for example—compounding pharmacies, which blend together medications, are called to create custom prescriptions.

Indiana has more than a dozen of these operations, including larger compounding operations known as outsourcing pharmacies. The Food and Drug Administration regulates these outsourcing facilities, but only if the pharmacy gives itself the outsourcing designation. Otherwise, it’s inspected by an understaffed state agency known as the Professional Licensing Board.

One such outsourcing pharmacy, Pharmakon Pharmaceuticals, has come under fire after the Food and Drug Administration announced it uncovered unsanitary and unsterile conditions at a Noblesville facility. Pharmakon recalled products made there and has temporarily ceased production.

The FDA investigation came after the company issued a voluntary recall earlier this year of a narcotic that proved to be incredibly potent and potentially dangerous.

Pharmakon lawyer David McNamar says he’s heard of worse conditions uncovered in other FDA investigations where similar companies weren’t forced to take the same actions.

“They weren’t asked to recall product, nor were they asked to do the extensive cleaning and testing they’ve asked us to do,” he says.

McNamar says Pharmakon hasn’t found anything out of the ordinary at its lab.

"Our experts our lab said there’s nothing,” he says. “These are common things found in any manufacturing place.”

Purdue pharmacy professor Kara Weatherman says compounding pharmacies offer a vital service, but at an increased risk over traditional mass-produced drug manufacturers, where the production is done by machines, not humans, and where pockets are deep.

She explains compounding pharmacies historically have been small operations, but factors as disparate as drug shortages and profit-chasing saw some begin to make products for larger patient bases – to the point where they had more in common with mass producers. She says that put patients in a potentially dangerous position.

“Trying to be compliant with all these things, it’s a very expensive process,” she says. “That’s why manufacturers charge big dollars for drugs and things like that, [because] we need all that kind of stuff to try to make sure nothing goes wrong. But when we’re in a compounding pharmacy, we don’t have nearly as many of those double checks, so something can go wrong very easily.”

As a result of increased compounding production, the Drug Act of 2013 created the "outsourcing" designation. But Weatherman says until regulatory rules—such as how big a compounding pharmacy needs to be in order to be considered an outsourcer—are clarified, problems such as unsanitary conditions could be hiding from regulators’ eyes.

Pharmakon says it has recalled medications that were shipped to nine states, and so far none of the returned products have shown any problems. 

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