Utah moving to fortify regulation of compounding pharmacies
The Massachusetts-based pharmacy blamed for a meningitis outbreak that has killed dozens and sickened hundreds can no longer ship drugs to Utah.
New England Compounding Center (NECC) voluntarily surrendered its mail-order privileges in October, not in response to any action taken by state licensers, said David Young, chairman of the Utah Board of Pharmacy. "We're not the only state. After losing their license in some states, I think they voluntarily surrendered them in multiple other states."
The move is mostly a formality, considering the compounding pharmacy closed in October and none of its tainted injections made it to Utah. But the scandal has highlighted regulatory weaknesses that states, including Utah, are moving to fortify. As a starting point, state inspectors are going to pharmacies statewide to determine which are compounding drugs.
It's not that the rules or standards for compounders are too loose, Young said. The problem, he said, is that some compounders are acting more like drug manufacturers without the same oversight.
Compounders are regulated by states, whereas drugmakers are overseen by the U.S. Food & Drug Administration. But the lines between the two are blurry, Young said.
In setting compounding rules, state regulators typically defer to standards set by the National Association of Boards of Pharmacy, Young said.
Utah law defines compounding as making a "limited quantity" drug, product or device as prescribed by a doctor, or for research, chemical analysis or teaching. Compounding does not include preparing a drug "in a dosage or form that is commonly available from a manufacturer" or preparing a drug that has been pulled from the market for safety reasons, the law states.
"What NECC was doing is making 17,000 doses of stuff and shipping it all over the place," Young said. "That's manufacturing, not compounding."
But Young isn't aware of any state that clearly defines when a compounder has crossed the line and should be subject to FDA oversight.
Drugmaking "is a different beast" that states aren't equipped to handle, Young said. "If [like NECC] you're making a steroid solution for injection into the spine, you need to be testing [drug] lots on a continuous basis and following quality control measures. The FDA has solid, tight rules on that stuff."
Congress is weighing various proposals for defining how and when the FDA should intervene. One fix could be to create a special class of compounders, Young said.
Another would be state-based rules to set compounders apart from other pharmacies.
Mark Steinegal, director of the state Division of Occupational and Professional Licensing (DOPL) estimates there are about 30 compounders in Utah.
"We do not have a complete list," because, he said, "they do not have a unique license ... [and] are lumped with other pharmacies in our databases."
To get an accurate count, DOPL is dispatching inspectors to pharmacies statewide. Results from their survey will be sent to the National Association of Boards of Pharmacy, which is reviewing its standards.
Depending on what action Congress takes, Young said Utah may also revise its compounding rules.
Utah's compounding pharmacies
Regulators are surveying pharmacies statewide for a tally of how many compound their own drugs. To date, they know of about 30:
Larry's Smithfield Pharmacy
Roe Rx Inc.
Peterson Foodtown Inc.
Mt. Olympus Compounding
Rock Canyon Pharmacy
Jolley's Corner Pharmacy
Jolley's Corner Pharmacy 3
Jolley's Sandy Pharmacy
TMJ Inc. (Jolley's Corner)
The Medicine Center
Skyline Pharmacy #2
Hurricane Family Pharmacy
Dry Creek Pharmacy
The Medicine Shoppe
North View Pharmacy
EJV F LLC (Bulloch Drug)
Superior Care Pharmacy Inc.
Rocky Mountain Infusion Clinic
Intermountain Homecare Pharmacy @ Dixie
Superior Care Pharmacy Inc.
Mountain Care Pharmacy
Coram Healthcare Corporation of Utah