Quantcast
Get breaking news alerts via email

Click here to manage your alerts
Utah moving to fortify regulation of compounding pharmacies
This is an archived article that was published on sltrib.com in 2012, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

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.

kstewart@sltrib.com

Twitter: @kirstendstewart —

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

Edgemont Pharmacy

Roe Rx Inc.

Peterson Foodtown Inc.

South Valley

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

Gibson's Pharmacy

Hurricane Family Pharmacy

Dry Creek Pharmacy

The Medicine Shoppe

Taylor Drug

Mountainwest Apothecary

North View Pharmacy

Salmons Pharmacy

Stapley Pharmacy

EJV F LLC (Bulloch Drug)

Superior Care Pharmacy Inc.

Rocky Mountain Infusion Clinic

Intermountain Homecare Pharmacy @ Dixie

Infusion Innovations

CNS Pharmacy

Superior Care Pharmacy Inc.

Mountain Care Pharmacy

Coram Healthcare Corporation of Utah

Public health • Meningitis outbreak pointed out state-federal weaknesses in oversight.
Article Tools

 Print Friendly
 
  • Search Obituaries
  • Place an Obituary

  • Search Cars
  • Search Homes
  • Search Jobs
  • Search Marketplace
  • Search Legal Notices

  • Other Services
  • Advertise With Us
  • Subscribe to the Newspaper
  • Login to the Electronic Edition
  • Frequently Asked Questions
  • Contact a newsroom staff member
  • Access the Trib Archives
  • Privacy Policy
  • Missing your paper? Need to place your paper on vacation hold? For this and any other subscription related needs, click here or call 801.204.6100.