Consumer group asks FDA to re-inspect Utah pharmacy

Health Report says pharmacies act like drugmakers with fewer consumer protections.

A consumer watchdog group is calling on the U.S. Food & Drug Administration to re-inspect more than a dozen compounding pharmacies with prior violations including one in Utah.

University Pharmacy in Salt Lake City is among 16 pharmacies in 15 states issued warnings by the FDA since 2003 for safety lapses that merit revisiting in light of a recent meningitis outbreak tied to compounded drugs, says the Washington, D.C.-based group Public Citizen.

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The warnings "reveal a thriving [drugmaking] industry ... being carried out under the guise of compounding," the group wrote on Thursday to FDA Commissioner Margaret Hamburg.

Public Citizen obtained and released the warnings to contradict the FDAs claim that it lacks authority to regulate specialty pharmacies like the Massachusetts-based compounder blamed for meningitis-tainted injections that have killed 36 people and sickened more than 500. The New England Compounding Center had been investigated three times by the FDA and was issued a warning in 2006, a congressional inquiry found.

Compounding pharmacies make small batches of commercially approved drugs, customized for doctors to give to patients with allergies or special medical needs.

But some have grown quite large and have taken on roles traditionally reserved for drug manufacturers, such as employing sales teams to market across state lines and operating commercial-sized equipment, said Michael Carome, deputy director of Public Citizens Health Research Group. "If these pharmacies are going to act like drug manufacturers they need to be held to the same standards as drug manufacturers."

University Pharmacy, 1320 E. 200 South, was targeted by the FDA in 2006 for selling topical anesthetic creams used to lessen pain in cosmetic procedures.

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Consumer group asks FDA to re-inspect Utah pharmacy