Saturday, October 6, 2012

Pennsylvania has no authority to halt tainted steroid shots from Massachusetts License not required here for out-of-state drug manufacturers


Saturday, October 06, 2012

If a Massachusetts pharmacy had not halted its shipment of steroid shots that have killed five people, Pennsylvania could not have stopped the distribution.
Pennsylvania, Georgia and Massachusetts are the only states that don't require out-of-state drug manufacturers to be licensed before they ship drugs within their borders.
The realization became apparent as the U.S. Centers for Disease Control and Prevention, the Food and Drug Administration, the Allegheny County Health Department and state Department of Health investigated recalled lots of the tainted pain medication -- methylprednisolone acetate -- a steroid that went to 75 facilities in 23 states, including Allegheny Pain Management in Altoona and South Hills Pain & Rehab Associates, which has facilities in Jefferson Hills, Bethel Park, Monessen and Brentwood.
The CDC said Friday that the outbreak of the rare fungal meningitis linked to the steroid shots now involves seven states. So far, no cases of illness related to the drug -- 47 sickened in addition to the five deaths -- have been identified in Pennsylvania.
"The results are real simple: The Pennsylvania Board of Pharmacy that protects citizens of the state does not have any regulatory authority of pharmacies that ship medicines into Pennsylvania," said David Miller, who is based in Philadelphia and heads the International Academy of Compounding Pharmacists.
"A guy in Pittsburgh who sells [prescription] drugs across the line in Ohio must be licensed in Ohio, but the guy in Ohio doesn't have to be licensed in Pennsylvania to sell drugs here," Mr. Miller said. "It's important in Pennsylvania that stuff is coming in from out of state and you would expect states to regulate those pharmacies."
The state Board of Pharmacy in the Department of State referred questions about drug-manufacturer licensing to the Health Department, which reported that the state Drug Device and Cosmetic Act requires that only out-of-state businesses with sales representatives within the state register with the health department if they distribute drugs or medical devices throughout the commonwealth. Those companies with no sales reps in the state can register voluntarily.
But out-of-state companies are required to be registered or licensed in the state in which they are located if they want to distribute prescription drugs here


Read more: http://old.post-gazette.com/pg/12280/1267251-114.stm#ixzz28ZcZWiIU

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