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
No comments:
Post a Comment