A South Jersey legislator has introduced a bill to tighten regulation of companies that produce customized medication in response to a fungal meningitis outbreak that affected dozens statewide.
The Compounding Pharmacy Quality Assurance Act — as introduced by state Sen. Jeff Van Drew, D-Cape May, Cumberland, Atlantic — would require compounding pharmacies to be accredited by the Pharmacy Compounding Accreditation Board before they can begin producing medications.
That process involves what Van Drew said in a statement are “stringent” inspections of compounding pharmacies.
The Senate bill is aimed at compounding pharmacies that combine or modify ingredients to create custom medication for patients.
It was prompted by an outbreak of fungal meningitis that has been linked to an allegedly tainted steroid vaccine produced by the New England Compounding Center in Massachusetts. More than 510 cases have been reported, involving patients who received spinal injections of the vaccine.
The most current figures from the state Department of Health show two confirmed cases of fungal meningitis in New Jersey, and 35 probable cases.
Those cases include 27 Cumberland County residents and one Atlantic County resident.
“Sadly, this health crisis may have been prevented with better oversight and regulation of these particular types of pharmacies,” Van Drew said in a written statement. “While we cannot prevent the sale of contaminated medicines nationally, we can strengthen regulation of pharmacies operating in our state.”
Officials with the Pharmacy Compounding Accreditation Board could not be reached for comment.
David Ball, a spokesman for the International Academy of Compounding Pharmacies, said the accreditation board follows the “highest standards in the country.” The IACP “strongly encourages” accreditation and was one of the accreditation board’s founding organizations, he said.
One concern that IACP has with Van Drew’s proposed legislation is that there are several different agencies that accredit compounding pharmacies, Ball said. Mandating one particular accreditation might not be fair to compounding pharmacies with similar accreditations, he said.
However, Ball said his organization “welcomes the state of New Jersey’s review of its regulations … and will provide whatever information or assistance is requested.”
With the exception of one out-of-state resident, New Jersey’s cases involved patients who received their spinal injections at either South Jersey Healthcare Regional Medical Center in Vineland or Premier Orthopedic Surgical Associates in Vineland. Officials with both facilities said they had no reason to believe the steroid vaccine was tainted when they administered the spinal injections.
At least 15 residents of Cumberland, Gloucester and Salem counties who received injections of the tainted vaccine are now suing the New England Compounding Center and the facilities where they received the injections.
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