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TRENTON – Prompted by contaminated spinal steroid injections that have sickened 33 people in New Jersey, State Senator Jeff Van Drew has introduced legislation to strengthen the regulation of certain pharmacies that prepare customized versions of prescription medications for patients.
The measure (S-2365) would create stronger oversight and regulation of “compounding pharmacies,” which combine or modify ingredients to create customized medicine for patients. A compounder is the type of pharmacy which distributed tainted steroid medication from its facility in Massachusetts. To date, dozens of cases of fungal meningitis resulting from exposure to the drug have cropped up in Atlantic, Cumberland, Gloucester and Salem counties. Nationally, the contaminated injections have been linked to 478 cases of meningitis (plus 12 peripheral joint infections) and 34 deaths, according to the Federal Centers for Disease Control and Prevention. No deaths have been reported in New Jersey.
“Dozens of New Jersey residents and hundreds of people across the country were provided tainted steroid injections which resulted in their contracting fungal meningitis,” said Senator Van Drew (D-Cape May/Cumberland/Atlantic). “Sadly, this health crisis may have been prevented with better oversight and regulation of these particular types of pharmacies. While we cannot prevent the sale of contaminated medicines nationally, we can strengthen regulation of pharmacies operating in our own state. This will help to prevent local companies from distributing tainted medication and reduce the amount of harmful or potentially deadly concoctions circulating nationwide.”
Called the “Compounding Pharmacy Quality Assurance Act,” the bill would require compounding pharmacies to be accredited by the Pharmacy Compounding Accreditation Board (PCAB) and to meet its nationally accepted quality assurance, quality control and quality improvement standards. Pharmacies already in operation at the bill’s effective date would be required to provide evidence to the New Jersey State Board of Pharmacy of accreditation within one year. Pharmacies that begin operating after the effective date of the bill would have six months to provide evidence of accreditation. In order to earn PCAB accreditation, a pharmacy must participate in an evaluation process that includes: verification the pharmacy is not on probation for issues related to compounding quality, public safety or controlled substances; verification the pharmacy is properly licensed in each state the pharmacy is doing business; and an extensive on-site evaluation by a PCAB surveyor who is a compounding pharmacist trained in evaluating compliance with PCAB quality standards. PCAB also conducts routine on-site surveys of its accredited pharmacies every three years and may select any of these pharmacies for an unannounced survey at any time during the accreditation cycle.
As many as 3,000 compounding pharmacies may exist in the United States. The lack of adequate regulatory oversight of these pharmacies has received national attention in the wake of a wave of reports of death and illness among patients exposed to fungal meningitis as a result of receiving contaminated spinal steroid injections. It is unclear at this point who is ultimately responsible, among state regulators, the federal Food and Drug Administration and the pharmaceutical industry for providing effective oversight of compounding pharmacies through the United States. As such, there is an urgent need to address the regulatory void in order to ensure the safety and effectiveness of medications made by these pharmacies.
“Clearly, we need stronger regulations at the federal level to protect the safety and well being of residents in New Jersey and nationwide. I am hopeful the national attention this issue has received will spur Congress to act immediately to resolve the regulatory confusion surrounding these pharmacies,” added Senator Van Drew. “In the meantime, New Jersey should take the action necessary to regulate compounding pharmacies operating here. This will ensure that local companies are distributing safe and effective medicines, and are not at risk of dispensing harmful substances. New Jersey can also serve as a model for other states looking to protect their residents against illnesses caused by contaminated medications.”
The bill was introduced in the Senate Monday.
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