by Bruce and Joan
Buckley
Inspectors from the National Association of Boards of Pharmacy (NABP) and
state pharmacy boards descended on six compounding pharmacies in four states
during the first two weeks of December as part of a broad, unified effort to
bolster the safety of customized medicines being shipped across state lines.
The inspections were carried out in California, New Jersey, Texas and Utah as public and political pressure for increased federal and state regulation of pharmacy compounders continued to mount in the wake of the fungal meningitis outbreak that, by mid-December, had sickened more than 650 individuals in 19 states and claimed nearly 40 lives.
The dual inspection campaign is set to continue well into 2013. It is part of the association’s contractual agreement with the Iowa State Board of Pharmacy to strengthen surveillance of compounding pharmacies licensed by Iowa but located outside its borders.
“We’re moving full bore ahead,” Carmen Catizone, MS, RPh, DPh, the executive director of the association, told Pharmacy Practice News. “The response from the states has been incredible. They’ve said, ‘This is an issue we own and we’re going to move quickly on it.’”
Preliminary findings from the inspections suggest that the New England Compounding Center (NECC), whose tainted methylprednisolone was the source of the meningitis outbreak, is by no means the only pharmacy to compound drugs that are seldom if ever tied to a specific prescription. Four of the six compounders were found to distribute non-patient-specific, preservative-free sterile injectables, which can be at odds with “traditional” compounding—that is, the preparation of medications prescribed in small quantities for specific individuals. Two of the pharmacies produced very large volumes of non-patient specific sterile drugs, Dr. Catizone reported.
The findings have been sent to Iowa, he said, and the state “is going to be making some determinations.” Dr. Catizone praised Iowa’s “innovative” initiative. “They were able to think outside the box and say, ‘We can’t hire staff to do this, but we have the funding and we can use it in a way that gets the outcomes accomplished.’” He said other states were weighing similar agreements with NABP.
The NABP approach—to preserve individual states’ ownership of traditional pharmacy compounding oversight while broadening their ability to monitor nonresident compounders who ship product into their states—appears to cross over into FDA turf, which is oversight of interstate-shipped medications.
The FDA, meanwhile, is pressing Congress for new legislation that will reinforce the agency’s hand in policing practices that go beyond prescription-driven compounding. But some pharmacy sources worry that the FDA’s push for new authority may threaten states’ traditional role and raise the risk for a possible “federalization” of compounding practice. “I am absolutely terrified that the FDA is going to get in the middle of this, and more importantly, I’m more afraid that Congress is going to get into the middle of this and they’re going to muck this thing up,” said Eric Kastango, RPh, MBA, the president and the CEO of Clinical IQ, speaking at the American Society of Health-System Pharmacists’ Midyear Clinical Meeting last month.
Others have raised doubts about whether a budget-minded Congress would allocate funds that the FDA needs to hire more inspectors and expand its national oversight of compounders. The FDA has moved to ease these concerns. In December, agency officials met with pharmacy and health department regulators from all 50 states to solicit input on how federal and state agencies might work together to “close gaps” in the “regulatory framework,” as Margaret Hamburg, MD, the FDA Commissioner, put it.
Pharmacy board officials who spoke at the two-hour FDA public hearing that followed their early meetings at the agency’s headquarters in Silver Spring, Md., expressed confidence in their capacity to regulate compounding pharmacies in their own states, but some said that they were challenged by the difficulty of controlling nonresident compounders. “We know what happens in pharmacies in Arkansas,” said John Clay Kirtley, PharmD, the executive director of the Arkansas State Board of Pharmacy. “We don’t necessarily know about what is happening in specific pharmacies in other states that ship into our state.”
Several board officials noted that insufficient funding often hampers states’ regulatory efforts. Jay Campbell, RPh, JD, the executive director of the North Carolina Board of Pharmacy, said that whereas his board and others in the Southeast region generally have the resources to carry out their missions, others around the country “are dealing with revenue challenges.” He said it was important for state lawmakers to recognize that pharmacy boards must be adequately funded “and not simply be viewed as a revenue stream” for general purposes.
Despite concerns about the potential for federal encroachment on what traditionally has been state regulatory terrain, some board officials saw areas where federal and state collaboration might prevent future public health calamities like the one caused by NECC. Cody Wiberg, PharmD, MS, RPh, the executive director of the Minnesota Board of Pharmacy, suggested that “joint investigations” by the FDA and state boards might be a way to ensure better enforcement of federal and state compounding standards. In most states, he said, pharmacy boards “are regulatory licensing agencies. We’re not law enforcement agencies. We can’t initiate criminal proceedings; the FDA can. In some of these really horrible situations, [that may] get the attention of folks even more” than separate actions by federal or state regulators alone, he noted.
At the federal level, Senate and House committees have launched investigations into the causes of the NECC disaster, laying the groundwork for legislative remedies later in 2013. At least two bills have been introduced in the House. The one gaining the most attention was initiated by Rep. Edward J. Markey (D-Mass.), in whose district NECC’s manufacturing facility is located. Under the bill, most compounding pharmacies that engage in mass production would be regulated by the FDA as drug manufacturers.
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The inspections were carried out in California, New Jersey, Texas and Utah as public and political pressure for increased federal and state regulation of pharmacy compounders continued to mount in the wake of the fungal meningitis outbreak that, by mid-December, had sickened more than 650 individuals in 19 states and claimed nearly 40 lives.
The dual inspection campaign is set to continue well into 2013. It is part of the association’s contractual agreement with the Iowa State Board of Pharmacy to strengthen surveillance of compounding pharmacies licensed by Iowa but located outside its borders.
“We’re moving full bore ahead,” Carmen Catizone, MS, RPh, DPh, the executive director of the association, told Pharmacy Practice News. “The response from the states has been incredible. They’ve said, ‘This is an issue we own and we’re going to move quickly on it.’”
Preliminary findings from the inspections suggest that the New England Compounding Center (NECC), whose tainted methylprednisolone was the source of the meningitis outbreak, is by no means the only pharmacy to compound drugs that are seldom if ever tied to a specific prescription. Four of the six compounders were found to distribute non-patient-specific, preservative-free sterile injectables, which can be at odds with “traditional” compounding—that is, the preparation of medications prescribed in small quantities for specific individuals. Two of the pharmacies produced very large volumes of non-patient specific sterile drugs, Dr. Catizone reported.
The findings have been sent to Iowa, he said, and the state “is going to be making some determinations.” Dr. Catizone praised Iowa’s “innovative” initiative. “They were able to think outside the box and say, ‘We can’t hire staff to do this, but we have the funding and we can use it in a way that gets the outcomes accomplished.’” He said other states were weighing similar agreements with NABP.
The NABP approach—to preserve individual states’ ownership of traditional pharmacy compounding oversight while broadening their ability to monitor nonresident compounders who ship product into their states—appears to cross over into FDA turf, which is oversight of interstate-shipped medications.
The FDA, meanwhile, is pressing Congress for new legislation that will reinforce the agency’s hand in policing practices that go beyond prescription-driven compounding. But some pharmacy sources worry that the FDA’s push for new authority may threaten states’ traditional role and raise the risk for a possible “federalization” of compounding practice. “I am absolutely terrified that the FDA is going to get in the middle of this, and more importantly, I’m more afraid that Congress is going to get into the middle of this and they’re going to muck this thing up,” said Eric Kastango, RPh, MBA, the president and the CEO of Clinical IQ, speaking at the American Society of Health-System Pharmacists’ Midyear Clinical Meeting last month.
Others have raised doubts about whether a budget-minded Congress would allocate funds that the FDA needs to hire more inspectors and expand its national oversight of compounders. The FDA has moved to ease these concerns. In December, agency officials met with pharmacy and health department regulators from all 50 states to solicit input on how federal and state agencies might work together to “close gaps” in the “regulatory framework,” as Margaret Hamburg, MD, the FDA Commissioner, put it.
Pharmacy board officials who spoke at the two-hour FDA public hearing that followed their early meetings at the agency’s headquarters in Silver Spring, Md., expressed confidence in their capacity to regulate compounding pharmacies in their own states, but some said that they were challenged by the difficulty of controlling nonresident compounders. “We know what happens in pharmacies in Arkansas,” said John Clay Kirtley, PharmD, the executive director of the Arkansas State Board of Pharmacy. “We don’t necessarily know about what is happening in specific pharmacies in other states that ship into our state.”
Several board officials noted that insufficient funding often hampers states’ regulatory efforts. Jay Campbell, RPh, JD, the executive director of the North Carolina Board of Pharmacy, said that whereas his board and others in the Southeast region generally have the resources to carry out their missions, others around the country “are dealing with revenue challenges.” He said it was important for state lawmakers to recognize that pharmacy boards must be adequately funded “and not simply be viewed as a revenue stream” for general purposes.
Despite concerns about the potential for federal encroachment on what traditionally has been state regulatory terrain, some board officials saw areas where federal and state collaboration might prevent future public health calamities like the one caused by NECC. Cody Wiberg, PharmD, MS, RPh, the executive director of the Minnesota Board of Pharmacy, suggested that “joint investigations” by the FDA and state boards might be a way to ensure better enforcement of federal and state compounding standards. In most states, he said, pharmacy boards “are regulatory licensing agencies. We’re not law enforcement agencies. We can’t initiate criminal proceedings; the FDA can. In some of these really horrible situations, [that may] get the attention of folks even more” than separate actions by federal or state regulators alone, he noted.
At the federal level, Senate and House committees have launched investigations into the causes of the NECC disaster, laying the groundwork for legislative remedies later in 2013. At least two bills have been introduced in the House. The one gaining the most attention was initiated by Rep. Edward J. Markey (D-Mass.), in whose district NECC’s manufacturing facility is located. Under the bill, most compounding pharmacies that engage in mass production would be regulated by the FDA as drug manufacturers.
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