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Rep. Ed Markey (D-Mass.)
Rep. Ed Markey (D-Mass.) at a news conference in November outlined a plan to give the FDA clear authority to regulate compounding facilities such as the NECC, which was linked to a deadly nationwide meningitis outbreak.
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Tightening oversight

FDA seeks more authority to regulate 'nontraditional' compounders

By Jaimy Lee
Posted: December 15, 2012 - 12:01 am ET

States are tightening their oversight of compounding pharmacies in response to a deadly meningitis outbreak as federal officials look to clarify the Food and Drug Administration's authority to insert itself more forcefully in regulating nontraditional compounders.

Some states, including Massachusetts and Michigan, have increased the number of surprise inspections of pharmacies that compound sterile injectable drugs. In California, the state board of pharmacy last week considered pushing an amendment that would give the state new authorities to inspect pharmacies that compound sterile injectable drugs regardless of where they are based.

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Federal officials say that nearly 600 people have reported infections and another 37 have died after receiving tainted steroid injections produced by the New England Compounding Center, a Framingham, Mass.-based compounder that has since closed.

Oversight of compounding pharmacies traditionally falls under the jurisdiction of state boards of pharmacy, while the FDA is responsible for regulating drug manufacturing.

As healthcare providers have become increasingly reliant on the loosely regulated sector and some compounders have evolved from local pharmacies to national distributors of compounded drugs, many are questioning whether large-scale compounding is, in fact, manufacturing and if the FDA should be responsible for regulating a new category of compounding.

The FDA said it needs additional authorities to oversee compounders and has proposed a risk-based approach that would put nontraditional compounding under the purview of the FDA. Some lawmakers have argued that the FDA already has the authority to regulate compounding pharmacies.

“There is precedent for FDA getting more authority after some tragedy occurs,” said Linda Bentley, a lawyer and chairwoman of Mintz Levin's FDA practice group. “That could happen here.”

The FDA has scheduled a public hearing this week to share the results of an intergovernmental meeting attended by the agency and state representatives. The FDA and state boards of pharmacy have been scrutinized for their roles in regulating compounders such as NECC.

However, officials at state boards of pharmacy say they need a better definition of what the FDA calls “nontraditional compounding.” Traditional compounding requires pharmacies to produce a drug based on a prescription for a specific patient.

The NECC, which was considered a compounding pharmacy by the FDA and Massachusetts after inspections conducted a decade ago, was producing drugs in large volumes. The company recalled 17,000 steroid injections that had been distributed to 23 states when the investigation into the outbreak began.

In a federal notice, the FDA said it aims to define the traditional pharmacy practices that the states should oversee and the higher-risk, nontraditional compounding practices that must comply with federal manufacturing standards.

“We need a clear path forward that is proactive and preventive and that takes the need for compounded products and the evolution and potential risks of pharmacy compounding into consideration,” an FDA spokeswoman said in an e-mail.

What makes oversight of compounding pharmacies particularly challenging are widely ranging state pharmacy laws.

In Michigan, state records do not distinguish sterile compounders from traditional pharmacies, said Rae Ramsdell, director of the bureau of health professions for the Michigan Department of Licensing and Regulatory Affairs.

To identify compounders for inspection, the state's five inspectors are combing records for its 3,200 pharmacies that have “compounding” in their business names. They are also relying on pharmacies to disclose whether they participate in sterile compounding.

Ramsdell said Michigan's state board of pharmacy is not looking to introduce any changes to state regulatory practices because of concerns those efforts may be hampered by federal legislation. “We're hesitant to move too quickly until we know what's going to happen at the national level,” she said.

Reps. Rosa DeLauro (D-Conn.) and Nita Lowey (D-N.Y.) introduced a bill this month that would require compounders to register with the FDA, while the House Committee on Energy and Commerce has requested information from a wide range of stakeholders affected by the outbreak as part of an ongoing investigation.

Other states are moving forward with their own evaluations of sterile compounding regulations.

A working group convened by North Carolina's board of pharmacy planned to meet for the first time this week to review state regulations on compounding pharmacies, said Jay Campbell, executive director of the North Carolina Board of Pharmacy.

North Carolina is one of the few states with the resources to send inspectors across state lines to inspect nonresident pharmacies, which are pharmacies licensed in multiple states. Nonresident compounding pharmacies are considered to be more likely to be producing drugs in large volumes.

The legislation in California, expected to be introduced next year, would significantly change the way nonresident pharmacies are licensed and inspected. The bill would also require pharmacies to disclose disciplinary actions in other states, problems with accreditation agencies and any consumer complaints. Virginia Herold, the California board of pharmacy's executive officer, said the state had relied on Massachusetts to conduct inspections of NECC.

“We're not going to rely on another agency in another state to do this,” she said.

However, increased collaboration between states and between the FDA and states will likely be necessary to fill the gaps in the current regulatory system.

The National Association of Boards of Pharmacy is developing an information- sharing network that will gather information about inspections of nonresident compounders and share it with pharmacy boards at no cost. It is also offering to conduct the inspections of those pharmacies at a reduced cost, said Carmen Catizone, the NABP's executive director.

Inspections on behalf of the Iowa Board of Pharmacy's 582 nonresident compounders began last week. The NABP is charging $350 per inspection.

“We're trying to pull together all those resources and work with the states to put back together some of the safeguards that have been lost because of the lack of resources,” Catizone said. “We thought this was the best way to do it, and the quickest and fastest way.”

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