States try to strengthen rules on drug compounders

By Todd Wallack

| Globe Staff November 16, 2012

State pharmacy regulators across the country are moving to strengthen their oversight of compounding pharmacies like the one in Framingham that has been blamed for a deadly outbreak of fungal meningitis in 19 states.
The Massachusetts pharmacy board, whose failure to ensure safe practices at New England Compounding Center was highlighted in two days of legislative hearings this week, has enacted emergency regulations and begun surprise inspections. Ohio and Texas have stepped up inspections in their states, Florida pulled the license of a pharmacy with a history of past problems, and several states have created task forces to revamp their rules.
Both government officials and watchdog groups say the outbreak underscores the need for tougher rules and enforcement to protect patients from compounding pharmacies with sloppy practices — especially those like New England Compounding that shipped large volumes of sterile injections across the country.
“I think it’s fair to say every state is looking at this,” said Caroline Juran, executive director of the Virginia Board of Pharmacy, which plans to take up the topic at its board meeting next month.

So far, at least 32 people have died and 461 have become ill from tainted steroid injections made by New England Compounding. The company has since shut down, laid off almost all its employees, and drawn dozens of lawsuits.

‘There was too much trusting of pharmacies to do what they were supposed to do. That trust is now gone.’

In Washington, lawmakers hammered Dr. Margaret Hamburg, the Food and Drug Administration commissioner, on Wednesday and Thursday, for her agency’s failure to crack down on New England Compounding and similar pharmacies, while she blamed a “crazy quilt” of confusing state and federal rules that have let many compounding companies operate with little oversight. Hamburg urged Congress to give the FDA more authority to inspect and demand documents from such pharmacies.
In the meantime, states are trying to beef up their own rules and enforcement. Ohio has begun re-inspecting compounding pharmacies to make sure they are complying with the state’s rules. Texas has stepped up inspections of sterile compounding pharmacies, which make the kind of injectable drugs New England Compounding did.
Last month, Florida suspended the license for Rejuvi Pharmaceuticals Inc., another compounding pharmacy that makes injectable drugs, after finding numerous problems, including “dirty/unsanitary” conditions and missing labels on medications, according to state records.
The pharmacy’s attorney, Julie Gallagher,said the Florida Department of Health probably would not have shut down the company for such “technical” violations, except for the attention on New England Compounding. She said the state did not find any contamination at the Boca Raton, Fla., pharmacy and had not received any complaints from doctors. “DOH is no doubt putting compounding pharmacies under a microscope,” Gallagher said.
Ashley Carr, an agency spokeswoman, insisted the suspension was unrelated to New England Compounding’s woes. She said the agency found similar violations in at least three prior inspections of Rejuvi since 2009 and thought the problems posed an “immediate threat to the public.”
Even states that feel they are already adequately supervising their own pharmacies are increasingly concerned about companies based elsewhere.
California long ago beefed up its regulations for sterile compounding pharmacies, requiring an inspection or accreditation through an approved national agency, after a Walnut Creek, Calif., firm was blamed for three deaths from a tainted injectable steroid it produced a decade ago. But Virginia Herold, executive director of the California Board of Pharmacy, said New England Compounding’s problems have proven that was not good enough, because many hospitals and clinics in California bought drugs from the Massachusetts pharmacy.
“We need to make certain that the medicines that reach patients are safe,” Herold said.
Most states simply require out-of-state pharmacies to fill out a brief form, prove they have a current license in their home state, and pay a fee. A handful of states, such as Massachusetts, have no licensing requirements for out-of-state pharmacies. Instead, states rely on pharmacies’ home states to follow up on complaints and do regular inspections.
“Obviously, we are pretty reliant on other states to do inspections,” said LaVerne Naesea, executive director for the Maryland Board of Pharmacy. Like most states, Maryland licensed New England Compounding but did not inspect the firm.
But now a number of states — including California and Maryland — are considering requiring out-of-state firms to be regularly inspected by an independent agency, such as the national Pharmacy Compounding Accreditation Board or the National Association of Boards of Pharmacy. The national association also plans to recommend state boards require such inspections.
Carmen Catizone, the association’s executive director, said “the overwhelming majority of states” do not even have enough resources to inspect pharmacies within their borders, let alone those based elsewhere. But he said his group is in talks with several states, including Indiana and Illinois, about handling such inspections.
He said regulators are particularly worried about the several hundred sterile compounding pharmacies, like New England Compounding, that produce large volumes of drugs.
“There was too much trusting of pharmacies to do what they were supposed to do,” Catizone said. “That trust is now gone.”

Catizone said every state he has talked to is considering new rules or tougher enforcement. Several states — such as Texas and Massachusetts — have formed task forces or commissions to examine the situation.
But Catizone said it could take months or years for states to implement all the changes, particularly where legislation is needed. And Catizone said states must be careful not to enact rules so stringent that they exacerbate drug shortages and prevent patients from obtaining medication they need. “There has got to be some sort of balance,” he said.
The industry could also fight some of the proposals. The International Academy of Compounding Pharmacies — which helped defeat a past proposal to increase federal regulation of compounding pharmacies and urged Massachusetts a decade ago not to expand safety testing — warned states against rushing to enact new rules.
“We think the top priority for states must be adequate enforcement of existing regulations,” said David Ball, a Newton consultant and spokesman for the association. “In many cases, good regulations are in place, but more resources must be directed to enforcement.”
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