An FDA agent stands at the doorway of the New England Compounding Center… (Bill Sikes, Associated…)
SACRAMENTO — State regulators are responding to a deadly nationwide meningitis outbreak linked to contaminated drugs by seeking new power to inspect out-of-state pharmacies that sell special-order prescription drugs in California.
In September, the New England Compounding Center in Framingham, Mass., sent three shipments of contaminated injectable steroid solutions to 76 healthcare facilities and pain-control clinics in 23 states, including four in California.
These customized drugs, which were injected into patients' spines and joints, caused 39 deaths among 620 reported cases of fungal meningitis and other infections, according to a Dec. 17 report from the federal Centers for Disease Control and Prevention in Atlanta.
The steroids were recalled by the now-bankrupt firm before they caused any deaths or illnesses in California. But that fortunate outcome hasn't kept the California Board of Pharmacy from being more aggressive about policing sometimes poorly regulated pharmacies that produce and ship large volumes of these medications, known as compounded drugs.
At issue is whether these outfits ought to be regulated by the U.S. Food and Drug Administration. The FDA regulates large drug manufacturers, but its legal authority to oversee the compounding pharmacies has been disputed in the courts. As a result, states are moving to play a bigger role in ensuring the safety of their products.
In one such case in 2012, the now-defunct Franck's Compounding Pharmacy in Ocala, Fla., shipped supposedly sterile products for injecting into the eye that caused infections in 17 California surgery patients.
The state pharmacy board, which oversees and licenses nearly 7,000 drugstores in California, plans to sponsor a bill in the Legislature this year that would give state agents the authority to make unannounced on-site inspections of out-of-state pharmacies that the board licenses to ship sterile medicines, such as injectable steroids, eyedrops and inhaled aerosol drugs, to healthcare providers here.
The California initiative is getting preliminary support from two industry trade groups, the Pharmacy Compounding Accreditation Board and the International Academy of Compounding Pharmacies. The FDA also is supportive of the thrust of the proposed legislation, said Virginia Herold, the state pharmacy board's executive director.
"We're being proactive for the public health because we don't want another incident," she said. "We want to make sure that if the product is coming into California, it meets the requirements of California law."
Increasing amounts of these compounded drugs are flowing into the state. The Board of Pharmacy told a congressional committee in December that it licensed 86 out-of-state compounding pharmacies to make sterile medications for use in California in fiscal year 2011-12, compared with just 17 in 2003-04 and none in 2002-03.
But keeping track of out-of-state, large-volume pharmacies isn't easy, Herold conceded, because both state and federal laws are ambiguous about who is responsible for regulating different types of compounded drugs.
The advantage of traditional compounding, federal and state health officials agree, is that it enables pharmacies to offer prescriptions in individualized formats. That includes producing such drugs as creams, powders or solutions to direct relief to specific parts of the body or supplying drugs as a liquid to make it easier for people who can't swallow pills, for example.
Any state-licensed pharmacist can make these drugs with a doctor's prescription, if the pharmacy also has a state license. In most cases, regulation and inspections are the legal province of state pharmacy boards, not the FDA.
But over the last decade, the definition of what is a compounding pharmacy has been blurred. Some pharmacies have begun manufacturing large volumes of drugs — such as sterile, injectable steroids used to temporarily ease back pain — that are shipped in bulk to hospitals and outpatient surgical centers.
"FDA's ability to take action against compounding … that exceeds the bounds of traditional pharmacy compounding and poses risks to patients has been hampered by gaps and ambiguities in the law, which have led to legal challenges to FDA's authority to inspect pharmacies and take appropriate enforcement actions," FDA Commissioner Margaret Hamburg said in congressional testimony Nov. 14.
The House Energy and Commerce subcommittee on oversight and investigations was probing the New England Compounding Center-related deaths.
As part of Hamburg's effort to boost enforcement and protect patients, she met in December with representatives from the boards of pharmacies in all 50 states.
California supports federal and state efforts to figure out a way to avoid more contamination-related illnesses from these drugs, said Amy Gutierrez, a California Board of Pharmacy member and chief pharmacy officer for the Los Angeles County Department of Health Services.
"The problem is really the other states" that might have different or weaker standards or less enforcement resources than California, she said.
"What we're looking for is holding the out-of-state pharmacies that compound sterile products to the same standards as our own state-licensed pharmacies."