Compounding pharmacies may face more regulations as lawmakers and stakeholders continue to question federal and state oversight of the Massachusetts pharmacy confirmed as responsible for the multistate fungal meningitis outbreak.
On Oct. 16, the Food and Drug Administration raided the New England Compounding Center, the Framingham, Mass.-based compounding pharmacy that distributed the contaminated steroid injections.
As of Oct. 19, there had been 268 cases of fungal meningitis, 21 deaths as a result of the outbreak and three peripheral joint infections. Sixteen states have reported infections.
NECC shut down operations this month and recalled more than 2,000 products, while Ameridose, a Westborough, Mass.-based provider of sterile admixing and repackaging services that shares ownership with NECC, announced plans to cease production and shipping of its products. Government officials said last week that they had confirmed that the fungus responsible for the outbreak was found in unopened vials of preservative-free methylprednisolone acetate from NECC.
Pharmacists and providers say that compounders fill a widening gap in the current system. Strict sterile compounding regulations in effect since 2004 have compelled many hospitals to outsource compounding. Compounding pharmacies also have served as a source of drugs in short supply
“The number of compounding pharmacies has grown significantly over the last few years,” said Linda Bentley, a lawyer and chairwoman of Mintz Levin's FDA practice group. “Going forward, there's going to have to be closer cooperation between FDA and all the state boards of pharmacy.”
State boards of pharmacy have oversight of pharmacies. The FDA, which regulates drug manufacturing, has attempted to inspect and regulate compounding pharmacies, including NECC, that were suspected of manufacturing, but many of the agency's efforts failed when compounders took their cases to court.
The Massachusetts Board of Pharmacy and the FDA have come under scrutiny for their oversight of NECC, prompting the House Committee on Energy and Commerce to request information last week about past FDA inspections of NECC facilities and communications between the agency and NECC.
“The FDA will continue to act within its existing authorities to protect public health and help ensure the safety of medical products,” an FDA spokeswoman said in a statement. “Once the immediate crisis is contained, the FDA is committed to working with Congress, compounders, the states and all other stakeholders to strengthen the system to prevent tragedies like this from happening again.”
Although lawmakers have said they will introduce legislation that would give the FDA greater authority to oversee compounding pharmacies, others have said it is still unclear whether there is a need for federal oversight.
In an Oct. 12 statement, the American Society of Health-System Pharmacists said any organization that manufactures medications without a prescription should be registered with the FDA as a manufacturer.
However, how the FDA and state boards of pharmacies view the line between compounding and manufacturing is unclear. There should be a “better understanding of compounding and manufacturing,” said Cynthia Reilly, ASHP's director of practice development division. “Defining that has been a gray area.”
The FDA spokeswoman said compounded drugs can serve an important public health need, but when compounded drugs are not prepared properly, they can pose potential health risks. “When such compounding occurs on a large scale, more patients are exposed to those risks,” she said.
Of the roughly 3,000 pharmacies that provide sterile compounding in the U.S., 162 have been accredited by the Pharmacy Compounding Accreditation Board, a not-for-profit that was formed by eight pharmacy organizations and accredited its first pharmacy in 2006. NECC is not accredited.
The PCAB standards meet or exceed the U.S. Pharmacopeia regulations, considered the industry benchmark on sterile compounding, said Alex Chervinsky, owner of HMCompounding, a PCAB-accredited pharmacy in Brooklyn, N.Y. “The industry itself saw the need for this nonprofit organization,” he said.
The board conducts site visits every three years and charges an annual fee of $1,500 to $5,000 to pharmacies seeking accreditation.
Three of PCAB's employees, including its executive director, are employees of the American Pharmacists Association, according to the accrediting board's 2011 tax filing. A spokeswoman for the APhA said in an e-mail that the other founding organizations are also represented on PCAB's board, and that the APhA serves as its payroll administrator.
The meningitis outbreak has led to increased interest in accreditation, said Joe Cabaleiro, PCAB's executive director. When asked why more compounding pharmacies haven't pursued accreditation, he said the payers, prescribers and patients haven't demanded it. “The market hasn't demonstrated the need for accreditation.”