Compounding Pharmacists Defend Their Trade After Meningitis Outbreak

Oct. 22, 2012— -- Chuck Leiter remembers getting an earful from his father after he helped a young Barry Cadden and his wife set up their booth at a conference for pharmacists in the late 1990s.

"My dad almost killed me," said Leiter, who works with his father at Leiter's Compounding Pharmacy in San Jose, Calif. The Caddens had an unsavory reputation. "I knew they were trouble," he said.

Cadden was the president of the New England Compounding Center, which shut down this month after it was blamed for distributing tainted steroid injections that caused deadly fungal meningitis, killing 23 people to date. Up to 14,000 patients could be at risk, and 294 cases have been reported. Another three people came down with joint infections.

Like many compounding pharmacists nationwide, Leiter wants to make it known that his family-owned business does not operate like NECC, which produced compounded drugs in such high volumes that some groups argue it was a drug manufacturer, not a compounding pharmacy, and should have been under stricter regulation. The Food and Drug Administration raided NECC's Framingham, Mass., facility on Tuesday.

Leiter's grandfather opened his family pharmacy in 1925, he said. Leiter began making compounded drugs for patients since the 1980s, starting with eye drops for patients allergic to the preservatives in most commercially available drops. He now makes 100 to 300 tailor-made prescriptions a day for everything from allergen-free thyroid medication to injectable erectile dysfunction drugs for prostate cancer survivors on whom Viagra has no effect.

It's not clear how much volume NECC was producing, but the director of the Massachusetts Bureau of Health Care Safety and Quality said that NECC was in violation of state licensing regulations. About 17,000 vials of the tainted steroid were shipped to pain clinics in 23 states.

Leiter actually doesn't produce spinal injections because of the liability, pointing out the fatal meningitis outbreak from 2001 that killed three people who received cortisone injections compounded at Doc's Pharmacy in nearby Walnut Creek, Calif. Its co-owner, Jamey Phillip Sheets, committed suicide by overdosing with painkiller patches a year later.

Unlike drug manufacturers, which are regulated by the FDA, compounding pharmacies usually fall under state pharmacy boards' jurisdiction. The FDA can step in if it has concerns about a compounding pharmacy, such as misbranding or adulteration.

FDA spokeswoman Erica Jefferson said, "FDA's legal authority to regulate compounded drugs is complex and has been challenged vigorously by the compounding industry both in courts and Congress."

Each custom drug has to be tailored to a single patient with a single prescription from a single doctor, Leiter said.

According to a 2006 FDA warning letter, NECC wasn't always doing that. Among other things, the letter said NECC was mass-producing a topical anesthetic cream, and jeopardizing another drug's sterility by repackaging it.

"Further, we have been informed that, although your firm advises physicians that a prescription for an individually identified patient is necessary to receive compounded drugs, your firm has reportedly also told physicians' offices that using a staff member's name on the prescription would suffice," the letter reads, adding the practice is not consistent with FDA policy.