Compounding Pharmacists Await Changes After Fungal Meningitis Scandal


Although FDA officials normally work with state pharmacy boards, FDA policy states that it should "seriously consider" independent "enforcement action" against compounding pharmacists in certain scenarios, such as when they are compounding large amounts of drugs without a prescription, compounding drugs for third parties for resale or compounding drugs that are copies of existing FDA-approved drugs typically made by drug manufacturers.

However, a 2011 federal court ruling in Texas "prohibited" the FDA from inspecting compounding pharmacies beyond the U.S. Food, Drug, and Cosmetic Act, which specifies that FDA inspectors cannot demand research, financial or sales data from pharmacists who are in compliance with state law unless those pharmacists are manufacturing a new drug.

The 2011 ruling trumped a 2008 ruling that determined the FDA actually did have additional authority over compounding pharmacists because all compounded drugs are new drugs. As such, the 2011 ruling was considered a win for compounding companies and a loss for the FDA.

And those are just the two most recent battles regarding how much authority the FDA has over compounding pharmacists. There are several others.

Chuck Leiter, the third generation president of Leiter's Compounding Pharmacy in San Jose, Calif., said more FDA regulation would be a good thing, and he'd like to see one clear law across the board.

"I think you need one law across the country," Leiter said. "While people are arguing jurisdictions, people are dying."

Clark-Lynn said Congress would have to pass new legislation to expand the FDA's power and allow it to oversee compounding pharmacists more efficiently.

"There should be appropriate federal standards for these products that are consistently enforced across all 50 states," Clark-Lynn said. "Until such legislation is enacted, the agency will continue to apply its existing legal authority to protect public health."

Since the revelations of NECC's business practices surfaced and continue to be exposed, notably in the March 10 episode of "60 Minutes," Leiter said compounding pharmacies and clients who were acting wrongly began to right themselves, but the industry still wasn't guilt-free.

RELATED: Compounding Pharmacists Defend Their Trade After Meningitis Outbreak

Leiter said that despite continued pressure from clinics or doctors' offices, he still refused to fill prescriptions for patients with fake names. He said, in his experience, fake names had become an industry practice as large-scale compounding pharmacies, such NECC, began acting more like drug manufacturers.

"It's changing, but some people are still trying to mess with the system," Leiter said.

Though Bernardi said he had not received requests for prescriptions for patients with fake names, he said he began receiving calls for bulk compounded drug orders once NECC and its sister company, Ameridose, closed. In Massachusetts, compounding drugs for "office use," meaning they aren't made specifically for one patient with a prescription, is not allowed.

"The answer is, 'We need a prescription for a patient,'" Bernardi said."That's usually where the conversation ends."

Both Leiter's and Bernardi's pharmacies are accredited by the Pharmacy Compounding Accreditation Board, or PCAB, which is considered the gold standard of compounding pharmacy safety and efficiency.

"I like to sleep at night," Leiter said. He intends for his daughter to follow in his footsteps and take over the family business, but she has to pass freshman chemistry first.

Since last fall, PCAB has received an increase of "300 or 400 times" its usual number of applicants, said Joe Cabaleiro, the board's executive director, and he takes that as an encouraging sign.

"I see a lot of our colleagues have also taken a second really hard look at their operations," Cabaleiro said, "and asked 'how can we improve as far as what we learned here.'"

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