March 14, 2013 -- Despite efforts to close perceived loopholes that allowed the New England Compounding Center to distribute thousands of tainted steroid injections that killed 50 people, questions continue to arise about the future of the compounding industry.
For compounding pharmacist Stephen Bernardi, who owns and runs Johnson Compounding and Wellness Center with his wife in Waltham, Mass., keeping up with the latest news on oversight, inspections and industry standards has been a challenge. He said he's not sure what compounding pharmacists can expect in the next year.
"We try to read every day, and we see something new every day," said Bernardi. "I don't think it's very clear. ... We think we're doing the right thing."
Since people started getting sick last fall, 17 different state laws began to make their way through state legislatures, some examining whether accreditation should be mandatory for compounding pharmacies, and others clarifying what constitutes a proper prescription, said David Miller, CEO of the International Academy of Compounding Pharmacists.
The International Academy of Compounding Pharmacists, or the IACP, includes more than 2,700 pharmacists, most of them in the United States, and Miller said many shouldn't need to adhere to the same standards as drug manufactures because they are so small. The compounding pharmacists have answered primarily to state pharmacy boards -- rather than the U.S. Food and Drug Administration -- for decades. As such, FDA inspections have been met with unease and confusion.
"One thing we know is that FDA's inspectors are not often familiar with pharmacy law," Miller said. "The pharmacy could be legally compliant, following all the laws of the state. They're not NECC in any way, and they could actually be found out of compliance by the FDA because agencies inspect using manufacturing standards."
FDA spokeswoman Sarah Clark-Lynn said the FDA has been coordinating with state officials to conduct 30 risk-based inspections at compounding pharmacies known to mix large quantities of sterile drugs. It is also conducting inspections following complaints about "serious adverse events," or when states have requested assistance.
So far, 14 inspections have yielded deficiency findings, which the FDA has published online. Although inspectors haven't found "greenish black foreign matter," as they found at NECC, the New England Compounding Pharmacy, in October, they posted findings, including how pharmacies had been deficient in practices to maintain sterility, which included keeping skin covered and maintaining proper air flow.
"The FDA's authority over compounding companies is limited but not nonexistent," Clark-Lynn said. "While the current FDA oversight over compounding pharmacies is limited, the agency continues to use its existing authorities to protect consumers."
But how limited is it?
Bernardi, who has not been visited by the FDA, said he wondered whether compounding pharmacists could refuse an FDA inspection if a state inspector wasn't present.
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.
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.'"