(NEW YORK) — Despite efforts to close perceived loopholes that allowed the New England Compounding Center (NECC) 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 (IACP).
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 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.
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