Six months after a U.S. meningitis outbreak that killed 51 people put the spotlight on their industry, specialty pharmacies that mix their own drugs are falling short of federal safety and sanitation requirements.
Since the deaths, the Food and Drug Administration has uncovered a wide range of shortcomings at so-called compounding pharmacies, including failure to set or follow procedures to prevent contamination, inappropriate protection worn by people working in sanitary areas and inadequate testing to determine expiration dates, a review of 30 inspection reports shows.
The reports covering inspections from January through March come as Congress investigates failures in regulating compounding pharmacies, a role typically held by states, following the meningitis deaths. The unprecedented number of publicly released inspection reports, known as form 483s, may be used as a tool by the FDA in its quest to gain authority over the industry.
“It’s very aggressive on the part of the FDA,” said Sarah Sellers, a former agency compliance officer who now works for the drugmaker Ther-Rx Corp., which sells a maternity medication threatened by compounding competition. “Without this information the FDA would not be able to move forward with new legislation. We’ve identified that there’s an absolute and critical need for greater oversight.”
The looming fight between the FDA and the estimated $3 billion to $9 billion compounding industry underscores the limits of federal oversight in a corner of the health-care industry where the lines between specialty drug mixing and full-fledged manufacturing have become increasingly blurred.
Compounding pharmacies are supposed to mix drugs on a small scale to respond directly to an individual doctor’s orders. New England Compounding Pharmacy Inc., which shut down in October after its contaminated steroid shots were linked to the deadly meningitis outbreak, was determined by state and federal investigators to be producing drugs on a much larger scale in anticipation of prescriptions, akin to traditional drugmakers.
Last month, Med Prep Consulting Inc. said it voluntarily recalled all of its sterile drugs after contaminants were found floating in five bags of an intravenous solution. The Tinton Falls, New Jersey-based company said that no injuries or illnesses have been reported.
Clinical Specialties Compounding Pharmacy also last month voluntarily pulled all sterile products after five people got serious eye infections associated with a repackaged cancer drug used to treat some vision loss, according to a company statement posted by the FDA.
Compounding pharmacists are subject to standards set by the U.S. Pharmacopoeial Convention, a non-profit standard-setting organization, not those the FDA imposes on drug manufacturers, David Miller, chief executive officer of the International Academy of Compounding Pharmacists, said in a phone interview.
Drug compounders want to keep the current system. They argue that requiring them to meet the same standard as drugmakers will cause shortages.
“If a pharmacy waits to do everything in compliance then patients won’t get treatment,” said Jeffrey Gibbs, a lawyer with Hyman, Phelps & McNamara who represents compounding pharmacies.
The debate should be about the best way to ensure quality in compounding rather than who should regulate it, Gibbs said.
The FDA doesn’t typically post inspection reports publicly though it does make them available through a Freedom of Information Act request, said Gibbs. A form 483 isn’t the agency’s final determination though companies that are in violation of the law may eventually receive a warning letter that is more official.
The 30 inspection reports released are from compounding pharmacies the FDA has deemed at high risk as well as others the FDA searched to investigate complaints, Erica Jefferson, an agency spokeswoman, said in interview. The FDA so far has conducted 44 high risk inspections this year through April 2, Jefferson said.
In the past, drug compounders haven’t been held to the same standard as drug manufacturers because of conflicting judicial decisions that make it unclear whether the pharmacies are exempt from federal law, Jefferson said in an e-mail. With a hodgepodge of differing state regulations in force, the FDA has moved to apply more rigorous and uniform federal standards to its investigations of what it deems are high-risk compounding pharmacies, she said.
“It has definitely caused a pause in the minds of pharmacies that are engaged in compounding because now they don’t know what the rules are,” IACP’s Miller said.
IACP estimates that compounded drugs account for 1 percent to 3 percent of the $300 billion U.S. prescription market.
FDA inspectors have been delayed in their work or denied full access to the pharmacies, FDA Commissioner Margaret Hamburg, said in a March 22 blog post. The FDA needs clear authority to inspect the pharmacies, she said.
The FDA has pushed for legislation to clarify and amplify its role, requiring compliance with federal quality standards, registration and adverse event reporting for some pharmacies. The agency is particularly concerned about pharmacies that widely distribute sterile drugs in advance of or without receiving a prescription, Hamburg said in the post.
The FDA should determine whether those pharmacies are conducting drug manufacturing and use its existing authorities to regulate rather than entering the field of pharmacy practice, Miller wrote March 20 in a letter to leaders of the Senate’s health committee who are crafting legislation. The committee anticipates having draft legislation ready this spring, Elizabeth Donovan, a spokeswoman for committee Democrats, said.
Miller said that his compounding pharmacists group will in the meantime work with state legislatures and pharmacy boards to strengthen their regulations. Miller said he has had 52 proposed state bills related to compounding come across his desk and is working with 27 state boards of pharmacy to update their rules.