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'Objectionable Conditions' Persist at Drug Compounding Facilities

 |  By cclark@healthleadersmedia.com  
   August 08, 2013

Problems discovered in federal inspections of compounding facilities include "inappropriate or inadequate, or both, clothing for sterile processing… insufficient microbiological testing, and other practices that create risk of contamination," says the GAO.

The U.S. Food and Drug Administration, stepping up its scrutiny, is finding multiple, serious sterility problems with compounding pharmacies that distribute to hospitals and doctors, says a report from the Government Accountability Office.

Prepared for Congress, the GAO report says the FDA in February went beyond its typical "for-cause inspections" criteria and targeted 31 compounding pharmacies that met any two of the following criteria:

  • Whether a warning letter had been issued to the pharmacy in in the past 10 years
  • Whether the pharmacy compounded sterile injectable drugs.
  • Whether there were adverse drug events reported.
  • Whether there were complaints from the FDA district office or from others.

By April 29, FDA had cited 30 of the 31 pharmacies for "objectionable conditions." In some cases the issues were sufficiently serious to generate warning letters to those companies.

The problems included "inappropriate or inadequate, or both, clothing for sterile processing, lack of appropriate air filtration systems, insufficient microbiological testing, and other practices that create risk of contamination," the GAO investigators wrote.

The issues were serious to result in seven of the 31 pharmacies recalling "some or all of their sterile compounded products" produced under these observed conditions. For example:

"FDA sampled a compounded sterile injectable solution during one of its inspections in March 2013 and found bacteria in the product," resulting in a nationwide recall of over 50 sterile drug products.

"Another compounding pharmacy recalled its sterile drug products that had not yet reached the expiration date listed on the product because of a lack of sterility assurance." The products had supplied medical professional offices in that state. "However, some patients that received products from those medical professionals may live in other states."

Joseph Hill, director of federal legislative affairs for the American Society of Health-System Pharmacists, praised the GAO report saying it "provides further credence to the argument that the current regulatory environment around compounding is flawed and the gaps that currently exist enabled NECC to be licensed as a pharmacy while behaving more like a drug manufacturer."

"This is additional evidence, in our view, that Congress needs to close the regulatory gaps and update FDA authority to reflect what is an evolving pharmaceutical marketplace where need for specific dosage forms or unique variations of sterile compounded products that go above and beyond traditional pharmacy compounding done pursuant to a patient prescription."

The GAO report drew numerous other conclusions, most of which have been reported since September's national compounding drug disaster. That's when an injectable steroid drug compounded by the New England Compounding Center in Framingham, MA, was found to be contaminated with a fungal toxin that has so far killed 63 people and sickened nearly 700 others in 20 states.

These issues are of grave concern to hospitals. According to a U.S. Office of Inspector General report issued in April, 92% of hospitals use compounded products, 92% of these use sterile-to-sterile products and 25% use non-sterile to sterile products.

"Of the hospitals that used nonsterile-to-sterile compounded sterile preparations, 85% outsourced at least some of these products [i.e., purchased them from outside pharmacies].

Among the GAO report's findings:

  • The FDA's ability to oversee drug compounding is unclear, in part because two federal circuit court decisions have granted different and conflicting sets of authorities over the agency's ability to inspect and take enforcement action.
  • Gaps in oversight of drug compounding result because although states generally regulate the practice of pharmacy, and the FDA oversees the practice of drug manufacturing, there is "no consensus on whether compounding drugs in large quantities —in anticipation of individual prescriptions or without prescriptions—and selling those drugs across state lines falls within the practice of pharmacy or is a type of drug manufacturing."
  • Even with its limited oversight and ability to get timely and reliable information, the FDA this year looked at pharmacies it considers high-risk or which had had problems in the past and found continued problems in almost all of those.
  • Some compounding pharmacies have "registered" with the FDA "to market themselves as 'FDA-registered,' which may lead some purchasers to assume that FDA has inspected or approved their compounded drugs" when "this is generally not the case."
  • National pharmacy organizations and officials from state boards of pharmacy say "some states do not have the resources to inspect pharmacies on a regular basis" but do so "only in response to a complaint or a reported adverse drug event."

In addition, only 25 state pharmacy regulatory boards require compliance with the generally recognized USP (U.S. Pharmacopeia-National Formulary) 797 guidelines for proper sterility practices and equipment.

The GAO report also says that legally, "pharmacies are generally not required to report to FDA adverse events regarding compounded drugs they have produced, unlike drug manufacturers," and instead, such reports about compounded drugs causing patient harm are merely voluntary.

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