Drugs from “The Compounding Shop” May Not Be Sterile: FDA Warns

Yet another compounding pharmacy is recalling all of its supposedly sterile products, as the FDA continues to crack down following a deadly fungal meningitis outbreak that killed dozens of people nationwide late last year.  

On May 8, the FDA issued an alert to health care professionals indicating that drugs from The Compounding Shop in St. Petersburg, Florida, may not be sterile, even when they claim sterility. Following the alert, a Compounding Shop drug recall was announced.

The drugs were pulled from the market after problems were discovered during a recent FDA inspection of the company’s facility. The agency reports that there were poor sterile production practices being carried out there.

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“If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients,” said the FDA’s director of the Center for Drug Evaluation and Research, Dr. Janet Woodcock, in a press release. “We do not have reports of patient infections. However, due to concerns about a lack of sterility assurance at the facility and out of an abundance of caution, we have advised the firm to remove its sterile products from the market to protect patients.”

The recall is the latest in a string of such actions taken by the FDA following a fungal meningitis outbreak that has sickened more than 700 people and killed more than 50. The outbreak has been traced back to the New England Compounding Center (NECC), a compounding pharmacy in Massachusetts. For years the FDA and state authorities knew there was a problem, according to government records, but did not act out of fear of litigation.

The FDA is currently pushing for expanded powers over all compounding pharmacies, which it says it needs to properly carry out its enforcement duties. A bill was introduced in the U.S. Senate last month that would grant much of that power.

NECC has been shut down and all of its drugs were recalled last fall. The company faces an increasing number of fungal meningitis outbreak lawsuits and has declared bankruptcy. The owners also may face criminal charges.


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