After a recent health inspection, a St. Petersburg-based compounding pharmacy, The Compounding Shop, is recalling all of its sterile drugs due to contamination concerns. During the inspection, the Food and Drug Administration (FDA) found “exposed rust” and “numerous splattered brownish stains” on the compounding pharmacy’s manufacturing equipment. Even though the Compounding Shop’s injectable drugs and eye medications have not been linked with any reports of illness, the FDA has urged the company to take preventive action. “If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients,” said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research. “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.”
In its May 8, 2013 news release, the FDA alerted health care providers, hospital supply manager, and pharmacists of the Compounding Shop’s questionable manufacturing practices which “potentially places patients at risk of serious infection.” In an effort to avert potential infections, the FDA urges health care professionals to halt any administration of products made by The Compounding Shop to their patients and to quarantine its remaining stock.
The FDA’s inspection comes on the heels last year’s outbreak of fungal meningitis. The Center for Disease Control and Prevention (CDC) linked the outbreak to three lots of medications used for epidural steroid injections produced by New England Compounding Center (NECC), a Massachusetts based compounding pharmacy. The medication produced by the NECC was administered to approximately 14,000 patients. As a result of the contaminated drugs, 55 people died and over 700 people were treated for persistent fungal infections.
After the NECC was forced to recall its contaminated drugs, the state of Massachusetts’ Department of Public Health conducted numerous surprise investigations of other compounding pharmacies. Ameridose, a sister company of NECC, was also shut down over sterility concerns in October of 2012.
In response to the serious health concerns posed by sub-standard sterility conditions found in compounding pharmacy facilities, members of the United States House of Representatives and United States Senate requested briefings as a preliminary step for drafting legislation to heighten federal drug safety regulation. In the meantime, individual state officials, such as Maryland’s Governor Martin O’Malley, aren’t waiting for Congress to act. This month, Governor O’Malley signed into law a measure that will require Maryland-based compounding pharmacies to seek an additional permit in order to manufacture drugs, and it will also permit state health officials to conduct more thorough inspections. Additionally, out-of-state pharmacies will face more exacting oversight if they wish to sell their medication to health care professionals in Maryland.
Still, before Congress authorizes the FDA to tighten its regulation of compounding pharmacies nationwide, individual states have the choice of either waiting or being pro-active.
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In regard to the medication distributed by The Compounding Shop, the FDA advises “patients who have received any products produced by The Compounding Shop and have concerns should contact their health care provider. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.