Case Against Compounding Facility, Owner Over Insanitary Conditions Resolved in Federal Court

FEBRUARY 06, 2019
A complaint filed by the US Department of Justice on behalf of the FDA against a Pennsylvania compounding facility and its owner was settled today in the US District Court for the Western District of Pennsylvania. The court entered a consent decree of permanent injunction between the United States and Ranier’s Rx Laboratory Inc. of Jeanette, Pennsylvania, and owner-pharmacist Francis H. Ranier.

“We continue to see concerning activity when it comes to some compounded drugs, including problems related to the conditions under which compounded sterile medicines are made, which can raise significant risks to patients. This is an area of intense focus for the FDA. We’re committed to making sure that compounded drugs are made under appropriate production standards and, when necessary, taking enforcement actions against compounders who fail to produce sterile drugs in compliance with the law,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “Despite our warning, Ranier’s and its owner placed patients at risk by compounding purportedly sterile drug products under insanitary conditions. The FDA will continue to pursue enforcement action against companies and owners who place American consumers at risk.”

The complaint filed with the consent decree alleges that Ranier’s manufactured and distributed purportedly sterile drug products, including injectable drugs, for conditions such as erectile dysfunction, as well as ophthalmic drugs for use as anesthetics, antibiotics, and cataract therapies, among others, that were adulterated under the  Food, Drug, and Cosmetic (FD&C) Act because the drugs were made under insanitary conditions. 

The consent decree prohibits the company and Ranier from manufacturing, holding, or distributing human or animal sterile drugs compounded at their facility until they comply with the FD&C Act and FDA regulations, among other things.

On July 10, 2018, the FDA warned the public against using any human and animal drug products intended to be sterile that were produced by Ranier’s, due to concerns about the company’s ability to assure the sterility of those products. On July 27, 2018, the compounder issued a press release regarding a voluntary recall of all its unexpired sterile compounded drug products.

Under the consent decree, Ranier’s and Ranier cannot resume sterile compounding operations for human and animal drugs until they complete required corrective actions and receive authorization from the FDA.
 

Reference

Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions [news release]. Silver Spring, MD; February 6, 2019: FDA website. http://www.pharmacytimes.com/link/254. Accessed February 6, 2019.

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