District Court Enters Permanent Injunction Against Pennsylvania Compounding Pharmacy and its Owner to Prevent Adulteration Of Drugs
The U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against defendants Ranier’s Rx Laboratory Inc., doing business as Ranier’s Compounding Laboratory, and Francis H. Ranier, its owner. The injunction permanently enjoins the defendants from doing any act that causes a drug to become adulterated based on insanitary conditions while such drug is held for sale after shipment of one or more of its components in interstate commerce, the Department of Justice announced today.
The entered permanent injunction stems from a complaint the Department filed in the U.S. District Court for the District of Western Pennsylvania on Feb. 1, 2019, at the request of the U.S. Food and Drug Administration (FDA). The complaint alleged that defendants violated the Federal Food, Drug, and Cosmetic Act by causing articles of drug to become adulterated. The complaint alleged that defendants’ drugs were adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or may have been rendered injurious to health.
“The Department of Justice aggressively pursues legal measures to help ensure that compounded drugs intended to be sterile are made under appropriate conditions and thereby to minimize risk to consumers,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “The Department of Justice will continue to work with the FDA to make sure that consumers can rely on the protections in the Federal Food, Drug, and Cosmetic Act.”
Defendants agreed to settle the complaint and be bound by a consent decree for permanent injunction. As part of the settlement, defendants represented that they are not engaged in manufacturing, holding, and/or distributing any sterile drugs manufactured at their facility. As part of the permanent injunction, if defendants intend to resume manufacturing, holding, and/or distributing any sterile drugs manufactured at their facility, they must comply with specific remedial measures set forth in the injunction. The measures include, among other things, retaining an independent person to assist with remedial efforts, submitting a work plan to FDA, and providing a certification from the independent expert that defendants have undertaken corrective actions to ensure that defendants’ facility, equipment, processes, and procedures are adequate to prevent defendants’ drugs from becoming adulterated based on insanitary conditions.
FDA conducted an inspection of defendants’ facility in May 2018. According to the complaint, FDA observed numerous insanitary conditions, including insanitary employee practices, poor aseptic technique, failure to ensure adequate air quality in the cleanroom, and inadequate environmental and personnel monitoring. Following the May 2018 inspection, defendants conducted a recall of all sterile drugs within expiry.
“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, M.D. “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.”
Trial Attorney Jocelyn Hines of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Rachael Mamula of the United States Attorney’s Office for the Western District of Pennsylvania represented the United States, along with the assistance of Senior Counsel Julie Lovas of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Western District of Pennsylvania, visit its website at https://www.justice.gov/usao-wdpa.