Jeannette pharmaceutical lab reaches agreement with FDA over sterilization concerns

An attorney for a Jeannette pharmaceutical business accused by the U.S. Food and Drug Administration of failing to properly sterilize its laboratory has reached a consent agreement in hopes of ending the dispute.

The FDA issued a public warning last summer alleging Ranier’s Compounding Laboratory, also known as Ranier’s Pharmacy and Ranier’s RX Laboratory, did not properly sterilize its environment while making drugs. The FDA warned in July that although there were no reports of the pharmacy’s medicine harming anyone, the agency recommended consumers not use products coming from the laboratory that were reported to be sterile.

“We had discussions with the FDA last week, and we negotiated a consent agreement on this issue. I’d like to point out that the complaint actually involved a very, very minute portion of Rainier’s pharmacy enterprise and had to do with a process known as sterile compounding,” said Francis Murrman, a Greensburg attorney who represents Ranier. “It’s a real specialty item in the manufacturing there and accounts for less than 5 percent of the production that occurs there.”

Fran Ranier, owner of the pharmacy, will stop that part of the business, Murrman said.

The FDA’s warning did not apply to products from the pharmacy at 1107 Lowry Ave. that were not labeled as sterile. The pharmacy celebrated its 25th year of operation last year, according to its Facebook page.

Although a federal judge has not yet signed off on the 21-page consent agreement, a copy signed by Murrman and attorneys with the civil division of the U.S. Department of Justice was posted online Monday.

“(Ranier) also represents that, as of the date of the entry of this decree, there are no finished and/or in-process compounded sterile drugs manufactured at and/or from defendants’ possession, custody or control,” the decree states.

The agreement also states Ranier agreed to submit a work plan to an independent drug compliance expert to conduct inspections at the facility ensuring the pharmacy has implemented all recommended corrective actions and ensure the firm’s manufacture, holding and distribution of sterile drugs will be continuously administered with those corrective actions implemented.

In its July warning, the FDA stated the laboratory had unsterile conditions for more than two years.

The FDA first recorded problems at the laboratory during an inspection in April 2016, noting it found “serious deficiencies in … practices for producing sterile drug products, which put patients at risk.”

During a follow-up inspection in May, inspectors found residue on an air filter in a sterile area, as well as “visible dirt, stains or residue that are not removed during routine cleaning” on the floor of a clean room, according to the FDA.

Equipment and materials were not properly disinfected, workers didn’t completely cover their hair while working on drugs, and they touched unsanitized surfaces with their gloved hands then returned to work without changing their gloves, the FDA maintained. The lab didn’t properly monitor the sterility of its operations, the inspection found.

At the time of the warning, the FDA also urged the pharmacy to recall the affected medicines.

Paul Peirce is a Tribune-Review staff writer. You can contact Paul at 724-850-2860, ppeirce@tribweb.com or via Twitter @ppeirce_trib.