Federal Court Enters Consent Decree Against Compounder
The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier’s Rx Laboratory Inc., a compounding facility.
On Feb. 6, 2019, the US District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction between the United States and Ranier’s Rx Laboratory Inc., doing business as Ranier’s Compounding Laboratory, of Jeanette, Pennsylvania, and pharmacist Francis H. Ranier, who owns the compounding facility. The consent decree prohibits the company and its owner from manufacturing, holding, or distributing human or animal sterile drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C) and FDA regulations.
The consent decree states that the company manufactured and distributed products purportedly to be sterile that were made under insanitary conditions. The company and its owner may not resume sterile compounding until they complete corrective actions and then receive authorization from FDA.
“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 press release. “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.”
Source: FDA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
