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Unique Pharmaceuticals Registers as Outsourcing Facility with FDA

Mon, 01/20/2014 - 3:54pm

Unique Pharmaceuticals, Ltd. has voluntarily registered with the U.S. Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility following guidance from the recently enacted Drug Quality and Security Act.

"At Unique Pharmaceuticals we have always been and will remain firmly committed to the quality and safety of our compounded preparations," said Unique Pharmaceuticals President Travis A. Leeah, RPh, MBA, who has championed UPI's involvement with regulators on both the state and federal levels. "We have long embraced a heightened level of oversight and transparency and we are committed to continuing to provide reliable, sterile medications to patients in hospitals throughout the U.S."

Passage of the Drug Quality and Security Act on Nov. 27 brought definition to the regulation of the compounding industry by establishing a new oversight section of the FDA for "outsourcing facilities" like UPI, allowing facilities to voluntarily register with the FDA under Section 503B of the Federal Food, Drug and Cosmetic Act. This new category of large sterile compounders will be held to rigorous requirements and subject to routine FDA inspections and quality standards much like drug manufacturers.

In a letter recently, the FDA urged hospital purchasers to require compounding pharmacies that supplied medications to their facility to register as outsourcing facilities and consider voluntary registration of those facilities in their future purchasing decisions, stating that if they did so, "hospitals and other healthcare providers that purchase compounded drugs necessary to meet the medical needs of their patients can provide patients with drugs that were compounded in outsourcing facilities, which are subject to cGMP (Current Good Manufacturing Practices ) requirements and increased federal oversight."

Prior to recent legislation, Unique Pharmaceuticals voluntarily registered with the FDA. The company continues to make significant investments in technology, training and human capital in order to exceed current industry standards for providing sterile compounded medications.

In May 2013, the company adopted Chemunex ScanRDI technology across their operations to confirm sterility of preparations developed in their laboratory. UPI is one of the very few compounding pharmacies in the U.S. with the capability to detect and identify any microorganism in a raw ingredient or preparation – down to one microbial cell – within 48 hours.

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