Unique Pharmaceuticals Launches Sterile Operations

Unique Pharmaceuticals, a 503B outsourcing facility, has initiated sterile compounding operations meeting the newly established federal guidelines.

“Our goal as a company is to meet and exceed industry standards,” said Unique Pharmaceuticals chief executive officer Travis Leeah. “Meeting the new regulations is validation of our quality management system and our dedicated staff. We’re embracing the future of our industry, investing in its continued success and are proud to be a pioneer among our competitors.”

Unique Pharmaceuticals was among the first companies in early 2014 to voluntarily register with the U.S. Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility following guidance from the Drug Quality and Security Act (DQSA) which congress passed in late 2013. Passage of the DQSA brought definition to the regulation of the compounding industry by establishing a new oversight section of the FDA for “outsourcing facilities” like Unique Pharmaceuticals, allowing facilities to voluntarily register with the FDA under Section 503B of the Federal Food, Drug and Cosmetic Act. This new category of large volume sterile compounders is now held to quality standards and subject to routine FDA oversights much like drug manufacturers.

Unique Pharmaceuticals and Regulatory Compliance Associates Inc. (RCA), a team of experienced professionals from FDA-regulated industries including pharmaceuticals, cooperated with the FDA to demonstrate compliance with new compounding industry regulations. Unique Pharmaceuticals has recently undergone two thorough inspections ensuring compliance with the new requirements including an independent inspection and certification by RCA, and an FDA follow-up inspection. Earlier this month the Dallas District Office of the FDA, upon assessment of corrective actions, notified Unique Pharmaceuticals in a written letter that it had “no objection to the company resuming sterile operations.”

“We’re proud to partner with Unique Pharmaceuticals as they demonstrate industry leadership in their commitment to 503B quality,” said Andrew Harrison, chief regulatory affairs officer at RCA. “As the regulatory framework for compounding pharmacies is maturing, Unique Pharmaceuticals has the early adopter advantage in the industry for showing dedication to sustainable compliance with the safety and quality standards from the FDA.”

Previous regulations required compounders to meet United States Pharmacopeia (USP) Chapter 797 standards, which were monitored and enforced by state boards of pharmacy. Though Unique Pharmaceuticals continually met and exceeded USP requirements, the company spent much of 2014 re-engineering its facility, processes, procedures and testing to meet the new 503B Current Good Manufacturing Practices (CGMP) guidance requirements. The company enhanced the design of its facilities; invested in technology such as new cleanroom equipment and upgrades to the HVAC system; validated processes and equipment; made investments in human capital by adding staff with experience in CGMP and pharmaceutical manufacturing; and increased environmental and personnel aseptic monitoring from weekly to daily to ensure delivery of sterile compounded products.

“We’ve spent an intense nine months transforming our company in order to continue providing our customers, and ultimately their patients, with high-quality, safe, life-saving and life-sustaining medications,” Leeah said.