Florida State Board of Pharmacy approves Unique Pharmaceuticals' license for sterile distribution

Jun 23 2015

UNIQUE PHARMACEUTICALS, a 503B current Good Manufacturing Practices (CGMP) Outsourcing Facility, today announced its licensure approval in Florida. The Florida State Board of Pharmacy review committee approved Unique Pharmaceuticals' license June 10 for distribution of sterile and non-sterile compounded medications. Unique completed its operational transformation to full CGMP standards in March, becoming one of the first facilities in the nation to meet newly established federal guidelines.

"Because we were one of the first in the nation to meet the new federal guidelines, our quality control processes and protocols are among the strongest in the nation," said Unique Pharmaceuticals CEO Travis Leeah. "We look forward to expanding our portfolio of life-saving, life-sustaining medications and meeting the needs of our customers in Florida."

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 completed two thorough inspections ensuring compliance with the new requirements including an independent inspection and certification by RCA, and an FDA follow-up inspection. On March 20, 2015 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 are proud to partner with Unique Pharmaceuticals as they continue to be an industry leader in adoption of the new FDA safety and quality standards," said Andrew Harrison, Chief Regulatory Affairs Officer at Regulatory Compliance Associates (RCA). "As the industry continues to change, I am confident Unique will set the benchmark for best practices in producing and distributing compounded sterile preparations."

In order to meet the newly established 503B CGMP guidance, the company spent much of 2014 re-engineering its facility, processes, procedures and testing. 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.