Unique Pharmaceuticals Approved for Sterile Distribution

Unique Pharmaceuticals, a 503B current good manufacturing practices (CGMP) outsourcing facility, has received 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. The company said it 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 chief executive officer, 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.