RCA helping Unique Pharmaceuticals adapt to new compounding laws

Regulatory Compliance Associates (RCA), a life-sciences consultancy, said on Thursday that its cooperative effort with Unique Pharmaceuticals will help the latter demonstrate compliance with new federal compounding industry regulations.

“We’re proud to partner with Unique Pharmaceuticals as they lead the compounding pharmacy industry in demonstrating their commitment to quality,” Andrew Harrison, chief regulatory affairs officer at RCA, said.

Recent federal legislation created a new oversight section of the Federal Food and Drug Administration for sterile compounding pharmacies. The legislation, the Drug Quality and Security Act, holds compounding pharmacies, such as Unique Pharmaceuticals, to more rigorous quality standards and requirements.

“The new requirements are strengthening the outsourcing compounding industry, and that’s good for our business, our customers and, ultimately, their patients who benefit from high-quality, safe, life-saving and life-sustaining medications,” Unique Pharmaceuticals CEO Travis Leeah said.

“The team at RCA has been a true blessing for Unique, and we would not have succeeded without their coaching, expertise and knowledge. We always felt that Unique was their top priority.”

Over a period of nine months, RCA did a complete cGMP baseline review of Unique Pharmaceuticals and guided it through thorough remediation and re-engineering of its facility, processes, procedures and testing to meet the new requirements.

“We wanted to be early adopters of this emerging regulatory framework, and we were fortunate to choose RCA as our independent third-party cGMP regulatory experts,” Leeah said. “Unique Pharmaceuticals leveraged RCA’s extensive experience surrounding the more mature regulatory landscape of aseptic processing for pharmaceuticals, and RCA accelerated our compliance path.”