ENGLEWOOD, Colo., Jan. 14, 2015 /PRNewswire/ -- Brown's Compounding Center, a Colorado pharmacy that creates customized prescription medications to meet individual patients' needs, today announced it has registered as an outsourcing facility with the U.S. Food and Drug Administration (FDA). The voluntary registration, finalized January 5, invites stricter FDA oversight and provides additional independent verification of Brown's compliance with the FDA's current good manufacturing practices (cGMPs), which are the same standards pharmaceutical manufacturers follow.
"Our registration with the FDA affirms Brown's Compounding Center's commitment to meeting and exceeding the highest standards for quality, safety and patient care," said Darby Brown, founder and CEO of Brown's Compounding Center. "We believe our state-of-the-art facility sets a national standard for compounding labs, and we're pleased to have the FDA's input as we continue to raise the bar on quality control and patient care."
In February 2014, Brown's opened a new 38,000-square-foot facility, including a $2 million clean room, that allows Brown's to meet the growing demand for prescription medications tailored specifically to individual patients' needs while maintaining strict standards for quality, safety and patient care. Since moving into the facility, Brown's has continued to update its quality assurance and quality control features, including the installation of a continuous particle monitoring system in August.
Brown's registration with the FDA comes just four months after it achieved accreditation from the Pharmacy Compounding Accreditation Board (PCAB), a service of the Accreditation Commission for Health Care (ACHC). PCAB's independent accreditation reflects a pharmacy's dedication and commitment to meeting standards that facilitate a higher level of performance and patient care.
As a registered outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act, Brown's will be subject to regular FDA inspections and will provide the FDA with detailed bi-annual reports on the medications produced at its facility outside Denver, Colorado. The outsourcing facility designation was created by the Drug Quality and Security Act of 2013.
About Brown's Compounding Center
Brown's Compounding Center is a pharmacy that creates customized prescription medications to meet individual patients' needs and sets industry standards for safety, quality and patient care. From its state-of-the-art pharmacy in Englewood, Colo., Brown's licensed pharmacists create personalized medications for patients in 42 states and counting, to address a wide variety of prescription needs.
SOURCE Brown's Compounding Center