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Avella Registers as an “Outsourcing Facility” with the FDA

March 18, 2014| CATEGORIES: Corporate , Press Release

New program aims to help providers identify compounding facilities that meet more rigorous standards around quality and patient safety.

Avella Specialty Pharmacy has announced that it has registered with the FDA as an Outsourcing Facility for sterile compounding as outlined in the recently enacted Drug Quality and Security Act (DQSA). Outsource Facilities must consent to greater federal oversight including more frequent inspections and are required to demonstrate their adherence to specific “good manufacturing practices.”

The new registration program was created to help healthcare providers, such as physicians and hospitals, identify a compounding pharmacy partner that meets high standards around quality control and patient safety.

“Avella has always welcomed new opportunities to illustrate the safety, efficacy and quality of our products,” said Rebecca Shanahan, CEO of Avella. “We are excited to see that the FDA is looking to recognize facilities that have a commitment to excellence in these areas.”

In fact, this participation is another milestone in Avella’s longstanding dedication to clinical excellence and patient safety. Avella was one of the first pharmacies in the nation to earn Pharmacy Compounding Accreditation Board (PCAB) accreditation. Today, less than 200 pharmacies in the U.S. share this distinction and only a fraction of those facilities have both sterile and non-sterile compounding accreditation through PCAB. Avella also maintains a dedicated internal quality assurance department and is accredited by URAC as both a specialty pharmacy and a mail service pharmacy.

About Avella Specialty Pharmacy

Headquartered in Phoenix, Arizona, Avella Specialty Pharmacy is a National Accredited Specialty Pharmacy, providing individualized care and support to patients since 1996. Avella's clinical pharmacists and staff members are experts in managing complex disease states and providing compassionate care. The company offers a nationwide distribution service to complement its retail locations. Avella reached 1,105th on Inc. magazine's 2013 list of the 5,000 fastest-growing private companies in the country. In addition, the Arizona Corporate Excellence Awards has named Avella Specialty Pharmacy as the fastest-growing private company based in the state. For more information, please visit www.avella.com.


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