PHOENIX — Avella Specialty Pharmacy on Tuesday announced that it has registered with the Food and Drug Administration as an outsourcing facility for sterile compounding as outlined in the recently enacted Drug Quality and Security Act. Outsource facilities must consent to greater federal oversight including more frequent inspections and are required to demonstrate their adherence to specific “good manufacturing practices,” Avella noted.
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,” stated 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.”