Cantrell Drug Company today announced amendment of its U.S. Food and Drug Administration (FDA) registration to include the new 503B "compounding outsourcing facility" designation established under the recently passed Drug Quality and Security Act so that it can continue to serve patients nationwide with sterile medications that meet the most exacting quality standards.
"This was a natural move for us because we have been an FDA-registered provider of sterile admixture and drug shortage solutions for four years," said Dell McCarley, Chief Executive Officer of Cantrell Drug Company. "We have extensive experience with cGMP-focused policies and procedures, and our specially engineered facilities, state-of-the-art equipment, and rigorous training and testing ensure that our customers receive the highest quality products and services."
Cantrell Drug Company is among the first pharmacies in the nation to register with the FDA following the passage of the new law, which aims to improve quality and safety among large-scale compounders who choose to adhere to more rigorous standards created under the federal Food, Drug and Cosmetic Act.
Prior to this registration, Cantrell Drug Company already voluntarily listed drug products with the FDA, which the company has regularly supplied to health care providers whose care for patients is threatened by shortages of certain medications.
Last year, McCarley joined five other industry executives to establish the Specialty Sterile Pharmaceutical Society, an organization dedicated to establishing stringent standards for specialty pharmaceutical manufacturing and to provide support for public policy that encourages the availability of outsourced sterile preparations. He now serves as president of that organization.
McCarley also participated in the U.S. Pharmacopeial Convention's Compounding Conclave, which met in December to discuss changes in the compounding profession and potential adjustments to USP standards in conjunction with new federal regulations.
"Our new FDA outsourcing facility designation will ensure that Cantrell can continue to serve the vital needs of hospitals and their patients," said McCarley. "We are here for them and we welcome their business."