|[January 24, 2014]
Cantrell Drug Company Updates FDA Registration to 503B Outsourcing Facility
LITTLE ROCK, Ark. --(Business Wire)--
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
"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 (News - Alert) 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 pharmcies 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."
About Cantrell Drug Company
Founded in 1952, Cantrell
Drug Company is a leading FDA-registered supplier of outsourced
pharmacy preparations, specializing in providing custom IV admixtures,
epidural preparations, PCA syringes, OR syringes, and drug shortage
formulations with the highest quality standards. Cantrell Drug Company
provides sterile and non-sterile compounded preparations that meet the
needs of patients, physicians, clinics and health care institutions.
Based in Little Rock, Ark., Cantrell Drug Company retains state licenses
nationwide, a DEA manufacturing license, and an FDA registration.
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