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New Guide Explains how Outsourcing Facilities will Ensure the Safety and Quality of Sterile Compounded Medications

August 11, 2014| CATEGORIES: ophthalmology , Press Release

Recent legislation helps providers identify pharmacies that maintain Current Good Manufacturing Practices 

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Avella Specialty Pharmacy has just introduced a new guide entitled Outsourcing Facilities Established to Ensure the Quality and Safety of Compounded Medications (http://info.avella.com/compounding-guide) which provides an in-depth examination of the history and potential impact of this new designation.

Outsourcing Facilities, established by the Drug Quality and Security Act (DQSA) enacted in 2013, must register with the FDA and agree to increased government oversight as well as the maintenance of Current Good Manufacturing Processes (cGMPs). cGMPs are strict, detailed guidelines that must be observed during the preparation of compounded medications. These principles are designed to prevent contamination of compounded medications, deviations from protocols or incorrect ingredients as well as other safety and quality issues.

Given that ophthalmology practices rely heavily on sterile compounded therapies for the prevention and treatment of many different eye conditions, it is essential these physicians and staff members understand how this legislation will impact their practice and the safety of their patients. Avella’s new guide provides this insight as well as a detailed history of pharmacy oversight by the federal government. In addition, the new guide reveals how a serious infection tied to compounded medications in 2012 led to the introduction of the DQSA.

“At Avella, we have always gone above and beyond in our efforts to ensure patient safety and quality,” said Eric Sredzinski, Pharm.D., Executive Vice President of Clinical Affairs and Quality at Avella. “To demonstrate the depth of our commitment, Avella has already registered as an Outsourcing Facility with the FDA.”

In fact, Avella is one of fewer than 50 pharmacies that have registered as an Outsourcing Facility to date. In addition to this registration, the company has voluntarily applied for accreditation by many of the most respected healthcare and pharmacy entities and adheres to current gold standards for compounding. These include accreditations with the Pharmacy Compounding Accreditation Board (PCAB), URAC, and Accreditation Commission for Health Care (ACHC) (in process).

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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