FOR IMMEDIATE RELEASE
Contacts: Amy Langan
alangan@pharmedium.com
847-457-2327
Elisabeth Ritz
elisabeth.ritz@ritzcommunications.com
312-932-0992
WASHINGTON, DC, November 18, 2013—PharMEDium congratulates Congress for coming together in a bipartisan fashion to reform the existing patchwork of compounding regulations. One year after the most deadly drug contamination incident in U.S. history, the Senate approved by voice vote the House-passed legislation to overhaul the way compounding is regulated. This process began many months ago and PharMEDium would like to applaud the determination and leadership of the Members of the Senate H.E.L.P. Committee and the House Energy and Commerce committee and their dedicated staffs in strengthening the oversight of the compounding industry.
The Drug Quality and Security
Act will finally instill clarity and certainty into the oversight of compounding facilities, ensuring that large-scale sterile compounding operations that conduct interstate commerce are subject to appropriate federal oversight. This will result in a significant advance in the integrity of customized, compounded sterile preparations administered to millions of patients.
Act will finally instill clarity and certainty into the oversight of compounding facilities, ensuring that large-scale sterile compounding operations that conduct interstate commerce are subject to appropriate federal oversight. This will result in a significant advance in the integrity of customized, compounded sterile preparations administered to millions of patients.
PharMEDium, the nation’s leading provider of sterile admixture preparations for hospitals across the country, supports the establishment of a new category for “outsourcing facilities” that are registered with the U.S. Food and Drug Administration (FDA), are held to rigorous manufacturing-like standards, and are subject to routine FDA inspections. Although PharMEDium would have preferred mandatory FDA registration for large-scale sterile compounding operations that ship across state lines, we believe that effective communication between state and federal authorities will have the same effect.
with the U.S. Food and Drug Administration (FDA), are held to rigorous manufacturing-like standards, and are subject to routine FDA inspections. Although PharMEDium would have preferred mandatory FDA registration for large-scale sterile compounding operations that ship across state lines, we believe that effective communication between state and federal authorities will have the same effect.
PharMEDium has long advocated for clearer FDA authority and stronger oversight and we look forward to working with the Agency and other policymakers as they implement this landmark legislation. We believe that if implemented swiftly and fully, the Drug Quality and Security Act will help prevent another national disaster like last year’s devastating fungal meningitis outbreak.
Act will help prevent another national disaster like last year’s devastating fungal meningitis outbreak.
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Who we are: PharMEDium is the nation’s leading provider of hospital pharmacy-outsourced, sterile admixture services with centers in four states and thousands of acute care hospital customers nationwide. Our qualified personnel and state-of-the-art centers are registered with the FDA, licensed by the states, and governed by our own rigorous quality standards. We begin the compounding process with sterile FDA-approved finished drugs from FDA-approved drug manufacturers. It is our mission to be the preeminent provider of choice for hospital customers and to attain the highest degree of integrity in the compounding of sterile preparations.
of integrity in the compounding of sterile preparations.
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