December 9, 2013
FOR IMMEDIATE RELEASE
LAKE FOREST, Ill., Dec. 9, 2013 /PRNewswire/ -- PharMEDium announced today that it is registered with the U.S. Food and Drug Administration (FDA) as a 503B large-scale sterile compounding "outsourcing facility" under the recently enacted Drug Quality and Security
Act (DQSA).
Act (DQSA).
The law, signed by the President on November 27, 2013, calls for large-scale entities engaged in non-prescription anticipatory compounding to voluntarily register with the FDA under the newly created section 503B of the federal Food, Drug, and Cosmetic (FDC) Act.
with the FDA under the newly created section 503B of the federal Food, Drug, and Cosmetic (FDC) Act.
"Our customers can continue to expect a high level of disclosure and transparency based on this new official outsourcing facility category and clarifying rules that govern it," said David Jonas, Chairman and CEO of PharMEDium Healthcare Corp. "Going forward, there will be more consistent regulations and consistent oversight, which should raise the level of confidence among hospital leaders, providers and their patients."
FDA urges providers to purchase from registered compounders
During a media briefing last week, FDA Commissioner Margaret Hamburg, MD, said: "Helping to protect Americans from unsafe drugs is among the FDA's highest priorities and is part of our core mission." She explained that the DQSA "represents a step forward by creating a new pathway in which a compounder can register with FDA as an outsourcing facility."
with FDA as an outsourcing facility."
Dr. Hamburg said that the section of the new law pertaining to compounders will give healthcare providers and health networks greater safeguards as related to medication safety if they purchase compounded products from registered outsourcing facilities.
"If compounders register with FDA as outsourcers, hospitals and other healthcare providers will be able to provide their patients with drugs that were compounded in facilities that are subject to increased FDA oversight, including inspections on a risk-based schedule, and federal requirements for current good manufacturing process, among others," Dr. Hamburg said.
with FDA as outsourcers, hospitals and other healthcare providers will be able to provide their patients with drugs that were compounded in facilities that are subject to increased FDA oversight, including inspections on a risk-based schedule, and federal requirements for current good manufacturing process, among others," Dr. Hamburg said.
She added: "With that in mind, we'll be encouraging healthcare providers and health networks to consider strongly purchasing compounded products from FDA-registered and regulated facilities. This will be a critical step they can take to better ensure the health and safety of their patients."
Dr. Hamburg said that FDA will be posting a list of registered compounders on its website to serve as a resource for healthcare providers, facilities and networks. A transcript of the full media briefing is available at: www.fda.gov/NewsEvents/Newsroom/MediaTranscripts/ucm334695.htm.
Clearer authority, stronger oversight for FDA
"PharMEDium has long advocated for clearer FDA authority and stronger oversight and believes that when the law is implemented swiftly and fully, the DQSA will help prevent another national tragedy like last year's devastating fungal meningitis outbreak," said Rich Kruzynski, President of PharMEDium. The company has been voluntarily registered with the FDA since the company's inception — more than a decade before it was requested by this much-needed new law.
The 503B registration obligates outsourcing facilities to comply with FDA oversight, manufacturing-like safety standards and routine inspection by the Agency. If an entity declines to register with the FDA, then it is not an "outsourcing facility," and its operation will be regulated under a different section of the FDC Act, 503A. Entities that do not elect to become 503B registrants and are engaged in large-scale anticipatory compounding without prescriptions are likely in violation of one or more provisions of the FDC Act if they are not inspected to the higher level of the FDA.
with the FDA, then it is not an "outsourcing facility," and its operation will be regulated under a different section of the FDC Act, 503A. Entities that do not elect to become 503B registrants and are engaged in large-scale anticipatory compounding without prescriptions are likely in violation of one or more provisions of the FDC Act if they are not inspected to the higher level of the FDA.
PharMEDium's registration as an outsourcing facility under the DQSA is based on draft guidance released by the FDA and listed in the Federal Register on December 4, 2013. Apart from the registration instructions, the draft guidance includes new drug labeling and drug event reporting regulations, and it also requires outsourcing facilities to submit a detailed report to the FDA identifying all drugs compounded by the facility during the previous six-month period. PharMEDium is actively engaged in complying with all draft guidelines.
guidance released by the FDA and listed in the Federal Register on December 4, 2013. Apart from the registration instructions, the draft guidance includes new drug labeling and drug event reporting regulations, and it also requires outsourcing facilities to submit a detailed report to the FDA identifying all drugs compounded by the facility during the previous six-month period. PharMEDium is actively engaged in complying with all draft guidelines.
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 states as compounding pharmacies, and governed by our own rigorous quality standards. We begin the compounding process with FDA-approved sterile drugs, diluent and containers from FDA-approved 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
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