PharMEDium Advances Commitment to 503B Registration

"Outsourcing Facility" recognizes importance of protecting hospitals and healthcare providers as well as patients

Jan 27, 2014, 09:00 ET from PharMEDium

LAKE FOREST, Ill., Jan. 27, 2014 /PRNewswire/ -- In the two months since the Drug Quality and Security Act (DQSA) was signed into law, 11 compounders have registered a total of 14 facilities as "Outsourcing Facilities" per the U.S. Food and Drug Administration's (FDA's)  Registered Outsourcing Facilities Web page, dated 1/17/14. This includes PharMEDium Healthcare Corporation, the largest compounder in the category, which has registered all four of its facilities.

The law, which calls for large-scale entities engaged in nonprescription compounding to voluntarily register with the FDA and comply with guidelines under the newly created section 503B of the Federal Food, Drug, and Cosmetic Act, has been recognized for the potential to improve patient safety. What hasn't been discussed with as much vigor is the protection DQSA also affords hospitals/health systems and other healthcare providers.

"It's extremely important for hospitals and other healthcare providers to work with FDA-registered compounders as FDA has advised. Not doing so could ultimately affect the provider in several ways. There may be patient safety implications, drug supply, and compliance issues, which ultimately could affect accreditation. Reimbursement issues from payers cannot be ruled out as well," said Andrew J. Donnelly, PharmD, MBA, FASHP, Director of Pharmacy Services, University of Illinois Hospital & Health Sciences System, which outsources a number of compounded drugs.

As a long-time advocate for clearer FDA authority and stronger oversight, PharMEDium has been voluntarily registered with the FDA since the company's inception—more than a decade before the passage of the new law. The company's support of the federal oversight continues with the preparation of its required Interim Product Reporting for Human Drug Compounding Outsourcing Facilities, and the early development of innovative solutions and processes to meet and exceed 503B requirements.

"Hospitals and other healthcare providers that choose to work with compounders that have registered as 503B outsourcing facilities with FDA can have confidence in the compounding category," said David Jonas, CEO of PharMEDium. "Likewise, they should have concerns about compounders that are not choosing to register and comply with FDA's reporting requirements and other guidance."

Buying from Registered Compounders

FDA has asked providers to help support the law and ensure the safety of the drug supply by doing business with the registered 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," FDA Commissioner Margaret Hamburg, MD, said in a media briefing after the law was passed.

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 followed this announcement by sending out letters in January to hospitals/healthcare providers urging them to use registered compounders.

In keeping with FDA's recommendations, a Perspectives article written by a healthcare attorney in the Jan. 9 edition of the New England Journal of Medicine opined: "Purchasers can demand that their sterile compounded drugs be sourced exclusively from outsourcing facilities regulated by the FDA. This decision could also be included in accreditation standards and reimbursement contracts. Such a market-based response would force compounders to accede to their major customers' demands and register with the FDA."

FDA Resources Available

The new regulations regarding 503B outsourcing facilities include requirements for registering with the agency, as well as drug labeling and adverse drug event reporting. Outsourcing facilities also are required to submit a detailed report to FDA identifying all drugs compounded by the facility during the previous six-month period. PharMEDium is actively engaged in complying with the legislation.

FDA's list of registered compounders on its website  ( can serve as a resource for healthcare providers, facilities and networks.

Who we are: 
PharMEDium is one of 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 sterile FDA-approved drugs in finished dosage form 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.