FDA Plans to Encourage Use of Compounders Registered as "Outsourcing Facilities"

Published Online: Monday, January 13, 2014
Follow Pharmacy_Times:
Under the Drug Quality and Security Act, signed into law by President Obama on November 27, 2013, large-scale compounding pharmacies can register with the FDA as “outsourcing facilities.” Although this registration is voluntary, the FDA plans to encourage physicians and other health care providers to use only large-scale compounders that have registered with it.

Compounding pharmacies that register with the agency will be subject to federal quality standards known as current good manufacturing practice and will be subject to FDA inspection on a risk-based schedule, noted FDA Commissioner Margaret Hamburg, MD, in a blog post on December 2, 2013.

“If compounders register with FDA as outsourcers, hospitals and other health care providers will be able to provide their patients with drugs that were compounded in facilities that are subject to FDA oversight and federal requirements for current good manufacturing practice, among others,” Dr. Hamburg wrote. “To that end, we will be encouraging health care providers and health networks to consider purchasing compounded products from facilities that are registered with FDA and subject to risk-based inspections.”

When asked during a conference call with reporters how the agency will encourage use of the registered facilities, Dr. Hamburg was vague, but hinted that it might seek to encourage insurers to favor drugs produced by the registered facilities when it comes to reimbursement.

Related Articles
The federal Drug Quality and Security Act was signed into law in 2013 with the intent to hold pharmacy stakeholders accountable for identifying suspect drug products and reporting related issues.
The news of Margaret A. Hamburg, MD, resigning from her long-standing post as FDA Commissioner stirred memories of her success with improving access to emergency contraception, but more so her struggles with regulating drug compounding following a deadly fungal meningitis outbreak traced to a compounding pharmacy’s tainted drugs.
Expanding upon efforts to implement the federal Drug Quality and Security Act enacted 1 year ago, the FDA today released 3 policy documents that assist companies that compound sterile drugs with registering as outsourcing facilities.
Latest Issues
$auto_registration$