Compounded Products Linked with Potential Deadly Infections, Putting New Pressure on FDA, Congress

Posted 12 August 2013 | By Alexander GaffneyRF News Editor

A steady drumbeat of recalls related to potentially non-sterile products manufactured at compounding pharmacies continues, with the US Food and Drug Administration (FDA) issuing announcements this weekend that Specialty Compounding LLC was recalling "all lots of sterile medications within expiry" after at least 15 patients experienced bacterial infections after being given the medication.

Background

FDA regulates pharmaceutical compounders differently than traditional manufacturers, both because of statutory limitations and their traditional roles within the healthcare system. Compounders have traditionally existed within hospitals, and make customized compounds for use by patients who may have particular restrictions or need a product at a dose or strength not available directly from the manufacturer. Unlike traditional manufacturers, these compounders do not need to seek approval from FDA for each compounded drug so long as they create the drug in response to a valid prescription.

The last two decades have seen a resurgence in the popularity of compounders, which many analysts attribute to two factors: the ease with which products can now be ordered through the Internet, and increasing drug shortages, which have made compounders an increasingly attractive option for physicians who may not be able to order their products from their preferred channels.

But in late 2012, a harsh spotlight was turned on the regulation of compounded products as a massive outbreak of fungal meningitis was traced back to a Massachusetts compounding pharmacy known as the New England Compounding Center (NECC). Once FDA investigators obtained access to the compounding facility, they found a host of alleged violations, including vials filled with fungal growth.

In the ensuing months, angry legislators pressed FDA for answers on why it had not stopped these products from reaching the market. FDA responded that its authority was in many ways limited, both by statute-for example, it does not have the authority to demand certain documents-and by judicial precedence, which has limited its authority in many parts of the country.

But while legislators continue to advance separate bills intended to shore up FDA's authority, new problems continue to emerge.

A New Recall

The latest compounding-related recall affects products manufactured by Specialty Compounding LLC, a subsidiary of Peoples Pharmacy Inc. In a statement released on 9 August 2013, the company said it had initiated the recall after two Texas-area hospitals had 15 of their combined patients fall ill with bacterial infections after receiving IV infusions of calcium gluconate.

"There is a potential association between the infections and the medication at this time," the statement said, adding that the infections have the potential to be fatal.

FDA elaborated in its own statement, noting that the bloodstream infections were of Rhondoccus equi, a gram-positive bacteria often found in soil and most often known to infect animals or immunocompromised people.

As with the outbreak of fungal meningitis, FDA said it is coordinating with the Centers for Disease Control and Prevention (CDC) to investigate the cause and scope of the outbreaks. FDA said the products had been distributed to 49 states, meaning the number of patients infected with Rhondoccus equi may well rise in the coming weeks as awareness of the association spreads.

The recall could also place more pressure on both legislators and FDA-for the former to expedite the passage of new authority and user fees to FDA, and for the latter to conduct more vigorous inspections to prevent the release of tainted products before they ever make their way to consumers. Congress, however, remains in recess for the next several weeks, diminishing the prospect of any expedited action.


Recall Notice

FDA Statement

MedWatch Notice


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