Editor’s note: See bottom of story for an update.

They’re labeled as pharmacies but work like drug manufacturers, and the association that represents them is ready to help legislators define what makes compounders different.

Here’s why the International Academy of Compounding Pharmacists (IACP) changed course after years of battling against federal regulation:

The root problem: Last year, a compounding pharmacy in Massachusetts, the New England Compounding Center (NECC), was found to be at fault for an outbreak of fungal meningitis that killed 47 people and sickened 660 others. The incident shined a dim light on the field of compounding, mail-order pharmacies that allow people to buy customized drugs based on a patient’s unique needs, and raised many questions about the regulatory processes used by compounders. IACP was brought into the issue after the association’s communications to its members, alleged to have worked against the Food and Drug Administration’s (FDA) investigation of the incident, raised congressional scrutiny.

The pressure builds: On Feburary 7, The Washington Post went a step further in analyzing the compounding pharmacies, noting that the industry is not supervised under FDA standards, and found that the industry’s issues go much deeper than the NECC incident. “Three of the firms, in addition to the NECC, have experienced significant safety problems over the past decade that were tied to at least 39 illnesses,” the article explained. “Two companies’ missteps were linked to at least six deaths. The problems included medications that were too potent or laced with bacteria.” Despite this, the article noted that the industry, which often was responsible for creating complex drugs, largely came under state-based—not federal—scrutiny.

The association’s latest move: On Thursday, the association announced it was changing its views on federal regulation of the industry. “We want to enable and clarify for the FDA that those businesses that are involved in the manufacturing of compounded drugs, regardless of size, be regulated like drug manufacturers,” the group’s Executive Vice President David G. Miller told The Post. The association had been fighting against such regulation since 2007, The Post notes. “They’re singing a different tune,” a congressional aide told the publication.

Why the change? Part of the reason is a potential change of opinion within the organization and the opportunity to shape the way the new regulations would affect IACP’s members. Federal legislators are looking to create a new registry category for compounders, treating them as a hybrid of a pharmacy and a drug manufacturer. While Miller argues that the size of the organization shouldn’t matter in these rules, many critics of the industry note that the large compounders—not smaller firms—are the ones in need of regulatory scrutiny.

The FDA’s commissioner, Margaret A. Hamburg, has previously made statements supporting a new enforcement category.

Editor’s note: After this story was published, Associations Now was contacted by IACP spokesman David Ball, who said that The Washington Post story “did not accurately reflect our position.” IACP provided this statement:

 IACP provided the following information to The Washington Post: ‘IACP is supportive of a discussion about the creation of a category of nontraditional manufacturing.  A formal position has not yet been taken by the IACP.  This is a concept that we believe needs to be reviewed and discussed in the public arena.’  [The Post’s ] story resulted from that statement.

“We believe that any compounding pharmacy—not a manufacturer, either traditional or nontraditional—should continue to be regulated and overseen by state boards of pharmacy.  We will continue to work closely with our members with whom we advocate for policies that are in the best interest of their patients.

“As IACP has repeatedly stated in public testimony, the FDA has clear statutory authority over the manufacturing of prescription drugs.  While we have and will continue to oppose attempts to create FDA oversight of pharmacy practice—an authority that rests solely with the state boards of pharmacy—we do believe that statements by the FDA regarding evolving manufacturing models requires a full public dialogue.”

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