Compounding Pharmacies Group Speaks Up on Efforts at New Regulation

A year after meningitis deaths linked to a compounding pharmacy rocked the industry, both the House and Senate are considering stricter regulation. The International Academy of Compounding Pharmacists spoke in favor of the House bill last week—albeit, with caveats.

After a tough year, the pharmaceutical compounding industry faces a challenging road ahead that could include tighter federal regulation.

But the association that represents its interests is making its stance known on federal efforts. That is, it’s open to Congress passing a new law regulating the pharmacies, which custom-mix large batches of medications not available from drugcompanies—but it says that the current House bill is better than the one that could reach the floor of the Senate.

“Even though we believe the House has a better understanding of the problems that lead up to the NECC [New England Compounding Center] tragedy last fall—particularly the failure of both state and federal agencies to take prompt action against a pharmacy that had violated the law—there are still several areas of concern for compounding pharmacists,” said Wade Siefert, the president of the International Academy of Compounding Pharmacists (IACP), in a statement.

More details below:

An industry in crisis: In the wake of an outbreak of fungal meningitis tied to Massachusetts-based NECC that killed has at least 63 people since last year, the industry has struggled to move past the crisis. In December, IACP found its member communication scrutinized by Congress due to its ties to the situation. And as The Wall Street Journal notes, cases of meningitis tied to the drugs from NECC are still surfacing. “There’s no way this is over for several years,” Tom Chiller of the Centers for Disease Control and Prevention’s mycotic-diseases branch told the newspaper.

Federal efforts: Since the NECC tragedy, Congress has been working on laws to help regulate the space—and which potentially could regulate compounders differently from traditional pharmacies. The WSJ reports that a Senate bill aiming to increase FDA oversight of the practice could get a full-floor vote. In the House, meanwhile, a recently introduced piece of legislation, the Compounding Clarity Act, makes an effort to distinguish between small-scale compounders and larger-scale ones, such as NECC, according to Law360.

The association’s take: Though IACP says the House bill improves upon the Senate’s and it supports the general direction it takes, the group raised concerns about a provision that would require doctors to gather the names of those taking such drugs within a seven-day period. “While well intended, we believe that this new mandate would create confusion between existing and evolving state policies on the provision of compounded preparations to physicians and other prescribers,” the association said in a press release, “IACP believes that individual state authority over, and regulation of, office-use medications must be recognized at the federal level.” The association also voiced concerns about a proposed FDA ban of “demonstrably difficult” compounded medications, saying that what is being proposed needs to be spelled out.

Ernie Smith

By Ernie Smith

Ernie Smith is a former senior editor for Associations Now. MORE

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