A Prescription for Problems: In October, a series of meningitis deaths caused by tainted steroids highlighted erratic oversight of the compounding pharmacy industry, as well as the unscrupulous practices of some compounders.
The outbreak, which to date has infected more than 700 people and killed 47, was linked to steroids manufactured by the New England Compounding Center, a state-licensed pharmacy allowed to create drugs in response to an individual prescription using FDA-approved materials when a commercial version isn’t available.
Unlike commercial manufacturers, compounding pharmacies like the NECC don’t have to adhere to Food and Drug Administration testing and regulation and only need to abide by state laws that regulate pharmacists. Attempts by the FDA to bring compounding pharmacies under its regulatory jurisdiction were shut down by a 2002 U.S. Supreme Court ruling that found a portion of the legislation unconstitutional, according to the Wall Street Journal.
Increased Dosage of Ills: A recent investigation by the Washington Post found that at least three other large-scale compounders had similarly serious problems reaching back long before the NECC case.
The companies—Central Admixture Pharmacy Services, PharMEDium, and ApotheCure—have histories of shoddy practices and unsanitary conditions that have been linked to deaths and illnesses for the past decade, according to the article. Central Admixture is currently under FDA investigation that was sparked by the NECC investigation.
Compounding Issues: Compounding pharmacies continue to operate under a state-by-state patchwork of regulations, although lawmakers have vowed to continue trying to bring the drugmakers under FDA oversight.
In the meantime, the FDA hosted a meeting in December to brainstorm ways in which states could bridge gaps in regulations. The meeting, which was attended by representatives of state pharmacy boards and departments of health, addressed issues of authority and enforcement, according to the Tennessean. While officials grappled with how to balance federal and state concerns, the biggest issues seem to stem from pharmacies with intrastate shipments.
“We feel great about what we’re doing in our states,” Jay Campbell, executive director of the North Carolina Board of Pharmacy, told the Tennessean, but gosh, we don’t know what those other guys are doing.”