FDA, states seek ways to prevent compounding pharmacy calamity

3:50 PM, Dec 19, 2012 

SILVER SPRING, MD. — The U.S. Food and Drug Administration met with representatives of all 50 states Wednesday to examine bridging regulatory gaps relating to compounding pharmacies in hopes of preventing a recurrence of the type of contaminated drug shipments this fall that caused widespread sickness and deaths.

“We do strongly believe we need additional legislation,” FDA Commissioner Margaret Hamburg said, adding she is “guardedly optimistic” the 113th Congress, which begins meeting in January, will approve a bill that will clarify exactly how entities like the New England Compounding Center of Framingham, Mass., should be regulated.

The NECC was the source of mass-produced steroid injections that led to 620 cases of fungal meningitis in 19 states this fall, resulting in 39 deaths. With 14 deaths so far, Tennessee has had more than any other state.

While states remain confident in their ability to regulate compounding within their own borders, they have concerns about compounding done in other areas and shipped in interstate commerce, Hamburg added during a break between meetings.

Jay Campbell, executive director of the North Carolina Board of Pharmacy, said: “We feel great about what we’re doing in our states, but gosh, we don’t know what those other guys are doing.”

While the FDA envisions a “tiered approach” to regulating compounders in the future that involves both the states and federal government, questions of exactly where jurisdictional lines will be drawn remain central to developing legislation for Congress to consider in 2013, the commissioner added.

Hamburg emphasized that the FDA is not yet ready to release any findings regarding its investigation of NECC.

While many legal experts and members of Congress argue the FDA already has authority over all forms of compounding under 1938 food and drug legislation, the federal agency has always left “traditional compounding” — drug mixing done by neighborhood pharmacies — to the states. Such compounding involves single prescriptions for individual patients.

Over the past two decades, concerns have grown about non-traditional compounders that mix large volumes of customized drugs for shipment to other states. While 1998 legislation supposedly strengthened the agency’s authority over such compounders, federal court cases in different parts of the country over the past decade have led to ambiguity over the agency’s authority.

Those at the meeting included representatives of governors’ offices, state pharmacy boards and state departments of health.

Themes from the discussions, Hamburg said, included a need to improve:

• Training of state regulators.

• Information sharing between the FDA and the states.

• Standards and clarity of standards.

“We all want to see the landscape in the same way,” Hamburg said.

Contact Paul C. Barton at pbarton@gannett.com.