BOSTON — A new federal report has concluded that the authority to regulate pharmacies engaged in drug compounding is “unclear” and “inconsistent” at the state and federal levels.
The Government Accountability Office also found that federal circuit court decisions have given the Food and Drug Administration different oversight authority in different parts of the country.
Democratic U.S. Reps. John Tierney of Massachusetts and Elijah Cummings of Maryland requested the report in the wake of a fatal nationwide meningitis outbreak linked to a Massachusetts compounding pharmacy.
The report also found that the lack of consensus about whether compounding drugs in large quantities should fall under federal or state regulators resulted in oversight gaps.
The report said that from 2002 to 2012, FDA officials had to obtain 11 warrants to inspect drug compounders’ facilities that had challenged the agency’s authority.