and are required by state boards of pharmacy to comply with USP
and other guidelines. They may not compound large batches.
"Some states have gotten a lot tougher in their oversight of 503As,
but a lot of states either haven't gotten tough or just don't have the
resources to oversee them," says Ms. Axelrad. "Some rely on self-
assessments by the compounders rather than going in and looking."
A compounding pharmacy in Irvine, Calif., received a scathing letter
from the FDA in April detailing a long list of "serious deficiencies in
its practices for producing sterile drug products," including producing
some drugs without prescriptions for individually identified patients,
using an expired sporicidal agent to disinfect its aseptic processing
area and failing to demonstrate that its hoods were able to provide
adequate protection of the cleanroom areas in which sterile products
are processed. Investigators also noted that the underside of the asep-
tic processing work surface consisted of exposed plywood and fiber
board that had significant discoloration and gaps around the edges of
the plastic panel cleanroom walls that could allow unclassified air
from the surrounding environment into the cleanroom. Testing results
of the environmental samples FDA investigators collected from the
facility identified microbial contamination in the aseptic processing
areas, including spore-forming bacteria. The FDA said the pharmacy's
products "may be produced in an environment that poses a significant
contamination risk."
The federal Food, Drug and Cosmetic Act (FD&C Act) returned to
oversight of a new category of high-volume sterile compounders,
called 503B outsourcing facilities, to the FDA and gave state boards
of pharmacy responsibility for traditional compounding pharmacies
called 503As that produce patient-specific medications one prescrip-
tion at a time. Since the NECC disaster, 73 high-volume com-
pounders have registered as an outsourcing facility with the FDA
5 8 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • J A n U A R Y 2 0 1 8
