cial, especially
when there are
drug short-
ages. Despite
the stigma,
there are safe
alternatives.
We're not com-
pletely out of
the woods yet,
and the new
system isn't
perfect, but
the new regulations have dramatically increased safety. Knowing how
the system works is the first big step toward being able to feel confi-
dent again.
The 503B designation created by the new law is an addition to the
503A designation that all compounders had previously. The difference is
that only 503B facilities can prepare sterile compounds without a
patient prescription and ship via interstate commerce. 503A facilities
must have individual patient prescriptions and they're limited on their
ability to prepare sterile compounds for "office use" (when a physician
orders specific medications for specific patients, as opposed to a phar-
macist dispensing medications without instructions from a prescriber).
While there are thousands of 503A compounders, there are fewer than
60 503B facilities nationwide.
But the fact that a compounder calls itself a 503B facility can be
misleading. That's because after a compounder completes an applica-
tion to be registered as a 503B facility, it takes time for the FDA to
complete its first onsite inspection. In the meantime, that com-
1 0 2 • 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 6
• SAFE SOURCES Oversight has improved dramatically, and the products and services compounders provide can be
crucial, especially when there are drug shortages.
