4 6 • 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 U L Y 2 0 1 6
Just as 9/11 changed air
travel, the New England
Compounding Center deba-
cle has changed how we
manufacture, distribute and
administer drugs. The
industry has gotten much
better as a result, but we
still need checks and balances. FDA really stepped up as a result,
but surgical facilities naturally still have some qualms about doing
business with drug compounders. Here are 5 ways can you be more
confident in your compounder.
• Know FDA designations. Large-scale entities engaged in non-pre-
scription anticipatory compounding must now register with the FDA as
503B compounders. But the elaborate FDA inspection that follows
doesn't always happen immediately, so there's a period when com-
pounders may call themselves 503Bs, before they're approved by the
FDA. You can monitor the status of all 503Bs on the FDA website
(osmag.net/mpham4), along with inspection dates, violations, and
whether those violations have been addressed. Of course, that process
is just the price of admission before you even consider doing business
with a compounder. There are always going to be human elements
involved, so you still need to monitor and share information.
• Know what to look for. The American Society of Health-System
Pharmacists recently issued detailed guidance designed to help
facilities evaluate and compare pharmaceutical services and com-
pounders (osmag.net/3bzuaa and osmag.net/6vjyyz). Among other
REGAINING TRUST
Can You Be Sure Your Compounder Is Safe?
• DUE DILIGENCE Be sure to investigate the drug compounders with whom you're considering doing business.
