speaking, there was little or no oversight.
When a compounder sought accreditation, it could expect an onsite
visit that might end up lasting 4 to 6 hours. Of course, that wasn't
nearly enough time to ensure compliance with the many intricacies of
sterile compounding. In short, the industry as a whole didn't seem to
understand that it was playing with fire.
Then came the New England Compounding Center (NECC) menin-
gitis outbreak of 2012. As the almost inevitable culmination of what
turned out to be years of reckless criminal conduct by the com-
pounder in question, the outbreak took the lives of 64 patients, sick-
ened hundreds more and cast a bright light on the intrinsic weakness-
es of the system.
Ultimately, it also brought a new sheriff to town. In 2013, President
Obama signed the Drug Quality and Security Act (DQSA). The DQSA
lets compounding pharmacies voluntarily register with the FDA as
503B human drug compounding facilities. Those that do are subject to
FDA inspection and current Good Manufacturing Practices (cGMP),
meaning they're subject to the same inspections and oversight that
large pharmaceutical manufacturers must adhere to. Believe me, it's a
high bar. For example, an FDA inspection may take 8 to 10 days, not
just a few hours. And all requirements are much, much stricter.
A happy ending to a tragic tale? Well, yes and no. As a result of the
new approach, we're in a much safer place than we were before. But
there are still some tricky areas to navigate. You can't just wave a
wand and turn an entire system around overnight.
New world order
After the NECC disaster, a lot of frightened surgical facilities cut off
compounders entirely. From epidural pain injections to eye dilation
cocktails, the products and services compounders provide can be cru-
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