pounder can continue to make product and refer to itself as a 503B
facility. But the distinction between having applied and having been
inspected by the FDA is extremely important.
Once the elaborate onsite inspection is complete, the agency issues
a letter outlining deficiencies. It's then up to the compounder to
demonstrate that it has addressed and is correcting those concerns.
How a compounder corrects deficiencies is important, and the com-
pounder should provide a detailed plan as to how it will do so.
Fortunately, the process is transparent. The FDA website
(osmag.net/rDE9Nx) includes a running list of compounders who've regis-
tered with the FDA as 503B outsourcing facilities. The list also shows
whether the compounder has been inspected, whether the FDA has
issued an observation letter (FDA FORM-483) or a warning letter, and,
in some cases, the compounder's response.
I sometimes get calls from clients who want to know about a com-
pounder they just met at a conference, one that's offering some really
good deals. It's important to remember, though, that compounders
can say they're 503B facilities because they've registered with the
FDA, but that doesn't mean they've been inspected. Unless they've
been inspected, I don't recommend them. The bottom line is patient
safety, and I simply can't recommend a facility that hasn't been
inspected.
For compounders, it's an expensive and time-consuming process to
implement the technology and manufacturing systems they have to
have in place. One result is that compounded drugs are going to end
up costing more, but compounders are going to deliver better prod-
uct, and the flaws that led to the catastrophes of the past are gradual-
ly being eliminated.
Incidentally, FDA inspections — unlike other kinds of facility
accreditations you may be familiar with — are crystal clear, black and
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