NECC. In 2012, the FDA inspected
4 compounders. Since 2013, the
FDA has inspected more than 400
pharmacies, says Ms. Axelrad. But
it's fair to question whether NECC
was enough of a wakeup call for
the industry.
"Have things gotten better since
NECC?" asks Ms. Axelrad.
"Absolutely not."
While increased scrutiny has
shuttered some rogue pharmacies
— "not enough, but some," says
Ms. Axelrad — who didn't want to
pay to bring their facilities up to
standards, it's still relatively easy
for a compounder to locate in a
state with lax governance and
ship products produced in unsani-
tary conditions to unsuspecting
surgical facilities all over the
country, says Ms. Axelrad.
State boards of pharmacy — or
in some cases state departments
of health — have primary juris-
diction over 503A pharmacies.
The FDA has designated 503A
compounding pharmacies as
those that compound according
to patient-specific prescriptions
JCBLabs.com
fagronsterile.com
Phone 316.7 73.0405
Fax 316.773.0406
Toll Free 877.405.8066
Fagron Sterile Services and JCB Laboratories
operates
two FDA registered 503B Outsourcing
Facilities and specialize in Anesthesia, Dialysis,
Ophthalmology, OR Syringes, Pain Management
and Urology.
1.
Data on file.
* Avastin is a registered trademark of Genentech, Inc.
JCBLabs.com
fagronsterile.com
Phone 316.7 73.0405
Fax 316.773.0406
Toll Free 877.405.8066
Fagron Sterile Services and JCB Laboratories
operates
two FDA registered 503B Outsourcing
Facilities and specialize in Anesthesia, Dialysis,
Ophthalmology, OR Syringes, Pain Management
and Urology.
1.
Data on file.
* Avastin is a registered trademark of Genentech, Inc.
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