Thursday, April 11, 2013

Compounding Pharmacy Industry Has Outgrown Its Regulatory System, ASHP and FDA Say


Pharmacy News


[May 1, 2013, AJHP News]
Cheryl A. Thompson
BETHESDA, MD 11 April 2013—In the half year since a compounding pharmacy in Massachusetts announced a recall of all its products "due to the potential risk of contamination," two other pharmacies declared recalls "due to lack of sterility assurance."
And at least two additional compounding pharmacies have recalled their maybe-not-so-sterile products after FDA personnel inspected the facilities.
The human toll is real.
Five patients have been diagnosed with a serious eye infection after receiving bevacizumab that Clinical Specialties Compounding Pharmacy had repackaged into single-use syringes from the manufacturer’s vials, the Georgia pharmacy stated on March 20.
More than 50 patients have died and about 680 others in 20 states have been diagnosed with a fungal infection after receiving an injection of methylprednisolone acetate produced by the New England Compounding Center, according to the latest federal report.
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