Wednesday, January 29, 2014

FDA List of Registered Outsourcing Facilities under 503B is Growing--There are now 23 Compounding Pharmacies on the List

Registered Outsourcing Facilities


Firms Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Updated as of 1/24/14
 
 
 
Firm Name
Date of Registration as an Outsourcing Facility1
End Date of Last FDA Inspection Related to Compounding2
Was a Form FDA-483 issued?3
Other FDA Action, if Any, Based on Last Inspection4,5
Compounds Sterile Drugs From Bulk Drug Substances6
Allergy Laboratories, Inc., Oklahoma City, OK
12/30/20134/26/2013Yes1Warning Letter - 9/4/20132Yes
Banner Health, Chandler, AZ12/26/2013Not yet inspectedN/AN/ANo
Cantrell Drug Company, Litte Rock, AR12/16/201311/4/2013Yes3OpenYes
Kings Park Slope, Inc., Brooklyn, NY12/23/2013Not yet inspectedN/AN/AYes
KRS Global Biotechnology, Inc., Boca Raton, FL12/15/2013Not yet inspectedN/AN/AYes
Marlborough Hospital, Marlborough, MA12/26/2013Not yet inspectedN/AN/AYes
Medi-Fare Drug & Home Health Center, Inc., Blacksburg SC
12/17/2013
1/18/2013
Yes4
 
Yes
PharMedium Services, LLC, Memphis, TN
12/11/2013
3/22/2013
Yes6
 
Open
No
PharMedium Services, LLC, Edison, NJ
12/11/2013
2/28/2013
Yes7
 
OpenNo
PharMedium Services, LLC, Cleveland, MS
12/11/2013
2/22/2013
Yes8
 
OpenNo
PharMedium Services, LLC, Sugarland, TX
12/11/2013
2/27/2013
Yes9
 
OpenNo
Region Care, Inc., Great Neck, NY12/24/2013Not yet inspectedN/AN/AYes
SCA Pharmaceuticals, Little Rock, AR
12/13/2013
Not yet inspected
N/AN/AYes
US Compounding, Inc., Conway, AR12/20/2013Not yet inspectedN/AN/AYes
Pharmagen Laboratories Inc., Stamford, CT
1/21/20148/23/2013Yes10OpenYes
JCB Laboratories, North Wichita, KS
1/21/20142/27/2013Yes11OpenYes
Pharmakon Pharmaceuticals, Inc., Carmel, IN
1/23/2014Not Yet InspectedN/AN/ANo
Edge Pharmacy Services LLC, Colchester, VT
1/21/2014Not Yet InspectedN/AN/AYes
Triangle Compounding Pharmacy Inc., Cary, NC
1/24/20143/1/2013Yes12Warning Letter - 1/14/201413Yes
Infusion Options, Brooklyn, NY
1/24/2014Not Yet InspectedN/AN/ANo
Advanced Pharma, Inc., Houston, TX1/22/20145/3/2006NoNoNo
Unique Pharmaceuticals, Ltd., Temple TX1/24/20145/19/2004NoNoYes

 
 

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