Wednesday, February 19, 2014

List of Compounding Pharmacies Registering With FDA Continues to Grow: Is it Because they see the benefits of being an outsourcing facility?

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
Advanced Pharma, Inc., Houston, TX
1/22/2014 5/3/2006 No No No
Allergy Laboratories, Inc., Oklahoma City, OK
12/30/2013 4/26/2013 Yes1 Warning Letter - 9/4/20132 Yes
Banner Health, Chandler, AZ 12/26/2013 Not yet inspected N/A N/A No
Cantrell Drug Company, Litte Rock, AR 12/16/2013 11/4/2013 Yes3 Open Yes
Edge Pharmacy Services LLC, Colchester, VT 1/21/2014 Not yet inspected N/A N/A Yes
Healix Infusion Therapy, Inc., Sugar Land, TX
2/12/2014 Not yet inspected N/A N/A Yes
Infusion Options INC., Brooklyn, NY 1/24/2014 Not yet inspected N/A N/A No
JCB Laboratories, North Wichita, KS
1/21/2014 2/27/2013 Yes4 Open Yes
Jungle Jim's Pharmacy, Fairfield, OH 2/11/2014 Not yet inspected N/A N/A Yes
Kings Park Slope, Inc., Brooklyn, NY 12/23/2013 Not yet inspected N/A N/A Yes
KRS Global Biotechnology, Inc., Boca Raton, FL 12/15/2013 Not yet inspected N/A N/A Yes
Leiter's Compounding, (Great Oaks Blvd), San Jose, CA 1/31/2014 Not yet inspected N/A N/A Yes
Marlborough Hospital, Marlborough, MA 12/26/2013 Not yet inspected N/A N/A Yes
Medi-Fare Drug & Home Health Center, Inc., Blacksburg SC
12/17/2013
1/18/2013
Yes5
 
Yes
Pharmagen Laboratories Inc., Stamford, CT
1/21/2014 8/23/2013 Yes7 Open Yes
Pharmakon Pharmaceuticals, Noblesville, IN 1/23/2014 Not yet inspected N/A N/A No
PharMedium Services, LLC, Cleveland, MS
12/11/2013 2/22/2013
Yes8
Open No
PharMedium Services, LLC, Edison, NJ
12/11/2013 2/28/2013
Yes9
Open No
PharMedium Services, LLC, Memphis, TN
12/11/2013
3/22/2013
Yes10
 
Open
No
PharMedium Services, LLC, Sugar Land, TX
12/11/2013
2/27/2013
Yes11
 
Open No
RC Compounding Services LLC, Poland, OH 2/12/2014 2/7/2013 Yes12 Open Yes
Region Care, Inc., Great Neck, NY 12/24/2013 Not yet inspected N/A N/A Yes
SCA Pharmaceuticals, Little Rock, AR
12/13/2013
Not yet inspected
N/A N/A Yes
Triangle Compounding Pharmacy Inc., Cary, NC
1/24/2014 3/1/2013 Yes13 Warning Letter - 1/14/201414 Yes
Unique Pharmaceuticals, Ltd., Temple TX 1/24/2014 5/19/2004 No No Yes
US Compounding, Inc., Conway, AR 12/20/2013 Not yet inspected N/A N/A Yes
US Specialty Formulations LLC, Bethlehem, PA
1/31/2014 Not yet inspected N/A N/A Yes

No comments: