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
|
Compounds Sterile Drugs From Bulk Drug Substances6
| |
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 |
| 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 |
| 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
|
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
| Open | No |
PharMedium Services, LLC, Cleveland, MS
|
12/11/2013
|
2/22/2013
|
Yes8
| Open | No |
PharMedium Services, LLC, Sugarland, TX
|
12/11/2013
|
2/27/2013
|
Yes9
| Open | No |
| 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 |
| US Compounding, Inc., Conway, AR | 12/20/2013 | Not yet inspected | N/A | N/A | Yes |
Pharmagen Laboratories Inc., Stamford, CT
| 1/21/2014 | 8/23/2013 | Yes10 | Open | Yes |
JCB Laboratories, North Wichita, KS
| 1/21/2014 | 2/27/2013 | Yes11 | Open | Yes |
Pharmakon Pharmaceuticals, Inc., Carmel, IN
| 1/23/2014 | Not Yet Inspected | N/A | N/A | No |
Edge Pharmacy Services LLC, Colchester, VT
| 1/21/2014 | Not Yet Inspected | N/A | N/A | Yes |
Triangle Compounding Pharmacy Inc., Cary, NC
| 1/24/2014 | 3/1/2013 | Yes12 | Warning Letter - 1/14/201413 | Yes |
Infusion Options, Brooklyn, NY
| 1/24/2014 | Not Yet Inspected | N/A | N/A | No |
| Advanced Pharma, Inc., Houston, TX | 1/22/2014 | 5/3/2006 | No | No | No |
| Unique Pharmaceuticals, Ltd., Temple TX | 1/24/2014 | 5/19/2004 | No | No | Yes |
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