Facilities Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Updated as of 10/16/15
This table lists the outsourcing facilities that have submitted registration information that has been determined to be complete by the data lock date for the latest weekly update of the table.
Facility Name | Initial Date of Registration as an Outsourcing Facility1 | Date of Most Recent Registration as an Outsourcing Facility1 | End Date of Last FDA Inspection Related to Compounding2 | Was a Form FDA-483 issued?3 | Other Action, if Any, Based on Last Inspection4,5 | Intends to Compounds Sterile Drugs From Bulk Drug Substances6 |
---|---|---|---|---|---|---|
Advanced Pharma, Inc., Houston, TX
| 1/22/2014 | 10/15/2015 | 3/17/2014 | Yes | Open | No |
Alexander Infusion LLC dba Avanti Health Care, New Hyde Park, NY | 4/21/2014 | 1/7/2015 | 7/9/2014 | Yes | Warning Letter - 3/27/2015 | Yes |
AnazaoHealth Corporation, Las Vegas, NV | 9/23/2014 | 12/29/2014 | 1/30/2015 | Yes | Open | Yes |
Avella Specialty Pharmacy, Phoenix, AZ | 2/24/2014 | 1/20/2015 | 7/31/2015 | Yes | Open7 | No |
Banner Health, Chandler, AZ | 12/26/2013 | 1/27/2015 | 3/20/2015 | Yes | Open | No |
Brookfield Medical/Surgical Supply, Inc., Brookfield, CT | 1/12/2015 | 1/12/2015 | 4/9/2015 | Yes | Open | Yes |
California Pharmacy and Compounding Center, Newport Beach, CA | 4/30/2014 | 11/24/2014 |
8/25/2014;
10/17/2014 |
Yes
| Warning Letter - 6/17/2015 | Yes |
Cantrell Drug Company, Little Rock, AR | 12/16/2013 | 12/30/2014 | 11/4/2013 | Yes | Warning Letter - 1/21/2015 | Yes |
Central Admixture Pharmacy Services, Inc., Allentown, PA | 2/28/2014 | 12/15/2014 | 2/11/2015 | Yes | Open7 | Yes |
Central Admixture Pharmacy Services, Inc., San Diego, CA
| 6/4/2014 | 12/15/2014 | 8/8/2014 | Yes | Open | No |
Coastal Meds LLC, Biloxi, MS | 12/23/2014 | 12/23/2014 | 9/23/2015 | Yes | Open | Yes |
Complete Pharmacy and Medical Systems, Miami Lakes, FL | 6/6/2014 | 1/13/2015 | 8/12/2014 | Yes | Open | Yes |
Delta Pharma, Inc., Ripley, MS | 8/6/2014 | 3/10/2015 | 10/2/2013 | Yes | Warning Letter - 12/9/2014 | Yes |
Downing Labs, LLC, Dallas, TX | 6/23/2015 | 6/23/2015 | 10/9/2015 | Yes | Ceased sterile operations and recalled sterile products 7 | Yes |
Eagle Pharmacy, Inc., Birmingham, AL | 6/16/2015 | 6/16/2015 | 8/21/2015 | Yes | Open | Yes |
Edge Pharmacy Services, LLC, Colchester, VT | 1/21/2014 | 10/16/2015 | 8/20/2014 | Yes | Open | Yes |
Exela Pharma Sciences, LLC, Lenoir, NC | 6/6/2014 | 1/5/2015 | 11/21/2014 | Yes | Open | Yes |
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS | 10/2/2015 | 10/2/2015 | Not yet inspected | N/A | N/A | Yes |
Hybrid Pharma, LLC, Deerfield Beach, FL | 1/14/2015 | 1/14/2015 | Not yet inspected | N/A | N/A | Yes |
ILS Genomics, LLC Morrisville, NC | 8/7/2015 | 8/7/2015 | Not yet inspected | N/A | N/A | No |
INCELL Corp., LLC, San Antonio, TX | 5/29/2015 | 5/29/2015 | Not yet inspected | N/A | N/A | Yes |
Infusion Options Inc., Brooklyn, NY | 1/24/2014 | 12/23/2014 | 4/23/2014 | Yes | Open | No |
Isomeric Pharmacy Solutions, LLC, Salt Lake City, UT | 7/14/2015 | 7/14/2015 | 8/28/2015 | Yes | Open | Yes |
JCB Laboratories, North Wichita, KS
| 1/21/2014 | 11/25/2014 | 2/27/2013 | Yes | Warning Letter - 7/7/2014 | Yes |
Jubilant HollisterStier LLC, Spokane, WA | 6/3/2014 | 2/13/2015 | 12/02/2014 | Yes | Open7 | Yes |
Kings Park Slope, Inc., Brooklyn, NY | 12/23/2013 | 1/5/2015 | 3/14/2014 | Yes | Warning Letter - 3/27/2015 | Yes |
KRS Global Biotechnology, Inc., Boca Raton, FL | 12/15/2013 | 1/7/2015 | 3/17/2014 | Yes | Warning Letter - 7/6/2015 | Yes |
LeeSar, Inc., Fort Myers, FL | 4/30/2014 | 1/30/2015 | 8/8/2014 | Yes | Open | No |
Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA | 1/31/2014 | 1/26/2015 | 10/7/2014 | Yes | Open | Yes |
Medi-Fare Drug, Blacksburg, SC | 12/17/2013 | 12/31/2014 | 9/12/2014 | Yes | Open7 | Yes |
Medistat RX, LLC, Foley, AL | 11/21/2014 | 11/21/2014 | 9/23/2015 | Yes | Ceased sterile operations and recalled sterile products7 | Yes |
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC | 7/15/2014 | 12/29/2014 | Not yet inspected | N/A | N/A | Yes |
OPS International Inc., Olympia Pharmacy, Orlando, FL | 3/10/2014 | 1/27/2015 | 12/4/2014 | Yes | Open7 | Yes |
Pacifico National dba Amex Pharmacy, Melbourne, FL | 9/21/2015 | 9/21/2015 | Not yet inspected | N/A | N/A | Yes |
Pharmaceutic Labs, LLC, Albany, NY | 3/10/2014 | 1/28/2015 | 9/23/2015 | Yes | Open | Yes |
Pharmakon Pharmaceuticals, Noblesville, IN | 1/23/2014 | 12/2/2014 | 3/13/2014; 4/8/2014 |
Yes
| Warning Letter - 5/21/15 | No |
Pharmalogic CSP, Bridgeport, WV | 7/1/2014 | 1/5/2015 | 12/12/2014 | Yes | Open | Yes |
Pharm D Solutions, LLC, Houston, TX | 8/6/2014 | 3/24/2015 | 6/5/2015 | Yes | Open | Yes |
PharMedium Services, LLC, Cleveland, MS
| 12/11/2013 | 11/24/2014 | 7/16/2015 | Open7 | No | |
PharMedium Services, LLC, Memphis, TN | 12/11/2013 | 11/24/2014 | 7/10/2015 |
|
Open7
| No |
PharMedium Services, LLC, Sugar Land, TX
|
12/11/2013
| 11/24/2014 |
9/24/2015
|
Yes
|
Open7
| No |
Pine Pharmaceuticals, LLC, Tonawanda, NY | 6/17/2014 | 10/7/2015 | 10/9/2015 | Yes | No | Yes |
Premier Pharmacy Labs Inc., Weeki Wachee, FL | 4/16/2014 | 12/18/2014 | 5/9/2014 | Yes | Warning Letter - 4/27/2015 | Yes |
Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OK | 5/23/2014 | 5/8/2015 | 9/17/2015 | Yes | Recall of sterile products | Yes |
Quva Pharma, Inc., Sugar Land, TX | 9/10/2015 | 9/10/2015 | Not yet inspected | N/A | N/A | No |
RC Outsourcing, LLC, Lowellville, OH | 10/6/2015 | 10/6/2015 | Not yet inspected | N/A | N/A | Yes |
Resource Optimization and Innovation, Springfield, MO | 9/22/2015 | 9/22/2015 | Not yet inspected | N/A | N/A | No |
RXQ Compounding LLC, Athens, OH | 1/2/2015 | 1/2/2015 | 9/21/2015 | Yes | Open | Yes |
SCA Pharmaceuticals, Little Rock, AR
|
12/13/2013
| 12/22/2014 |
4/1/2014
| Yes | Warning Letter - 6/25/2015 | Yes |
SSM St. Clare Health Center, Fenton, MO | 2/18/2014 | 1/5/2015 | 8/14/2014 | Yes | Open | No |
STERRX, LLC, Plattsburgh, NY | 5/29/2015 | 5/29/2015 | Not yet inspected | N/A | N/A | Yes |
Triangle Compounding Pharmacy Inc., Cary, NC
| 1/24/2014 | 12/15/2014 |
9/22/2014;
1/16/2015
| Yes (9/22/2014and 1/16/2015) | Open7 | Yes |
Unique Pharmaceuticals, Ltd., Temple TX | 1/17/2014 | 11/25/2014 |
1/23/2015
| Open7 | Yes | |
US Compounding, Inc., Conway, AR | 12/20/2013 | 12/24/2014 | 8/21/2015 | Yes | Ceased sterile operations and recalled sterile products7 | Yes |
US Specialty Formulations LLC, Bethlehem, PA
| 1/31/2014 | 11/28/2014 | 5/29/2015 | Yes | Open | Yes |
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