Drugs

Registered Outsourcing Facilities

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 5/15/15

Information Concerning Outsourcing Facility Registration

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 FDA Action, if Any, Based on Last Inspection4,5 Intends to Compounds Sterile Drugs From Bulk Drug Substances6
Absolute Pharmacy, Lutz, FL 9/3/2014 12/30/2014 11/19/2014 Yes Warning Letter - 4/27/2015 Yes
ACS Dobfar Info S.A., Campascio, Switzerland 1/9/2015 1/9/2015 Not yet inspected N/A N/A Yes
Advanced Pharma, Inc., Houston, TX
1/22/2014 11/26/2014 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 2/25/2013 Yes Warning Letter - 1/17/2014 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
Brown's Compounding Center, Inc., Englewood, CO 12/22/2014 12/22/2014 4/27/2015 Yes Open Yes
California Pharmacy and Compounding Center, Newport Beach, CA 4/30/2014 11/24/2014

8/25/2014;
10/17/2014

Yes

(8/25/2014
and
(10/17/2014)

Open 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 Open 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 11/10/2014 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
Edge Pharmacy Services, LLC, Colchester, VT 1/21/2014 1/15/2015 8/20/2014 Yes Open Yes
Exela Pharma Sciences, LLC, Lenoir, NC 6/6/2014 1/5/2015 11/21/2014 Yes Open Yes
Greer Laboratories, Inc., Lenoir, NC 2/24/2014 2/11/2015 11/15/2013 Yes Warning Letter - 4/21/2014 Yes

Healix Infusion Therapy, Inc., Sugar Land, TX

2/12/2014 11/25/2014 5/16/2014 Yes Open Yes
Hybrid Pharma, LLC, Deerfield Beach, FL 1/14/2015 1/14/2015 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
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 Open 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 Open 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 Open Yes
Medistat RX, LLC, Foley, AL 11/21/2014 11/21/2014 9/18/2014 Yes Open 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 Open Yes
PHARMACEUTIC LABS, LLC, Albany, NY 3/10/2014 1/28/2015 Not yet inspected N/A N/A Yes
Pharmakon Pharmaceuticals, Noblesville, IN 1/23/2014 12/2/2014 3/13/2014; 4/8/2014

Yes

(3/13/2014) and (4/8/2014)

Open 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 Not yet inspected N/A N/A Yes
PharMedium Services, LLC, Cleveland, MS
12/11/2013 11/24/2014 2/22/2013 Warning letter - 7/18/2014 No
PharMedium Services, LLC, Edison, NJ
12/11/2013 11/24/2014 2/28/2013 Warning letter - 7/18/2014 No
PharMedium Services, LLC, Memphis, TN 12/11/2013 11/24/2014 3/22/2013
 
No
PharMedium Services, LLC, Sugar Land, TX
12/11/2013
11/24/2014
2/27/2013
 
Warning letter - 7/18/2014 No
Pine Pharmaceuticals, LLC, Tonawanda, NY 6/17/2014 12/29/2014 10/16/2014 No 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 Not yet inspected N/A N/A Yes
RC Compounding Services, LLC, Poland, OH 2/12/2014 1/5/2015 2/7/2013 Yes Warning letter - 7/14/2014 Yes
Region Care, Inc., Great Neck, NY 12/24/2013 1/7/2015 3/20/2014 Yes Warning letter - 4/8/2015 Yes
RXQ Compounding LLC, Athens, OH 1/2/2015 1/2/2015 Not yet inspected N/A N/A Yes
SCA Pharmaceuticals, Little Rock, AR
12/13/2013
12/22/2014
4/1/2014
Yes Open Yes
SSM St. Clare Health Center, Fenton, MO 2/18/2014 1/5/2015 8/14/2014 Yes Open No
Triangle Compounding Pharmacy Inc., Cary, NC
1/24/2014 12/15/2014

9/22/2014;

1/16/2015

Yes (9/22/2014 and 1/16/2015) Open Yes
Unique Pharmaceuticals, Ltd., Temple TX 1/17/2014 11/25/2014

1/23/2015

Yes

Open Yes
US Compounding, Inc., Conway, AR 12/20/2013 12/24/2014 3/27/2014 Yes Open Yes
US Specialty Formulations LLC, Bethlehem, PA
1/31/2014 11/28/2014 Not yet inspected N/A N/A Yes

Notes

1.       The "initial date of registration as an outsourcing facility" is the date the facility was first registered (i.e., the date FDA determined that the initial registration information submitted for the facility was complete, and for firms first registering onor after October 1, 2014, the establishment fee was paid in full).

Under section 503B(b) of the FD&C Act, after the initial registration, a facility that elects to continue to be registered with FDA as an outsourcing facility must re-register annually. Beginning in fiscal year (FY) 2015 (October 1, 2014 to September 30, 2015), a facility that elects to register (or re-register) with FDA as an outsourcing facility must pay an annual establishment fee. The “date of most recent registration as an outsourcing facility” reflects the date FDA determined the most recently submitted registration information was complete and the annual establishment fee for that fiscal year paid in full. 

Unless a previously registered outsourcing facility re-registers and pays the annual establishment fee in full during the registration period (between October 1 and December 31 of each calendar year), the facility will be removed from the list of registered outsourcing facilities on January 1 of the next calendar year. 

2.       Inspections identified in this table are associated with the facility at the listed address. A company may own or operate more than one registered outsourcing facility. FDA’s web page Compounding: Inspections, Recalls, and Other Actions may contain information about compounding facilities under the same ownership as the listed registered outsourcing facility.

Inspections may take place over several days, weeks, or longer. The date of the inspection is the date a Form FDA-483 listing the investigators' observations was issued. If no FDA Form-483 was issued, the date is the last day of the inspection.

3.       A Form FDA-483 is issued when investigators observe any significant objectionable conditions. It does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any relevant regulations. 

4.       This table reflects only FDA actions. It does not include State Board of Pharmacy actions, if any. To determine whether a registered outsourcing facility has been the subject of a State enforcement action, check with the State Board of Pharmacy for the state in which the facility is located. Some states post disciplinary or other actions on their web sites. For more information, please see Compounding: Inspections, Recalls, and other Actions.

5.       "Closed" means the inspection has been closed without further action. "Open" means that FDA has not made a determination as to whether further action will be taken. If an action has been taken, it will be listed. Possible FDA actions include: warning letter; seizure; or injunction.

6.       The information in this column was provided by the registered outsourcing facility at the time of registration and has not been verified by FDA. “N/A”, indicates the registered outsourcing facility has not provided this information. In the future, FDA intends to provide information about whether the outsourcing facility also intends to compound nonsterile drugs from bulk drug substances. That information is not currently available to the Agency. 

 

Page Last Updated: 05/26/2015
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