List of Outsourcing Facilities Registered with the FDA as of 9/4/2017

acility 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. dba Avella of Houston, Houston, TX	12/21/2016	12/21/2016	7/22/2016	Yes	Open	No
AnazaoHealth Corporation, Las Vegas, NV	9/23/2014	10/18/2016	3/24/2017	Yes	Open7	Yes
ASP CARES, San Antonio, TX	2/14/2017	2/14/2017	3/2/2017	Yes	Open	Yes
Athenex Pharma Solutions, LLC, Clarence, NY	4/10/2017	4/10/2017	Not yet inspected	N/A	N/A	No
Atlas Pharmaceuticals, Phoenix, AZ	11/8/2016	11/8/2016	Not yet inspected	N/A	N/A	Yes
Auro Pharmacies, Inc, DBA Central Drugs, 511 S. Harbor Blvd, Bldg F, La Habra, CA	9/1/2016	10/19/2016	6/29/2017	Yes	Open7	Yes
Avella of Deer Valley, Inc. #38, Phoenix, AZ	6/21/2016	10/8/2016	4/24/2017	No	Open	N/A
Avella Specialty Pharmacy, Phoenix, AZ	2/24/2014	10/13/2016	7/31/2015	Yes	Untitled Letter - 2/3/20177	No
Banner Health, Chandler, AZ	12/26/2013	11/23/2016	3/20/2015	Yes	Warning Letter - 5/5/16	No
Bella Pharmaceuticals, Inc., Chicago, IL	2/23/2017	2/23/2017	Not yet inspected	N/A	N/A	Yes
Bioserv Corporation, San Diego, CA	2/23/2016	1/25/2017	Not yet inspected	N/A	N/A	Yes
Brookfield Medical/Surgical Supply, Inc., Brookfield, CT	1/12/2015	12/21/2016	4/9/2015	Yes	Warning Letter - 7/5/2016	Yes
BSO LLC, Lakewood, CO	11/24/2015	11/7/2016	9/2/2016	Yes	Open	Yes
California Pharmacy and Compounding Center, Newport Beach, CA	4/30/2014	11/18/2016	4/21/2017	Yes	Open7	Yes
Cantrell Drug Company, Little Rock, AR	12/16/2013	10/12/2016	6/29/2017	Yes	Ceased sterile operations and recalled sterile products	Yes
Central Admixture Pharmacy Services, Inc., Allentown, PA	2/28/2014	11/3/2016	9/19/2016	Yes	Open7	Yes
Central Admixture Pharmacy Services, Inc., San Diego, CA	6/4/2014	11/3/2016	8/8/2014	Yes	Warning Letter - 8/18/16	No
Coastal Meds LLC, Biloxi, MS	12/23/2014	12/6/2016	9/23/2015	Yes	Warning Letter - 6/22/2016	Yes
Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL	6/6/2014	1/4/2017	2/23/2017	Yes	Open7	Yes
Delta Pharma, Inc., Ripley, MS	8/6/2014	10/26/2016	2/23/2017	Yes	Open7	Yes
Denver Solutions, LLC dba Leiters Health, Englewood, CO	3/24/2017	3/24/2017	Not yet inspected	N/A	N/A	Yes
Eagle Pharmacy, Inc., Birmingham, AL	6/16/2015	10/20/2016	8/21/2015	Yes	Warning Letter - 10/13/2016	Yes
Edge Pharmacy Services, LLC, Colchester, VT	1/21/2014	11/4/2016	1/20/2017	Yes	Open7	Yes
Empower Pharmacy, Houston, TX	7/16/2016	10/13/2016	Not yet inspected	N/A	Open	Yes
Exela Pharma Sciences, LLC, Lenoir, NC	6/6/2014	6/23/2017	11/21/2014	Yes	Untitled Letter - 4/28/2016	Yes
F.H. Investments, Inc., DBA Asteria Health, Birmingham, AL	5/18/2017	5/18/2017	Not yet inspected	N/A	N/A	Yes
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS	10/2/2015	10/27/2016	9/21/2016	Yes	Open	Yes
Fresenius Kabi Compounding, LLC, Canton, MA	4/21/2017	4/21/2017	Not yet inspected	N/A	N/A	No
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical, Los Angeles, CA	1/6/2017	1/6/2017	3/23/2017	Yes	Open	Yes
Hybrid Pharma, LLC, Deerfield Beach, FL	1/14/2015	12/20/2016	7/28/2016	Yes	Open	Yes
Imprimis NJOF, LLC, Ledgewood, NJ	11/12/2016	11/12/2016	7/10/2017	Yes	Open	Yes
Infusion Options Inc., Brooklyn, NY	1/24/2014	12/8/2016	6/1/2017	Yes	Open7	No
Isomeric Pharmacy Solutions, LLC, Salt Lake City, UT	7/14/2015	1/25/2017	3/24/2017	Yes	Ceased sterile operations and recalled sterile products7	Yes
JCB Laboratories, North Wichita, KS	1/21/2014	10/27/2016	12/3/2015	Yes	Open7	Yes
KRS Global Biotechnology, Inc., Boca Raton, FL	12/15/2013	1/3/2017	8/31/2016	Yes	Open7	Yes
LeeSar, Inc., Fort Myers, FL	4/30/2014	11/11/2016	7/7/2017	Yes	Open	No
Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA	1/31/2014	10/28/2016	6/15/2017	Yes	Open7	Yes
Medcraft LLC, Mounds, OK	2/23/2017	2/23/2017	Not yet inspected	N/A	N/A	Yes
Medi-Fare Drug, Blacksburg, SC	12/17/2013	11/9/2016	4/5/2017	No	Open7	Yes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC	7/15/2014	10/21/2016	4/21/2017	Yes	Open	Yes
New England Life Care, Inc. dba: Advanced Compounding Solutions, Woburn, MA	3/2/2017	3/2/2017	Not yet inspected	N/A	N/A	No
Nubratori, Inc., Torrance, CA	2/24/2017	2/24/2017	Not yet inspected	N/A	N/A	Yes
Olympia Compounding Pharmacy, Orlando, FL	3/10/2014	11/5/2016	12/4/2014	Yes	Warning Letter - 2/4/2016	Yes
Pacifico National dba Amex Pharmacy, Melbourne, FL	9/21/2015	12/17/2016	1/21/2016	Yes	Open	Yes
Pentec Health, Boothwyn, PA	9/21/2016	11/22/2016	Not yet inspected	N/A	N/A	Yes
Pharm D Solutions, LLC, Houston, TX	8/6/2014	10/25/2016	6/5/2015	Yes	Warning Letter - 12/8/2016	Yes
Pharmaceutic Labs, LLC, Albany, NY	3/10/2014	10/27/2016	9/23/2015	Yes	Warning Letter - 5/3/2017	Yes
PharMedium Services, LLC, Cleveland, MS	12/11/2013	10/11/2016	7/16/2015	Yes	Regulatory Meeting - 11/18/2016	No
PharMedium Services, LLC, Dayton. NJ	11/3/2015	10/11/2016	5/26/2016	Yes	Regulatory Meeting - 11/18/2016	No
PharMedium Services, LLC, Memphis, TN	12/11/2013	10/17/2016	7/10/2015	Yes	Regulatory Meeting - 11/18/2016	No
PharMedium Services, LLC, Sugar Land, TX	12/11/2013	10/17/2016	9/24/2015	Yes	Regulatory Meeting - 11/18/2016	No
Pine Pharmaceuticals, LLC, Tonawanda, NY	6/17/2014	12/8/2016	10/9/2015	Yes	Warning Letter - 11/7/2016	Yes
Premier Pharmacy Labs Inc., Brooksville, FL	4/16/2014	10/31/2016	6/13/2016	Yes	Open7	Yes
Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OK	5/23/2014	11/8/2016	5/10/2017	Yes	Open7	Yes
Queens Express Pharmacy, Jackson Heights, NY	5/10/2016	10/14/2016	7/11/2016	Yes	Open	Yes
Quva Pharma, Inc., Sugar Land, TX	9/10/2015	10/12/2016	6/2/2017	Yes	Open7	No
QuVa Pharma, Inc., Temple, TX	12/15/2015	10/12/2016	12/8/2016	Yes	Open	Yes
RAM Pharma, Inc. Idaho Falls, ID	7/21/2016	12/19/2016	3/1/2017	Yes	Open	Yes
RC Outsourcing, LLC, Lowellville, OH	10/6/2015	10/25/2016	3/31/2017	Yes	Open7	Yes
Resource Optimization and Innovation, Springfield, MO	9/22/2015	12/22/2016	11/29/2016	Yes	Open	No
Right Value Drug Store dba Carie Boyd's Prescription Shop, Hurst, TX	1/11/2016	11/5/2016	5/12/2017	Yes	Open7	Yes
RXQ Compounding LLC, Athens, OH	1/2/2015	11/28/2016	9/21/2015	Yes	Warning Letter - 5/19/2016	Yes
SCA Pharmaceuticals, Little Rock, AR	12/13/2013	10/31/2016	4/1/2014	Yes	Warning Letter - 6/25/2015	Yes
Seaview Enterprises, Los Alamitos, CA	2/14/2017	2/14/2017	Not yet inspected	N/A	N/A	Yes
Sincerus Florida, LLC, Pompano Beach, FL	3/10/2016	11/30/2016	6/29/2017	Yes	Open7	Yes
SSM St. Clare Health Center, Fenton, MO	2/18/2014	10/26/2016	8/14/2014	Yes	Warning Letter - 10/19/2015	No
STERRX, LLC, Plattsburgh, NY	5/29/2015	11/30/2016	3/17/2017	Yes	Open	Yes
Stokes Healthcare Inc, Mt. Laurel, NJ	6/28/2017	6/28/2017	Not yet inspected	N/A	N/A	Yes
Triangle Compounding Pharmacy, Inc., Cary, NC	1/24/2014	11/21/2016	9/22/2014; 1/16/2015	Yes (9/22/2014and 1/16/2015)	Warning Letter - 11/2/20157	Yes
US Compounding, Inc., Conway, AR	12/20/2013	12/15/2016	7/15/2016	Yes	Resumed operations after cessation of sterile operations and recall of sterile products7	Yes
US Specialty Formulations LLC, Bethlehem, PA	1/31/2014	10/27/2016	5/29/2015	Yes	Warning Letter - 9/30/2016	Yes
Wells Pharmacy, Inc., Dyersburg, TN	6/7/2016	2/28/2017	10/20/2016	Yes	Regulatory Meeting - 3/8/2017	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 on or 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 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.

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.

7.       This facility was the subject of at least one previous inspection relating to compounding that resulted in a Form 483, warning letter, or other action. For information about such inspections and resulting actions, see Compounding: Inspections, Recalls, and other Actions.