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 12/05/14
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||9/3/2014||Not yet inspected||N/A||N/A||Yes|
Advanced Pharma, Inc., Houston, TX
|Alexander Infusion LLC dba Avanti Health Care, New Hyde Park, NY||4/21/2014||4/21/2014||7/9/2014||Yes||Open||Yes|
ALK-Abelló, Inc., Port Washington, NY
Allergy Laboratories, Inc., Oklahoma City, OK
|12/30/2013||12/30/2013||4/26/2013||Yes||Warning Letter - 9/4/2013||Yes|
Amerilab LLC, Edmond, OK
|5/23/2014||5/23/2014||Not yet inspected||N/A||N/A||Yes|
|AnazaoHealth Corporation, Las Vegas, NV||9/23/2014||9/23/2014||Not yet inspected||N/A||N/A||Yes|
|Avella of Deer Valley, Phoenix, AZ||2/24/2014||2/24/2014||2/25/2013||Yes||Warning Letter - 1/17/2014||No|
|Banner Health, Chandler, AZ||12/26/2013||12/26/2013||3/5/2014 (incomplete)||No||No||No|
|California Pharmacy and Compounding Center, Newport Beach, CA||4/30/2014||12/1/2014|
|Cantrell Drug Company, Litte Rock, AR||12/16/2013||12/16/2013||11/4/2013||Yes||Open||Yes|
|Central Admixture Pharmacy Services, Inc., Allentown, PA||2/28/2014||2/28/2013||6/11/2014||Yes||Open||Yes|
Central Admixture Pharmacy Services, Inc., San Diego, CA
|Complete Pharmacy and Medical Solutions, Miami Lakes, FL||6/6/2014||6/6/2014||8/12/2014||Yes||Open||Yes|
|Delta Pharma, Inc., Ripley, MS||8/6/2014||8/6/2014||10/2/2013||Yes||Open||Yes|
|Edge Pharmacy Services LLC, Colchester, VT||1/21/2014||1/21/2014||8/20/2014||Yes||Open||Yes|
|Essential Pharmacy Compounding Division of Kohll's Pharmacy, Omaha, NE||7/17/2014||7/17/2014||Not yet inspected||N/A||N/A||Yes|
|Exela Pharma Sciences, LLC., Lenoir, NC||6/6/2014||6/6/2014||11/21/2014||Yes||Open||Yes|
|Greer Laboratories, Inc., Lenoir, NC||2/24/2014||2/24/2014||11/15/2013||Yes||Warning Letter - 4/21/2014||Yes|
Healix Infusion Therapy, Inc., Sugar Land, TX
|Infusion Options Inc., Brooklyn, NY||1/24/2014||1/24/2014||4/23/2014||Yes||Open||No|
|Institutional Pharmacy Solutions, LLC, Virginia Beach, VA||3/4/2014||3/4/2014||Not yet inspected||N/A||N/A||No|
|Institutional Pharmacy Solutions, LLC, Irwindale, CA||3/6/2014||3/6/2014||6/20/2014||No||Open||No|
|IV Specialty Ltd, Austin, TX||2/26/2014||2/26/2014||7/22/2014||Yes||Open||No|
JCB Laboratories, North Wichita, KS
|1/21/2014||12/1/2014||2/27/2013||Yes||Warning Letter - 7/7/2014||Yes|
|Jubilant HollisterStier LLC, Spokane, WA||6/3/2014||6/3/2014||4/15/2014||Yes||Open||Yes|
|Kings Park Slope, Inc., Brooklyn, NY||12/23/2013||12/23/2013||3/14/2014||Yes||Open||Yes|
|KRS Global Biotechnology, Inc., Boca Raton, FL||12/15/2013||12/15/2013||3/17/2014||Yes||Open||Yes|
|LEESAR INC, Fort Myers, FL||4/30/2014||4/30/2014||8/8/2014||Yes||Open||No|
|Leiter's Compounding, (Great Oaks Blvd), San Jose, CA||1/31/2014||1/31/2014||10/7/2014||Yes||Open||Yes|
|Lowlite Investments, Inc. dba Olympia Pharmacy, Orlando, FL||3/17/2014||3/17/2014||3/21/2013||Yes||Warning letter - 2/18/2014||No|
|Medistat RX, LLC, Foley, AL||12/1/2014||12/1/2014||9/18/2014||Yes||Open||Yes|
Medi-Fare Drug & Home Health Center, Inc., Blacksburg SC
|Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC||7/15/2014||7/15/2014||Not yet inspected||N/A||N/A||Yes|
|OPS International, Inc. dba Olympia Pharmacy, Orlando, FL||3/10/2014||3/10/2014||Not yet inspected||N/A||N/A||Yes|
|Pharm D Solutions dba PDS Compounding, West Houston, TX||8/6/2014||8/6/2014||Not yet inspected||N/A||N/A||Yes|
|Pharmaceutic Labs, LLC, Albany, NY||3/10/2014||3/10/2014||Not yet inspected||N/A||N/A||Yes|
Pharmagen Laboratories Inc., Stamford, CT
|1/21/2014||1/21/2014||8/23/2013||Yes||Warning letter - 10/24/2014||Yes|
|Pharmakon Pharmaceuticals, Noblesville, IN||1/23/2014||12/5/2014||3/13/2014; 4/8/2014|
|Pharmalogic CSP Inc., Bridgeport, WV||7/1/2014||7/1/2014||Not yet inspected||N/A||N/A||No|
PharMedium Services, LLC, Cleveland, MS
|12/11/2013||12/1/2014||2/22/2013||Warning letter - 7/18/2014||No|
PharMedium Services, LLC, Edison, NJ
|12/11/2013||12/1/2014||2/28/2013||Warning letter - 7/18/2014||No|
|PharMedium Services, LLC, Memphis, TN||12/11/2013||12/1/2014||3/22/2013||No|
PharMedium Services, LLC, Sugar Land, TX
|Warning letter - 7/18/2014||No|
|Pine Pharmaceuticals, LLC, Tonawanda, NY||6/17/2014||6/17/2014||10/16/2014||No||No||Yes|
|Premier Pharmacy Labs Inc., Weeki Wachee, FL||4/16/2014||4/16/2014||5/9/2014||Yes||Open||Yes|
|Professional Pharmacy & Compounding Services LLC, Miami, FL||6/13/2014||6/13/2014||Not yet inspected||N/A||N/A||Yes|
|RC Compounding Services LLC, Poland, OH||2/12/2014||2/12/2014||2/7/2013||Yes||Warning Letter - 7/14/2014||Yes|
|Region Care, Inc., Great Neck, NY||12/24/2013||12/24/2013||3/20/2014||Yes||Open||Yes|
SCA Pharmaceuticals, Little Rock, AR
|SSM St. Clare Health Center, Fenton, MO||2/18/2014||2/18/2014||8/14/2014||Yes||Open||No|
|Syenz Laboratory, LLC, Norwood, NJ||9/9/2014||9/9/2014||Not yet inspected||N/A||Open||Yes|
|Texas Health Infusion, The Woodlands, TX||8/8/2014||8/8/2014||Not yet inspected||N/A||N/A||Yes|
Triangle Compounding Pharmacy Inc., Cary, NC
|Unique Pharmaceuticals, Ltd., Temple TX||1/17/2014||12/2/2014|
|FDA Requested Recall Letter 7/11/14 (PDF - 754KB)||Yes|
|US Compounding, Inc., Conway, AR||12/20/2013||12/20/2013||3/27/2014||Yes||Open||Yes|
US Specialty Formulations LLC, Bethlehem, PA
|1/31/2014||12/1/2014||Not yet inspected||N/A||N/A||Yes|
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.