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 12/05/14

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 NameInitial Date of Registration as an Outsourcing Facility1Date of Most Recent Registration as an Outsourcing Facility1End Date of Last FDA Inspection Related to Compounding2Was a Form FDA-483 issued?3Other FDA Action, if Any, Based on Last Inspection4,5Intends to Compounds Sterile Drugs From Bulk Drug Substances6
Absolute Pharmacy, Lutz, FL9/3/20149/3/2014Not yet inspectedN/AN/AYes
Advanced Pharma, Inc., Houston, TX
1/22/201412/1/20143/17/2014YesOpenNo
Alexander Infusion LLC dba Avanti Health Care, New Hyde Park, NY4/21/20144/21/20147/9/2014  YesOpenYes
ALK-Abelló, Inc., Port Washington, NY
6/3/20146/3/20142/25/2014YesOpenYes
Allergy Laboratories, Inc., Oklahoma City, OK
12/30/201312/30/20134/26/2013YesWarning Letter - 9/4/2013Yes
Amerilab LLC, Edmond, OK
5/23/20145/23/2014Not yet inspectedN/AN/AYes
AnazaoHealth Corporation, Las Vegas, NV9/23/20149/23/2014Not yet inspectedN/AN/AYes
Avella of Deer Valley, Phoenix, AZ2/24/20142/24/20142/25/2013YesWarning Letter - 1/17/2014No
Banner Health, Chandler, AZ12/26/201312/26/20133/5/2014 (incomplete)NoNoNo
California Pharmacy and Compounding Center, Newport Beach, CA4/30/201412/1/2014

8/25/2014;
10/17/2014

Yes

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

OpenYes
Cantrell Drug Company, Litte Rock, AR12/16/201312/16/201311/4/2013YesOpenYes
Central Admixture Pharmacy Services, Inc., Allentown, PA2/28/20142/28/20136/11/2014YesOpenYes
Central Admixture Pharmacy Services, Inc., San Diego, CA
6/4/20146/4/20148/8/2014YesOpenNo
Complete Pharmacy and Medical Solutions, Miami Lakes, FL6/6/20146/6/20148/12/2014YesOpenYes
Delta Pharma, Inc., Ripley, MS8/6/20148/6/201410/2/2013YesOpenYes
Edge Pharmacy Services LLC, Colchester, VT1/21/20141/21/20148/20/2014YesOpenYes
Essential Pharmacy Compounding Division of Kohll's Pharmacy, Omaha, NE7/17/20147/17/2014Not yet inspectedN/AN/AYes
Exela Pharma Sciences, LLC., Lenoir, NC6/6/20146/6/201411/21/2014YesOpenYes
Greer Laboratories, Inc., Lenoir, NC2/24/20142/24/201411/15/2013YesWarning Letter - 4/21/2014Yes

Healix Infusion Therapy, Inc., Sugar Land, TX

2/12/201412/1/20145/16/2014YesOpenYes
Infusion Options Inc., Brooklyn, NY1/24/20141/24/20144/23/2014YesOpenNo
Institutional Pharmacy Solutions, LLC, Virginia Beach, VA3/4/20143/4/2014Not yet inspectedN/AN/ANo
Institutional Pharmacy Solutions, LLC, Irwindale, CA 3/6/20143/6/20146/20/2014NoOpenNo
IV Specialty Ltd, Austin, TX2/26/20142/26/20147/22/2014YesOpenNo
JCB Laboratories, North Wichita, KS
1/21/201412/1/20142/27/2013YesWarning Letter - 7/7/2014Yes
Jubilant HollisterStier LLC, Spokane, WA6/3/20146/3/20144/15/2014YesOpenYes
Kings Park Slope, Inc., Brooklyn, NY12/23/201312/23/20133/14/2014YesOpenYes
KRS Global Biotechnology, Inc., Boca Raton, FL12/15/201312/15/20133/17/2014YesOpenYes
LEESAR INC, Fort Myers, FL4/30/20144/30/20148/8/2014YesOpenNo
Leiter's Compounding, (Great Oaks Blvd), San Jose, CA1/31/20141/31/201410/7/2014YesOpenYes
Lowlite Investments, Inc. dba Olympia Pharmacy, Orlando, FL3/17/20143/17/20143/21/2013YesWarning letter - 2/18/2014No
Medistat RX, LLC, Foley, AL12/1/201412/1/20149/18/2014YesOpenYes
Medi-Fare Drug & Home Health Center, Inc., Blacksburg SC
12/17/2013
12/17/2013
9/12/2014  
 
Open 
Yes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC7/15/20147/15/2014Not yet inspectedN/AN/AYes
OPS International, Inc. dba Olympia Pharmacy, Orlando, FL3/10/20143/10/2014Not yet inspectedN/AN/AYes
Pharm D Solutions dba PDS Compounding, West Houston, TX8/6/20148/6/2014Not yet inspectedN/AN/AYes
Pharmaceutic Labs, LLC, Albany, NY3/10/20143/10/2014Not yet inspectedN/AN/AYes
Pharmagen Laboratories Inc., Stamford, CT
1/21/20141/21/20148/23/2013YesWarning letter - 10/24/2014Yes
Pharmakon Pharmaceuticals, Noblesville, IN1/23/201412/5/20143/13/2014; 4/8/2014

Yes

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

OpenNo
Pharmalogic CSP Inc., Bridgeport, WV7/1/20147/1/2014Not yet inspectedN/AN/ANo
PharMedium Services, LLC, Cleveland, MS
12/11/201312/1/20142/22/2013Warning letter - 7/18/2014No
PharMedium Services, LLC, Edison, NJ
12/11/201312/1/20142/28/2013Warning letter - 7/18/2014No
PharMedium Services, LLC, Memphis, TN12/11/201312/1/20143/22/2013
 
No
PharMedium Services, LLC, Sugar Land, TX
12/11/2013
12/1/2014
2/27/2013
 
Warning letter - 7/18/2014No
Pine Pharmaceuticals, LLC, Tonawanda, NY6/17/20146/17/201410/16/2014NoNoYes
Premier Pharmacy Labs Inc., Weeki Wachee, FL4/16/20144/16/20145/9/2014YesOpenYes
Professional Pharmacy & Compounding Services LLC, Miami, FL6/13/20146/13/2014Not yet inspectedN/AN/AYes
RC Compounding Services LLC, Poland, OH2/12/20142/12/20142/7/2013YesWarning Letter - 7/14/2014Yes
Region Care, Inc., Great Neck, NY12/24/201312/24/20133/20/2014YesOpenYes
SCA Pharmaceuticals, Little Rock, AR
12/13/2013
12/13/2013
4/1/2014
YesOpenYes
SSM St. Clare Health Center, Fenton, MO2/18/20142/18/20148/14/2014YesOpenNo
Syenz Laboratory, LLC, Norwood, NJ9/9/20149/9/2014Not yet inspectedN/AOpenYes
Texas Health Infusion, The Woodlands, TX8/8/20148/8/2014Not yet inspectedN/AN/AYes
Triangle Compounding Pharmacy Inc., Cary, NC
1/24/20141/24/20149/22/2014YesOpenYes
Unique Pharmaceuticals, Ltd., Temple TX1/17/201412/2/2014

4/2/2014;

6/20/2014

Yes

(4/4/2014 and 6/20/2014)

FDA Requested Recall Letter 7/11/14 (PDF - 754KB)Yes
US Compounding, Inc., Conway, AR12/20/201312/20/20133/27/2014YesOpenYes
US Specialty Formulations LLC, Bethlehem, PA
1/31/201412/1/2014Not yet inspectedN/AN/AYes

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: 12/12/2014
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