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U.S. Department of Health and Human Services

Drugs

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Registered Outsourcing Facilities

 

Firms Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Updated as of 4/11/14
 
Information Concerning Outsourcing Facility Registration
 
 

Firm Name
Date of 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
Compounds Sterile Drugs From Bulk Drug Substances6
Advanced Pharma, Inc., Houston, TX
1/22/20143/17/2014YesOpenNo
Allergy Laboratories, Inc., Oklahoma City, OK
12/30/20134/26/2013YesWarning Letter - 9/4/2013Yes
Avella of Deer Valley, Phoenix, AZ2/24/20142/25/2013YesWarning Letter - 1/17/2014No
Banner Health, Chandler, AZ12/26/2013Not yet inspectedN/AN/ANo
Cantrell Drug Company, Litte Rock, AR12/16/201311/4/2013YesOpenYes
Central Admixture Pharmacy Services, Inc., Allentown, PA2/28/2014Not yet inspectedN/AN/AYes
Edge Pharmacy Services LLC, Colchester, VT1/21/2014Not yet inspectedN/AN/AYes
Greer Laboratories, Inc., Lenoir, NC2/24/201411/15/2013YesOpenYes

Healix Infusion Therapy, Inc., Sugar Land, TX

2/12/2014Not yet inspectedN/AN/AYes
Infusion Options INC., Brooklyn, NY1/24/2014Not yet inspectedN/AN/ANo
Institutional Pharmacy Solutions, LLC, Virginia Beach, VA3/4/2014Not yet inspectedN/AN/ANo
Institutional Pharmacy Solutions, LLC, Irwindale, CA 3/6/2014Not yet inspectedN/AN/ANo
IV Specialty Ltd, Austin, TX2/26/2014Not yet inspectedN/AN/ANo
JCB Laboratories, North Wichita, KS
1/21/20142/27/2013YesOpenYes
Kings Park Slope, Inc., Brooklyn, NY12/23/20133/14/2014YesOpenYes
KRS Global Biotechnology, Inc., Boca Raton, FL12/15/20133/17/2014YesOpenYes
Leiter's Compounding, (Great Oaks Blvd), San Jose, CA1/31/2014Not yet inspectedN/AN/AYes
Lowlite Investments, Inc. dba Olympia Pharmacy, Orlando, FL3/17/20143/21/2013YesWarning letter - 2/18/2014Yes
Marlborough Hospital, Marlborough, MA12/26/2013Not yet inspectedN/AN/AYes
Medi-Fare Drug & Home Health Center, Inc., Blacksburg SC
12/17/2013
1/18/2013
 
Yes
Methodist Hospital, Omaha, NE3/17/2014Not yet inspectedN/AN/AYes
OPS International, Inc. dba Olympia Pharmacy, Orlando, FL3/10/2014Not yet inspectedN/AN/AYes
Pharmaceutic Labs, LLC, Albany, NY3/10/2014Not yet inspectedN/AN/AYes
Pharmagen Laboratories Inc., Stamford, CT
1/21/20148/23/2013YesOpenYes
Pharmakon Pharmaceuticals, Noblesville, IN1/23/20143/13/2014; 4/8/2014

Yes

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

OpenNo
PharMedium Services, LLC, Cleveland, MS
12/11/20132/22/2013OpenNo
PharMedium Services, LLC, Edison, NJ
12/11/20132/28/2013OpenNo
PharMedium Services, LLC, Memphis, TN
12/11/2013
3/22/2013
 
Open
No
PharMedium Services, LLC, Sugar Land, TX
12/11/2013
2/27/2013
 
OpenNo
RC Compounding Services LLC, Poland, OH2/12/20142/7/2013YesOpenYes
Region Care, Inc., Great Neck, NY12/24/20133/20/2014YesOpenYes
SCA Pharmaceuticals, Little Rock, AR
12/13/2013
4/1/2014
YesOpenYes
SSM St. Clare Health Center, Fenton, MO2/18/2014Not yet inspectedN/AN/ANo
Triangle Compounding Pharmacy Inc., Cary, NC
1/24/20143/1/2013YesWarning Letter - 1/14/2014Yes
Unique Pharmaceuticals, Ltd., Temple TX1/17/20144/2/2014YesOpenYes
US Compounding, Inc., Conway, AR12/20/20133/27/2014YesOpenYes
US Specialty Formulations LLC, Bethlehem, PA
1/31/2014Not yet inspectedN/AN/AYes

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

 
Notes: 
 
1.       The date of registration is the date upon which the required registration information has been determined by FDA to be complete. This table will be updated weekly and will list 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.
2.       Inspections and other history referenced in this table are associated with the specific registered outsourcing facility at the listed address. A registered outsourcing facility may be owned or operated by a company that also owns or operates other compounding facilities. FDA’s web page on Compounding: Inspections, Recalls, and Other Actions may contain information about other related compounding facilities which may be under the same ownership as the listed registered outsourcing facility.
In addition, please note that 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 is issued or, if no FDA Form-483 is issued, the last day of the inspection.
3.       An FDA Form 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 of our relevant regulations. 
4.       This table includes only FDA actions. It does not include actions, if any, by a State Board of Pharmacy. 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.       If the inspection has been closed without further action, the word “closed” will appear. If the inspection has not been closed, the word “open” will appear. Open does not mean that FDA has determined that further action will be taken. It means only that a determination has not yet been made. If an action has been taken, it will be listed. Possible FDA actions may include: warning letter; seizure; or injunction.
6.       This column is based on information provided by the registered outsourcing facility at the time of registration and has not been verified by FDA. If this column says “N/A”, it is because 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, but this information is not currently available to the Agency.