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 4/22/16

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 Action, if Any, Based on Last Inspection4,5Intends to Compounds Sterile Drugs From Bulk Drug Substances6
Advanced Pharma, Inc., Houston, TX
1/22/201410/15/20153/17/2014YesOpenNo
American Specialty Pharmacy, San Antonio, TX12/22/201512/22/2015Not yet inspectedN/AN/AYes
AnazaoHealth Corporation, Las Vegas, NV9/23/201411/18/20151/30/2015YesWarning Letter - 12/9/2015Yes
Avella Specialty Pharmacy, Phoenix, AZ2/24/201411/20/20157/31/2015YesOpen7No
Banner Health, Chandler, AZ12/26/201312/28/20153/20/2015YesOpenNo
Bioserv Corporation, San Diego, CA2/23/20162/23/2016Not yet inspectedN/AN/AYes
BSO LLC, Lakewood, CO11/24/201511/24/2015Not yet inspectedN/AN/AYes
Brookfield Medical/Surgical Supply, Inc., Brookfield, CT1/12/201512/23/20154/9/2015YesOpenYes
California Pharmacy and Compounding Center, Newport Beach, CA4/30/201412/1/2015

8/25/2014;
10/17/2014

Yes

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

Warning Letter - 6/17/2015Yes
Cantrell Drug Company, Little Rock, AR12/16/201311/5/201511/4/2013YesWarning Letter - 1/21/2015Yes
Central Admixture Pharmacy Services, Inc., Allentown, PA2/28/201412/23/20152/11/2015YesOpen7Yes
Central Admixture Pharmacy Services, Inc., San Diego, CA
6/4/201412/23/20158/8/2014YesOpenNo
Coastal Meds LLC, Biloxi, MS12/23/201412/16/20159/23/2015YesOpen7Yes
Complete Pharmacy and Medical Systems, Miami Lakes, FL6/6/201412/31/20158/12/2014YesWarning Letter - 3/10/2016Yes
Delta Pharma, Inc., Ripley, MS8/6/201411/9/201510/2/2013YesWarning Letter - 12/9/2014Yes
Eagle Pharmacy, Inc., Birmingham, AL6/16/201511/23/20158/21/2015YesOpenYes
Edge Pharmacy Services, LLC, Colchester, VT1/21/201410/16/20158/20/2014YesWarning Letter - 11/12/2015Yes
Exela Pharma Sciences, LLC., Lenoir, NC6/6/20141/12/201611/21/2014YesOpenYes
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS10/2/201512/31/2015Not yet inspectedN/AN/AYes
Hybrid Pharma, LLC, Deerfield Beach, FL1/14/201512/24/2015Not yet inspectedN/AN/AYes
INCELL Corp., LLC, San Antonio, TX  5/29/2015 12/18/2015 9/1/2015YesOpen Yes 
Infusion Options Inc., Brooklyn, NY1/24/201412/22/20154/23/2014YesWarning Letter - 3/21/2016No
Isomeric Pharmacy Solutions, LLC, Salt Lake City, UT7/14/201512/31/20158/28/2015YesOpenYes
JCB Laboratories, North Wichita, KS
1/21/201410/30/201512/3/2015YesOpen7Yes
Jubilant HollisterStier LLC, Spokane, WA6/3/201412/31/201512/02/2014YesOpen7Yes
Kings Park Slope, Inc., Brooklyn, NY12/23/201312/31/20154/22/2016YesOpen7Yes
KRS Global Biotechnology, Inc., Boca Raton, FL12/15/201310/27/20153/17/2014YesWarning Letter - 7/6/2015Yes
LeeSar, Inc., Fort Myers, FL4/30/201411/24/20158/8/2014YesOpenNo
Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA1/31/201411/2/201510/7/2014YesWarning Letter - 2/29/2016Yes
Medi-Fare Drug, Blacksburg, SC12/17/201311/24/20159/12/2014YesOpen7Yes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC7/15/201412/21/2015Not yet inspectedN/AN/AYes
Olympia Compounding Pharmacy, Orlando, FL3/10/201411/10/201512/4/2014YesWarning Letter - 2/4/2016Yes
Pacifico National dba Amex Pharmacy, Melbourne, FL9/21/201512/16/20151/21/2016YesOpenYes
Pharmaceutic Labs, LLC, Albany, NY3/10/201410/6/20159/23/2015YesOpenYes
Pharmakon Pharmaceuticals, Noblesville, IN1/23/201411/30/20153/16/2016

Yes

Ceased sterile operations and recalled sterile productNo
Pharm D Solutions, LLC, Houston, TX8/6/201411/6/20156/5/2015YesOpenYes
PharMedium Services, LLC, Cleveland, MS
12/11/201311/3/20157/16/2015Open7No
PharMedium Services, LLC, Dayton. NJ11/3/201511/3/2015Not yet inspectedN/AN/ANo
PharMedium Services, LLC, Memphis, TN12/11/201311/3/20157/10/2015
 
Open7
No
PharMedium Services, LLC, Sugar Land, TX
12/11/2013
11/3/2015
9/24/2015
Yes 
Open7
No
Pine Pharmaceuticals, LLC, Tonawanda, NY6/17/201410/7/201510/9/2015YesOpenYes
Premier Pharmacy Labs Inc., Brooksville, FL4/16/201410/22/20155/9/2014YesWarning Letter - 4/27/2015Yes
Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OK5/23/20141/14/20169/17/2015YesRecall of sterile productsYes
Quva Pharma, Inc., Sugar Land, TX9/10/201512/15/20152/8/2016Yes (2/5/2016) and (2/8/2016)OpenNo
QuVa Pharma, Inc., Temple, TX12/15/201512/15/2015Not yet inspectedN/AN/AYes
RC Outsourcing, LLC, Lowellville, OH10/6/201510/6/20152/9/2016Yes (2/9/2016) and (2/25/2016)OpenYes
Resource Optimization and Innovation, Springfield, MO9/22/201511/24/2015Not yet inspectedN/AN/ANo
Right Value Drug Store dba Carie Boyd's Prescription Shop, Hurst, TX1/11/20161/11/201612/12/2014YesOpenYes
RXQ Compounding LLC, Athens, OH1/2/201512/31/20159/21/2015YesOpenYes
SCA Pharmaceuticals, Little Rock, AR
12/13/2013
11/5/2015
4/1/2014
YesWarning Letter - 6/25/2015Yes
Sincerus Florida, LLC, Pompano Beach, FL3/10/20163/10/2016Not yet inspectedN/AN/AYes
SSM St. Clare Health Center, Fenton, MO2/18/201411/13/20158/14/2014YesWarning Letter - 10/19/2015No
STERRX, LLC, Plattsburgh, NY  5/29/2015 12/22/2015 Not yet inspected N/A N/A Yes 
Topicare Management LLC, Conroe, TX2/12/20162/12/2016Not yet inspectedN/AN/ANo
Triangle Compounding Pharmacy, Inc., Cary, NC1/24/20142/2/2016 9/22/2014; 1/16/2015Yes (9/22/2014 and 1/16/2015Warning Letter - 11/2/20157 Yes
Unique Pharmaceuticals, Ltd., Temple TX1/17/201412/15/2015

1/23/2015

Yes

ClosedYes
US Compounding, Inc., Conway, AR12/20/201312/31/20158/21/2015YesResumed operations after cessation of sterile operations and recall of sterile products7Yes
US Specialty Formulations LLC, Bethlehem, PA
1/31/201412/24/20155/29/2015YesOpenYes

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

 

Page Last Updated: 04/28/2016
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