Drugs

Registered Outsourcing Facilities

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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 10/5/2018

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 NameContact Name and Phone NumberInitial 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. dba Avella of Houston, Houston, TXBourjois Abboud
713-794-0404
 
12/21/201610/5/20177/22/2016YesUntitled Letter 8/14/20187No
AnazaoHealth Corporation, Las Vegas, NVJaclyn Yeomans
800-995-4363
9/23/201410/12/20173/24/2017YesRegulatory Meeting 3/29/2018Yes
Apollo Care, Columbia, MOJarred Dudding
573-441-8900
9/14/201712/1/20173/13/2018YesOpenYes
ASP CARES, San Antonio, TXJacqueline Esqueda
210-417-4567 
2/14/201711/16/20178/23/2018YesOpenYes
Athenex Pharma Solutions, LLC, Clarence, NYMichael Scribner
888-629-8593
4/10/201710/18/201712/13/2017YesOpenYes
Atlas Pharmaceuticals, Phoenix, AZNancy Costlow
844-661-1829 
11/8/201611/8/20179/26/2017YesWarning Letter - 9/11/2018Yes 
Auro Pharmacies, Inc, DBA Central Drugs, 511 S. Harbor Blvd, Bldg F, La Habra, CANayan Patel
562-352-9630 
9/1/201610/12/20176/29/2017YesOpen7Yes
Avella of Deer Valley, Inc. #38, Phoenix, AZChristopher Dinoffria
623-238-7073
6/21/201612/28/20174/20/2018YesOpenYes
Avella Specialty Pharmacy, Phoenix, AZChris Griffee
877-546-5779 
2/24/201410/5/20174/19/2018YesOpenNo
BMD SKINCARE INC, Canoga, CABittu Ramani
818-514-2246 
1/11/20181/11/2018Not yet inspectedN/AN/AYes
Brookfield Medical/Surgical Supply, Inc., Brookfield, CTJames Cangelosi
203-775-0862 
1/12/201512/19/20174/19/2017YesRegulatory Meeting 1/8/187Yes
BSO LLC, Lakewood, CODavid W. Hill
303-589-8677 
11/24/201511/9/20179/2/2016YesOpenYes
Cantrell Drug Company, Little Rock, ARLeslie Wilson
501-908-2964 
12/16/201312/19/20178/22/2018YesOpen7Yes
Central Admixture Pharmacy Services, Inc., Allentown, PAWm. John Brandon
205-945-1955
Ext=106 
2/28/201410/30/20178/22/2018YesOpen7Yes
Central Admixture Pharmacy Services, Phoenix, AZWm. John Brandon
205-945-1955
Ext=106 
3/29/20183/29/2018Not yet inspectedN/AN/AYes
Central Admixture Pharmacy Services, Inc., San Diego, CA
Wm. John Brandon
205-945-1955
Ext=106 
6/4/201410/30/20179/11/2018YesOpen7No
Coastal Meds LLC, Biloxi, MS Rickey L. Chance
228-388-1327
12/23/201410/27/20174/6/2018YesCeased Operations and Recalled Product 4/13/20187Yes
Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL Lester Triana
305-397-2035
Ext=223
6/6/201412/28/20172/23/2017YesOpen7Yes
Delta Pharma, Inc., Ripley, MSTommy Simpson
662-512-5191
8/6/201410/20/20172/23/2017YesConsent Decree of Permanent Injunction entered 6/8/2018Yes
Denver Solutions, LLC dba Leiters Health, Englewood, CORon Stephens
408-292-6772
3/24/20171/24/20182/23/2018YesOpenYes
Eagle Pharmacy, Inc., Hoover, ALHaleigh Cawood
205-682-7999 
6/16/201510/18/20175/18/2018YesOpen7Yes
Edge Pharmacy Services, LLC, Colchester, VTWilliam Chatoff
802-497-0161 
1/21/201411/9/20173/8/2018YesOpenYes
Empower Pharmacy, Houston, TXShaun Noorian
877-562-8577 
7/16/201610/26/20171/24/2018YesOpenYes
Exela Pharma Sciences, LLC., Lenoir, NCAruna Koganti
828-758-5474
Ext=181 
6/6/20141/26/20189/28/2017YesOpen7Yes
F.H. Investments, Inc., DBA Asteria Health, Birmingham, ALWilliam Fixler
855-771-0505 
5/18/20171/6/20187/10/2018YesOpenYes
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KSDavid Lawn
877-405-8066 
10/2/201510/18/20179/21/2016YesWarning Letter 11/28/2017Yes
Fresenius Kabi Compounding, LLC, Canton, MADeborah McHugh
781-298-7577 
4/21/201711/30/2017Not yet inspectedN/AN/ANo
Fusion IV Pharmaceuticals, Inc., dba Axia Pharmaceutical, Los Angeles, CAEric Feinstein
877-685-8222 
1/6/20173/9/20183/23/2017YesWarning Letter 02/21/2018Yes
Hybrid Pharma, LLC, Deerfield Beach, FLPonswamy Rajalingam
954-708-2771 
1/14/201512/28/20177/28/2016YesOpenYes
Imprimis NJOF, LLC, Ledgewood, NJBrad M. Bingham
858-704-4625 
11/12/201610/26/20177/10/2017YesOpenYes
Infusion Options Inc., Brooklyn, NYNabil Kass-Gergi
718-283-6907 
1/24/201411/30/20176/1/2017YesRegulatory Meeting 03/14/2018No
INTACT PHARMACEUTICALS LLC, New Milford, CTMaclean dan-Jumbo
860-350-1900
Ext=303 
1/12/20181/12/2018Not yet inspectedN/AN/AYes
IntegraDose Compounding Services, LLC, Minneapolis, MNJoseph Stanek
612-672-7071 
5/8/20185/8/20189/19/2018YesOpenNo
JCB Laboratories, North Wichita, KS
Jason Syring
316-773-0405/
877-405-8066 
1/21/201410/20/20179/14/2018YesOpen7Yes
KRS Global Biotechnology, Inc., Boca Raton, FLCheryl Oleski
888-502-2050
12/15/201312/27/201710/23/2017YesOpen7Yes
Leesar Inc., Fort Myers, FLMaria Gautier
239-939-8925 
4/30/20141/3/20187/27/2017YesOpenNo
Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CAChristopher Long
800-292-6772 
1/31/201410/17/20176/15/2017YesFMD-145 Letter issued 5/29/2018Yes
Maitland Labs of Central Florida, Orlando, FLPaul Reid
754-224-1242 
3/23/20183/23/2018Not yet inspectedN/AN/AYes
Medcraft LLC, Mounds, OKMatthew Davidson
918-938-0642 
2/23/201711/23/20177/27/2018YesOpenYes
Medi-Fare Drug, Blacksburg, SCPatricia Stephens
864-839-6500 
12/17/201312/14/20174/5/2017NoOpen7Yes
MedisourceRx, Los Alamitos, CANicole Burtt
714-455-1300 
2/14/201712/29/20179/27/2018YesOpenYes
Molecular PharmaGroup, New Providence, NJMillan Bhatt
855-674-7828 
5/8/20185/8/2018Not yet inspectedN/AN/AYes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SCLou Kennedy
803-569-3110
7/15/201410/21/20174/20/2018YesOpen7Yes
New England Life Care, Inc., dba: Advanced Compounding Solutions, Woburn, MAJill Hunter
844-649-6352 
3/2/20171/24/20188/22/2017YesOpenNo
Nubratori, Inc., Torrance, CAGulshakar Khwaja
310-218-4153 
2/24/201711/3/20174/10/2018NoOpenYes
Olympia Compounding Pharmacy, Orlando, FLConfidence Ekeanyanwu
407-673-2222 
3/10/201410/13/20174/13/2018YesOpen7Yes
Pacifico National dba Amex Pharmacy, Melbourne, FLChristina Buhrman
800-644-9431 
9/21/201512/14/20171/21/2016YesOpenYes
Pentec Health, Boothwyn, PAJohn Beres
877-369-1833 
9/21/201611/18/20172/23/2018YesFMD-145 Letter 8/31/20187Yes
Pharm D Solutions, LLC, Houston, TXLuis De Leon
713-790-1693 
8/6/201410/25/20178/28/2018YesCeased Operations and Recalled Product 7Yes
PharMedium Services, LLC, Cleveland, MS
Brenda Womack
800-523-7749 
12/11/201310/16/20171/5/2018Open7No
PharMedium Services, LLC, Dayton. NJWalter Kelso
800-523-7749 
11/3/201510/16/201712/13/2017YesOpen7No
PharMedium Services, LLC, Memphis, TNApril Armstrong
800-523-7749 
12/11/201310/16/201712/15/2017
Yes
 
No
PharMedium Services, LLC, Sugar Land, TX
Bruce Bagley
800-523-7749 
12/11/2013
10/16/2017
12/22/2017
Yes
Open7
No
Pine Pharmaceuticals, LLC, 355 Riverwalk Pkwy, Tonawanda, NYAlfonse Muto
844-218-4138 
3/9/20183/9/20184/26/2018YesOpenYes
Premier Pharmacy Labs Inc., Brooksville, FLVern Allen
352-597-4950 
4/16/201410/23/20176/13/2016YesRegulatory Meeting - 1/31/2018Yes
Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OKShaun Riney
405-818-9029 
5/23/201411/28/20179/13/2018Yes
Open7
Yes
Queens Express Pharmacy, Jackson Heights, NYSilvia Segarra
718-565-1009
Ext=3 
5/10/201612/19/20177/11/2016YesOpenYes
QuVa Pharma, Inc., Bloomsbury, NJMike Rutkowski
908-388-1418 
9/15/201710/27/201711/30/2017YesOpenYes
Quva Pharma, Inc., Sugar Land, TXStuart Hinchen
201-306-4412 
9/10/201510/25/20176/2/2017YesFMD-145 Letter 8/20/20187No
QuVa Pharma, Inc., Temple, TXTravis Leeah
254-933-4429 
12/15/201510/27/20174/20/2018YesOpen7Yes
RAM Pharma, Inc. Idaho Falls, IDRobert A. Myers
208-419-0613 
7/21/201612/26/20173/1/2017YesWarning Letter - 11/1/2017Yes
RC Outsourcing, LLC, Lowellville, OHRaymond R. Carlson
330-536-8500 
10/6/201510/24/20173/31/2017YesWarning Letter - 11/28/20177Yes
Right Value Drug Store dba Carie Boyd's Prescription Shop, Hurst, TXDavid Smith
800-930-4361 
1/11/201612/15/20175/12/2017YesOpen7Yes
RXQ Compounding LLC, Athens, OHEdward J. Zatta
866-280-0031 
1/2/201510/19/20178/8/2017YesRegulatory Meeting - 05/23/2018Yes
SCA Pharmaceuticals, Little Rock, AR
Mary Edelman
877-550-5059 
12/13/2013
12/7/2017
9/29/2017
YesOpen7Yes
SCA Pharmaceuticals, Windsor, CtLessley Denton
877-550-5059 
8/3/201711/15/20173/5/2018YesOpenYes
Sincerus Florida, LLC, Pompano Beach, FLJoanne Hoefling
800-604-5032 
3/10/201611/2/20179/17/2018YesOpen7Yes
SSM Health Care Corporation, Fenton, MOKelly Klotz
636-496-2685 
2/18/201411/16/201711/16/2017YesOpen7No
STERRX, LLC, Plattsburgh, NY  Sue Martin
518-324-7879 
5/29/2015 10/16/20173/17/2017Yes Open Yes 
Stokes Healthcare Inc., Mt. Laurel, NJMichael Tursi
856-222-4218 
1/30/20181/30/20186/19/2018YesOpenYes
Triangle Compounding Pharmacy, Inc., Cary, NCDanny Barnes
919-858-0809
Ext=201 
1/24/201411/9/20177/13/2017YesRegulatory Meeting 8/6/2018Yes
US Compounding, Inc., Conway, ARRebecca Mitchell
800-718-3588 
12/20/201310/21/20177/15/2016YesWarning Letter - 10/10/20177Yes
US Specialty Formulations LLC, Bethlehem, PA
Kyle Flanigan
610-849-5023 
1/31/201412/7/20178/29/2017YesOpen7Yes
Wells Pharmacy, Inc., Dyersburg, TNMelissa Stefko
800-622-4510
6/7/201611/8/20174/27/2018YesOpen7Yes

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: 10/12/2018
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