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  1. Human Drug Compounding

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 11/29/2019

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 Contact Name and Phone Number 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 Action, if Any, Based on Last Inspection4,5 Intends to Compounds Sterile Drugs From Bulk Drug Substances6
Advanced Pharmaceutical Technology, Inc., Elmsford, NY Marco Persichillo
914-358-5260
2/26/2019 11/18/2019 Not yet inspected N/A N/A Yes
AnazaoHealth Corporation, Las Vegas, NV Jaclyn Wong
800-995-4363
9/23/2014 10/22/2019 9/19/2019 Yes Open7 Yes
Apollo Care, Columbia, MO Jarred Dudding
573-441-8900
9/14/2017 11/21/2018 3/13/2018 Yes Warning Letter - 3/20/2019 Yes
ASP CARES, San Antonio, TX Jacqueline Esqueda
210-417-4567 
2/14/2017 1/4/2019 8/23/2018 Yes Open Yes
Athenex Pharma Solutions, LLC, Clarence, NY Michael Scribner
888-629-8593
4/10/2017 10/25/2019 8/28/2019 Yes Open7 Yes
Atlas Pharmaceuticals, Phoenix, AZ Nancy Costlow
844-661-1829 
11/8/2016 11/22/2019 9/26/2017 Yes Warning Letter - 9/11/2018 Yes 
Auro Pharmacies, Inc, DBA Central Drugs, 511 S. Harbor Blvd, Bldg F, La Habra, CA Nayan Patel
562-352-9630 
9/1/2016 11/3/2018 10/18/2019 Yes Open7 Yes
Avella of Deer Valley, Inc. #38, Phoenix, AZ Christopher Dinoffria
623-238-7073
6/21/2016 10/11/2018 4/20/2018 Yes Open Yes
BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL Kenneth Jozefczyk
813-901-6339
6/4/2019 6/4/2019 Not yet inspected N/A N/A No
BPI Labs LLC, Largo, FL Chandra Kasireddy
727-471-0850
3/4/2019 3/4/2019 Not yet inspected N/A N/A Yes
Brookfield Medical/Surgical Supply, Inc., Brookfield, CT James Cangelosi
203-775-0862 
1/12/2015 2/14/2019 12/21/2018 Yes Open Yes
BSO LLC, Lakewood, CO David W. Hill
303-589-8677 
11/24/2015 10/17/2019 9/20/2019 Yes Open7 Yes
Central Admixture Pharmacy Services, Inc., Allentown, PA Wm. John Brandon
205-945-1955
Ext=106 
2/28/2014 10/18/2019 8/22/2018 Yes Open7 Yes
Central Admixture Pharmacy Services, Phoenix, AZ Wm. John Brandon
205-945-1955
Ext=106 
3/29/2018 10/18/2019 4/26/2019 No N/A Yes
Central Admixture Pharmacy Services, Inc., San Diego, CA
Wm. John Brandon
205-945-1955
Ext=106 
6/4/2014 10/18/2019 9/11/2018 Yes Open7 No
Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL Lester Triana
305-397-2035
Ext=223
6/6/2014 2/13/2019 1/23/2019 Yes Open7 Yes
Denver Solutions, LLC dba Leiters Health, Englewood, CO Ron Stephens
408-292-6772
3/24/2017 11/5/2019 7/18/2019 Yes Open7 Yes
Eagle Pharmacy, Inc., Hoover, AL Haleigh Cawood
205-682-7999 
6/16/2015 11/7/2019 5/18/2018 Yes Open7 Yes
Edge Pharmacy Services, LLC, Colchester, VT William Chatoff
802-497-0161 
1/21/2014 10/13/2018 3/8/2018 Yes Open Yes
Empower Pharmacy, Houston, TX Shaun Noorian
877-562-8577 
7/16/2016 10/11/2018 1/24/2018 Yes Untitled Letter - 7/22/2019 Yes
Exela Pharma Sciences, LLC., Lenoir, NC Aruna Koganti
828-758-5474
Ext=181 
6/6/2014 2/22/2019 7/18/2019 Yes Open7 Yes
F.H. Investments, Inc., DBA Asteria Health, Birmingham, AL William Fixler
855-771-0505 
5/18/2017 11/13/2019 7/10/2018 Yes Open Yes
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS David Lawn
877-405-8066 
10/2/2015 10/18/2019 6/21/2019 Yes Open7 Yes
Farmakeio Outsourcing LLC, Southlake, TX Cody Boatman
817-203-8216
12/12/2018 12/12/2018 10/30/2019 Yes Open Yes
Fresenius Kabi Compounding, LLC, Canton, MA Deborah McHugh
781-298-7577 
4/21/2017 11/13/2018 12/4/2018 Yes Open No
Fusion IV Pharmaceuticals, Inc., dba Axia Pharmaceutical, Los Angeles, CA Eric Feinstein
877-685-8222 
1/6/2017 11/28/2018 3/23/2017 Yes Warning Letter - 02/21/2018 Yes
Hybrid Pharma, LLC, Deerfield Beach, FL Ponswamy Rajalingam
954-708-2771 
1/14/2015 12/17/2018 6/20/2019 Yes Open7 Yes
Imprimis NJOF, LLC, Ledgewood, NJ Pramod Sharma
973-804-1623
11/12/2016 10/18/2019 7/10/2017 Yes Warning Letter 6/7/2019 Yes
INTACT PHARMACEUTICALS LLC, New Milford, CT Maclean dan-Jumbo
860-350-1900
Ext=303 
1/12/2018 3/6/2019 10/12/2018 Yes Open Yes
IntegraDose Compounding Services, LLC, Minneapolis, MN Craig Else
612-672-5216
5/8/2018 11/21/2019 9/19/2018 Yes Open No
JCB Laboratories, North Wichita, KS
Jason Syring
316-773-0405
1/21/2014 10/31/2019 9/14/2018 Yes Open7 Yes
KRS Global Biotechnology, Inc., Boca Raton, FL Cheryl Oleski
888-502-2050
12/15/2013 12/20/2018 8/14/2019 Yes Open7 Yes
Leesar Inc., Fort Myers, FL Maria Gautier
239-939-8925 
4/30/2014 12/19/2018 7/12/2017 Yes Open No
Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA Chang Liu
408-506-2963 
1/31/2014 11/25/2019 12/19/2018 Yes Open Yes
Maitland Labs of Central Florida, Orlando, FL Paul Reid
754-224-1242 
3/23/2018 2/14/2019 6/17/2019 Yes Open Yes
Medcraft LLC, Mounds, OK Matthew Davidson
918-938-0642 
2/23/2017 12/6/2018 7/27/2018 Yes FMD-145 Letter Issued 1/30/2019 Yes
Medi-Fare Drug, Blacksburg, SC Anne-Marie Davis
864-839-6500 
12/17/2013 12/13/2018 4/5/2017 No Untitled Letter Issued 3/18/20197 Yes
MedisourceRx, Los Alamitos, CA Amy Summers
714-455-1300 
2/14/2017 1/28/2019 9/27/2018 Yes Open Yes
Molecular PharmaGroup, New Providence, NJ Millan Bhatt
855-674-7828 
5/8/2018 2/16/2019 Not yet inspected N/A N/A Yes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC Lou Kennedy
803-569-3110
7/15/2014 10/19/2019 11/15/2019 Yes Open7 Yes
New England Life Care, Inc., dba: Advanced Compounding Solutions, Woburn, MA Jill Hunter
844-649-6352 
3/2/2017 11/19/2019 8/22/2017 Yes Warning Letter - 8/21/2019 No
Nexgen Labs, LLC, Arlington, TX Michelle Shaw
817-583-6611
7/9/2019 7/9/2019 Not yet inspected N/A N/A Yes
Nubratori, Inc., Torrance, CA Gulshakar Khwaja
310-218-4153 
2/24/2017 10/17/2019 9/26/2019 Yes Open7 Yes
Olympia Compounding Pharmacy, Orlando, FL Confidence Ekeanyanwu
407-673-2222 
3/10/2014 11/28/2018 4/13/2018 Yes Open7 Yes
OurPharma LLC, Fayetteville, AR Kandace Greene
479-313-8200
3/15/2019 3/15/2019 Not yet inspected N/A N/A Yes
Pantheon Labs LLC, Rancho Santa Margarita, CA Rashmi Mediratta
714-726-6429
2/7/2019 2/7/2019 Not yet inspected N/A N/A Yes
Pentec Health, Boothwyn, PA John Beres
877-369-1833 
9/21/2016 10/24/2018 5/30/2019 No Open7 Yes
Pharmaceutic Labs, LLC, Albany, NY Ernesto Samuel
518-210-7164 
3/10/2014 11/14/2019 9/23/2015 Yes Warning Letter - 5/3/2017 Yes
PharMedium Services, LLC, Dayton. NJ Walter Kelso
800-523-7749 
11/3/2015 10/25/2019 12/13/2017 Yes Under consent decree of permanent injunction - 5/22/2019 No
PharMedium Services, LLC, Memphis, TN April Armstrong
800-523-7749 
12/11/2013 10/25/2019 12/15/2017
 
No
PharMedium Services, LLC, Sugar Land, TX
Bruce Bagley
800-523-7749 
12/11/2013
10/25/2019
12/22/2017
No
Pine Pharmaceuticals, LLC, 355 Riverwalk Pkwy, Tonawanda, NY Alfonse Muto
844-218-4138 
3/9/2018 11/16/2019 4/26/2018 Yes Open Yes
Premier Pharmacy Labs Inc., Brooksville, FL Vern Allen
352-597-4950 
4/16/2014 10/24/2018 6/12/2019 Yes Open7 Yes
Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OK Shaun Riney
405-818-9029 
5/23/2014 12/13/2018 9/13/2018 Yes
Regulatory Meeting - 6/18/2019
Yes
Queens Express Pharmacy, Jackson Heights, NY Silvia Segarra
718-565-1009
Ext=3 
5/10/2016 11/9/2019 10/31/2018 Yes Open Yes
QuVa Pharma, Inc., Bloomsbury, NJ Mike Rutkowski
908-388-1418 
9/15/2017 11/26/2019 5/31/2019 Yes Open Yes
Quva Pharma, Inc., Sugar Land, TX Travis McGrady
832-500-7113
9/10/2015 11/26/2019 4/23/2019 Yes Open7 No
QuVa Pharma, Inc., Temple, TX Travis Leeah
254-933-4429 
12/15/2015 11/26/2019 3/14/2019 Yes Open7 Yes
RAM Pharma, Inc. Idaho Falls, ID Robert A. Myers
208-419-0613 
7/21/2016 1/4/2019 8/1/2019 Yes Open7 Yes
RC Outsourcing, LLC, Lowellville, OH Raymond R. Carlson
330-536-8500 
10/6/2015 2/28/2019 2/8/2019 Yes Open7 Yes
Rhombus Pharmaceuticals Corporation, Conway, AR Robert Hopkins
501-327-1222
12/17/2018 12/17/2018 Not yet inspected No N/A Yes
Right Value Drug Stores, LLC, Irving, TX Syed Saleem
405-410-8244
7/3/2019 7/3/2019 11/12/2019 Yes Open Yes
RXQ Compounding LLC, Athens, OH Edward J. Zatta
866-280-0031 
1/2/2015 11/7/2018 6/6/2019 Yes Open7 Yes
SCA Pharmaceuticals, Little Rock, AR
Mary Edelman
877-550-5059 
12/13/2013
11/22/2019
11/7/2019
Yes Open7 Yes
SCA Pharmaceuticals, Windsor, CT Lessley Denton
877-550-5059 
8/3/2017 11/22/2019 11/19/2019 Yes Open7 Yes
Sincerus Florida, LLC, Pompano Beach, FL Joanne Hoefling
800-604-5032 
3/10/2016 11/23/2019 9/17/2018 Yes Open7 Yes
SSM Health Care Corporation, Fenton, MO Jill Stimac
636-496-2685 
2/18/2014 11/27/2019 8/28/2019 Yes Open7 No
STAQ Pharma, Inc., Denver, CO Joe Bagan
303-810-6777
2/5/2019 11/2/2019 Not yet inspected N/A N/A Yes
STERRX, LLC, Plattsburgh, NY   Sue Martin
518-324-7879 
5/29/2015  10/26/2018 6/7/2019 No Open7 Yes 
Stokes Healthcare Inc., Mt. Laurel, NJ Michael Tursi
888-508-5032
1/30/2018 10/18/2019 6/19/2018 Yes Open Yes
Strukmyer Medical, Mesquite, TX Pam Liberto
972/284/1614
2/8/2019 2/8/2019 Not yet inspected N/A N/A Yes
Tailstorm Health Inc., Chandler AZ VIraj Gandhi
347-990-4238
10/23/2019 10/23/2019 Not yet inspected N/A N/A Yes
University of Tennessee, Memphis, TN Harry Kochat
901-448-1440
6/26/2019 6/26/2019 Not yet inspected N/A N/A Yes
US Compounding, Inc., Conway, AR Robert Hopkins
501-327-1222
12/20/2013 11/13/2018 2/7/2019 Yes Open7 Yes
US Specialty Formulations LLC, Bethlehem, PA
Kyle Flanigan
610-849-5023 
1/31/2014 11/5/2019 7/23/2019 Yes Open7 Yes
Wells Pharmacy, Inc., Dyersburg, TN Melissa Stefko
800-622-4510
6/7/2016 1/28/2019 4/27/2018 Yes Open7 Yes

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

 

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