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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 9/12/2023

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
AnazaoHealth Corporation, Las Vegas, NV Jaclyn Wong
9/23/2014 11/29/2022 7/29/2022 Yes Open7 Yes
ANNOVEX PHARMA, INC, Lorton, VA Kenneth Erickson
10/14/2021 10/30/2022 Not yet inspected N/A N/A Yes
Apollo Care, Columbia, MO Jarred Dudding
9/14/2017 1/3/2023 4/5/2023 Yes Open7 Yes
Athenex Pharma Solutions, LLC, Clarence, NY Lori Giles Aleshin
4/10/2017 11/10/2022 8/28/2019 Yes FMD-145 Letter Issued 8/10/2021 Yes
Atlas Pharmaceuticals, Phoenix, AZ Nickolaus Banda
11/8/2017 12/21/2022 5/21/2021 Yes FMD-145 Letter Issued 5/3/2022 Yes 
BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL Kenneth Jozefczyk
6/4/2019 11/10/2022 6/2/2023 Yes FMD-145 Letter Issued 4/4/2022 No
Belcher Pharmaceuticals, LLC, Largo, FL Shyam Busireddy
05/18/2021 11/9/2022 Not yet inspected N/A N/A No
Bennett Pharmaceuticals of America LLC, Hudson, WI

James Mulvahill 952-381-9027

4/19/2022 1/16/2023 Not yet inspected N/A N/A Yes
BPI Labs LLC, Largo, FL Chandra Kasireddy
3/4/2019 11/10/2022 4/30/2021 Yes FMD-145 Letter Issued 9/10/2021 Yes
Brookfield Medical/Surgical Supply, Inc., Brookfield, CT James Cangelosi
1/12/2015 12/20/2022 4/4/2022 Yes Open Yes
BSO LLC, Lakewood, CO Anne Szilagyi
11/24/2015 11/2/2022 3/11/2021 Yes FMD-145 Letter Issued 9/10/2021 Yes
Central Admixture Pharmacy Services, Inc., Allentown, PA Thomas Kelsey
2/28/2014 10/27/2022 3/30/2023 Yes Remote Regulatory Assessment Assignment Issued 1/26/20218 Yes
Central Admixture Pharmacy Services, Phoenix, AZ Thomas Kelsey
3/29/2018 10/27/2022 2/25/2022 Yes FMD-145 Letter Issued 1/18/2023 Yes
Central Admixture Pharmacy Services, Inc., San Diego, CA
Thomas Kelsey
6/4/2014 10/27/2022 9/11/2018 Yes Remote Regulatory Assessment Assignment Issued 1/27/20218 No
Delta Pharma, Inc., Ripley, MS Stuart Simpson
8/6/2014 12/20/2022 5/20/2022 Yes Open7 Yes
Denver Solutions, LLC, dba Leiters Health, Englewood, CO Ivan Martinez
3/24/2017 11/17/2022 10/7/2021 Yes FMD-145 issued 3/29/2022 Yes
Denver Solutions, LLC, dba Leiters Health, Buena, NJ Ivan Martinez
7/1/2022 11/17/2022 Not yet inspected N/A N/A Yes
Eagle Pharma Outsourcing, LLC
Birmingham, AL
Haleigh Cawood
6/16/2015 11/3/2022 8/12/2021 Yes Untitled Letter Issued 5/17/2022 Yes
Empower Pharmacy, Houston, TX Shaun Noorian
7/16/2016 11/9/2022 8/5/2022 Yes Open7 Yes
Excite Pharma Services, LLC Robert Pendland
6/1/2021 2/23/2022 Not yet inspected N/A N/A Yes
Exela Pharma Sciences, LLC, Lenoir, NC Auna Koganti


1/20/2023 7/18/2019 Yes WLCO and FMD-145 Letters Issued 4/30/2021 Yes
F.H. Investments, Inc., dba Asteria Health, Birmingham, AL William Fixler
5/18/2017 11/11/2022 7/10/2018 Yes FMD-145 Letter Issued 9/10/2021 Yes
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS David Lawn
10/2/2015 10/28/2022 3/24/2022 Yes FMD-145 Letter Issued 11/21/22 Yes
Farmakeio Outsourcing LLC, Southlake, TX Cody Boatman
12/12/2018 12/20/2022 6/10/2022 Yes Open7 Yes

Fresenius Kabi Compounding LLC dba Fagron Sterile Services, Canton, MA

Deborah McHugh



Yes FMD-145 Letter Issued 08/11/2023 No
Genixus, Corp, Kannapolis, NC Kendall Foster
6/22/2022 11/15/2022 Not yet inspected N/A N/A Yes
Hikma Injectables USA Inc., Dayton, NJ J. Barton Kalis
9/15/2021 12/5/2022 6/8/2022 Yes FMD-145 Letter Issued 2/10/2023 No
Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ J. Barton Kalis
9/15/2021 12/5/2022 7/7/2022 No FMD 145 Letter Issued 5/11/2023 Yes
Hybrid Pharma, LLC, Deerfield Beach, FL Ponswamy Rajalingam
1/14/2015 11/7/2022 9/3/2021 Yes Warning Letter Issued 6/7/2022 Yes
Imprimis NJOF, LLC, Ledgewood, NJ Jeffrey Palmer
11/12/2016 11/19/2022 1/29/2021 Yes Regulatory Meeting Held 8/29/22 Yes
IntegraDose Compounding Services, LLC, Minneapolis, MN Craig Else
5/8/2018 11/2/2022 8/2/2021 Yes Recall Initiated 9/2021 No
KRS Global Biotechnology, Inc., Boca Raton, FL Charles Richardson
12/15/2013 12/6/2022 8/14/2019 Yes Regulatory Meeting Held 7/30/2021 Yes
Leesar Inc., Fort Myers, FL Maria Gautier
4/30/2014 11/15/2022 10/29/2021 Yes Untitled Letter Issued 6/17/2022 No
Mark Cuban Cost Plus Manufacturing and Compounding LLC, Dallas, TX Alexander Oshmyansky
11/2/2022 2/8/2023 Not yet inspected N/A N/A Yes
McGuff Outsourcing Solutions, Inc. Santa Ana, CA
Si Pham 1-800-603-4795; ext=314  1/11/2023 1/11/2023 Not yet inspected N/A Yes Yes
Medi-Fare Drug, Blacksburg, SC Anne-Marie Davis
12/17/2013 12/27/2022 4/6/2017 No Remote Regulatory Assessment Assignment Issued 1/25/20218 Yes
MedisourceRx, Los Alamitos, CA Amy Summers
2/14/2017 11/15/2022 11/10/2022 No FMD-145 Letter Issued 4/14/2023 Yes
Molecular PharmaGroup, New Providence, NJ Amanda Lanze
5/8/2018 12/19/2022
Not yet inspected N/A N/A Yes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC Lou Kennedy
7/15/2014 11/9/2022 2/10/2023 Yes Open7 Yes
New England Life Care, Inc. dba Advanced Compounding Solutions, Woburn, MA Roula Samhoun
3/2/2017 12/20/2022 4/28/2022 Yes Open7 No
Nubratori, Inc., Torrance, CA Gulshakar Khwaja
2/24/2017 10/28/2022 12/20/2021 No FMD-145 Letter Issued 5/6/2022 Yes
Olympia Compounding Pharmacy, Orlando, FL Marco Loleit
3/10/2014 11/1/2022 3/2/2022 Yes Open7 Yes
OurPharma LLC, Fayetteville, AR Morgan Strickland
3/15/2019 11/8/2022 9/30/2021 Yes FMD-145 Letter Issued 3/14/2022 Yes
Pharmaceutics International, Inc., Cockeysville, MD Srilatha Jaini
4/28/2020 12/9/2022 Not yet inspected N/A N/A Yes
Pine Pharmaceuticals, LLC, Tonawanda, NY Alfonse Muto
3/9/2018 10/28/2022 5/14/2021 Yes Open7 Yes
PQ Pharmacy LLC, Brooksville, FL Angela Kassay
10/29/2020 1/10/2023 10/27/2022 N/A N/A Yes
Primera Compounding, LLC, Rosenberg, TX Basil Raad
5/24/2021 12/9/2022 Not yet inspected N/A N/A Yes
Prisma Health Outsourcing Facility, Simpsonville, SC Gary Jones
12/9/2019 11/22/2022 Not yet inspected N/A N/A No
ProRx LLC, Exton, PA Pardeep Gupta
4/27/2022 2/9/2023 Not yet inspected N/A N/A Yes
Providence Health & Services-Washington, Tukwila, WA Jacqueline A. Biery
3/2/2020 11/2/2022 4/13/2022 Yes FMD-145 Letter Issued 8/16/2022 No
Qualgen LLC, Edmond, OK Shaun Riney
5/23/2014 11/28/2022 9/30/2022 Yes Open Yes
QuVa Pharma, Inc., Bloomsbury, NJ Robert Nelson
9/15/2017 12/17/2022 10/14/2022 Yes Open7 Yes
Quva Pharma, Inc., Sugar Land, TX Robert Nelson
9/10/2015 11/23/2022 8/18/2022 Yes Open7 No
QuVa Pharma, Inc., Temple, TX Travis Leeah
12/15/2015 11/23/2022 6/16/2022 Yes FMD-145 Letter Issued 1/3/2023 Yes
RC Outsourcing, LLC, Lowellville, OH Raymond R. Carlson
10/6/2015 11/30/2022 2/8/2019 Yes Remote Regulatory Assessment Assignment Issued 3/26/20218 Yes
Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop, Irving, TX Sara Lange
7/3/2019 12/2/2022 6/27/2022 Yes Open7 Yes
RXQ Compounding LLC, Albany, OH Edward J. Zatta
12/11/2019 11/24/2022 Not yet inspected N/A N/A Yes
SCA Pharmaceuticals, Little Rock, AR
Lessley Denton
Yes WLCO and FMD-145 Letters Issued 8/19/2021 Yes
SCA Pharmaceuticals, Windsor, CT Lessley Denton
8/3/2017 12/12/2022 11/19/2019 Yes FMD-145 Letter Issued 10/22/2021 Yes
SKNV formerly registered as Sincerus Florida, LLC, Pompano Beach, FL Michael Morelli
3/10/2016 12/6/2022 9/17/2018 Yes Remote Regulatory Assessment Assignment Issued 1/29/20218 Yes
SSM Health Care Corporation, Fenton, MO Melissa Mays
2/18/2014 12/5/2022 9/28/2021 Yes Open7 No
STAQ Pharma, Inc., Denver, CO Joe Bagan
2/5/2019 12/28/2022 9/29/2021 Yes FMD-145 Letter Issued 3/25/2022 Yes
STAQ Pharma of Ohio, LLC, Columbus, OH

Joe Bagan

1/26/2023 1/25/2023 Not yet inspected N/A N/A Yes
Staska Pharmaceuticals, Inc., Bennet, NE Lyndon Leitner
12/3/2020 12/22/2022
Not yet inspected N/A N/A Yes
SterRx LLC, Plattsburgh, NY Thomas J. Dominy
5/29/2015 10/31/2022 11/4/2021 Yes Open7 Yes
Stokes Healthcare Inc., dba Epicur Pharma, Mt. Laurel, NJ Michael Tursi
1/30/2018 7/18/2023 10/9/2020 Yes Untitled Letter Issued 5/2/2022 Yes
Tailstorm Health Inc., Chandler, AZ Andrew Stasiak
10/23/2019 12/10/2022 7/21/2021 Yes Untitled Letter Issued 6/17/2022 Yes
Tailstorm Health Inc., Phoenix, AZ Mitexh Gandhi
10/23/2019 2/8/2023 Not yet inspected N/A N/A Yes
The Ritedose Corporation, Columbia, SC Arianne Lindsey
12/20/2019 10/28/2022 3/22/2022 Yes FMD-145 Letter Issued 9/23/2022 Yes

Turbare Manufacturing, Conway, AR

Deketric Smith






US Specialty Formulations LLC, Allentown, PA
Kyle Flanigan


4/26/2022 Yes Open7 Yes
Wedgewood Connect, LLC, formerly registered as Leiter's Compounding, San Jose, CA Paul Yamamoto
1/31/2014 12/5/2022 12/3/2021 Yes FMD-145 Letter Issued 4/29/2022 Yes
Wells Pharma of Houston, LLC, Houston, TX Theaquiata A. Mitchell
3/9/2020 12/15/2022 6/17/2021 Yes FMD-145 issued 1/10/2022 Yes
Wells Pharmacy, Inc., Dyersburg, TN Melissa Stefko
6/7/2016 12/13/2022 1/28/2021 Yes Untitled Letter Issued 5/19/2022 Yes


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.

8.  Remote Regulatory Assessment (RRA) definition: An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. RRAs assist in protecting human and animal health, informing regulatory decisions, and verifying certain information submitted to the Agency.


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