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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 4/19/2024

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 Was a recall conducted?9 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 12/17/2023 7/29/2022 Yes No Regulatory Meeting Held 5/2/2023 Yes
Annovex Pharma, Inc., Lorton, VA Adedayo Akinbi
10/14/2021 3/06/2024 Not yet inspected N/A N/A N/A Yes
Apocus, Inc., San Antonio, TX Suryanarayana Raju Sagi
10/17/2023 10/17/2023 Not yet inspected N/A N/A N/A Yes
Apollo Care, Columbia, MO Jarred Dudding
9/14/2017 12/27/2023 4/5/2023 Yes Yes Regulatory Meeting Held 11/30/2023 Yes
Atlas Pharmaceuticals, LLC, Phoenix, AZ Michael Papenthien
11/8/2017 11/10/2023 5/21/2021 Yes No FMD-145 Letter Issued 5/3/2022 Yes 
Atlas Pharmaceuticals, LLC (Grandview), Phoenix, AZ Lee Martin
8/5/2023 10/25/2023 Not yet inspected N/A N/A N/A Yes
BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL Kenneth Jozefczyk
6/4/2019 10/7/2023 6/2/2023 Yes No FMD-145 Letter Issued 9/18/2023 No
Belcher Pharmaceuticals, LLC, Largo, FL Shyam Busireddy
5/18/2021 11/15/2023 Not yet inspected N/A N/A N/A No
Bennett Pharmaceuticals of America LLC, Hudson, WI James Mulvahill
4/19/2022 1/19/2024 Not yet inspected N/A N/A N/A Yes
BPI Labs LLC, Largo, FL Chandra Kasireddy
3/4/2019 10/13/2023 4/30/2021 Yes No FMD-145 Letter Issued 9/10/2021 Yes
Brookfield Medical/Surgical Supply, Inc., Brookfield, CT James Cangelosi
1/12/2015 1/2/2024 4/4/2022 Yes No FMD-145 Letter Issued 2/6/2023 Yes
BSO LLC, Golden, CO Michelle Violi
608-221-7800 ext 1113
1/24/2024 1/24/2024 Not yet inspected N/A N/A N/A Yes
BSO LLC, Lakewood, CO Anne Szilagyi
11/24/2015 12/13/2023 3/11/2021 Yes No FMD-145 Letter Issued 9/10/2021 Yes
Central Admixture Pharmacy Services, Inc., Allentown, PA Thomas Kelsey
2/28/2014 11/8/2023 3/30/2023 Yes Yes Open7 Yes
Central Admixture Pharmacy Services, Phoenix, AZ Thomas Kelsey
3/29/2018 11/8/2023 7/31/2023 Yes Yes Open7 Yes
Delta Pharma, Inc., Ripley, MS Stuart Simpson
8/6/2014 1/4/2024 6/2/2023 Yes No Open7 Yes
Denver Solutions, LLC, dba Leiters Health, Englewood, CO Barbara Knightly +1-720-697-5140 ext 4004 3/24/2017 11/30/2023 10/7/2021 Yes No FMD-145 issued 3/29/2022 Yes
Denver Solutions, LLC, dba Leiters Health, Buena, NJ Barbara Knightly +1-720-697-5140 ext 4004 7/1/2022 12/21/2023 Not yet inspected N/A N/A N/A Yes
Eagle Pharma Outsourcing, LLC
Birmingham, AL
Haleigh Cawood
6/16/2015 11/8/2023 8/12/2021 Yes No Untitled Letter Issued 5/17/2022 Yes
Empower Pharmacy, Houston, TX Shaun Noorian
7/16/2016 10/19/2023 8/5/2022 Yes No Regulatory Meeting Held 5/4/2023 Yes
Excite Pharma Services, LLC, Tonganoxie, KS Robert Pendland
6/1/2021 12/28/2023 Not yet inspected N/A N/A N/A Yes
Exela Pharma Sciences, LLC, Lenoir, NC Auna Koganti


1/22/2024 7/18/2019 Yes No WLCO and FMD-145 Letters Issued 4/30/2021 Yes
F.H. Investments, Inc., dba Asteria Health, Birmingham, AL William Fixler
5/18/2017 11/10/2023 7/10/2018 Yes No FMD-145 Letter Issued 9/10/2021 Yes
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS Josh Parks
10/2/2015 10/25/2023 3/24/2022 Yes No FMD-145 Letter Issued 11/21/22 Yes
Farmakeio Outsourcing LLC, Southlake, TX Cody Boatman


6/10/2022 Yes No Regulatory Meeting Held 1/31/2023 Yes

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

Deborah McHugh



Yes No FMD-145 Letter Issued 08/11/2023 No
Hikma Injectables USA Inc., Dayton, NJ J. Barton Kalis
9/15/2021 10/27/2023 6/8/2022 Yes No FMD-145 Letter Issued 2/10/2023 No
Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ J. Barton Kalis
9/15/2021 10/27/2023 7/7/2022 No No FMD 145 Letter Issued 5/11/2023 Yes
Hybrid Pharma, LLC, Deerfield Beach, FL Ponswamy Rajalingam
1/14/2015 1/9/2024 11/9/2023 Yes No Open7 Yes
Imprimis NJOF, LLC, Ledgewood, NJ Jeffrey Palmer
11/12/2016 11/2/2023 1/29/2021 Yes No Regulatory Meeting Held 8/29/22 Yes
IntegraDose Compounding Services, LLC, Minneapolis, MN Craig Else
5/8/2018 12/12/2023 8/2/2021 Yes No Recall Initiated 9/2021 No
Leesar Inc., Fort Myers, FL Maria Gautier
4/30/2014 12/22/2023 10/29/2021 Yes No Untitled Letter Issued 6/17/2022 No
Mark Cuban Cost Plus Manufacturing and Compounding, LLC, Dallas, TX Alexander Oshmyansky
11/2/2022 1/31/2024 Not yet inspected N/A N/A N/A Yes
McGuff Outsourcing Solutions, Inc. Santa Ana, CA Jacqueline McKay 1-714-918-7277; ext=314 1/11/2023 1/8/2024 Not yet inspected N/A N/A N/A Yes
Medi-Fare Drug, Blacksburg, SC Anne-Marie Davis
12/17/2013 1/2/2024 5/26/2023 Yes No FMD-145 Letter Issued 10/23/2023 Yes
MedisourceRx, Los Alamitos, CA Pallavi Badkar
2/14/2017 12/4/2023 11/10/2022 No No FMD-145 Letter Issued 4/14/2023 Yes
Molecular PharmaGroup, New Providence, NJ Amanda Lanze
5/8/2018 12/21/2023 12/11/2023 Yes No Open Yes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC Lou Wood Kennedy
7/15/2014 10/24/2023 2/10/2023 Yes Yes Regulatory Meeting Held 11/16/2023 Yes
Nubratori, Inc., Torrance, CA Gulshakar Khwaja
2/24/2017 10/24/2023 12/20/2021 No No FMD-145 Letter Issued 5/6/2022 Yes
Olympia Compounding Pharmacy, Orlando, FL Marco Loleit
3/10/2014 10/19/2023 3/2/2022 Yes No Regulatory Meeting Held 2/22/2023 Yes
OSRX, Inc., Missoula, MT Amy Frost
10/28/2023 10/28/2023 Not yet inspected N/A N/A N/A Yes
OurPharma LLC, Fayetteville, AR Morgan Strickland
3/15/2019 10/24/2023 9/30/2021 Yes No FMD-145 Letter Issued 3/14/2022 Yes
Park Avenue Compounding, St. Louis, MO Kristina Bryowsky
12/23/2023 12/23/2023 Not yet inspected N/A N/A N/A No
Pine Pharmaceuticals, LLC, Tonawanda, NY Alfonse Muto
3/9/2018 10/24/2023 9/19/2023 Yes Yes Open7 Yes
PQ Pharmacy LLC, Brooksville, FL Angela Kassay
10/29/2020 12/5/2023 10/27/2022 Yes No FMD-145 Letter Issued 3/30/2023 Yes
Prisma Health Outsourcing Facility, Simpsonville, SC Gary Jones
12/9/2019 11/7/2023 3/3/2023 Yes No FMD-145 Letter Issued 8/21/2023 No
ProRx LLC, Exton, PA Pardeep Gupta
4/27/2022 11/25/2023 Not yet inspected N/A N/A N/A Yes
Providence Health & Services-Washington, Tukwila, WA Jacqueline A. Biery
3/2/2020 10/21/2023 4/13/2022 Yes No FMD-145 Issued 8/16/2022 No
Qualgen LLC, Edmond, OK Shaun Riney
5/23/2014 11/9/2023 9/30/2022 Yes No Open7 Yes
QuVa Pharma, Inc., Bloomsbury, NJ Travis McGrady
9/15/2017 12/14/2023 10/14/2022 Yes No Warning Letter Issued 1/26/2024 Yes
Quva Pharma, Inc., Sugar Land, TX Robert Nelson
9/10/2015 12/14/2023 8/18/2022 Yes No FMD-145 Letter Issued 1/24/2023 No
QuVa Pharma, Inc., Temple, TX Travis Leeah
12/15/2015 12/14/2023 6/16/2022 Yes No FMD-145 Letter Issued 1/3/2023 Yes
RC Outsourcing, LLC, Lowellville, OH Raymond R. Carlson
10/6/2015 12/2/2023 9/23/2022 Yes No Regulatory Meeting Held 7/25/2023 Yes
Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop, Irving, TX Sara Lange
7/3/2019 12/12/2023 6/27/2022 Yes No Regulatory Meeting Held 6/5/2023 Yes
SCA Pharmaceuticals, Little Rock, AR
Karmen Kelly
+1 877-550-5059
Yes   FMD-145 Letter Issued 9/29/2023 Yes
SCA Pharmaceuticals, Windsor, CT Karmen Kelly
+1 877-550-5059
8/3/2017 11/24/2023 10/20/2023



  Open7 Yes
Signature Rx, Delray Beach, FL David Hughes
10/13/2023 10/13/2023 Not yet inspected N/A N/A N/A Yes
SKNV formerly registered as Sincerus Florida, LLC, Pompano Beach, FL Michael Morelli
3/10/2016 11/29/2023 9/17/2018 Yes No Remote Regulatory Assessment Assignment Issued 1/29/20218 Yes
SSM Health Care St. Louis dba SSM Health St. Clare Hospital - Fenton, Fenton, MO Kristina Bryowsky
2/18/2014 12/7/2023 2/12/2024 Yes No Open7 No
STAQ Pharma, Inc., Denver, CO Joe Bagan
2/5/2019 12/12/2023 9/29/2021 Yes No FMD-145 Letter Issued 3/25/2022 Yes
STAQ Pharma of Ohio, LLC, Columbus, OH Joe Bagan
1/26/2023 12/14/2023 10/4/2023 Yes No Open7 Yes
Staska Pharmaceuticals, Inc., Bennet, NE Lyndon Leitner
12/3/2020 12/20/2023 Not yet inspected N/A N/A N/A Yes
Stokes Healthcare Inc., dba Epicur Pharma, Mt. Laurel, NJ Michael Tursi
1/30/2018 10/11/2023 10/25/2023 Yes No Open7 Yes
Tailstorm Health Inc., Chandler, AZ Mitexh Gandhi
10/23/2019 11/30/2023 7/21/2021 Yes No FMD-145 Letter Issued 10/23/2023 Yes
Tailstorm Health Inc., Phoenix, AZ Mitexh Gandhi
+1 480-274-8617
10/23/2019 11/30/2023 Not yet inspected N/A N/A N/A Yes
The Ritedose Corporation, Columbia, SC Arianne Lindsey
12/20/2019 10/25/2023 3/22/2022 Yes No FMD-145 Letter Issued 9/23/2022 Yes
Turbare Manufacturing, Conway, AR Deketric Smith
6/23/2023 1/2/2024 Not yet inspected N/A N/A N/A Yes
US Specialty Formulations LLC, Allentown, PA
Kyle Flanigan


4/26/2022 Yes No Warning Letter Issued 7/26/2023 Yes
Vitae Enim Vitae Scientific, Inc., San Diego, CA Boris Gites
1/2/2024 1/2/2024 Not yet inspected N/A N/A N/A No
Wedgewood Connect, LLC, formerly registered as Leiter's Compounding, San Jose, CA Paul Yamamoto
1/31/2014 12/8/2023 11/17/2023 Yes No Open7 Yes
Wedgewood Connect Ohio, LLC, Albany, OH Paul Yamamoto
10/19/2023 10/19/2023 Not yet inspected N/A N/A N/A Yes
Wells Pharma of Houston, LLC, Houston, TX Theaquiata A. Mitchell
3/9/2020 10/26/2023 12/14/2022 Yes No FMD-145 Letter Issued 4/18/2023 Yes
Wells Pharmacy, Inc., Dyersburg, TN Melissa Stefko
6/7/2016 1/2/2024 1/28/2021 Yes No Untitled Letter Issued 5/19/2022 Yes
Willowbend Pharma Select, LLC, Houston, TX

Basil Raad

4/11/2024 4/11/2024 Not yet inspected N/A N/A N/A Yes
World Reach Pharma, LLC, Albany, NY Ernesto Samuel
1/26/2024 1/26/2024 Not yet inspected N/A N/A N/A Yes
Xseer Pharmaceuticals, Inc., Los Angeles, CA Ali Khosrovni
10/21/2023 10/21/2023 Not yet inspected N/A N/A N/A 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.  Once an outsourcing facility is registered, the facility will be added to the list of facilities FDA intends to inspect according to a risk-based schedule. FDA plans to inspect outsourcing facilities within a reasonable period of time following initial registration, once it is confirmed that the facility has initiated drug production and distribution. However, the exact timing of the inspections can be affected by a number of variables, including the number of outsourcing facility registrants, other inspection priorities, and the operational status of the newly registered outsourcing facility.

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.

9.  Based on inspectional findings, the inspection revealed significant issues. As a result, the firm may have either initiated a recall on their own following conversation(s) with the FDA investigator or FDA recommended a recall at the conclusion of the inspection or both (firm initiated a recall and FDA recommended a recall). In addition, the firm may have conducted multiple recalls or recalled multiple products.





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