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
- Information Concerning Outsourcing Facility Registration
- Outsourcing Facility Product Reporting Information
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 800-995-4363 Ext=3120 |
9/23/2014 | 11/29/2022 | 7/29/2022 | Yes | Open7 | Yes |
ANNOVEX PHARMA, INC, Lorton, VA | Kenneth Erickson 540-642-5104 |
10/14/2021 | 10/30/2022 | Not yet inspected | N/A | N/A | Yes |
Apollo Care, Columbia, MO | Jarred Dudding 573-441-8900 |
9/14/2017 | 1/3/2023 | 4/5/2023 | Yes | Open7 | Yes |
Athenex Pharma Solutions, LLC, Clarence, NY | Lori Giles Aleshin 716-815-6478 |
4/10/2017 | 11/10/2022 | 8/28/2019 | Yes | FMD-145 Letter Issued 8/10/2021 | Yes |
Atlas Pharmaceuticals, Phoenix, AZ | Nickolaus Banda 480-208-1855 |
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 813-901-6339 |
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 727-471-0850 |
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 727-471-0850 |
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 203-775-0862 |
1/12/2015 | 12/20/2022 | 4/4/2022 | Yes | Open | Yes |
BSO LLC, Lakewood, CO | Anne Szilagyi 877-267-3410 |
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 216-233-0766 |
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 216-233-0766 |
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 216-233-0766 |
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 662-512-5191 |
8/6/2014 | 12/20/2022 | 5/20/2022 | Yes | Open7 | Yes |
Denver Solutions, LLC, dba Leiters Health, Englewood, CO | Ivan Martinez 720-697-4597 |
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 800-292-6772 |
7/1/2022 | 11/17/2022 | Not yet inspected | N/A | N/A | Yes |
Eagle Pharma Outsourcing, LLC Birmingham, AL |
Haleigh Cawood 205-682-7999 |
6/16/2015 | 11/3/2022 | 8/12/2021 | Yes | Untitled Letter Issued 5/17/2022 | Yes |
Empower Pharmacy, Houston, TX | Shaun Noorian 877-562-8577 |
7/16/2016 | 11/9/2022 | 8/5/2022 | Yes | Open7 | Yes |
Excite Pharma Services, LLC | Robert Pendland 816-389-8402 |
6/1/2021 | 2/23/2022 | Not yet inspected | N/A | N/A | Yes |
Exela Pharma Sciences, LLC, Lenoir, NC | Auna Koganti 828-758-5474 Ext=181 |
6/6/2014 |
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 855-771-0505 |
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 316-773-0405 |
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 817-203-8216 |
12/12/2018 | 12/20/2022 | 6/10/2022 | Yes | Open7 | Yes |
Fresenius Kabi Compounding LLC dba Fagron Sterile Services, Canton, MA |
Deborah McHugh 316-773-0405 |
4/21/2017 |
12/06/2022 |
03/06/2023 |
Yes | FMD-145 Letter Issued 08/11/2023 | No |
Genixus, Corp, Kannapolis, NC | Kendall Foster 877-436-4987 |
6/22/2022 | 11/15/2022 | Not yet inspected | N/A | N/A | Yes |
Hikma Injectables USA Inc., Dayton, NJ | J. Barton Kalis 856-489-2247 |
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 856-489-2247 |
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 954-708-2771 |
1/14/2015 | 11/7/2022 | 9/3/2021 | Yes | Warning Letter Issued 6/7/2022 | Yes |
Imprimis NJOF, LLC, Ledgewood, NJ | Jeffrey Palmer +1-973-804-1635 |
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 612-672-5216 |
5/8/2018 | 11/2/2022 | 8/2/2021 | Yes | Recall Initiated 9/2021 | No |
KRS Global Biotechnology, Inc., Boca Raton, FL | Charles Richardson 888-502-2050 |
12/15/2013 | 12/6/2022 | 8/14/2019 | Yes | Regulatory Meeting Held 7/30/2021 | Yes |
Leesar Inc., Fort Myers, FL | Maria Gautier 239-939-8925 |
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 303-907-8003 |
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 864-839-6500 |
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 714-455-1300 |
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 908-588-3440 |
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 803-569-3110 |
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 781-832-5758 |
3/2/2017 | 12/20/2022 | 4/28/2022 | Yes | Open7 | No |
Nubratori, Inc., Torrance, CA | Gulshakar Khwaja 310-218-4153 |
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 407-673-2222 |
3/10/2014 | 11/1/2022 | 3/2/2022 | Yes | Open7 | Yes |
OurPharma LLC, Fayetteville, AR | Morgan Strickland 479-313-8200 |
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 410-584-0001 ext=1167 |
4/28/2020 | 12/9/2022 | Not yet inspected | N/A | N/A | Yes |
Pine Pharmaceuticals, LLC, Tonawanda, NY | Alfonse Muto 716-248-1025 |
3/9/2018 | 10/28/2022 | 5/14/2021 | Yes | Open7 | Yes |
PQ Pharmacy LLC, Brooksville, FL | Angela Kassay 352-477-8977 |
10/29/2020 | 1/10/2023 | 10/27/2022 | N/A | N/A | Yes |
Primera Compounding, LLC, Rosenberg, TX | Basil Raad 281-202-6136 |
5/24/2021 | 12/9/2022 | Not yet inspected | N/A | N/A | Yes |
Prisma Health Outsourcing Facility, Simpsonville, SC | Gary Jones 864-522-3800 |
12/9/2019 | 11/22/2022 | Not yet inspected | N/A | N/A | No |
ProRx LLC, Exton, PA | Pardeep Gupta 484-678-8579 |
4/27/2022 | 2/9/2023 | Not yet inspected | N/A | N/A | Yes |
Providence Health & Services-Washington, Tukwila, WA | Jacqueline A. Biery 425-687-4460 |
3/2/2020 | 11/2/2022 | 4/13/2022 | Yes | FMD-145 Letter Issued 8/16/2022 | No |
Qualgen LLC, Edmond, OK | Shaun Riney 405-551-8216 |
5/23/2014 | 11/28/2022 | 9/30/2022 | Yes | Open | Yes |
QuVa Pharma, Inc., Bloomsbury, NJ | Robert Nelson 832-495-4216 |
9/15/2017 | 12/17/2022 | 10/14/2022 | Yes | Open7 | Yes |
Quva Pharma, Inc., Sugar Land, TX | Robert Nelson 832-495-4216 |
9/10/2015 | 11/23/2022 | 8/18/2022 | Yes | Open7 | No |
QuVa Pharma, Inc., Temple, TX | Travis Leeah 254-933-4429 |
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 330-536-8500 |
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 817-282-9376 |
7/3/2019 | 12/2/2022 | 6/27/2022 | Yes | Open7 | Yes |
RXQ Compounding LLC, Albany, OH | Edward J. Zatta 866-355-3804 |
12/11/2019 | 11/24/2022 | Not yet inspected | N/A | N/A | Yes |
SCA Pharmaceuticals, Little Rock, AR
|
Lessley Denton 877-550-5059 |
12/13/2013
|
12/19/2022 |
11/7/2019
|
Yes | WLCO and FMD-145 Letters Issued 8/19/2021 | Yes |
SCA Pharmaceuticals, Windsor, CT | Lessley Denton 877-550-5059 |
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 800-604-5032 Ext=313 |
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 636-496-2681 |
2/18/2014 | 12/5/2022 | 9/28/2021 | Yes | Open7 | No |
STAQ Pharma, Inc., Denver, CO | Joe Bagan 303-810-6777 |
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 |
|
1/26/2023 | 1/25/2023 | Not yet inspected | N/A | N/A | Yes |
Staska Pharmaceuticals, Inc., Bennet, NE | Lyndon Leitner 402-782-2207 |
12/3/2020 | 12/22/2022 |
Not yet inspected | N/A | N/A | Yes |
SterRx LLC, Plattsburgh, NY | Thomas J. Dominy 518-324-7879 Ext=1249 |
5/29/2015 | 10/31/2022 | 11/4/2021 | Yes | Open7 | Yes |
Stokes Healthcare Inc., dba Epicur Pharma, Mt. Laurel, NJ | Michael Tursi 888-508-5032 |
1/30/2018 | 7/18/2023 | 10/9/2020 | Yes | Untitled Letter Issued 5/2/2022 | Yes |
Tailstorm Health Inc., Chandler, AZ | Andrew Stasiak 520-465-8496 |
10/23/2019 | 12/10/2022 | 7/21/2021 | Yes | Untitled Letter Issued 6/17/2022 | Yes |
Tailstorm Health Inc., Phoenix, AZ | Mitexh Gandhi 480-274-8617 |
10/23/2019 | 2/8/2023 | Not yet inspected | N/A | N/A | Yes |
The Ritedose Corporation, Columbia, SC | Arianne Lindsey 803-626-3737 |
12/20/2019 | 10/28/2022 | 3/22/2022 | Yes | FMD-145 Letter Issued 9/23/2022 | Yes |
Turbare Manufacturing, Conway, AR |
Deketric Smith |
6/23/2023 |
6/23/2023 |
N/A |
N/A |
N/A |
Yes |
US Specialty Formulations LLC, Allentown, PA
|
Kyle Flanigan 610-849-5023 |
1/31/2014 |
11/22/2022 |
4/26/2022 | Yes | Open7 | Yes |
Wedgewood Connect, LLC, formerly registered as Leiter's Compounding, San Jose, CA | Paul Yamamoto 408-687-0943 |
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 346-888-1010 Ext=4811 |
3/9/2020 | 12/15/2022 | 6/17/2021 | Yes | FMD-145 issued 1/10/2022 | Yes |
Wells Pharmacy, Inc., Dyersburg, TN | Melissa Stefko 800-622-4510 |
6/7/2016 | 12/13/2022 | 1/28/2021 | Yes | Untitled Letter Issued 5/19/2022 | 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.
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.