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 1/16/2025
- 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 | Contact | Initial Registration Date 1 | Most Recent Registration Date 1 | Last Inspection 2 | Form 483 Issued? 3 | Recall Conducted? 9 | Action Based on Last Inspection 4,5 | Intends to Compound Sterile Drugs From Bulk Substances 6 |
|---|---|---|---|---|---|---|---|---|
| Advanced Pharmacteutical Technology, Inc., Elmsford, NY | Marco Persichillo 1-914-358-5260 | 8/19/2024 | 8/19/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| AH Nutraceutical Compounding, Inc., McQueeny, TX | Michael Chase 312-401-7455 | 7/8/2024 | 7/8/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| AnazaoHealth Corporation, Las Vegas, NV | Jaclyn Wong 800-995-4363 Ext 3120 | 9/23/2014 | 12/10/2024 | 9/23/2024 | Yes | No | Open7 | Yes |
| Annovex Pharma, Inc., Lorton, VA | Adedayo Akinbi 1-571-642-5104 | 10/14/2021 | 11/22/2024 | 9/6/2024 | Yes | No | Open | Yes |
| Apocus, Inc., San Antonio, TX | Suryanarayana Raju Sagi 214-797-7172 | 10/17/2023 | 10/17/2023 | Not yet inspected | N/A | N/A | N/A | Yes |
| Apollo Care, Columbia, MO | Jarred Dudding 573-441-8900 | 9/14/2017 | 12/16/2024 | 4/5/2023 | Yes | Yes | Regulatory Meeting Held 11/30/2023 | Yes |
| Apothecary Pharma, LLC, Cary, NC | Priyanka Rana 1-919-760-5478 | 9/7/2024 | 1/11/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| Arc Compounding Pharmacy LLC, Waco, TX | Clifton King 512-665-6911 | 6/22/2024 | 6/22/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Assure Infusions, Inc., Bartow, FL | Gloria Imbimbo 1-386-451-2673 | 11/22/2024 | 11/22/2024 | Not yet inspected | N/A | N/A | N/A | No |
| Atlas Pharmaceuticals, LLC, Phoenix, AZ | Michael Papenthien 480-349-2233 | 11/8/2017 | 11/10/2023 | 5/21/2021 | Yes | No | FMD-145 Letter Issued 5/3/2022 | Yes |
| Aveva Drug Delivery Systems, Inc, Tamarac, FL | Madhuri Gupta 1-954-218-1570 | 11/4/2024 | 11/4/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL | Kenneth Jozefczyk 813-901-6339 | 6/4/2019 | 10/25/2024 | 6/2/2023 | Yes | No | FMD-145 Letter Issued 9/18/2023 | No |
| Belcher Pharmaceuticals, LLC, Largo, FL | Shyam Busireddy 727-471-0850 Ext 239 | 5/18/2021 | 10/18/2024 | 8/16/2024 | Yes | No | Open | No |
| Bennett Pharmaceuticals of AmericaLLC, Hudson, WI | James Mulvahill 952-381-9027 | 4/19/2022 | 1/19/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| BPI Labs LLC, Largo, FL | Chandra Kasireddy 727-471-0850 | 3/4/2019 | 10/17/2024 | 4/30/2021 | No | No | FMD-145 Letter Issued 9/10/2021 | Yes |
| Brookfield Medical/Surgical Supply, Inc., Brookfiled, CT | James Cangelosi 203-775-0862 | 1/12/2015 | 1/10/2025 | 5/10/2024 | Yes | No | Untitled Letter Issued 9/27/2024 | Yes |
| BSO LLC, Golden, CO | Michelle Violi 608-221-7800 Ext 1113 | 1/24/2024 | 10/18/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| BSO LLC, Lakewood, CO | Michelle Violi 608-221-7800 Ext 1113 | 11/24/2015 | 10/31/2024 | 7/3/2024 | Yes | No | Open7 | Yes |
| C S Bio Co., Menlo Park, CA | Jason Yowei Chang 650-322-1111 | 5/23/2024 | 5/23/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Central Admixture Pharmacy Services, Inc., Allentown, PA | Eric Bauer 1-551-204-4178 | 2/28/2014 | 10/22/2024 | 3/30/2023 | Yes | Yes | Warning Letter Issued 3/29/2024 | Yes |
| Central Admixture Pharmacy Services, Phoenix, AZ | Eric Bauer 1-551-204-4178 | 3/29/2018 | 10/22/2024 | 7/31/2023 | Yes | Yes | Warning Letter Issued 3/25/2024 | Yes |
| Delta Pharma, Inc., Ripley, MS | Stuart Simpson 662-512-5191 | 8/6/2014 | 12/31/2024 | 4/12/2024 | Yes | No | Open7 | Yes |
| Denver Solutions, LLC, dba Leiters Health, Englewood, CO | Barbara Knightly 720-697-5140 Ext 4004 | 3/24/2017 | 11/18/2024 | 4/5/2024 | Yes | No | FMD-145 issued 11/20/24 | Yes |
| Denver Solutions, LLC, dba Leiters Health, Buena, NJ | Barbara Knightly 720-697-5140 Ext 4004 | 7/1/2022 | 11/18/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Eagle Pharma, Birmingham, AL | Haleigh Cawood 205-682-7999 | 6/16/2015 | 10/23/2024 | 8/12/2021 | Yes | No | Untitled Letter Issued 5/17/2022 | Yes |
| Echo Health LLC dba Nova Specialty Pharmacy, Mansfield, TX | Obiechina Ezekwesili +1-682-267-8586 | 5/20/2024 | 5/20/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Empower Clinic Services New Jersey, East Windsor, NJ | Shaun Noorian 877-562-8577 | 6/10/2024 | 11/20/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Empower Pharma, Houston, TX | Shaun Noorian 877-562-8577 | 7/16/2016 | 12/6/2024 | 8/28/2024 | Yes | No | Open7 | Yes |
| Excite Pharma Services, LLC, Tonganoxie, KS | Robert Pendland 816-389-8402 | 6/1/2021 | 12/28/2023 | Not yet inspected | N/A | N/A | N/A | Yes |
| F.H. Investments, Inc., dba Asteria Health, Birmingham, AL | Christopher S. Musser 1-205-995-0505 | 5/18/2017 | 10/17/2024 | 11/8/2024 | Yes | No | FMD-145 Letter Issued 9/10/2021 | Yes |
| Fagron Compounding Services dba Fagron Sterile Services, Wichita, KS | Josh Parks 316-773-0405 | 10/2/2015 | 10/18/2024 | 6/28/2024 | Yes | No | Open7 | Yes |
| Farmakeio Outsourcing LLC, Southlake, TX | Cody Boatman 817-203-8216 | 12/12/2018 | 12/6/2024 | 6/10/2022 | Yes | No | Regulatory Meeting Held 1/31/2023 | Yes |
| Fresenius Kabi Compounding LLC dba Fagron Sterile Services, Canton, MA | Deborah McHugh 316-773-0405 | 4/21/2017 | 10/18/2024 | 03/06/2023 | Yes | No | FMD-145 Letter Issued 08/11/2023 | No |
| GFC Pharma, LLC, Westminster, MD | Ranjeesh Gopinathan 215-264-9995 | 12/16/2024 | 12/16/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Hikma Injectables USA Inc., Dayton, NJ | J. Barton Kalis 856-489-2247 | 9/15/2021 | 12/20/2024 | 6/25/2024 | Yes | No | Open7 | No |
| Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ | J. Barton Kalis 856-489-2247 | 9/15/2021 | 10/27/2023 | 6/12/2024 | Yes | No | FMD-145 Letter Issued 12/18/2024 | Yes |
| Hybrid Pharma, LLC, Deerfield Beach, FL | Ponswamy Rajalingam 954-708-2771 | 1/14/2015 | 1/8/2025 | 11/9/2023 | Yes | No | Open7 | Yes |
| Imprimis NJOF, LLC, Ledgewood, NJ | Fred Weiss 973-328-8756 Ext=5411 | 11/12/2016 | 10/23/2024 | 4/3/2024 | Yes | No | Open7 | Yes |
| IntegraDose Compounding Services, LLC, Minneapolis, MN | Craig Else 612-672-5216 | 5/8/2018 | 12/13/2024 | 3/1/2024 | Yes | No | Open7 | No |
| Leesar Inc., Fort Myers, FL | Maria Gautier 239-939-8925 | 4/30/2014 | 12/19/2024 | 10/29/2021 | Yes | No | 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 | 12/14/2024 | 9/6/2024 | Yes | No | Open | Yes |
| McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions, Santa Ana, CA | Jacqueline McKay 714-918-7277 Ext 314 | 1/11/2023 | 11/21/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Medi-Fare Drug, Blacksburg, SC | Anne-Marie Davis 864-839-6500 | 12/17/2013 | 12/24/2024 | 5/26/2023 | Yes | No | FMD-145 Letter Issued 10/23/2023 | Yes |
| MedisourceRx, Los Alamitos, CA | Venus Firouzehee 714-455-1300 | 2/14/2017 | 12/31/2024 | 11/10/2022 | No | No | FMD-145 Letter Issued 4/14/2023 | Yes |
| Molecular PharmaGroup, New Providence, NJ | Amanda Lanze 908-588-3440 | 5/8/2018 | 12/10/2024 | 12/11/2023 | Yes | No | FMD-145 Issued 3/18/2024 | Yes |
| Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC | Lou Wood Kennedy 803-569-3110 | 7/15/2014 | 11/25/2024 | 9/25/2024 | Yes | Yes | Open7 | Yes |
| Nubratori, Inc., Torrance, CA | Gulshakar Khwaja 310-218-4153 | 2/24/2017 | 10/22/2024 | 7/26/2024 | Yes | No | Open7 | Yes |
| Olympia Pharmaceuticals, Orlando, FL | Mark Mikhael 1-407-673-2222 | 3/10/2014 | 10/18/2024 | 5/29/2024 | Yes | No | Open7 | Yes |
| OSRX, Inc., Missoula, MT | Amy Frost 406-541-6121 | 10/28/2023 | 10/25/2024 | 10/25/2024 | Yes | No | Open | Yes |
| OurPharma LLC, Fayetteville, AR | Morgan Strickland 479-313-8200 | 3/15/2019 | 11/14/2024 | 9/27/2024 | Yes | No | Open7 | Yes |
| Park Avenue Compounding, St. Louis, MO | Kristina Bryowsky 314-989-2843 | 12/23/2023 | 11/8/2024 | Not yet inspected | N/A | N/A | N/A | No |
| PGRrx LLC, Exton, PA | Amit Gupta 1-484-883-7597 | 12/10/2024 | 12/10/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Pine Pharmaceuticals, LLC, Tonawanda, NY | Alfonse Muto 716-248-1025 | 3/9/2018 | 10/16/2024 | 9/30/2024 | Yes | No | Open7 | Yes |
| Pharmacorr Sterile, LLC, Oklahoma City, OK | Eti Garcia 1-833-327-9567 | 9/16/2024 | 9/16/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| PQ Pharmacy LLC, Brooksville, FL | Angela Kassay 352-477-8977 | 10/29/2020 | 11/26/2024 | 10/27/2022 | Yes | No | FMD-145 Letter Issued 3/30/2023 | Yes |
| ProRx LLC, Exton, PA | Mark L'Hommedieu 1-904-616-7355 | 4/27/2022 | 11/22/2024 | 8/2/2024 | Yes | No | Warning Letter Issued 12/20/2024 | Yes |
| Qualgen LLC, Edmond, OK | Shaun Riney 405-551-8216 | 5/23/2014 | 11/15/2024 | 3/19/2024 | Yes | No | Open7 | Yes |
| Quantum Pharmaceuticals, LLC, Mounds, OK | Albert Sanchez 479-263-2690 Ext 3062138 | 5/30/2024 | 5/30/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Quva Pharma, Inc., Bloomsbury, NJ | Kevin White 1-908-388-1079 | 9/15/2017 | 11/22/2024 | 10/14/2022 | Yes | No | Warning Letter Issued 1/26/2024 | Yes |
| Quva Pharma, Inc., Sugar Land, TX | Sophia Flores 1-832-500-7450 | 9/10/2015 | 12/92024 | 10/28/2024 | Yes | No | Open7 | Yes |
| Rapha Phrmaceuticals, lnc., Tampa, FL | Hector Molina 1-407-362-7638 | 12/23/2024 | 12/23/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| RC Outsourcing, LLC, Lowellville, OH | Raymond R. Carlson 330-770-6156 | 10/6/2015 | 11/22/2024 | 9/27/2024 | Yes | No | Open7 | Yes |
| Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop, Irving, TX | Sara Lange 817-282-9376 | 7/3/2019 | 12/23/2024 | 6/21/2024 | Yes | No | Warning Letter Issued 12/17/2024 | Yes |
| SCA Pharmaceuticals, Little Rock, AR | Karmen Kelly 877-550-5059 | 12/13/2013 | 12/23/2024 | 5/17/2023 | Yes | FMD-145 Letter Issued 9/29/2023 | Yes | |
| SCA Pharmaceuticals, Windsor, CT | Joanna DiStefano 877-550-5059 | 8/3/2017 | 12/9/2024 | 10/20/2023 | Yes Yes | Open7 | Yes | |
| Signature Rx, Delray Beach, FL | David Hughes 401-249-1963 | 10/13/2023 | 1/9/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| SKNV formerly registered as Sincerus Florida, LLC, Pompano Beach, FL | Michael Morelli 800-604-5032 Ext 313 | 3/10/2016 | 11/22/2024 | 5/23/2024 | Yes | No | Open7 | Yes |
| STAQ Pharma, Inc., Denver, CO | Mark Spiecker 1-303-921-5789 | 2/5/2019 | 11/19/2024 | 9/29/2021 | Yes | No | FMD-145 Letter Issued 3/25/2022 | Yes |
| STAQ Pharma of Ohio, LLC, Columbus, OH | Patrick Welsh 1-440-384-0676 | 1/26/2023 | 11/19/2024 | 10/4/2023 | Yes | No | FMD-145 Letter Issued 3/20/2024 | Yes |
| Staska Pharmaceuticals, Inc., Bennet, NE | Lyndon Leitner 402-782-2207 | 12/3/2020 | 12/18/2024 | 9/18/2024 | Yes | No | Open | Yes |
| Stokes Healthcare Inc., dba Epicur Pharma, Mt. Laurel, NJ | Michael Tursi 888-508-5032 | 1/30/2018 | 10/16/2024 | 10/25/2023 | Yes | No | Warning Letter Issued 4/2/2024 | Yes |
| Tailstorm Health Inc., Chandler, AZ | Mitexh Gandhi 480-274-8617 | 10/23/2019 | 12/10/2024 | 7/21/2021 | Yes | No | FMD-145 Letter Issued 10/23/2023 | Yes |
| Tailstorm Health Inc., Phoenix, AZ | Mitexh Gandhi 480-274-8617 | 10/23/2019 | 12/18/2024 | 10/10/2024 | Yes | No | Open | Yes |
| Tomorrowmed Pharma, LLC, Morrisville, NC | Sean Hatfield +1-919-747-3222 | 11/22/2024 | 11/22/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Turbare Manufacturing, Conway, AR | Deketric Smith 501-504-6635 | 6/23/2023 | 1/2/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| University of Tennessee, Memphis, TN | Harry Kochat 901-448-1440 | 5/19/2024 | 12/12/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| US Specialty Formulations LLC, Allentown, PA | Kyle Flanigan 610-849-5023 | 1/31/2014 | 11/14/2024 | 6/28/2024 | Yes | No | Open7 | Yes |
| Vitae Enim Vitae Scientific, Inc., San Diego, CA | Boris Gites 858-222-0746 | 1/2/2024 | 1/2/2024 | Not yet inspected | N/A | N/A | N/A | No |
| VitalRx Pharmacy, LLC, Houston, TX | Linda Sarpong 832-259-1362 | 8/27/2024 | 12/31/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Vivasor, San Diego, CA | Mark Brunswick 1-858-652-0084 | 10/31/2024 | 10/31/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Wedgewood Connect, LLC, formerly registered as Leiter's Compounding, San Jose, CA | Paul Yamamoto 408-687-0943 | 1/31/2014 | 10/16/2024 | 11/17/2023 | Yes | No | Untitled Letter Issued 4/25/2024 | Yes |
| Wedgewood Connect Ohio, LLC, Albany, OH | Andrea Murray 1-877-357-6613 | 10/19/2023 | 11/7/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Wells Pharma of Houston, LLC, Houston, TX | Lisa Hawkins 1-423-621-2588 | 3/9/2020 | 11/5/2024 | 12/14/2022 | Yes | No | FMD-145 Letter Issued 4/18/2023 | Yes |
| Wells Pharmacy, Inc., Dyersburg, TN | Melissa Stefko 800-622-4510 | 6/7/2016 | 10/24/2024 | 1/28/2021 | Yes | No | Untitled Letter Issued 5/19/2022 | Yes |
| Willowbend Pharma Select, LLC, Houston, TX | Basil Raad 832-628-3260 | 4/11/2024 | 11/5/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| World Reach Pharma, LLC, Albany, NY | Jim Pesoli 1-847-721-8122 | 1/26/2024 | 1/26/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
| Xenith Pharmaceutical, Las Vegas, NV | Samantha Koegel 516-761-1433 | 1/2/2025 | 1/2/2025 | Not yet inspected | N/A | N/A | N/A | Yes |
| Xseer Pharmaceuticals, Inc., Los Angeles, CA | Ali Khosrovni 310-606-0146 | 10/21/2023 | 11/27/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
Notes
- 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 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. 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. - 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. - 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.
- 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.
- “Closed” means the inspection has been closed without further action. “Open” means FDA has not determined 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.
- 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.
- This outsourcing facility was the subject of at least one previous inspection relating to compounding that resulted in a Form FDA 483, warning letter or other action. For information about such inspections and resulting actions, visit Compounding: Inspections, Recalls, and other Actions.
- A remote regulatory assessment (RRA) is an examination of an FDA-regulated establishment and/or its records, conducted remotely, to evaluate compliance with applicable FDA requirements. These assessments assist in protecting human and animal health, inform regulatory decisions and verify certain information submitted to the agency.
- Based on inspectional findings, the inspection revealed significant issues. As a result, the outsourcing facility 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. Additionally, the outsourcing facility may have conducted multiple recalls or recalled multiple drugs.