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 8/15/2024
- 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 | Was a recall conducted?9 | Other Action, if Any, Based on Last Inspection4,5 | Intends to Compounds Sterile Drugs From Bulk Drug Substances6 |
---|---|---|---|---|---|---|---|---|
AH Nutraceutical Compounding, Inc. | 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 | 12/17/2023 | 7/29/2022 | Yes | No | Regulatory Meeting Held 5/2/2023 | Yes |
Annovex Pharma, Inc., Lorton, VA | Adedayo Akinbi 571-642-5262 |
10/14/2021 | 3/06/2024 | Not yet inspected | N/A | N/A | N/A | 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 | 12/27/2023 | 4/5/2023 | Yes | Yes | Regulatory Meeting Held 11/30/2023 | 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 |
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 |
BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL | Kenneth Jozefczyk 813-901-6339 |
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 727-471-0850 Ext 239 |
5/18/2021 | 11/15/2023 | Not yet inspected | N/A | N/A | N/A | 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 | 10/13/2023 | 4/30/2021 | No | No | FMD-145 LetterIssued 9/10/2021 | Yes |
Brookfield Medical/Surgical Supply, Inc. | James Cangelosi 203-775-0862 |
1/12/2015 | 1/2/2024 | 5/10/2024 | Yes | No | Open7 | 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 | Michelle Violi 608-221-7800 Ext 1113 |
11/24/2015 | 12/13/2023 | 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 |
Canadian Valley Pharmacy, Reno, OK | John T Smith 405-262-4154 |
7/25/2024 | 7/25/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
Central Admixture Pharmacy Services, Inc., Allentown, PA | Thomas Kelsey 216-233-0766 |
2/28/2014 | 11/8/2023 | 3/30/2023 | Yes | Yes | Warning Letter Issued 3/29/2024 | Yes |
Central Admixture Pharmacy Services, Phoenix, AZ | Thomas Kelsey 216-233-0766 |
3/29/2018 | 11/8/2023 | 7/31/2023 | Yes | Yes | Warning Letter Issued 3/25/2024 | Yes |
Delta Pharma, Inc., Ripley, MS | StuartSimpson 662-512-5191 |
8/6/2014 | 1/4/2024 | 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 | 11/30/2023 | 4/5/2024 | Yes | No | Open7 | Yes |
Denver Solutions, LLC, dba Leiters Health, Buena, NJ | Barbara Knightly 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 205-682-7999 |
6/16/2015 | 11/8/2023 | 8/12/2021 | Yes | No | Untitled Letter Issued 5/17/2022 | Yes |
Echo Health LLC dba Nova Specialty Pharmacy, Mansfield, TX | Obiechina Ezekwesili 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 | 6/10/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
Empower Pharma, Houston, TX | Shaun Noorian 877-562-8577 |
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 816-389-8402 |
6/1/2021 | 12/28/2023 | Not yet inspected | N/A | N/A | N/A | Yes |
Exela Pharma Sciences, LLC, Lenoir, NC | Auna Koganti 828-758-5474 Ext=181 |
6/6/2014 |
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 855-771-0505 |
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 316-773-0405 |
10/2/2015 | 10/25/2023 | 6/28/2024 | Yes | No | Open7 | Yes |
Farmakeio Outsourcing LLC, Southlake, TX | Cody Boatman 817-203-8216 |
12/12/2018 |
12/15/2023 |
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 |
10/25/2023 |
03/06/2023 |
Yes | No | FMD-145 Letter Issued 08/11/2023 | No |
Hikma Injectables USA Inc., Dayton, NJ | J. Barton Kalis 856-489-2247 |
9/15/2021 | 10/27/2023 | 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 | Open7 | Yes |
Hybrid Pharma, LLC, Deerfield Beach, FL | Ponswamy Rajalingam 954-708-2771 |
1/14/2015 | 1/9/2024 | 11/9/2023 | Yes | No | Open7 | Yes |
HYD Pharmacy, Newport Beach, CA | Bryan Godbar 949-991-1355 |
5/21/2024 | 5/21/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
Imprimis NJOF, LLC, Ledgewood, NJ | Jeffrey Palmer 973-804-1635 |
11/12/2016 | 11/2/2023 | 4/3/2024 | Yes | No | Open7 | Yes |
IntegraDose Compounding Services, LLC, Minneapolis, MN | Craig Else 612-672-5216 |
5/8/2018 | 12/12/2023 | 3/1/2024 | Yes | No | Open7 | No |
Leesar Inc., Fort Myers, FL | Maria Gautier 239-939-8925 |
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 303-907-8003 |
11/2/2022 | 1/31/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions, Santa Ana, CA | Jacqueline McKay 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 864-839-6500 |
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 973-303-1642 |
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 908-588-3440 |
5/8/2018 | 12/21/2023 | 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 | 10/24/2023 | 2/10/2023 | Yes | Yes | Regulatory Meeting Held 11/16/2023 | Yes |
Nubratori, Inc., Torrance, CA | Gulshakar Khwaja 310-218-4153 |
2/24/2017 | 10/24/2023 | 7/26/2024 | Yes | No | Open7 | Yes |
Olympia Compounding Pharmacy, Orlando, FL | Marco Loleit 407-673-2222 |
3/10/2014 | 10/19/2023 | 5/29/2024 | Yes | No | Open7 | Yes |
OSRX, Inc., Missoula, MT | Amy Frost 406-541-6121 |
10/28/2023 | 10/28/2023 | Not yet inspected | N/A | N/A | N/A | Yes |
OurPharma LLC, Fayetteville, AR | Morgan Strickland 479-313-8200 |
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 314-989-2843 |
12/23/2023 | 12/23/2023 | Not yet inspected | N/A | N/A | N/A | No |
Pine Pharmaceuticals, LLC, Tonawanda, NY | Alfonse Muto 716-248-1025 |
3/9/2018 | 10/24/2023 | 9/19/2023 | Yes | Yes | Regulatory Meeting Held 3/14/2024 | Yes |
PQ Pharmacy LLC, Brooksville, FL | Angela Kassay 352-477-8977 |
10/29/2020 | 12/5/2023 | 10/27/2022 | Yes | No | FMD-145 Letter Issued 3/30/2023 | Yes |
ProRx LLC, Exton, PA | Pardeep Gupta 484-678-8579 |
4/27/2022 | 11/25/2023 | 8/2/2024 | Yes | No | Open7 | Yes |
Providence Health & Services-Washington, Tukwila, WA | Jacqueline A. Biery 425-687-4460 |
3/2/2020 | 10/21/2023 | 4/13/2022 | Yes | No | FMD-145 Issued 8/16/2022 | No |
Qualgen LLC, Edmond, OK | Shaun Riney 405-551-8216 |
5/23/2014 | 11/9/2023 | 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 | Travis McGrady 248-408-4152 |
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 832-495-4216 |
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 254-933-4429 |
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 330-536-8500 |
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 817-282-9376 |
7/3/2019 | 12/12/2023 | 6/21/2024 | Yes | No | Open7 | Yes |
SCA Pharmaceuticals, Little Rock, AR
|
Karmen Kelly 877-550-5059 |
12/13/2013
|
11/24/2023 |
5/17/2023
|
Yes | FMD-145 Letter Issued 9/29/2023 | Yes | |
SCA Pharmaceuticals, Windsor, CT | Karmen Kelly 877-550-5059 |
8/3/2017 | 11/24/2023 | 10/20/2023 | Yes Yes |
Open7 | Yes | |
Signature Rx, Delray Beach, FL | David Hughes 888-807-4462 |
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 800-604-5032 Ext 313 |
3/10/2016 | 11/29/2023 | 9/17/2018 | Yes | No | Remote Regulatory Assessment Assignment Issued 1/29/20218 | Yes |
STAQ Pharma, Inc., Denver, CO | Joe Bagan 303-810-6777 |
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 303-810-6777 |
1/26/2023 | 12/14/2023 | 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 | 12/20/2023 | Not yet inspected | N/A | N/A | N/A | Yes |
Stokes Healthcare Inc., dba Epicur Pharma, Mt. Laurel, NJ | Michael Tursi 888-508-5032 |
1/30/2018 | 10/11/2023 | 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 | 11/30/2023 | 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 | 11/30/2023 | Not yet inspected | N/A | N/A | N/A | Yes |
The Ritedose Corporation, Columbia, SC | Arianne Lindsey 803-626-3737 |
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 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 |
5/19/20/2024 | 5/19/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
US Specialty Formulations LLC, Allentown, PA
|
Kyle Flanigan 610-849-5023 |
1/31/2014 |
11/20/2023 |
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 |
Wedgewood Connect, LLC, formerly registered as Leiter's Compounding, San Jose, CA | Paul Yamamoto 408-687-0943 |
1/31/2014 | 12/8/2023 | 11/17/2023 | Yes | No | Untitled Letter Issued 4/25/2024 | Yes |
Wedgewood Connect Ohio, LLC, Albany, OH | Paul Yamamoto 877-357-6613 |
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 346-888-1010 Ext 4811 |
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 800-622-4510 |
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 832-628-3260 |
4/11/2024 | 4/11/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
World Reach Pharma, LLC, Albany, NY | Ernesto Samuel 518-210-7164 |
1/26/2024 | 1/26/2024 | Not yet inspected | N/A | N/A | N/A | Yes |
Xseer Pharmaceuticals, Inc., Los Angeles, CA | Ali Khosrovni 310-606-0146 |
10/21/2023 | 10/21/2023 | Not yet inspected | N/A | N/A | N/A | Yes |
Notes
- The "initial date of registration as an outsourcing facility"is the datethe 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. - 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 anyrelevant regulations.
- Thistabledoes 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" meansthe inspection has been closed without further action."Open" meansthat FDA has not made a determination as to whetherfurther action will be taken.If an action has been taken, it will be listed.Possible FDA actions include:warning letter; seizure; or injunction.
- Theinformation in this column was provided by the registered outsourcing facility at the time of registration and has not been verified by FDA.“N/A”, indicatesthe 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.
- 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.
- 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.
- 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.