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 10/8/2021
- 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 | 12/9/2020 | 9/19/2019 | Yes | Warning Letter Issued 8/19/2021 | Yes |
| Apollo Care, Columbia, MO | Jarred Dudding 573-441-8900 |
9/14/2017 | 12/21/2020 | 9/8/2021 | Yes | Open7 | Yes |
| ASP CARES, San Antonio, TX | Jacqueline Esqueda 210-417-4567 |
2/14/2017 | 11/20/2020 | 8/23/2018 | Yes | Open | Yes |
| Athenex Pharma Solutions, LLC, Clarence, NY | Emmett Henry 716-427-2880 |
4/10/2017 | 11/17/2020 | 8/28/2019 | Yes | Open7 | Yes |
| Atlas Pharmaceuticals, Phoenix, AZ | Nickolaus Banda 480-208-1855 |
11/8/2016 | 10/8/2020 | 5/21/2021 | Yes | Open7 | Yes |
| BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL | Kenneth Jozefczyk 813-901-6339 |
6/4/2019 | 12/4/2020 | 12/10/2019 | Yes | Untitled Letter Issued 9/13/2021 | No |
| Belcher Pharmaceuticals, LLC, Largo, FL | Shyam Busireddy 727-471-0850 |
05/18/2021 | 05/18/2021 | Not yet inspected | N/A | N/A | No |
| BPI Labs LLC, Largo, FL | Chandra Kasireddy 727-471-0850 |
3/4/2019 | 12/28/2020 | 4/30/2021 | Yes | FMD-145 Issued 9/10/2021 | Yes |
| Brookfield Medical/Surgical Supply, Inc., Brookfield, CT | James Cangelosi 203-775-0862 |
1/12/2015 | 12/30/2020 | 12/21/2018 | Yes | Open | Yes |
| BSO LLC, Lakewood, CO | David W. Hill 877-267-3410 |
11/24/2015 | 11/5/2020 | 3/11/2021 | Yes | FMD-145 Issued 9/15/2021 | Yes |
| Central Admixture Pharmacy Services, Inc., Allentown, PA | Thomas Kelsey 216-233-0766 |
2/28/2014 | 10/19/2020 | 8/22/2018 | Yes | FMD-145 Issued 6/17/2020 | Yes |
| Central Admixture Pharmacy Services, Phoenix, AZ | Thomas Kelsey 216-233-0766 |
3/29/2018 | 10/19/2020 | 4/26/2019 | No | FMD-145 Issued 6/3/2020 | Yes |
|
Central Admixture Pharmacy Services, Inc., San Diego, CA
|
Thomas Kelsey 216-233-0766 |
6/4/2014 | 10/19/2020 | 9/11/2018 | Yes | FMD-145 Issued 5/27/2020 | No |
| Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL | Charles Richardson 305-397-2035 |
6/6/2014 | 2/1/2021 | 1/23/2019 | Yes | Regulatory Meeting Held 11/3/2020 | Yes |
| Compound Preferred, LLC, formerly registered as RAM Pharma, Inc., Ammon, ID | Casey Hunter 208-419-0613 Ext=203 |
7/21/2016 | 1/5/2021 | 8/1/2019 | Yes | Open7 | Yes |
| Denver Solutions, LLC dba Leiters Health, Englewood, CO | Ron Stephens 408-292-6772 |
3/24/2017 | 11/23/2020 | 10/7/2021 | Yes | Open7 | Yes |
| Eagle Pharmacy, Inc., Hoover, AL | Haleigh Cawood 205-682-7999 |
6/16/2015 | 11/13/2020 | 8/12/2021 | Yes | Open7 | Yes |
| Edge Pharma, Winooski, VT | Tyler Wingood 802-992-1178 |
1/21/2014 | 12/22/2020 | 3/30/2020 | Yes | Open7 | Yes |
| Empower Pharmacy, Houston, TX | Shaun Noorian 877-562-8577 |
7/16/2016 | 10/26/2020 | 3/6/2020 | Yes | Open7 | Yes |
| Exela Pharma Sciences, LLC., Lenoir, NC | Arun Koganti 828-758-5474 Ext=181 |
6/6/2014 | 11/16/2020 | 7/18/2019 | Yes | WLCO and FMD-145 Issued 4/30/2021 | Yes |
| Excite Pharma Services, LLC, Tonganoxie, KS | Robert Pendland 816-389-8402 |
6/1/2021 | 6/1/2021 | Not yet inspected | N/A | N/A | Yes |
| F.H. Investments, Inc., dba Asteria Health, Birmingham, AL | William Fixler 855-771-0505 |
5/18/2017 | 12/2/2020 | 7/10/2018 | Yes | Open | Yes |
| Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS | Jason Syring 316-773-0405 |
10/2/2015 | 10/29/2020 | 6/21/2019 | Yes | Regulatory Meeting Held 1/21/2021 | Yes |
| Farmakeio Outsourcing LLC, Southlake, TX | Cody Boatman 817-203-8216 |
12/12/2018 | 12/23/2020 | 10/30/2019 | Yes | Warning Letter Issued 7/29/2021 | Yes |
| Fresenius Kabi Compounding, LLC, Canton, MA | Deborah McHugh 781-298-7577 |
4/21/2017 | 11/9/2020 | 12/4/2018 | Yes | FMD-145 Issued 4/22/2020 | No |
| Hikma Injectables USA Inc., Dayton, NJ | J. Barton Kalis 856-489-2247 |
8/6/2021 | 8/6/2021 | Not yet inspected | N/A | N/A | No |
| Hikma Injectables USA Inc., Cherry Hill, NJ | J. Barton Kalis 856-489-2247 |
8/6/2021 | 8/6/2021 | Not yet inspected | N/A | N/A | Yes |
| Hybrid Pharma, LLC, Deerfield Beach, FL | Ponswamy Rajalingam 954-708-2771 |
1/14/2015 | 1/11/2021 | 9/3/2021 | Yes | Open7 | Yes |
| Imprimis NJOF, LLC, Ledgewood, NJ | Pramod Sharma 973-804-1623 |
11/12/2016 | 11/19/2020 | 1/29/2021 | Yes | Open7 | Yes |
| INTACT PHARMACEUTICALS LLC, New Milford, CT | Debashis Sahoo 860-350-1900 |
1/12/2018 | 1/5/2021 | 10/12/2018 | Yes | Open | Yes |
| IntegraDose Compounding Services, LLC, Minneapolis, MN | Craig Else 612-672-5216 |
5/8/2018 | 11/25/2020 | 8/2/2021 | Yes | Recall Initiated 9/2021 | No |
|
JCB Laboratories, North Wichita, KS
|
Tanis Flinkman 316-773-0405 |
1/21/2014 | 11/5/2020 | 9/14/2018 | Yes | FMD-145 Issued 9/22/2021 | Yes |
| Kashiv BioSciences, LLC, Chicago, IL | Chandramauli Rawal 312-620-1500 ext=103 |
5/27/2021 | 5/27/2021 | Not yet inspected | N/A | N/A | No |
| KRS Global Biotechnology, Inc., Boca Raton, FL | Charles Richardson 888-502-2050 |
12/15/2013 | 1/6/2021 | 8/14/2019 | Yes | Regulatory Meeting Held 7/30/2021 | Yes |
| Leesar Inc., Fort Myers, FL | Maria Gautier 239-939-8925 |
4/30/2014 | 12/22/2020 | 7/12/2017 | Yes | Warning Letter Issued 2/18/2020 | No |
| Medi-Fare Drug, Blacksburg, SC | Anne-Marie Davis 864-839-6500 |
12/17/2013 | 12/31/2020 | 4/5/2017 | No | Untitled Letter Issued 3/18/2019 | Yes |
| MedisourceRx, Los Alamitos, CA | Amy Summers 714-455-1300 |
2/14/2017 | 1/14/2021 | 10/22/2020 | Yes | FMD-145 Issued 6/28/2021 | Yes |
| Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC | Lou Kennedy 803-569-3110 |
7/15/2014 | 10/22/2020 | 11/15/2019 | Yes | Regulatory Meeting Held 11/20/2020 | Yes |
| New England Life Care, Inc. dba Advanced Compounding Solutions, Woburn, MA | Marco Romano 781-832-5776 |
3/2/2017 | 1/5/2021 | 8/22/2017 | Yes | Untitled Letter Issued 8/21/2019 | No |
| Nubratori, Inc., Torrance, CA | Gulshakar Khwaja 310-218-4153 |
2/24/2017 | 10/22/2020 | 9/26/2019 | Yes | FMD-145 Issued 9/21/2021 | Yes |
| Olympia Compounding Pharmacy, Orlando, FL | Confidence Ekeanyanwu 407-673-2222 |
3/10/2014 | 12/31/2020 | 4/13/2018 | Yes | Regulatory Meeting Held 9/12/2019 | Yes |
| OurPharma LLC, Fayetteville, AR | Morgan Strickland 479-313-8200 |
3/15/2019 | 10/23/2020 | Not yet inspected | N/A | N/A | Yes |
| Pharmaceutics International, Inc., Cockeysville, MD | Veeranna Lolla 410-584-0001 ext=1423 |
4/28/2020 | 11/18/2020 | Not yet inspected | N/A | N/A | Yes |
| Pharmaceutic Labs, LLC, Albany, NY | Ernesto Samuel 518-210-7164 |
3/10/2014 | 12/23/2020 | 9/23/2015 | Yes | Warning Letter Issued 5/3/2017 | Yes |
| Pine Pharmaceuticals, LLC, 355 Riverwalk Pkwy, Tonawanda, NY | Alfonse Muto 716-248-1025 |
3/9/2018 | 10/29/2020 | 5/14/2021 | Yes | Open7 | Yes |
| PQ Pharmacy LLC, Brooksville, FL | Angela Kassay 352-477-8977 |
10/29/2020 | 10/29/2020 | Not yet inspected | N/A | N/A | Yes |
| Primera Compounding, LLC, Rosenberg, TX | Basil Raad 281-202-6136 |
5/24/2021 | 5/24/2021 | Not yet inspected | N/A | N/A | Yes |
| Prisma Health Outsourcing Facility, Simpsonville, SC | Gary Jones 864-522-3800 |
12/9/2019 | 2/11/2021 | Not yet inspected | N/A | N/A | No |
| Providence Health & Services-Washington, Tukwila, WA | Jacqueline A. Biery 425-687-4460 |
3/2/2020 | 12/14/2020 | 10/5/2020 | Yes | FMD-145 Issued 9/10/2021 | No |
| Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OK | Shaun Riney 405-551-8216 |
5/23/2014 | 11/13/2020 | 6/15/2021 | Yes |
Open7
|
Yes |
| QuVa Pharma, Inc., Bloomsbury, NJ | Robert Brown 908-388-1719 |
9/15/2017 | 11/24/2020 | 5/31/2019 | Yes | Regulatory Meeting Held 11/20/2020 | Yes |
| Quva Pharma, Inc., Sugar Land, TX | Travis McGrady 832-500-7113 |
9/10/2015 | 11/24/2020 | 4/23/2019 | Yes | Regulatory Meeting Held 11/20/2020 | No |
| QuVa Pharma, Inc., Temple, TX | Travis Leeah 254-933-4429 |
12/15/2015 | 11/24/2020 | 3/14/2019 | Yes | Regulatory Meeting Held 11/20/2020 | Yes |
| RC Outsourcing, LLC, Lowellville, OH | Raymond R. Carlson 330-536-8500 |
10/6/2015 | 12/2/2020 | 2/8/2019 | Yes | FMD-145 Issued 5/22/2020 | Yes |
| Rhombus Pharmaceuticals Corporation, Conway, AR | Robert Hopkins 501-327-1222 |
12/17/2018 | 12/30/2020 | Not yet inspected | No | N/A | Yes |
| Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop, Irving, TX | Sara Lange 817-282-9376 |
7/3/2019 | 11/19/2020 | 11/12/2019 | Yes | Warning Letter Issued 9/20/2021 | Yes |
| RXQ Compounding LLC, Albany, OH | Tracy Clark 866-280-0031 Ext=8 |
12/11/2019 | 1/15/2021 | Not yet inspected | N/A | N/A | Yes |
|
SCA Pharmaceuticals, Little Rock, AR
|
Lessley Denton 877-550-5059 |
12/13/2013
|
11/27/2020 |
11/7/2019
|
Yes | WLCO and FMD-145 Issued 8/19/2021 | Yes |
| SCA Pharmaceuticals, Windsor, CT | Lessley Denton 877-550-5059 |
8/3/2017 | 11/27/2020 | 11/19/2019 | Yes | WLCO and FMD-145 Issued 8/19/2021 | Yes |
| Sincerus Florida, LLC, Pompano Beach, FL | Michael Morelli 800-604-5032 Ext=313 |
3/10/2016 | 11/5/2020 | 9/17/2018 | Yes | FMD-145 Issued 11/16/2020 | Yes |
| SSM Health Care Corporation, Fenton, MO | Jill Stimac 636-496-2685 |
2/18/2014 | 11/27/2020 | 9/28/2021 | Yes | Open7 | No |
| STAQ Pharma, Inc., Denver, CO | Joe Bagan 303-810-6777 |
2/5/2019 | 12/24/2020 | 9/3/2020 | Yes | Open | Yes |
| STASKA PHARMACEUTICALS, Bennet, NE | Lyndon Leitner 402-560-4688 |
12/3/2020 | 12/3/2020 | Not yet inspected | N/A | N/A | Yes |
| STERRX, LLC, Plattsburgh, NY | Sue Martin 518-324-7879 |
5/29/2015 | 11/18/2020 | 6/7/2019 | No | FMD-145 Issued 7/7/2020 | Yes |
| Stokes Healthcare Inc., dba Epicur Pharma, Mt. Laurel, NJ | Michael Tursi 888-508-5032 |
1/30/2018 | 11/24/2020 | 10/9/2020 | Yes | Open7 | Yes |
| Strukmyer Medical, Mesquite, TX | Sudheer Kancherla 972-284-1614 |
2/8/2019 | 10/7/2021 | Not yet inspected | N/A | N/A | Yes |
| Tailstorm Health Inc., Chandler AZ | Mitesh Gandhi 480-770-6890 |
10/23/2019 | 12/31/2020 | 7/21/2021 | Yes | Open | Yes |
| The Ritedose Corporation, Columbia, SC | Jody Chastain 803-935-4060 |
12/20/2019 | 11/25/2020 | Not yet inspected | N/A | N/A | Yes |
| University of Tennessee, Memphis, TN | Harry Kochat 901-448-1440 |
6/26/2019 | 12/8/2020 | Not yet inspected | N/A | N/A | Yes |
|
US Specialty Formulations LLC, Bethlehem, PA
|
Kyle Flanigan 610-849-5023 |
1/31/2014 | 12/2/2020 | 7/23/2019 | Yes | Regulatory Meeting Held 6/7/2021 | Yes |
| Wedgewood Connect, LLC, formerly registered as Leiter's Compounding, San Jose, CA | Paul Yamamoto 408-687-0943 |
1/31/2014 | 1/14/2021 | 12/19/2018 | Yes | FMD-145 Issued 8/3/2021 | Yes |
| Wells Pharma of Houston, LLC, Houston, TX | Theaquiata A. Mitchell 346-888-1010 Ext=4811 |
3/9/2020 | 1/15/2021 | 6/17/2021 | Yes | Open | Yes |
| Wells Pharmacy, Inc., Dyersburg, TN | Melissa Stefko 800-622-4510 |
6/7/2016 | 1/6/2021 | 1/28/2021 | Yes | Open7 | 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.