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 10/9/2020
- 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 |
|---|---|---|---|---|---|---|---|
| Advanced Pharmaceutical Technology, Inc., Elmsford, NY | Marco Persichillo 914-358-5260 |
2/26/2019 | 11/18/2019 | Not yet inspected | N/A | N/A | Yes |
| AnazaoHealth Corporation, Las Vegas, NV | Jaclyn Wong 800-995-4363 Ext=3120 |
9/23/2014 | 10/22/2019 | 9/19/2019 | Yes | Open7 | Yes |
| Apollo Care, Columbia, MO | Jarred Dudding 573-441-8900 |
9/14/2017 | 12/11/2019 | 3/13/2018 | Yes | Warning Letter - 3/20/2019 | Yes |
| AptiPharma, LLC, Loveland, CO | Jennifer Travis 970-685-1078 |
2/7/2020 | 2/7/2020 | Not yet inspected | N/A | N/A | No |
| ASP CARES, San Antonio, TX | Jacqueline Esqueda 210-417-4567 |
2/14/2017 | 12/3/2019 | 8/23/2018 | Yes | Open | Yes |
| Athenex Pharma Solutions, LLC, Clarence, NY | Michael Scribner 888-629-8593 |
4/10/2017 | 10/25/2019 | 8/28/2019 | Yes | Open7 | Yes |
| Atlas Pharmaceuticals, Phoenix, AZ | Nickolaus Banda 480-208-1855 |
11/8/2016 | 10/8/2020 | 9/26/2017 | Yes | Warning Letter - 9/11/2018 | Yes |
| BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL | Kenneth Jozefczyk 813-901-6339 |
6/4/2019 | 12/7/2019 | 12/10/2019 | Yes | Yes | No |
| BPI Labs LLC, Largo, FL | Chandra Kasireddy 727-471-0850 |
3/4/2019 | 12/3/2019 | Not yet inspected | N/A | N/A | Yes |
| Brookfield Medical/Surgical Supply, Inc., Brookfield, CT | James Cangelosi 203-775-0862 |
1/12/2015 | 1/16/2020 | 12/21/2018 | Yes | Open | Yes |
| BSO LLC, Lakewood, CO | David W. Hill 303-589-8677 |
11/24/2015 | 10/17/2019 | 9/20/2019 | Yes | FMD-145 Issued 6/22/2020 | Yes |
| Central Admixture Pharmacy Services, Inc., Allentown, PA | Wm. John Brandon 205-945-1955 Ext=106 |
2/28/2014 | 10/18/2019 | 8/22/2018 | Yes | FMD-145 Issued 6/17/2020 | Yes |
| Central Admixture Pharmacy Services, Phoenix, AZ | Wm. John Brandon 205-945-1955 Ext=106 |
3/29/2018 | 10/18/2019 | 4/26/2019 | No | FMD-145 Issued 6/3/2020 | Yes |
|
Central Admixture Pharmacy Services, Inc., San Diego, CA
|
Wm. John Brandon 205-945-1955 Ext=106 |
6/4/2014 | 10/18/2019 | 9/11/2018 | Yes | FMD-145 Issued 5/27/2020 | No |
| Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL | Esan Forde 305-397-2035 |
6/6/2014 | 1/26/2020 | 1/23/2019 | Yes | Open7 | Yes |
| Denver Solutions, LLC dba Leiters Health, Englewood, CO | Ron Stephens 408-292-6772 |
3/24/2017 | 11/5/2019 | 7/18/2019 | Yes | Open7 | Yes |
| Eagle Pharmacy, Inc., Hoover, AL | Haleigh Cawood 205-682-7999 |
6/16/2015 | 11/7/2019 | 5/18/2018 | Yes | Regulatory Meeting Held 12/2/2019 | Yes |
| Edge Pharma, Colchester, VT | Tyler Wingood 802-449-0341 |
1/21/2014 | 12/3/2019 | 3/30/2020 | Yes | Open7 | Yes |
| Empower Pharmacy, Houston, TX | Shaun Noorian 877-562-8577 |
7/16/2016 | 1/2/2020 | 3/6/2020 | Yes | Open7 | Yes |
| Exela Pharma Sciences, LLC., Lenoir, NC | Arun Koganti 828-758-5474 Ext=181 |
6/6/2014 | 1/7/2020 | 7/18/2019 | Yes | Open7 | Yes |
| F.H. Investments, Inc., DBA Asteria Health, Birmingham, AL | William Fixler 855-771-0505 |
5/18/2017 | 11/13/2019 | 7/10/2018 | Yes | Open | Yes |
| Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS | David Lawn 877-405-8066 |
10/2/2015 | 10/18/2019 | 6/21/2019 | Yes | Open7 | Yes |
| Farmakeio Outsourcing LLC, Southlake, TX | Cody Boatman 817-203-8216 |
12/12/2018 | 12/10/2019 | 10/30/2019 | Yes | Open | Yes |
| Fresenius Kabi Compounding, LLC, Canton, MA | Deborah McHugh 781-298-7577 |
4/21/2017 | 12/2/2019 | 12/4/2018 | Yes | FMD-145 Issued 4/22/2020 | No |
| Fusion IV Pharmaceuticals, Inc., dba Axia Pharmaceutical, Los Angeles, CA | Navid Vahedi 877-685-8222 |
1/6/2017 | 1/15/2020 | 12/20/2019 | Yes | Firm recalled all sterile drug products within expiry due to a lack of sterility assurance 1/15/2020 | Yes |
| Hybrid Pharma, LLC, Deerfield Beach, FL | Ponswamy Rajalingam 954-708-2771 |
1/14/2015 | 12/26/2019 | 6/20/2019 | Yes | Regulatory Meeting Held 9/29/2020 | Yes |
| Imprimis NJOF, LLC, Ledgewood, NJ | Pramod Sharma 973-804-1623 |
11/12/2016 | 10/18/2019 | 7/10/2017 | Yes | Warning Letter 6/7/2019 | Yes |
| INTACT PHARMACEUTICALS LLC, New Milford, CT | Debashis Sahoo 860-350-1900 |
1/12/2018 | 2/10/2020 | 10/12/2018 | Yes | Open | Yes |
| IntegraDose Compounding Services, LLC, Minneapolis, MN | Craig Else 612-672-5216 |
5/8/2018 | 11/21/2019 | 9/19/2018 | Yes | Warning Letter 5/6/2020 | No |
|
JCB Laboratories, North Wichita, KS
|
Jason Syring 316-773-0405 |
1/21/2014 | 10/31/2019 | 9/14/2018 | Yes | Open7 | Yes |
| KRS Global Biotechnology, Inc., Boca Raton, FL | Elsa Kerpi 888-502-2050 |
12/15/2013 | 12/31/2019 | 8/14/2019 | Yes | Open7 | Yes |
| Leesar Inc., Fort Myers, FL | Maria Gautier 239-939-8925 |
4/30/2014 | 1/3/2020 | 7/12/2017 | Yes | Warning Letter 2/18/2020 | No |
| Maitland Labs of Central Florida, Orlando, FL | Paul Reid 754-224-1242 |
3/23/2018 | 1/22/2020 | 2/28/2020 | Yes | Open | Yes |
| Medi-Fare Drug, Blacksburg, SC | Anne-Marie Davis 864-839-6500 |
12/17/2013 | 12/27/2019 | 4/5/2017 | No | Untitled Letter Issued 3/18/2019 | Yes |
| MedisourceRx, Los Alamitos, CA | Amy Summers 714-455-1300 |
2/14/2017 | 1/16/2020 | 9/27/2018 | Yes | Open | Yes |
| Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC | Lou Kennedy 803-569-3110 |
7/15/2014 | 10/19/2019 | 11/15/2019 | Yes | Open7 | Yes |
| New England Life Care, Inc., dba: Advanced Compounding Solutions, Woburn, MA | Jill Hunter 844-649-6352 |
3/2/2017 | 11/19/2019 | 8/22/2017 | Yes | Untitled Letter - 8/21/2019 | No |
| Nubratori, Inc., Torrance, CA | Gulshakar Khwaja 310-218-4153 |
2/24/2017 | 10/17/2019 | 9/26/2019 | Yes | Open7 | Yes |
| Olympia Compounding Pharmacy, Orlando, FL | Confidence Ekeanyanwu 407-673-2222 |
3/10/2014 | 1/18/2020 | 4/13/2018 | Yes | Regulatory Meeting Held 9/12/2019 | Yes |
| Optum Compounding Services, LLC, formerly registered as Avella of Deer Valley, Inc., Phoenix, AZ | Christopher Dinoffria 877-794-0404 |
6/21/2016 | 12/11/2019 | 4/20/2018 | Yes | Open | Yes |
| OurPharma LLC, Fayetteville, AR | Morgan Strickland 479-313-8200 |
3/15/2019 | 1/21/2020 | Not yet inspected | N/A | N/A | Yes |
| Pantheon Labs LLC, Rancho Santa Margarita, CA | Rashmi Mediratta 714-726-6429 |
2/7/2019 | 12/27/2019 | Not yet inspected | N/A | N/A | Yes |
| Pharmaceutics International, Inc., Cockeysville, MD | Veeranna Lolla 410-584-0001 ext=1423 |
4/28/2020 | 4/28/2020 | Not yet inspected | N/A | N/A | Yes |
| Pharmaceutic Labs, LLC, Albany, NY | Ernesto Samuel 518-210-7164 |
3/10/2014 | 11/14/2019 | 9/23/2015 | Yes | Warning Letter - 5/3/2017 | Yes |
| Pine Pharmaceuticals, LLC, 355 Riverwalk Pkwy, Tonawanda, NY | Alfonse Muto 844-218-4138 |
3/9/2018 | 11/16/2019 | 4/26/2018 | Yes | Regulatory Meeting Held 12/16/2019 | Yes |
| Prisma Health Outsourcing Facility, Simpsonville, SC | Gary Jones 864-522-3800 |
12/9/2019 | 12/9/2019 | Not yet inspected | N/A | N/A | No |
| Providence Health & Services-Washington, Tukwila, WA | Jacqueline A. Biery 425-687-4460 |
3/2/2020 | 3/2/2020 | 10/5/2020 | Yes | Open | No |
| Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OK | Shaun Riney 405-551-8216 |
5/23/2014 | 12/3/2019 | 9/13/2018 | Yes |
Regulatory Meeting - 6/18/2019
|
Yes |
| Queens Express Pharmacy, Jackson Heights, NY | Silvia Segarra 718-565-1009 Ext=3 |
5/10/2016 | 11/9/2019 | 7/11/2016 | Yes | Open | Yes |
| QuVa Pharma, Inc., Bloomsbury, NJ | Robert Brown 908-388-1719 |
9/15/2017 | 11/26/2019 | 5/31/2019 | Yes | Open | Yes |
| Quva Pharma, Inc., Sugar Land, TX | Travis McGrady 832-500-7113 |
9/10/2015 | 11/26/2019 | 4/23/2019 | Yes | Open7 | No |
| QuVa Pharma, Inc., Temple, TX | Travis Leeah 254-933-4429 |
12/15/2015 | 11/26/2019 | 3/14/2019 | Yes | Open7 | Yes |
| RAM Pharma, Inc. Idaho Falls, ID | Robert A. Myers 208-419-0613 |
7/21/2016 | 12/31/2019 | 8/1/2019 | Yes | Open7 | Yes |
| RC Outsourcing, LLC, Lowellville, OH | Raymond R. Carlson 330-536-8500 |
10/6/2015 | 12/13/2019 | 2/8/2019 | Yes | FMD-145 Issued 5/22/2020 | Yes |
| Rhombus Pharmaceuticals Corporation, Conway, AR | Robert Hopkins 501-327-1222 |
12/17/2018 | 12/23/2019 | Not yet inspected | No | N/A | Yes |
| Right Value Drug Stores, LLC, Irving, TX | Syed Saleem 405-410-8244 |
7/3/2019 | 12/5/2019 | 11/12/2019 | Yes | Open | Yes |
| RXQ Compounding LLC, Albany, OH | Tracy Clark 866-280-0031 Ext=8 |
12/11/2019 | 12/11/2019 | Not yet inspected | N/A | N/A | Yes |
|
SCA Pharmaceuticals, Little Rock, AR
|
Mary Edelman 877-550-5059 |
12/13/2013
|
11/22/2019 |
11/7/2019
|
Yes | Open7 | Yes |
| SCA Pharmaceuticals, Windsor, CT | Lessley Denton 877-550-5059 |
8/3/2017 | 11/22/2019 | 11/19/2019 | Yes | 8/18/2020 Firm recalled Heparin Sodium compounded products due to incorrect preservative (benzyl alcohol) |
Yes |
| Sincerus Florida, LLC, Pompano Beach, FL | Joanne Hoefling 800-604-5032 |
3/10/2016 | 11/23/2019 | 9/17/2018 | Yes | Open7 | Yes |
| SSM Health Care Corporation, Fenton, MO | Jill Stimac 636-496-2685 |
2/18/2014 | 11/27/2019 | 8/28/2019 | Yes | Open7 | No |
| STAQ Pharma, Inc., Denver, CO | Joe Bagan 303-810-6777 |
2/5/2019 | 11/2/2019 | 9/3/2020 | Yes | Open | Yes |
| STERRX, LLC, Plattsburgh, NY | Sue Martin 518-324-7879 |
5/29/2015 | 12/5/2019 | 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 | 10/18/2019 | 10/9/2020 | Yes | Open7 | Yes |
| Strukmyer Medical, Mesquite, TX | Pam Liberto 972/284/1614 |
2/8/2019 | 12/5/2019 | Not yet inspected | N/A | N/A | Yes |
| Tailstorm Health Inc., Chandler AZ | VIraj Gandhi 347-990-4238 |
10/23/2019 | 10/23/2019 | Not yet inspected | N/A | N/A | Yes |
| The Ritedose Corporation, Columbia, SC | Jody Chastain 803-935-4060 |
12/20/2019 | 12/20/2019 | Not yet inspected | N/A | N/A | Yes |
| University of Tennessee, Memphis, TN | Harry Kochat 901-448-1440 |
6/26/2019 | 12/3/2019 | Not yet inspected | N/A | N/A | Yes |
| US Compounding, Inc., Conway, AR | Robert Hopkins 501-327-1222 |
12/20/2013 | 12/23/2019 | 2/7/2019 | Yes | Open7 | Yes |
|
US Specialty Formulations LLC, Bethlehem, PA
|
Kyle Flanigan 610-849-5023 |
1/31/2014 | 11/5/2019 | 7/23/2019 | Yes | Open7 | Yes |
| Wedgewood Connect, LLC, formerly registered as Leiter's Compounding, San Jose, CA | Paul Yamamoto 408-687-0943 |
1/31/2014 | 11/25/2019 | 12/19/2018 | Yes | Open | Yes |
| Wells Pharma of Houston, LLC, Houston, TX | Nikki Edner 346-888-1010 Ext=4806 |
3/9/2020 | 3/9/2020 | Not yet inspected | N/A | N/A | Yes |
| Wells Pharmacy, Inc., Dyersburg, TN | Melissa Stefko 800-622-4510 |
6/7/2016 | 12/18/2019 | 4/27/2018 | Yes | FMD-145 Issued 4/15/2020 | 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.