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

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	Joe Bagan 303-810-6777	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 501-504-6635	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.

Facilities Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Notes

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