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 1/15/2021

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	Open⁷	Yes
Apollo Care, Columbia, MO	Jarred Dudding 573-441-8900	9/14/2017	12/21/2020	3/13/2018	Yes	Warning Letter - 3/20/2019	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	9/26/2017	Yes	Warning Letter - 9/11/2018	Yes
Baxter Pharmaceutical Solutions, LLC, Bloomington, IN	Stacia Jones 812-355-4128	12/11/2020	12/11/2020	Not yet inspected	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	12/4/2020	12/10/2019	Yes	Yes	No
BPI Labs LLC, Largo, FL	Chandra Kasireddy 727-471-0850	3/4/2019	12/28/2020	Not yet inspected	N/A	N/A	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	9/20/2019	Yes	FMD-145 Issued 6/22/2020	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
Compound Preferred, LLC, Ammon, ID	Casey Hunter 208-419-0613 Ext=203	1/5/2021	1/5/2021	Not yet inspected	N/A	N/A	Yes
Denver Solutions, LLC dba Leiters Health, Englewood, CO	Ron Stephens 408-292-6772	3/24/2017	11/23/2020	7/18/2019	Yes	Open⁷	Yes
Eagle Pharmacy, Inc., Hoover, AL	Haleigh Cawood 205-682-7999	6/16/2015	11/13/2020	5/18/2018	Yes	Regulatory Meeting Held 12/2/2019	Yes
Edge Pharma, Colchester, VT	Tyler Wingood 802-449-0341	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	Open⁷	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	Open⁷	Yes
Farmakeio Outsourcing LLC, Southlake, TX	Cody Boatman 817-203-8216	12/12/2018	12/23/2020	10/30/2019	Yes	Open	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
Hybrid Pharma, LLC, Deerfield Beach, FL	Ponswamy Rajalingam 954-708-2771	1/14/2015	1/11/2021	6/20/2019	Yes	Regulatory Meeting Held 9/29/2020	Yes
Imprimis NJOF, LLC, Ledgewood, NJ	Pramod Sharma 973-804-1623	11/12/2016	11/19/2020	7/10/2017	Yes	Warning Letter 6/7/2019	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	9/19/2018	Yes	Warning Letter 5/6/2020	No
JCB Laboratories, North Wichita, KS	Tanis Flinkman 316-773-0405	1/21/2014	11/5/2020	9/14/2018	Yes	Open⁷	Yes
KRS Global Biotechnology, Inc., Boca Raton, FL	Charles Richardson 888-502-2050	12/15/2013	1/6/2021	8/14/2019	Yes	Open⁷	Yes
Leesar Inc., Fort Myers, FL	Maria Gautier 239-939-8925	4/30/2014	12/22/2020	7/12/2017	Yes	Warning Letter 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	Open⁷	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. d/b/a Advanced Compounding Solutions, Woburn, MA	Marco Romano 781-832-5776	3/2/2017	1/5/2021	8/22/2017	Yes	Untitled Letter - 8/21/2019	No
Nubratori, Inc., Torrance, CA	Gulshakar Khwaja 310-218-4153	2/24/2017	10/22/2020	9/26/2019	Yes	Open⁷	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
Optum Compounding Services, LLC, formerly registered as Avella of Deer Valley, Inc., Phoenix, AZ	Christopher Dinoffria 623-238-7073	6/21/2016	10/15/2020	4/20/2018	Yes	Open	No
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 - 5/3/2017	Yes
Pine Pharmaceuticals, LLC, 355 Riverwalk Pkwy, Tonawanda, NY	Alfonse Muto 716-248-1025	3/9/2018	10/29/2020	4/26/2018	Yes	Regulatory Meeting Held 12/16/2019	Yes
PQ Pharmacy LLC, Brooksville, FL	Angela Kassay 352-277-6419	10/29/2020	10/29/2020	Not yet inspected	N/A	N/A	Yes
Providence Health & Services-Washington, Tukwila, WA	Jacqueline A. Biery 425-687-4460	3/2/2020	12/14/2020	10/5/2020	Yes	Open	No
Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OK	Shaun Riney 405-551-8216	5/23/2014	11/13/2020	9/13/2018	Yes	Regulatory Meeting - 6/18/2019	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	Syed Saleem 405-410-8244	7/3/2019	11/19/2020	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	11/27/2020	11/7/2019	Yes	Open⁷	Yes
SCA Pharmaceuticals, Windsor, CT	Lessley Denton 877-550-5059	8/3/2017	11/27/2020	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	Michael Morelli 800-604-5032 Ext=313	3/10/2016	11/5/2020	9/17/2018	Yes	Open⁷	Yes
SSM Health Care Corporation, Fenton, MO	Jill Stimac 636-496-2685	2/18/2014	11/27/2020	8/28/2019	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
Tailstorm Health Inc., Chandler AZ	VIraj Gandhi 347-990-4238	10/23/2019	12/31/2020	Not yet inspected	N/A	N/A	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 Compounding, Inc., Conway, AR	Robert Hopkins 501-327-1222	12/20/2013	12/24/2020	2/7/2019	Yes	Open⁷	Yes
US Specialty Formulations LLC, Bethlehem, PA	Kyle Flanigan 610-849-5023	1/31/2014	12/2/2020	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	1/14/2021	12/19/2018	Yes	Open	Yes
Wells Pharmacy, Inc., Dyersburg, TN	Melissa Stefko 800-622-4510	6/7/2016	1/6/2021	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.

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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