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 6/1/2018

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 NameInitial Date of Registration as an Outsourcing Facility1Date of Most Recent Registration as an Outsourcing Facility1End Date of Last FDA Inspection Related to Compounding2Was a Form FDA-483 issued?3Other Action, if Any, Based on Last Inspection4,5Intends to Compounds Sterile Drugs From Bulk Drug Substances6
Advanced Pharma, Inc. dba Avella of Houston, Houston, TX12/21/201610/5/20177/22/2016YesOpenNo
AnazaoHealth Corporation, Las Vegas, NV9/23/201410/12/20173/24/2017YesRegulatory Meeting 3/29/2018Yes
Apollo Care, Columbia, MO9/14/201712/1/20173/13/2018YesOpenYes
ASP CARES, San Antonio, TX2/14/201711/16/20173/2/2017YesFMD-145 Letter 10/26/2017Yes
Athenex Pharma Solutions, LLC, Clarence, NY4/10/201710/18/201712/13/2017YesOpenYes
Atlas Pharmaceuticals, Phoenix, AZ11/8/201611/8/20179/26/2017YesOpenYes 
Auro Pharmacies, Inc, DBA Central Drugs, 511 S. Harbor Blvd, Bldg F, La Habra, CA9/1/201610/12/20176/29/2017YesOpen7Yes
Avella of Deer Valley, Inc. #38, Phoenix, AZ6/21/201612/28/20174/20/2018YesOpenYes
Avella Specialty Pharmacy, Phoenix, AZ2/24/201410/5/20174/19/2018YesOpenNo
BMD SKINCARE INC, Canoga, CA1/11/20181/11/2018Not yet inspectedN/AN/AYes
Brookfield Medical/Surgical Supply, Inc., Brookfield, CT1/12/201512/19/20174/19/2017YesRegulatory Meeting 1/8/187Yes
BSO LLC, Lakewood, CO11/24/201511/9/20179/2/2016YesOpenYes
Cantrell Drug Company, Little Rock, AR12/16/201312/19/20173/22/2018YesConsent Decree of Permanent Injunction entered 4/19/20187Yes
Central Admixture Pharmacy Services, Inc., Allentown, PA2/28/201410/30/20179/19/2016YesOpen7Yes
Central Admixture Pharmacy Services, Phoenix, AZ3/29/20183/29/2018Not yet inspectedN/AN/AYes
Central Admixture Pharmacy Services, Inc., San Diego, CA
6/4/201410/30/20178/8/2014YesWarning Letter - 8/18/16No
Coastal Meds LLC, Biloxi, MS12/23/201410/27/20174/6/2018YesCeased Operations and Recalled Product 4/13/20187Yes
Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL6/6/201412/28/20172/23/2017YesOpen7Yes
Delta Pharma, Inc., Ripley, MS8/6/201410/20/20172/23/2017YesOpen7Yes
Denver Solutions, LLC dba Leiters Health, Englewood, CO3/24/20171/24/20182/23/2018YesOpenYes
Eagle Pharmacy, Inc., Hoover, AL6/16/201510/18/20175/18/2018YesOpen7Yes
Edge Pharmacy Services, LLC, Colchester, VT1/21/201411/9/20173/8/2018YesOpenYes
Empower Pharmacy, Houston, TX7/16/201610/26/20171/24/2018YesOpenYes
Exela Pharma Sciences, LLC., Lenoir, NC6/6/20141/26/20189/28/2017YesOpen7Yes
F.H. Investments, Inc., DBA Asteria Health, Birmingham, AL5/18/20171/6/2018Not yet inspectedN/AN/AYes
Fagron Compounding Services d/b/a Fagron Sterile Services, Wichita, KS10/2/201510/18/20179/21/2016YesWarning Letter 11/28/2017Yes
Fresenius Kabi Compounding, LLC, Canton, MA4/21/201711/30/2017Not yet inspectedN/AN/ANo
Fusion IV Pharmaceuticals, Inc., dba Axia Pharmaceutical, Los Angeles, CA1/6/20173/9/20183/23/2017YesWarning Letter 02/21/2018Yes
Hybrid Pharma, LLC, Deerfield Beach, FL1/14/201512/28/20177/28/2016YesOpenYes
Imprimis NJOF, LLC, Ledgewood, NJ11/12/201610/26/20177/10/2017YesOpenYes
Infusion Options Inc., Brooklyn, NY1/24/201411/30/20176/1/2017YesRegulatory Meeting 03/14/2018No
INTACT PHARMACEUTICALS LLC, New Milford, CT1/12/20181/12/2018Not yet inspectedN/AN/AYes
IntegraDose Compounding Services, LLC, Minneapolis, MN5/8/20185/8/2018Not yet inspectedN/AN/ANo
JCB Laboratories, North Wichita, KS
KRS Global Biotechnology, Inc., Boca Raton, FL12/15/201312/27/201710/23/2017YesOpen7Yes
Leesar Inc., Fort Myers, FL4/30/20141/3/20187/27/2017YesOpenNo
Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA1/31/201410/17/20176/15/2017YesFMD-145 Letter issued 5/29/2018Yes
Maitland Labs of Central Florida, Orlando, FL3/23/20183/23/2018Not yet inspectedN/AN/AYes
Medcraft LLC, Mounds, OK2/23/201711/23/2017Not yet inspectedN/AN/AYes
Medi-Fare Drug, Blacksburg, SC12/17/201312/14/20174/5/2017NoOpen7Yes
Molecular PharmaGroup, New Providence, NJ5/8/20185/8/2018Not yet inspectedN/AN/AYes
Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC7/15/201410/21/20174/20/2018YesOpen7Yes
New England Life Care, Inc., dba: Advanced Compounding Solutions, Woburn, MA3/2/20171/24/20188/22/2017YesOpenNo
Nubratori, Inc., Torrance, CA2/24/201711/3/20174/10/2018NoOpenYes
Olympia Compounding Pharmacy, Orlando, FL3/10/201410/13/20174/13/2018YesOpen7Yes
Pacifico National dba Amex Pharmacy, Melbourne, FL9/21/201512/14/20171/21/2016YesOpenYes
Pentec Health, Boothwyn, PA9/21/201611/18/20172/23/2018YesOpenYes
Pharm D Solutions, LLC, Houston, TX8/6/201410/25/20176/5/2015YesWarning Letter - 12/8/2016Yes
PharMedium Services, LLC, Cleveland, MS
PharMedium Services, LLC, Dayton. NJ11/3/201510/16/201712/13/2017YesOpen7No
PharMedium Services, LLC, Memphis, TN12/11/201310/16/201712/15/2017
PharMedium Services, LLC, Sugar Land, TX
Pine Pharmaceuticals, LLC, 355 Riverwalk Pkwy, Tonawanda, NY3/9/20183/9/20184/26/2018YesOpenYes
Premier Pharmacy Labs Inc., Brooksville, FL4/16/201410/23/20176/13/2016YesRegulatory Meeting - 1/31/2018Yes
Qualgen LLC, formerly registered as Amerilab LLC, Edmond, OK5/23/201411/28/20175/10/2017YesRegulatory Meeting - 5/14/2018Yes
Queens Express Pharmacy, Jackson Heights, NY5/10/201612/19/20177/11/2016YesOpenYes
QuVa Pharma, Inc., Bloomsbury, NJ9/15/201710/27/201711/30/2017YesOpenYes
Quva Pharma, Inc., Sugar Land, TX9/10/201510/25/20176/2/2017YesOpen7No
QuVa Pharma, Inc., Temple, TX12/15/201510/27/20174/20/2018YesOpen7Yes
RAM Pharma, Inc. Idaho Falls, ID7/21/201612/26/20173/1/2017YesWarning Letter - 11/1/2017Yes
RC Outsourcing, LLC, Lowellville, OH10/6/201510/24/20173/31/2017YesWarning Letter - 11/28/20177Yes
Right Value Drug Store dba Carie Boyd's Prescription Shop, Hurst, TX1/11/201612/15/20175/12/2017YesOpen7Yes
RXQ Compounding LLC, Athens, OH1/2/201510/19/20178/8/2017YesRegulatory Meeting - 05/23/2018Yes
SCA Pharmaceuticals, Little Rock, AR
SCA Pharmaceuticals, Windsor, Ct8/3/201711/15/20173/5/2018YesOpenYes
Seaview Enterprises, Los Alamitos, CA2/14/201712/29/2017Not yet inspectedN/AN/AYes
Sincerus Florida, LLC, Pompano Beach, FL3/10/201611/2/20176/26/2017YesOpen7Yes
SSM Health Care Corporation, Fenton, MO2/18/201411/16/201711/16/2017YesOpen7No
STERRX, LLC, Plattsburgh, NY  5/29/2015 10/16/20173/17/2017Yes Open Yes 
Stokes Healthcare Inc., Mt. Laurel, NJ1/30/20181/30/2018Not yet InspectedN/AN/AYes
Triangle Compounding Pharmacy, Inc., Cary, NC1/24/201411/9/20177/13/2017YesOpen7Yes
US Compounding, Inc., Conway, AR12/20/201310/21/20177/15/2016YesWarning Letter - 10/10/20177Yes
US Specialty Formulations LLC, Bethlehem, PA
Wells Pharmacy, Inc., Dyersburg, TN6/7/201611/8/20174/27/2018YesOpen7Yes


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


Page Last Updated: 06/11/2018
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