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FDA record · 503B register · read from fda.gov

98 FDA-registered 503B outsourcing facilities: 42 not yet inspected

FDA's register of 503B outsourcing facilities lists 98 facilities as of Sep 30, 2026. 56 have a published FDA inspection date and 42 are marked "Not yet inspected"; 51 were issued a Form FDA 483 at their last inspection. Registration is a filing with FDA, not an approval of any drug.

Julian CaraulaniFounder, PriceTracker GLP-1FDA register read Oct 3
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What the register shows

98registered facilities
56with an FDA inspection date
42not yet inspected
51Form 483 at last inspection
0recall noted

A 503B outsourcing facilityis a compounder registered with FDA under section 503B of the FD&C Act. Registration is a filing, not an approval of any drug it makes.

A Form FDA 483lists what investigators observed. In FDA’s words it “does not constitute a final agency determination of whether any condition is in violation of the FD&C Act or any relevant regulations.”

Every registered facility

Showing 98 of 98 facilities

FDA registered 503B outsourcing facilities
Form 483Action FDA lists
503B Outsourcing Facility One, LLCWest Palm Beach, FLFeb 18, 2025Not yet inspectedn/an/a
Ajenat Pharmaceuticals, LLCLargo, FLMar 26, 2025Not yet inspectedn/an/a
AnazaoHealth CorporationLas Vegas, NVSep 23, 2014Aug 8, 2025YesOpen
Annovex Pharma, Inc.Lorton, VAOct 14, 2021Jun 3, 2026YesOpen
Apertus Compounding, LLCMaryland Heights, MONov 26, 2025Not yet inspectedn/an/a
Apocus, Inc.San Antonio, TXOct 17, 2023Not yet inspectedn/an/a
Apollo CareColumbia, MOSep 14, 2017Jul 28, 2026YesOpen
Apothecary Pharma, LLCCary, NCSep 7, 2024Sep 2, 2026YesOpen
Arc Compounding Pharmacy, LLCWaco, TXJun 22, 2024Not yet inspectedn/an/a
Aspire Compounding PharmacySugar Land, TXMar 21, 2025Not yet inspectedn/an/a
Assure Infusions, Inc.Bartow, FLNov 22, 2024Sep 17, 2026YesOpen
Atilar Pharma CorporationHouston, TXFeb 20, 2025Not yet inspectedn/an/a
Aveva Drug Delivery Systems, IncTamarac, FLNov 4, 2024Not yet inspectedn/an/a
BayCare Integrated Service Center, LLC dba BayCare Central PharmacyTemple Terrace, FLJun 4, 2019Mar 12, 2026YesFMD-145 Letter Issued 9/18/2023
Bennett Pharmaceuticals of America LLCHudson, WIApr 19, 2022Not yet inspectedn/an/a
Bespoke Pharmaceutical, LLCLas Vegas, NVMar 7, 2026Not yet inspectedn/an/a
BPI Labs LLCLargo, FLMar 4, 2019Apr 17, 2026YesOpen
Bravado Pharmaceuticals, LLCLutz, FLFeb 28, 2025Not yet inspectedn/an/a
Brookfield Medical/Surgical Supply, Inc.Brookfield, CTJan 12, 2015Jul 10, 2026YesOpen
BSO LLCGolden, COJan 24, 2024Jun 27, 2025483Open
BSO LLCLakewood, CONov 24, 2015Jul 16, 2025483Regulatory Meeting Held 3/3/2026
Central Admixture Pharmacy ServicesPhoenix, AZMar 29, 2018Sep 5, 2025YesRegulatory Meeting Held 5/5/2026
Central Admixture Pharmacy Services, Inc.Allentown, PAFeb 28, 2014Sep 5, 2025YesRegulatory Meeting Held 5/5/2026
Delta Pharma, Inc.Ripley, MSAug 6, 2014Nov 21, 2025YesOpen
Denver Solutions, LLC, dba Leiters HealthEnglewood, COMar 24, 2017Dec 11, 2025YesUntitled Letter Issued 6/8/2026
Denver Solutions, LLC, dba Leiters HealthBuena, NJJul 1, 2022Not yet inspectedn/an/a
Eagle PharmaBirmingham, ALJun 16, 2015Feb 27, 2025YesOpen
Empower Clinic Services New JerseyEast Windsor, NJJun 10, 2024Not yet inspectedn/an/a
Empower PharmaHouston, TXJul 16, 2016Nov 14, 2025YesOpen
F.H. Investments, Inc.Birmingham, ALMay 13, 2025Dec 19, 2025YesOpen
Fagron Compounding Services dba Fagron Sterile ServicesWichita, KSOct 2, 2015Aug 8, 2025483Regulatory Meeting Held 2/27/2026
Farmakeio Outsourcing LLCSouthlake, TXDec 12, 2018Sep 5, 2025YesOpen
Fresenius Kabi Compounding LLC dba Fagron Sterile ServicesCanton, MAApr 21, 2017Nov 5, 2025YesWarning Letter Issued 5/12/2026
Galaxy Pharmaceuticals, LLCAlbany, NYJan 26, 2024Not yet inspectedn/an/a
GenoGenix LLCRaton, FLFeb 4, 2025Jul 18, 2025YesOpen
GFC Pharma, LLCWestminster, MDDec 16, 2024Not yet inspectedn/an/a
Healthwealth Pharmacy, LLCHouston, TXJul 21, 2026Not yet inspectedn/an/a
Hyalo Technologies Limited Liability CompanySomerset, NJMay 1, 2025Not yet inspectedn/an/a
Hybrid Pharma, LLCDeerfield Beach, CAJan 14, 2015Aug 27, 2026YesOpen
Imprimis NJOF, LLCLedgewood, NJNov 12, 2016Aug 18, 2026YesOpen
IntegraDose Compounding Services, LLCShoreview, MNFeb 13, 2026Not yet inspectedn/an/a
Leesar Inc.Fort Myers, FLApr 30, 2014Sep 28, 2026YesOpen
Mark Cuban Cost Plus Manufacturing and Compounding, LLCDallas, TXNov 2, 2022Jan 28, 2026YesFMD-145 Letter Issued 6/5/2025
Maxhealth Group, LLC dba New Life RxDallas, TXApr 29, 2026Not yet inspectedn/an/a
McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing SolutionsSanta Ana, CAJan 11, 2023Not yet inspectedn/an/a
Medi-Fare DrugBlacksburg, SCDec 17, 2013Jun 6, 2025YesOpen
Medicinal Sciences Ltd. Co.Heath, TXSep 21, 2026Not yet inspectedn/an/a
MedisourceRxLos Alamitos, CAFeb 14, 2017Jun 10, 2025YesWarning Letter Closeout Issued 7/27/2026 Warning Letter Issued 12/12/2025
Molecular PharmaGroupNew Providence, NJMay 8, 2018Aug 11, 2025YesUntitled Letter Issued 2/5/2026
Navinta III Inc.Boca Raton, FLFeb 6, 2026Not yet inspectedn/an/a
Nephron Sterile Compounding Center, LLC (NSCC)West Columbia, SCJul 15, 2014Aug 22, 2025483Open
Nexgen FormulationsFolcroft, PAJan 15, 2026Not yet inspectedn/an/a
Nivagen Pharmaceuticals, LLCSacramento, CAMar 13, 2026Not yet inspectedn/an/a
NLRx, LLCCookeville, TNAug 7, 2026Not yet inspectedn/an/a
Nubratori, Inc.Torrance, CAFeb 24, 2017Dec 11, 2025YesWarning Letter Closeout Issued 7/27/2026 FMD-145 Letter Issued 7/21/2026
Ocyon Bio PR, LLCAguadilla, PRApr 23, 2026Not yet inspectedn/an/a
Olympia PharmaceuticalsOrlando, FLMar 10, 2014Sep 3, 2026YesOpen
Olyx PharmaSchertz, TXAug 3, 2026Not yet inspectedn/an/a
Orion Specialty Labs, LLCSep 19, 2025Not yet inspectedn/an/a
OSRX, Inc.Missoula, MTOct 28, 2023Nov 14, 2025YesOpen
OurPharma LLCFayetteville, ARMar 15, 2019Sep 27, 2024YesFMD-145 Letter Issued 6/23/2025
Park Avenue CompoundingSt. Louis, MODec 23, 2023Sep 23, 2025YesRegulatory Meeting Held 5/7/2026
PGRrx LLCExton, PADec 10, 2024Not yet inspectedn/an/a
Pine Pharmaceuticals, LLCTonawanda, NYMar 9, 2018Nov 14, 2025YesWarning Letter Issued 8/7/2026
PQ Pharmacy LLCBrooksville, FLOct 29, 2020Jun 1, 2026YesOpen
ProRx LLCExton, PAApr 27, 2022Sep 19, 2025YesWarning Letter Issued 4/7/2026
Qualgen LLCEdmond, OKMay 23, 2015Sep 4, 2025YesOpen
Quantum Pharmaceuticals, LLCMounds, OKMay 30, 2024Not yet inspectedn/an/a
Quva Pharma, Inc.Bloomsbury, NJSep 15, 2017Apr 4, 2025YesOpen
Quva Pharma, Inc.Sugar Land, TXSep 10, 2015May 4, 2026YesOpen
Rapha Pharmaceuticals, lnc.Las Vegas, NVDec 23, 2024Not yet inspectedn/an/a
RC Outsourcing, LLCLowellville, OHOct 7, 2015Sep 3, 2026YesOpen
Right Value Drug Stores, LLC, dba Carie Boyd's Prescription ShopIrving, TXJul 3, 2019Jul 18, 2025YesRegulatory Meeting Held 1/8/2026
Sankav Pharmaceuticals, LLCHackettstown, NJMar 21, 2025Not yet inspectedn/an/a
SCA PharmaceuticalsLittle Rock, ARDec 13, 2013Oct 30, 2025YesWarning Letter Issued 9/14/2026
SCA PharmaceuticalsWindsor, CTAug 3, 2017Mar 13, 2026YesOpen7
Signature RxDelray Beach, FLOct 13, 2023Not yet inspectedn/an/a
Simple RX Solutions, P.C.Lewisburg, TNAug 26, 2026Not yet inspectedn/an/a
SKNV formerly registered as Sincerus Florida, LLCPompano Beach, FLMar 10, 2016May 29, 2026YesOpen
STAQ Pharma of Ohio, LLCColumbus, OHJan 26, 2023Aug 19, 2026YesOpen
STAQ Pharma, Inc.Denver, COFeb 5, 2019Sep 8, 2026YesOpen
Staska Pharmaceuticals, Inc.Bennet, NEDec 3, 2020Feb 20, 2026YesOpen
Stokes Healthcare Inc., dba Epicur PharmaMt. Laurel, NJJan 30, 2018May 23, 2025YesOpen
Tailstorm Health Inc.Chandler, AZOct 23, 2019Aug 28, 2026YesOpen
Turbare ManufacturingConway, ARJun 23, 2023May 7, 2026YesOpen
University of TennesseeMemphis, TNMay 19, 2024Not yet inspectedn/an/a
US Specialty Formulations LLCAllentown, PAJan 31, 2014Jan 14, 2026YesOpen
Vitae Enim Vitae Scientific, Inc.San Diego, CAJan 2, 2024Not yet inspectedn/an/a
VitalRx Pharmacy, LLCHouston, TXAug 27, 2024Not yet inspectedn/an/a
Wedgewood Connect Ohio, LLCAlbany, OHOct 19, 2023Not yet inspectedn/an/a
Wedgewood Connect, LLC, formerly registered as Leiter's CompoundingSan Jose, CAJan 31, 2014Jul 3, 2025YesOpen
Wells Pharma of Houston, LLCHouston, TXMar 9, 2020Apr 13, 2026YesOpen
Wells Pharmacy, Inc.Dyersburg, TNJun 7, 2016Apr 9, 2026YesOpen
Wesley PharmaceuticalsOrlando, FLJul 25, 2025Mar 16, 2026NoFMD-145 Letter Issued 6/17/2026
White Label Pharmacy dba Nova PharmacyKaty, TXDec 16, 2025Not yet inspectedn/an/a
Wilcrest Pharmaceuticals, Inc.Houston, TXMar 13, 2025Not yet inspectedn/an/a
Willowbend Pharma Select, LLCHouston, TXApr 11, 2024Not yet inspectedn/an/a
Xseer Pharmaceuticals, Inc.Los Angeles, CAOct 21, 2023Not yet inspectedn/an/a

Source and limits

  • Copied from FDA’s Registered Outsourcing Facilities table ↗, updated by FDA Sep 30, 2026 and read by us Oct 3, 2026.
  • FDA notes the table does not include State Board of Pharmacy actions, and that one company may run more than one facility.
  • This register covers 503B outsourcing facilities only; state-licensed 503A pharmacies are not on it. For letters FDA sent to GLP-1 sellers of any kind, see FDA warning letters naming GLP-1 drugs.