FDA 503B outsourcing facility directory
A searchable directory of 96 FDA-registered 503B outsourcing facilities, combining FDA registration, inspection, Form 483, recall, and product-report records. Updated June 6, 2026.
Directory summary
- 96 registered facilities in the published directory
- 58 have a published FDA inspection date
- 51 have ingredients in FDA outsourcing-facility product reports
- Registration is not FDA approval or an endorsement of a facility or its products
Search the 503B pharmacy list
| Facility | Location | Registered since | Last inspection | Form 483 | Recalls | Ingredients |
|---|---|---|---|---|---|---|
| 503B Outsourcing Facility One, LLC | West Palm Beach, Florida | 2025 | Not yet inspected | N/A | 0 | — |
| AH Nutraceutical Compounding, Inc. | McQueeny, Texas | 2024 | Not yet inspected | N/A | 0 | — |
| Ajenat Pharmaceuticals, LLC | Largo, Florida | 2025 | Not yet inspected | N/A | 0 | — |
| AnazaoHealth Corporation | Las Vegas, Nevada | 2014 | Aug 8, 2025 | Yes | 3 | 18 |
| Annovex Pharma, Inc. | Lorton, Virginia | 2021 | Jun 3, 2026 | Yes | 0 | 17 |
| Apertus Compounding, LLC | Maryland Heights, Missouri | 2025 | Not yet inspected | N/A | 0 | — |
| Apocus, Inc. | San Antonio, Texas | 2023 | Not yet inspected | N/A | 0 | — |
| Apollo Care | Columbia, Missouri | 2017 | Mar 28, 2025 | Yes | 23 | 10 |
| Apothecary Pharma, LLC | Cary, North Carolina | 2024 | May 15, 2025 | Yes | 0 | — |
| Arc Compounding Pharmacy, LLC | Waco, Texas | 2024 | Not yet inspected | N/A | 0 | — |
| Aspire Compounding Pharmacy | Sugar Land, Texas | 2025 | Not yet inspected | N/A | 0 | — |
| Assure Infusions, Inc. | Bartow, Florida | 2024 | Not yet inspected | N/A | 0 | — |
| Atilar Pharma Corporation | Houston, Texas | 2025 | Not yet inspected | N/A | 0 | — |
| Aveva Drug Delivery Systems, Inc | Tamarac, Florida | 2024 | Not yet inspected | N/A | 3 | — |
| BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy | Temple Terrace, Florida | 2019 | Mar 12, 2026 | Yes | 3 | — |
| Bennett Pharmaceuticals of America LLC | Hudson, Wisconsin | 2022 | Not yet inspected | N/A | 0 | 1 |
| Bespoke Pharmaceutical, LLC | Las Vegas, Nevada | 2026 | Not yet inspected | N/A | 0 | — |
| BPI Labs LLC | Largo, Florida | 2019 | Apr 17, 2026 | Yes | 0 | 3 |
| Bravado Pharmaceuticals, LLC | Lutz, Florida | 2025 | Not yet inspected | N/A | 0 | — |
| Brookfield Medical/Surgical Supply, Inc. | Brookfield, Connecticut | 2015 | May 10, 2024 | Yes | 0 | 4 |
| BSO LLC | Golden, Colorado | 2024 | Jun 27, 2025 | 483 | 5 | 6 |
| BSO LLC | Lakewood, Colorado | 2024 | Jun 27, 2025 | 483 | 5 | 6 |
| Central Admixture Pharmacy Services | Phoenix, Arizona | 2018 | Sep 5, 2025 | Yes | 345 | 69 |
| Central Admixture Pharmacy Services, Inc. | Allentown, Pennsylvania | 2014 | Sep 5, 2025 | Yes | 345 | 69 |
| Delta Pharma, Inc. | Ripley, Mississippi | 2014 | Nov 21, 2025 | Yes | 0 | 1 |
| Denver Solutions, LLC, dba Leiters Health | Englewood, Colorado | 2017 | Dec 11, 2025 | Yes | 22 | — |
| Denver Solutions, LLC, dba Leiters Health | Buena, New Jersey | 2022 | Not yet inspected | N/A | 22 | — |
| Eagle Pharma | Birmingham, Alabama | 2015 | Feb 27, 2025 | Yes | 1 | 9 |
| Empower Clinic Services New Jersey | East Windsor, New Jersey | 2024 | Not yet inspected | N/A | 0 | 2 |
| Empower Pharma | Houston, Texas | 2016 | Nov 14, 2025 | Yes | 1 | 29 |
| F.H. Investments, Inc. | Birmingham, Alabama | 2025 | Dec 19, 2025 | Yes | 0 | — |
| Fagron Compounding Services dba Fagron Sterile Services | Wichita, Kansas | 2015 | Aug 8, 2025 | 483 | 13 | 42 |
| Farmakeio Outsourcing LLC | Southlake, Texas | 2018 | Sep 5, 2025 | Yes | 15 | 4 |
| Fresenius Kabi Compounding LLC dba Fagron Sterile Services | Canton, Massachusetts | 2017 | Nov 5, 2025 | Yes | 0 | — |
| Galaxy Pharmaceuticals, LLC | Albany, New York | 2024 | Not yet inspected | N/A | 0 | — |
| GenoGenix LLC | Boca Raton, Florida | 2025 | Jul 18, 2025 | Yes | 57 | — |
| GFC Pharma, LLC | Westminster, Maryland | 2024 | Not yet inspected | N/A | 0 | — |
| Hikma Injectables USA Inc. | Dayton, New Jersey | 2021 | Aug 8, 2025 | Yes | 4 | 8 |
| Hikma Pharmaceuticals USA Inc. | Cherry Hill, New Jersey | 2021 | May 13, 2026 | No | 19 | 1 |
| Hyalo Technologies Limited Liability Company | Somerset, New Jersey | 2025 | Not yet inspected | N/A | 0 | — |
| Hybrid Pharma, LLC | Deerfield Beach, Florida | 2015 | Nov 9, 2023 | Yes | 0 | 74 |
| Imprimis NJOF, LLC | Ledgewood, New Jersey | 2016 | Apr 3, 2024 | Yes | 21 | 33 |
| IntegraDose Compounding Services, LLC | Shoreview, Minnesota | 2026 | Not yet inspected | N/A | 7 | 9 |
| Leesar Inc. | Fort Myers, Florida | 2014 | May 9, 2025 | Yes | 0 | 12 |
| Mark Cuban Cost Plus Manufacturing and Compounding, LLC | Dallas, Texas | 2022 | Jan 28, 2026 | Yes | 0 | 5 |
| Maxhealth Group, LLC dba New Life Rx | Dallas, Texas | 2026 | Not yet inspected | N/A | 0 | — |
| McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions | Santa Ana, California | 2023 | Not yet inspected | N/A | 4 | 4 |
| Medi-Fare Drug | Blacksburg, South Carolina | 2013 | Jun 6, 2025 | Yes | 0 | 8 |
| MedisourceRx | Los Alamitos, California | 2017 | Jun 10, 2025 | Yes | 0 | 3 |
| Molecular PharmaGroup | New Providence, New Jersey | 2018 | Aug 11, 2025 | Yes | 0 | 1 |
| Navinta III Inc. | Boca Raton, Florida | 2026 | Not yet inspected | N/A | 0 | — |
| Nephron Sterile Compounding Center, LLC (NSCC) | West Columbia, South Carolina | 2014 | Aug 22, 2025 | 483 | 0 | — |
| Nexgen Formulations | Folcroft, Pennsylvania | 2026 | Not yet inspected | N/A | 0 | — |
| Nivagen Pharmaceuticals, LLC | Sacramento, California | 2026 | Not yet inspected | N/A | 1 | — |
| Nubratori, Inc. | Torrance, California | 2017 | Dec 11, 2025 | Yes | 1 | 12 |
| Ocyon Bio PR, LLC | Aguadilla, Puerto Rico | 2026 | Not yet inspected | N/A | 0 | — |
| Olympia Pharmaceuticals | Orlando, Florida | 2014 | Aug 8, 2025 | 483 | 94 | 57 |
| Orion Specialty Labs, LLC | Not published | 2025 | Not yet inspected | N/A | 0 | — |
| OSRX, Inc. | Missoula, Montana | 2023 | Nov 14, 2025 | Yes | 0 | 16 |
| OurPharma LLC | Fayetteville, Arkansas | 2019 | Sep 27, 2024 | Yes | 3 | 9 |
| Park Avenue Compounding | St. Louis, Missouri | 2023 | Sep 23, 2025 | Yes | 2 | — |
| PGRrx LLC | Exton, Pennsylvania | 2024 | Not yet inspected | N/A | 0 | — |
| Pine Pharmaceuticals, LLC | Tonawanda, New York | 2018 | Nov 14, 2025 | Yes | 24 | 32 |
| PQ Pharmacy LLC | Brooksville, Florida | 2020 | Jun 1, 2026 | Yes | 0 | 12 |
| ProRx LLC | Exton, Pennsylvania | 2022 | Sep 19, 2025 | Yes | 14 | 21 |
| Qualgen LLC | Edmond, Oklahoma | 2015 | Sep 4, 2025 | Yes | 27 | 3 |
| Quantum Pharmaceuticals, LLC | Mounds, Oklahoma | 2024 | Not yet inspected | Yes | 0 | — |
| Quva Pharma, Inc. | Bloomsbury, New Jersey | 2017 | Apr 4, 2025 | Yes | 37 | 53 |
| Quva Pharma, Inc. | Sugar Land, Texas | 2015 | May 4, 2026 | Yes | 37 | 53 |
| Rapha Pharmaceuticals, lnc. | Tampa, Florida | 2024 | Not yet inspected | N/A | 0 | — |
| RC Outsourcing, LLC | Lowellville, Ohio | 2015 | Aug 28, 2025 | Yes | 1 | — |
| Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop | Irving, Texas | 2019 | Jul 18, 2025 | Yes | 1 | — |
| Sankav Pharmaceuticals, LLC | Hackettstown, New Jersey | 2025 | Not yet inspected | N/A | 0 | — |
| SCA Pharmaceuticals | Little Rock, Arkansas | 2013 | Oct 30, 2025 | Yes | 166 | 22 |
| SCA Pharmaceuticals | Windsor, Connecticut | 2017 | Mar 13, 2026 | Yes | 166 | 22 |
| SKNV formerly registered as Sincerus Florida, LLC | Pompano Beach, Florida | 2016 | May 29, 2026 | Yes | 0 | 90 |
| STAQ Pharma of Ohio, LLC | Columbus, Ohio | 2023 | May 16, 2025 | Yes | 0 | 6 |
| STAQ Pharma, Inc. | Denver, Colorado | 2019 | Feb 10, 2025 | No | 6 | 21 |
| Staska Pharmaceuticals, Inc. | Bennet, Nebraska | 2020 | Feb 20, 2026 | Yes | 1 | 9 |
| Stokes Healthcare Inc., dba Epicur Pharma | Mt. Laurel, New Jersey | 2018 | May 23, 2025 | Yes | 0 | — |
| Tailstorm Health Inc. | Chandler, Arizona | 2019 | May 23, 2025 | Yes | 8 | 12 |
| Tailstorm Health Inc. | Phoenix, Arizona | 2019 | May 23, 2025 | Yes | 8 | 12 |
| Turbare Manufacturing | Conway, Arkansas | 2023 | May 7, 2026 | Yes | 1 | 4 |
| University of Tennessee | Memphis, Tennessee | 2024 | Not yet inspected | N/A | 0 | — |
| US Specialty Formulations LLC | Allentown, Pennsylvania | 2014 | Jan 14, 2026 | Yes | 2 | 1 |
| Vitae Enim Vitae Scientific, Inc. | San Diego, California | 2024 | Not yet inspected | N/A | 4 | — |
| VitalRx Pharmacy, LLC | Houston, Texas | 2024 | Not yet inspected | N/A | 0 | — |
| Wedgewood Connect Ohio, LLC | Albany, Ohio | 2023 | Not yet inspected | N/A | 0 | — |
| Wedgewood Connect, LLC, formerly registered as Leiter's Compounding | San Jose, California | 2014 | Jul 3, 2025 | Yes | 0 | 1 |
| Wells Pharma of Houston, LLC | Houston, Texas | 2020 | Apr 13, 2026 | Yes | 8 | 20 |
| Wells Pharmacy, Inc. | Dyersburg, Tennessee | 2016 | Apr 9, 2026 | Yes | 0 | 5 |
| Wesley Pharmaceuticals | Orlando, Florida | 2025 | Mar 16, 2026 | No | 0 | 1 |
| White Label Pharmacy dba Nova Pharmacy | Katy, Texas | 2025 | Not yet inspected | N/A | 0 | — |
| Wilcrest Pharmaceuticals, Inc. | Houston, Texas | 2025 | Not yet inspected | N/A | 0 | — |
| Willowbend Pharma Select, LLC | Houston, Texas | 2024 | Not yet inspected | N/A | 0 | — |
| Xseer Pharmaceuticals, Inc. | Los Angeles, California | 2023 | Not yet inspected | N/A | 0 | — |
Showing 96 facilities
What is a 503B outsourcing facility?
A 503B outsourcing facility registers with the FDA under section 503B of the Federal Food, Drug, and Cosmetic Act. It may compound sterile drugs in bulk without patient-specific prescriptions when federal conditions are met and is subject to current good manufacturing practice requirements and risk-based FDA inspection.
“FDA registered” does not mean “FDA approved.” The FDA does not review each compounded drug for safety, effectiveness, or manufacturing quality before it is distributed. Registration, inspection observations, recalls, and state licensing should be evaluated separately.
How to use this directory
- Open a facility record to see its dated FDA registration and inspection history.
- Review Form 483 and enforcement information in context; an observation is not a final agency determination.
- Check the relevant state board of pharmacy for current license status.
- Use product reports only as evidence that a facility reported an ingredient—not as proof of current availability or endorsement.